Skip to main content
Category

Advent Life Sciences

Oct 25
Love0

Bayer’s Lynkuet™ (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause

By Advent Life Sciences, KaNDy Therapeutics, Press Release
Press Release.

 

October 24, 2025

Bayer’s Lynkuet™ (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause

This approval is supported by data from the Phase III OASIS clinical program evaluating Lynkuet™ (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes), due to menopause1 / In OASIS 1 and 2, elinzanetant met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline1 / Hot flashes are a common symptom of menopause2 and one of the main reasons women seek treatment3, hot flashes may impact women differently4 and some can be disruptive5 / Elinzanetant is the first dual neurokinin (NK) targeted therapy,1 NK1 and NK3 receptor antagonist

Berlin, October 24, 2025 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved elinzanetant as the first dual neurokinin (NK) targeted therapy1, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, under the brand name Lynkuet™ for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) due to menopause. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons with elinzanetant can modulate neuronal activity in the thermoregulation associated with hot flashes.1 The FDA approval is supported by data from three Phase III clinical studies (OASIS 1, OASIS 2 and OASIS 3) that evaluated the efficacy and safety of elinzanetant for the treatment of moderate to severe VMS due to menopause.

“For more than a century, Bayer has been dedicated to pioneering advances in women’s health, and this FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “There is a need for more individualized approaches to menopause care, and Lynkuet™ addresses a significant gap in treatment options. The approval in the U.S. reflects our unwavering commitment to delivering science-driven solutions that meet women’s evolving healthcare needs and empower them to take charge of their health at every stage of life.”

The efficacy of elinzanetant for the treatment of moderate to severe VMS due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS 1 and OASIS 2, in 796 menopausal women.1 The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe VMS from baselines to weeks 4 and 12, including day and night hot flashes.1 The safety of elinzanetant was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2 and OASIS 3) in 1420 women. In OASIS 3, 627 women received elinzanetant or placebo for up to 52 weeks to evaluate long-term safety.1

“These three studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial. “Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.”

Hot flashes are a common symptom of menopause2 that may impact women differently4. Hot flashes can be disruptive5 and are a common reason for which women in menopause seek treatment3.

“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” said Claire Gill, President and Founder of the National Menopause Foundation.

Elinzanetant is expected to be available in the U.S. beginning in November 2025.

About elinzanetant
Elinzanetant is the first dual neurokinin (NK) targeted therapy,1 neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, approved in the U.S. for the treatment of moderate to severe VMS due to menopause.1

The compound is being developed globally for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer, administered orally once daily. Increasing evidence indicates that hypothalamic neurons called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons, expressing both NK-1 and NK-3 receptors and their ligands Substance P and NKB, play a role in thermoregulation. Declining estrogenic activity due to natural menopause or endocrine therapy leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS. NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbance.

Elinzanetant has been approved under the brand name Lynkuet™ in the U.S. as well as in Australia, Canada, the UK, and Switzerland. It is pending approval in the European Union and under review in other markets around the world.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. Menopause symptoms can also be a consequence of surgical (such as bilateral oophorectomy) or medical treatment (such as endocrine therapy for breast cancer). The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes.6-8Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

1LYNKUET® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2025
2Thurston, R. C., & Joffe, H. (2011). Vasomotor symptoms and menopause: Findings from the Study of Women’s Health across the Nation. Obstetrics and Gynecology Clinics of North America, 38(3), 489–501. https://doi.org/10.1016/j.ogc.2011.05.006.
3Kronenberg F. Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment. J Nutr. 2010;140(7):1380S-5S.
4Shepherd JA, Shiozawa A, Schild AL, Singh D, Mancuso SA. Retrospective text and qualitative analyses of patient experience and management of vasomotor symptoms due to menopause: voices from the PatientsLikeMe community. Menopause. 2024 Sep 1;31(9):789-795. doi: 10.1097/GME.0000000000002391. Epub 2024 Jul 8. PMID: 38980735; PMCID: PMC11469626.
5US Food and Drug Administration. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy. FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy. Accessed October 23, 2025.
6Thurston & Joffe, Obstet Gynecol Clin North Am. 2011 September ; 38(3): 489–501.
7Thurston, Climacteric 2018 April; 21(2): 96-100 6. Thurston RC et al, Sleep. 2019;42(9)
8.Utian, W.H. Health Qual Life Outcomes 3, 47 (2005)

Oct 18
Love0

Boston Scientific Announces Agreement to Acquire Nalu Medical, Inc.

By Advent Life Sciences, Nalu Medical, Press Release
Press Release.

 

Acquisition to expand the neuromodulation offerings for people living with chronic pain

MARLBOROUGH, Mass., Oct. 17, 2025 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Nalu Medical, Inc., a privately held medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic pain.

Boston Scientific has been a strategic investor in Nalu Medical since 2017. The transaction consists of an upfront cash payment of approximately $533 million for the remaining equity not owned by Boston Scientific.*

The Nalu Neurostimulation System is designed to deliver targeted relief for adults living with severe, intractable chronic pain of peripheral nerve origin, including areas such as the shoulder, lower back and knee, through peripheral nerve stimulation (PNS). The therapy uses mild electrical impulses to interrupt pain signals before they reach the brain. The system features a miniaturized, battery-free implantable pulse generator, powered wirelessly by a small, externally worn therapy disc and controlled via a smartphone app.

Nalu Medical received U.S. Food and Drug Administration 510(k) clearance for the Nalu system in 2019. In the COMFORT and COMFORT 2 randomized controlled trials, evaluating the safety and efficacy of PNS, the system demonstrated significant and sustained pain relief for patients. In COMFORT, 87% of participants reported more than a 50% reduction in pain at 12 months,i while in COMFORT 2, 79% of patients reached an average pain relief of 64% at six months.ii Real-world data from more than 2,000 individuals reinforced these findings, with 94% of patients achieving clinically meaningful improvement across a broad range of chronic peripheral nerve pain conditions.iii

“Peripheral nerve stimulation is an exciting field with a significant unmet patient need,” said Jim Cassidy, president, Neuromodulation, Boston Scientific. “Adding the highly differentiated Nalu Medical technology complements our existing therapies—including spinal cord stimulation, basivertebral nerve ablation and radiofrequency ablation—enabling us to deliver advanced pain relief options to a wider variety of patient populations.”

Boston Scientific expects to complete the transaction in the first half of 2026, subject to customary closing conditions. Nalu is expected to generate sales in excess of $60 million in 2025 and to deliver year-over-year growth in excess of 25% in 2026. On an adjusted basis, the transaction is expected to be immaterial to adjusted earnings per share (EPS) in 2026, slightly accretive in 2027, and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges.

*On a 100% basis before consideration of Boston Scientific’s current equity ownership in Nalu Medical, Inc. and other closing adjustments, the transaction price consists of an upfront cash payment of $600 million.  

About Boston Scientific

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “may,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding statements regarding our business plans, the financial and business impact of the transaction and the anticipated benefits of the transaction, the closing of the transaction and the timing thereof, anticipated sales by Nalu, and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Risks and uncertainties that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future U.S. and global political, competitive, reimbursement and regulatory conditions, including changing trade and tariff policies; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Nalu’s operations; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the proposed transaction; demographic trends; intellectual property; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of any required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed. These and any new risks and uncertainties, which may arise from time to time, are difficult to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this press release.

Note: Amounts reported in millions within this press release are computed based on the amounts in thousands. As a result, the sum of the components reported in millions may not equal the total amount reported in millions due to rounding. Certain columns and rows within tables may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying unrounded amounts.

CONTACTS:
Jessica Sachariason
Media Relations
+1 (415) 720-2310
jessica.sachariason@bsci.com

Lauren Tengler
Investor Relations
+1 (508) 683-4479
BSXInvestorRelations@bsci.com

i Hatheway, J., Hersel, A., Engle, M., Gutierrez, G., Khemlani, V., Kapural, L., Moore, G., Ajakwe, R., Trainor, D., Hah, J., Staats, P., Makous, J., Heit, G., Kottalgi, S., & Desai, M. J. (2024). Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial. Regional Anesthesia & Pain Medicine. Advance online publication. https://doi.org/10.1136/rapm-2024-106099
ii Engle M, Gutierrez G, Hersel A, Netzel C, Khemlani V, Kapural L, Cubillo E, Hatheway J, Moore G, Valimahomed A, Khan K, Shuayto M, Majjhoo A, Sayed D, Latif U, Trainor D, Ajakwe R, Staats P, Makous J, Martin P*, Kottalgi S, Desai MJ; COMFORT 2 Study Group. A Confirmatory Randomized Controlled Trial Evaluating a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain: 3- and 6-Month Results from the COMFORT 2 Study. Chronic Pain & Management. 2025; 9: 171. DOI: 10.29011/2576-957X.1000171
iii Hatheway, J. A., Ratino, T., Swain, A. R., Ratino, T., Latif, U., Arulkumar, S., & Desai, M. J. (2025). Long-term pain relief delivered by micro-implantable pulse generator: Findings from a large-scale, real-world data peripheral nerve stimulation patient registry. Chronic Pain & Management, 9, 169. https://doi.org/10.29011/2576-957X.100069

 

SOURCE Boston Scientific Corporation

Sep 03
Love0

Glycomine Initiates Dosing in a Global, Randomized, Placebo-Controlled Phase 2b Study of GLM101 for the Treatment of PMM2-CDG

By Advent Life Sciences, Press Release
Press Release.

 

Glycomine Initiates Dosing in a Global, Randomized, Placebo-Controlled Phase 2b Study of GLM101 for the Treatment of PMM2-CDG

September 3, 2025

SAN CARLOS, Calif., September 3, 2025 — Glycomine, Inc. announced today that the first participant has been dosed in the global Phase 2b study, called POLAR. This randomized placebo-controlled multi-center clinical trial is designed to assess the safety and efficacy of GLM101, an investigational mannose-1-phosphate substrate replacement therapy for the treatment of phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG), a rare genetic disorder leading to serious neurological and multi-systemic impairments.

“We’ve been encouraged by the improvements in ataxia seen in our Phase 2 open-label study, and we are excited to bring GLM101 forward into this next phase of clinical development to further assess its safety and efficacy,” said Dr. Marino, Glycomine’s CMO.

POLAR (ClinicalTrials.gov Identifier: NCT06892288) plans to enroll approximately 50 adults and children ≥4 years of age living with PMM2-CDG across a planned 16 sites and 10 countries. The trial will consist of two phases. Part A is a 24-week randomized, double-blind, placebo-controlled treatment period designed to evaluate the primary efficacy of GLM101 compared to placebo. Participants will be randomized 1:1 to receive weekly intravenous infusions of 30 mg/kg GLM101 or placebo for 24 weeks before transitioning into Part B of the study. Part B is a 24-week open-label extension phase in which all participants will receive weekly IV infusions of GLM101.

The primary outcome assessment, evaluated after Part A of the study, is improvement in ataxia as measured by the International Cooperative Ataxia Rating Scale (ICARS), a clinical tool to assess the severity of ataxia. Ataxia is a hallmark of PMM2-CDG and has been reported to be a key driver of disease burden. Additional secondary and exploratory endpoints include clinical assessments of gross motor function, cognition, strength, and patient and clinician-reported global impressions of change.

The POLAR study design has been informed by results of an ongoing open-label Phase 2 study in pediatric and adult patients with PMM2-CDG, which has demonstrated encouraging clinical improvements in ataxia as measured by the ICARS and a favorable safety and tolerability profile.

About PMM2-CDG

Phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG), previously known as CDG-1a, is the most prevalent congenital disease of glycosylation. PMM2-CDG is caused by a genetic mutation in phosphomannomutase 2 (PMM2), which results in the protein having reduced activity. PMM2 is an enzyme that converts mannose-6-phosphate to mannose-1-phosphate, which is required to insert the mannose sugar building block into developing glycans that are crucial for proper protein structure and function. The deficiency of mannose-1-phosphate disrupts the process of N-glycosylation and causes a wide array of clinical symptoms and, in many cases, can be life-threatening.

About Glycomine, Inc.

Glycomine is a clinical-stage biotechnology company that is advancing treatments for serious rare diseases with no other therapeutic options. The Company’s lead investigational drug candidate GLM101 is a mannose-1-phosphate replacement therapy in development to treat PMM2-CDG. GLM101 is designed to deliver mannose-1-phosphate into cells and thereby bypass disease-causing PMM2 mutations to restore pathway function. GLM101 has received Orphan Drug Designation in the U.S. and E.U. and Rare Pediatric Disease Designation and Fast Track Designation in the U.S. The company is based in San Carlos, California, and supported by leading international life sciences investors. For more info visit www.glycomine.com.

Contacts

Corporate Contact: Peter McWilliams, Ph.D., info@glycomine.com
Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com

Sep 01
Love0

Cyted Health Secures $44 Million in Series B Financing to Accelerate US Expansion

By Advent Life Sciences, Press Release
Press Release.

 

Cyted Health, a leading gastrointestinal (GI) molecular diagnostics company, today announces a first close of $44 million in its Series B financing round to accelerate its ongoing US expansion.

The round was led by EQT Life Sciences, investing through its EQT Health Economics strategy, and co-led by Advent Life Sciences and British Business Bank with continued support from existing investors Morningside and BGF.

The financing will be used to accelerate the commercial expansion of Cyted’s diagnostics platform in the US, consolidate existing commercial success across the UK, and expand its portfolio of advanced diagnostic tests. Cyted’s existing platform consists of EndoSign®, an FDA 510(k)-cleared device enabling minimally invasive collection of esophageal cells, and advanced biomarker molecular testing for the detection of esophageal conditions.

Cyted’s technology has already demonstrated significant success across the UK’s National HealthService, completing over 35,000 tests and building a robust portfolio of peer-reviewed publications proving unmatched patient acceptability and real-world clinical impact. Esophageal cancer is considered one of the deadliest cancers globally, with a survival rate of only 20%.

“This Series B financing marks a defining moment for Cyted as we continue to deepen our commitment to detecting esophageal diseases earlier,”said Marcel Gehrung, CEO and Co-founder of Cyted Health. “This investment will help us consolidate our leading position in the market by expanding our US presence and adding new life-saving innovations to our advanced diagnostics portfolio.”

Bruno Holthof, Partner at EQT Life Sciences, commented: “Cyted is strongly positioned to redefine the standard of care in upper GI diagnostics worldwide.Its minimally invasive diagnostics platform is the standout innovation to capture this significant market opportunity, and we’re delighted to add the company to our portfolio.”

“Cyted has demonstrated a rare combination of clinical innovation, patient-centered delivery, and commercial execution with an impressive foundation in the UK. We’re proud to support its next phase of growth,” said Kaasim Mahmood, General Partner at Advent Life Sciences.

Carmine Circelli, Director, Life Sciences at British Business Bank, added: “Cyted is an excellent example of the kind of high-impact business we aim to back. Their innovation has the potential to transform early cancer detection and create lasting health outcomes both in the UK and globally.”

Science Minister Lord Vallance said: “I am pleased to see the British Business Bank back Cyted – a company whose growth demonstrates the ability of our universities to turn world-class life sciences research into successful commercial opportunities with the potential to improve people’s lives. Life sciences form a critical part of this Government’s ambitions for both the economy and healthcare – and through our Life Sciences Sector Plan, we will continue to support the industry to even greater success.”

Founded by leading experts at the University of Cambridge, Cyted is pioneering the development of minimally invasive cell collection coupled with proprietary biomarker discovery to transform the detection of pre-cancerous, cancerous and inflammatory esophageal conditions.

Cyted’s Series B financing round follows the recent launch of Cyted’s DETECT-ME clinical validation study, which has been enrolling patients across multiple sites in the US since March 2025. This study will validate clinical performance of Cyted’s newest assays and molecular tests for the detection of esophageal conditions using EndoSign®.

Jul 08
Love0

MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause

By Advent Life Sciences, Press Release
Press Release.

 

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.

When oestrogen levels drop during menopause, certain brain cells become overactive and interrupt the body’s ability to control temperature, which leads to hot flushes and night sweats.   Elinzanetant is a new non-hormonal medication which works by calming these signals in the brain, helping bring the body’s temperature control back into balance.

It may also help improve sleep problems that often come with menopause.   This medicine is administered in capsule form, to be taken orally.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:

“Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life.

“We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA’s standards for safety, quality and effectiveness.

“Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.”

Elinzanetant’s approval is based on results from the OASIS clinical trials, which involved over 1,400 women aged 40 to 65 across several countries. These studies showed that taking a daily 120 mg capsule of elinzanetant significantly reduced the number and intensity of hot flushes and night sweats over 26 to 52 weeks, compared to a placebo.

Like all medicines, this medicine can cause side effects in some people. A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.

Anyone who suspects they are having a side effect from this medicine should talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes to editors

  • The new marketing authorisation was granted on 8 July 2025 to Bayer plc.
  • This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.
  • More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
  • The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  • The MHRA is an executive agency of the Department of Health and Social Care.
  • For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Jan 09
Love0

Relief Cardiovascular Announces $12M Series A Financing to Advance First-in-Human Study of the Relief System

By Advent Life Sciences, Press Release
Press Release.

 

Relief Cardiovascular Announces $12M Series A Financing to Advance First-in-Human Study of the Relief System

Irvine, California – January 8, 2025 – Relief Cardiovascular, an inQB8 Medical Technologies portfolio company pioneering innovative solutions for the management of heart failure, today announced the closing of a $12M Series A financing. The funding round was co-led by Broadview Ventures and Advent Life Sciences, with participation from Pacific Health Investment, Heartwork Capital, and an undisclosed multinational strategic. The funds will support further product development and the initiation of the company’s first-in-human feasibility study, designed to evaluate the safety and efficacy of the Relief System – a transcatheter smart implant designed to monitor and modulate renal vein pressures, offering a novel approach to fluid management in heart failure.

As part of the financing, Shahzad Malik, MD, General Partner at Advent Life Sciences, and Maria Berkman, MD, Head of Medtech at Broadview Ventures, will join the company’s Board of Directors.

“Heart failure continues to impose a tremendous burden on patients and healthcare systems,” said Maria Berkman, MD. “The Relief System addresses a critical gap in patient care, and we are proud to partner with the team at Relief Cardiovascular to advance this novel therapy into the clinic.”

“Relief Cardiovascular’s innovative approach to volume management tackles the unmet needs of diuretic-resistant heart failure,” said Shahzad Malik, MD. “The Relief System’s ability to dynamically modulate renal vein pressures offers the potential to redefine treatment and improve outcomes for patients facing limited options.”

The Relief System employs a transcatheter implant to reduce renal vein pressure using an innovative “puller” mechanism, paired with integrated sensors that autonomously capture renal vein pressures and multiparametric data. The system provides physicians with actionable data for optimizing fluid management and offers tailored therapeutic device-driven intervention.

“The Relief System’s ability to integrate monitoring and therapeutic modulation of renal pressures represents a promising advance in volume management in heart failure,” said William T. Abraham, MD, Professor of Medicine at The Ohio State University Wexner Medical Center. Alex Rothman, MD, Professor of Cardiology at the University of Sheffield, added, “By enabling data-driven adjustments, the Relief System empowers more personalized and effective care for patients, particularly those with diuretic resistance.”

“This financing marks a pivotal milestone for us as we advance the Relief System into human clinical studies,” said Alex Cooper, CEO of Relief Cardiovascular. “We’re honored to have the support of world-class investors and clinicians, along with industry veterans like Michael Minogue. With Shahzad and Maria joining our board, our team is positioned to transform the management and treatment of heart failure”

About Relief Cardiovascular
Relief Cardiovascular is a privately held medical device company committed to improving outcomes for patients with heart failure. The company’s flagship technology, the Relief System, is a transcatheter smart implant designed to enhance fluid management and improve quality of life for heart failure patients. Relief Cardiovascular was founded and incubated within inQB8 Medical Technologies, LLC.

About Broadview Ventures
Broadview Ventures is a mission-driven investment firm focused on accelerating the development of transformative solutions for cardiovascular and neurovascular diseases. Broadview partners with innovators to address significant clinical challenges and improve patient outcomes globally. For more information, please visit www.broadviewventures.org

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.Adventls.com

About inQB8 Medical Technologies

inQB8 Medical Technologies is a privately held medical device incubator based in Massachusetts, co-founded by Dr. Arshad Quadri, MD, and J. Brent Ratz, MBA. inQB8 specializes in developing cutting-edge interventional solutions for major cardiovascular diseases, accelerating projects through prototyping, bench, and pre-clinical testing.

For inquiries, contact: info@reliefcardio.com

Oct 09
Love0

U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant

By Advent Life Sciences, KaNDy Therapeutics, Press Release
Press Release.

 

U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant

  • The New Drug Application (NDA) for elinzanetant, an investigational compound for the treatment of moderate to severe vasomotor symptoms associated with menopause, is based on the positive data from three Phase III studies OASIS 1, 2 and 3
  • Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily
BERLIN–(BUSINESS WIRE)–Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the investigational compound elinzanetant seeking approval for the treatment of moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

Post this

“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the U.S.,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the Pharmaceutical Leadership Team at Bayer.“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

The NDA application is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Findings from OASIS 1 and 2 were published in August 2024 in JAMA.1 Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024.

Bayer is continuing to submit applications for marketing authorizations of elinzanetant to further health authorities as well.

About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. The OASIS 4 study is an expansion of the clinical Phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause (SDM) as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.

About Elinzanetant
Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

kw (2024-0157E)

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

_________________________
1 https://jamanetwork.com/journals/jama/fullarticle/2822766

Contacts

Contact for US media inquiries:
Courtney Ambrosi, phone 1 (908) 798-1107
Email: courtney.ambrosi@bayer.com

Contact for global media inquiries:
Katja Wiggers, phone +49 30 221541614
Email: katja.wiggers@bayer.com

Apr 22
Love0

Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024

By Advent Life Sciences, Press Release
Press Release.

 

Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024
April 22, 2024

BOSTON and LONDON, April 22, 2024 (GLOBE NEWSWIRE) — Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1), with potential applicability to narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other sleep-wake disorders with normal orexin levels.

The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects. In parallel to the SAD, a cross-over pharmacodynamic (PD) assessment will be performed utilizing the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived healthy adult subjects which is intended to provide proof-of-concept data to enable dose selection for NT1, NT2 and IH indications. The study has a maximum exposure limit specified by the FDA which the Company believes significantly exceeds the predicted efficacious doses of ORX750 in indications associated with or without orexin loss; therefore, the Company does not expect this limit to affect any of the planned clinical development activities for ORX750. The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024.

The Phase 1 study design of ORX750 includes SAD combined with PoC cohorts to assess PD effects of ORX750 by measuring sleep latency with the MWT and subjective sleepiness with the KSS in acutely sleep-deprived healthy subjects.

SAD combined with PoC cohorts to assess PD effects of ORX750 by measuring sleep latency with the MWT and KSS in acute sleep-deprived healthy subjects.

“This is a significant milestone for the development of our potential best-in-class OX2R agonist, ORX750, for the treatment of narcolepsy and other sleep-wake disorders,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “We are excited to begin executing what we believe is an elegant, adaptive Phase 1 study aimed at generating early proof-of-concept data for ORX750 in acutely sleep-deprived healthy volunteers in the second half of this year. We expect this study to enable dose selection for planned studies evaluating ORX750 in patients with NT1 and in patient populations with normal orexin levels, including NT2 and IH.”

About ORX750
ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1). ORX750 has been shown to potently activate the OX2R with an in vitro EC50 of 0.11 nM and 9,800-fold selectivity over the human orexin receptor (hOX1R). ORX750 is Centessa’s first orexin product candidate being developed for the treatment of narcolepsy with potential expansion into narcolepsy type 2 (NT2), idiopathic hypersomnia (IH) and other sleep-wake disorders.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company that aims to discover and develop transformational medicines for patients. Our most advanced programs include a hemophilia program, an orexin agonist program for the treatment of narcolepsy and other sleep-wake disorders and an immuno-oncology program focused on our LockBody® technology platform. We operate with the conviction that each of our programs has the potential to change the current treatment paradigm and establish a new standard of care. For more information, visit www.centessa.com, which does not form part of this release.

Forward Looking Statements
This press release contains forward-looking statements. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” “aim,” “seek,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company’s ability to discover and develop transformational medicines for patients; the timing of commencement of new studies or clinical trials of ORX750 and other potential orexin agonist candidates; research and clinical development plans and the timing thereof; the Company’s ability to differentiate ORX750 and other potential orexin agonist candidates from other treatment options; the development and therapeutic potential of ORX750 and other potential orexin agonist candidates; predicted efficacious doses of ORX750; the Company’s ability to successfully conduct its clinical development of ORX750 below the maximum exposure limit set by the FDA or, in the event the Company plans to exceed the maximum exposure limit, the Company’s ability to successfully have the maximum exposure limit removed; and other regulatory matters, including the timing and likelihood of success of obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability profile of our product candidates; our ability to protect and maintain our intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; future expenditures risks related to our asset-centric corporate model; the risk that any one or more of our product candidates will not be successfully developed and/or commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; geo-political risks such as the Russia-Ukraine war and conflicts in the Middle East. These and other risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on file with the U.S. Securities and Exchange Commission (SEC). We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

Contact: 
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b64204a9-7c64-47fd-b834-598ca0e45978

May 26
Love0

Advent Life Sciences Announces Growth of Investment Team with Three Senior Appointments

By Advent Life Sciences, Press Release
Press Release.

 

26 May 2022, London, UK: Advent Life Sciences, a leading transatlantic venture and growth investor focused on building innovative life science companies in the UK, Europe, and the US, announced today that it has appointed three senior members to its team, all sector investment specialists, and adept at building companies and supporting them in translating ideas into transformative medicines. Dominic Schmidt, based in the UK, and Satish Jindal, based in Boston, USA, have been appointed General Partners. Katrine Bosley, based in Boston, USA, joins as Venture Partner.  Advent’s investment team now includes 18 professionals with a track record of nurturing entrepreneurs and companies to deliver innovative new medicines.

Dominic previously spent eight years as a Partner in the investment team of Syncona, where he was involved in the founding, funding, and building of several life science businesses and served on the Boards of Anaveon, Orbit Biomedical, Gyroscope Therapeutics (acquired by Novartis), Purespring Therapeutics and Forcefield Therapeutics. Dominic has a degree in Biochemistry from the Free University of Berlin and the Max Planck Institute for Molecular Genetics, and a PhD from the Department of Oncology at the University of Cambridge. Dominic was a Cancer Research UK scholar, and his award-winning research has been published in Cell, Nature, and Science.

Satish was previously serving as CEO of BioMotiv, an early-stage investment fund. Satish was a co-founder and CEO of NeoGenesis (acquired by Schering-Plough, now Merck), co-founder and President of Verastem (NADAQ: VSTM) and co-founder of Elicio Therapeutics. He also served as Vice President and Site Head at Schering-Plough Research Institute in Cambridge, Massachusetts, and Vice President at Bristol-Myers Squibb. Satish’s PhD in Biochemistry is from Punjab University in India. He did his postdoctoral research at MIT’s Whitehead Institute.

Katrine is an entrepreneur with over 30 years biotech industry experience. She is Chair of the Board of Arrakis Therapeutics, founding CEO of DaCapo Brainscience, and a Board member of Genocea Biosciences. Katrine was CEO of Editas Medicine, the first company established to develop CRISPR-based gene editing therapeutics. Before that she was CEO of Avila Therapeutics, and held various roles at The Broad Institute, Adnexus Therapeutics, Biogen, Highland Capital Partners, and Alkermes. Katrine has been recognized as one of the 100 Most Creative People in Business by Fast Company, as CEO of the Year by Xconomy, as one of 30 Global Game Changers by Forbes, as Entrepreneur of the Year by the New England Venture Capital Association, and as one of the Top Ten Women in Biotech by Fierce Biotech.

Shahzad Malik, General Partner, Advent Life Sciences said:

“I’m delighted to welcome Dominic, Satish, and Katrine. They bring a wealth of expertise to our talented team. Since its launch, Advent Life Sciences has invested at the interface of academic research and commercial drug development with a focus on identifying and backing high-potential innovations that can deliver important new medicines for unmet medical needs. The last few years have reinforced the vital need to translate world class science into the discovery and development of new medicines to tackle devasting diseases.”

Dominic Schmidt, General Partner, Advent Life Sciences said:

“Advent is one Europe’s leading venture capital firms in the life sciences space with a long successful track record resulting in an impressive 14 approved medicines and products to the benefit of patients. I am looking forward to working with such a hands-on and entrepreneurial team supporting Advent’s long-standing successful strategy of backing high-potential life sciences companies.”

Satish Jindal, General Partner, Advent Life Sciences said:

“It’s a great pleasure to join the stellar team at Advent, who have founded over 35 new biotech companies that are focused on translating academic research into the next generation of medicines. This stage of development in life sciences is underserved and we have extensive experience in supporting new companies through the critical early years.”

Katrine Bosley, Venture Partner, Advent Life Sciences said:

“I’m delighted to join the Advent team and provide on-the-ground in-market support in Boston, USA, right at the heart of the world’s biggest cluster of biotech expertise. Venture financing is critical to the development of new medicines, more so than ever in these turbulent public market times, and it will continue to deliver real impact to patients in addition to strong financial returns.”

–    ENDS   –

 

Notes to Editors:

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.Adventls.com

 

Contacts:

Katja Stout, Scius Communications
Daniel Gooch, Scius Communications
katja@sciuscommunications.com
daniel@sciuscommunications.com
+44 (0) 7747 875 479

Mar 17
Love0

Advent Life Sciences’ founded Amphista Therapeutics raises $53M in oversubscribed Series B round to advance next generation targeted protein degradation assets

By Advent Life Sciences, Press Release
Press Release.

 

This investment will fund Amphista Therapeutics’  growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and extend its proprietary platform.

London, UK, 17 March 2021 – Advent Life Sciences (“Advent”) a leading transatlantic venture investor focused on building innovative life science companies in the UK, Europe and the US, today announces that Amphista Therapeutics, an Advent founded biotech and leader in next generation targeted protein degradation (TPD) approaches, has closed a $53 million (£38 million) Series B financing round. Advent Life Sciences, and existing investor BioMotiv, will be joined by a strong syndicate of new investors:  Forbion, Gilde Healthcare, the Novartis Venture Fund and Eli Lilly & Company.

Amphista’s TPD approach offers a greatly improved way of treating disease and modulating drug targets, using synthetic small molecule degraders. Amphista’s next generation bifunctional degraders use a novel set of mechanisms that make use of a wider range of the body’s own innate protein degrading proteins, instead of the very narrow set of ubiquitin E3 ligase-based mechanisms used by most other TPD companies. This proprietary approach offers the potential to overcome many of the limitations seen with current TPD approaches, providing the opportunity to treat a wider range of diseases. Amphista is focused on biological targets with a high level of clinical or genetic validation, allowing the team to focus on the translation of their novel TPD approach for clinical benefit in areas of high unmet need.

Raj Parekh, General Partner, Advent Life Sciences commented:
“Advent over the last 20 years has continued to found and invest in the highest quality life science companies. With its exceptional  academic and medical science base, many of these companies  have originated from the UK. Amphista is another example of Advent’s continuing strategy to identify innovative and differentiated science as the basis of world-leading companies that will address areas of high unmet medical need. The Advent team have worked closely with Professor Alessio Ciulli, the University of Dundee and the Amphista team to found and to grow the company. We are delighted to be joined by this strong syndicate of experienced investors and pharmaceutical companies for the next stage in Amphista’s growth.”

Nicola Thompson, CEO, Amphista Therapeutics commented:

“This financing round, led by an outstanding investor syndicate, is a strong endorsement of our world class team and our novel approach. Amphista will now accelerate its oncology pipeline towards the clinic and extend our portfolio into indications largely inaccessible by traditional TPD approaches, such as diseases of the central nervous system (CNS). This oversubscribed Series B supports our ambition as a world-leading next generation protein degradation company delivering ground-breaking new medicines to patients in areas of high unmet need.”

In addition to Amphista, Advent has founded over 20 new biotech companies. Recent examples include Arrakis Therapeutics that struck an $190 million partnership deal with Roche in the first half of 2020, and KaNDy Therapeutics which was acquired by Bayer Pharmaceuticals for over $875 million also last year. Advent continues to invest at seed, series A and beyond, backing companies to develop new therapeutics and high-potential medical technologies. Advent’s team includes 16 investment professionals with a track record of supporting entrepreneurs to deliver innovative new medicines and products. In the last 15 years, Advent’s portfolio companies have discovered 14 first- or best-in-class medicines and products that have successfully achieved regulatory approval, each for a different and unmet medical need.

The full announcement from Amphista can be found here: Amphista Therapeutics raises $53M

–    Ends   –

Media contacts:

Advent Life Sciences
Laura Lane
+ 44 (0) 7795 469 847
pr@adventls.com

Amphista Therapeutics
CEO Nicola Thompson
+44 (0) 7464 974714
nicki@amphista.com

Scius Communications for Amphista
Katja Stout
+44 (0) 7789 435990
katja@sciuscommunications.com

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the UK, the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

For more information, refer to: www.adventls.com

About Amphista Therapeutics
Amphista Therapeutics is a biopharmaceutical company creating first-in-class therapeutics that harness the body’s natural processes to selectively and efficiently degrade and remove disease-causing proteins. The company’s pipeline of novel targeted protein degradation (TPD) based medicines is focused on challenging diseases including cancer. Founded by Advent Life Sciences, Amphista is a spin-out of TPD expert Professor Alessio Ciulli’s labs at the University of Dundee. The company has raised approximately £45M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly and Company.

For more information, refer to: www.amphista.com