Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)




Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on April 1, 2025, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 23,875 shares of Puma common stock to four new non-executive employees.

The awards were granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying each award vesting on the first anniversary of the award’s vesting commencement date, April 1, 2025, and one-sixth of the shares underlying each award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4).

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc.

In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer.

Contacts

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500

info@pumabiotechnology.com
ir@pumabiotechnology.com

Merck to Hold First-Quarter 2025 Sales and Earnings Conference Call April 24




Merck to Hold First-Quarter 2025 Sales and Earnings Conference Call April 24

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2025 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, April 24. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available at www.merck.com.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Robert Josephson

(203) 914-2372

robert.josephson@merck.com

Michael Levey

(215) 872-1462

michael.levey@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

Exact Sciences Schedules First Quarter 2025 Earnings Call




Exact Sciences Schedules First Quarter 2025 Earnings Call

MADISON, Wis.–(BUSINESS WIRE)–Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the company plans to release its first quarter 2025 financial results after the close of the U.S. financial markets on May 1, 2025. Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

First quarter 2025 webcast & conference call details

A replay of the webcast will be available at www.exactsciences.com. The webcast, conference call, and replay are open to all interested parties.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

Contacts

Derek Leckow

Exact Sciences Corp.

investorrelations@exactsciences.com
608-893-0009

Title restor3d receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System




Title restor3d receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System

DURHAM, N.C.–(BUSINESS WIRE)–#3DPrinting–restor3d, a leader in 3D-printed, personalized orthopedic implant care, has received FDA 510(k) clearance for the iTotal Identity™ CR 3DP Porous Total Knee Replacement System. This milestone marks a significant achievement in expanding restor3d’s knee replacement technology since the acquisition of Conformis, introducing the first cementless offering to the patient-specific implant portfolio. The company plans a limited market release in Q3 of 2025.

The Identity 3D-printed cementless system is built on restor3d’s proven approach to personalized orthopedics, integrating patient-matched design with advanced 3D-printed porous technology. As the first cementless addition to the Identity knee platform, it provides an alternative to traditional fixation methods while preserving the benefits of a patient-specific implant. The pre-navigated surgical system enhances efficiency by eliminating intraoperative guesswork, with personalized surgical instruments and implants delivered in a sterile, single-use kit.

“For the first time, we have a truly patient-specific, cementless knee replacement option, and that’s incredibly exciting,” said Brian Palumbo, MD at Florida Orthopaedic Institute, Florida. “The cementless tibial baseplate is designed for optimal stability and fixation, providing maximum coverage without overhang or compromise in rotational alignment. Its strategically placed peripheral pegs enhance stability while avoiding impingement with the tibial cortex, a key factor for long-term implant success. Combined with a femoral component that maintains the patient’s native joint mechanics, this system offers a more natural feel and function for patients undergoing knee replacement.”

Available on the femoral, tibial, and patellar components, the system incorporates restor3d’s TIDAL Technology delivering market leading optimized osseointegration strength¹, offering superior fatigue resistance and load distribution compared to traditional truss-based lattices.

restor3d will continue working closely with leading orthopedic surgeons during the limited market release in Q3 2025, ensuring that the Identity Personalized Knee Cementless System meets the highest standards of performance, reliability, and patient outcomes.

¹ Kelly CN, Wang T, Crowley J, Wills D, Pelletier MH, Westrick ER, Adams SB, Gall K, Walsh WR. High-strength, porous additively manufactured implants with optimized mechanical osseointegration. Biomaterials. 2021 Dec;279:121206. doi: 10.1016/j.biomaterials.2021.121206. Epub 2021 Oct 22. PMID: 34715639.

About restor3d, Inc.

restor3d is a world leader in 3D printed patient specific musculoskeletal implants and driven by the belief that every patient deserves personalized care. The company holds proprietary expertise and intellectual property in 3D printing of osseointegrative materials, AI-based planning and design automation tools, and digital health solutions to provide seamless data-backed care to optimize individual patient outcomes. Alongside its customers, restor3d is reimagining the musculoskeletal reconstruction landscape. More information is available at www.restor3d.com.

Forward Looking Statements

Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as “future,” “believes,” “expects,” “may,” “will,” “should,” “potential,” “estimates,” “intends,” “anticipates” or “plans” or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, distribution challenges, market trends and demand, product efficacy and safety concerns, product or raw material availability and other supply constraints. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only as the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law.

Contacts

Jordan Wagner

Vice President of Marketing, restor3d

Phone: (281) 866-4988

Email: Jordan.Wagner@restor3d.com

Researchers Develop Test Using Machine Learning to Help Predict Immunotherapy Response in Lymphoma Patients




Researchers Develop Test Using Machine Learning to Help Predict Immunotherapy Response in Lymphoma Patients

A Nature Medicine paper by City of Hope and Memorial Sloan Kettering (MSK) Cancer Center outlines a new tool that measures blood inflammation as a marker for poor CAR T therapy outcomes

LOS ANGELES–(BUSINESS WIRE)–Researchers with City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center in Los Angeles ranked among the nation’s top 5 cancer centers by U.S. News & World Report, and MSK have created a tool that uses machine learning to assess a non-Hodgkin lymphoma (NHL) patient’s likely response to chimeric antigen receptor (CAR) T cell therapy before starting the treatment, according to study results published today in Nature Medicine.

CAR T cell therapy is one of the most promising recent advances made in the fight against blood cancers. But more than half of NHL patients who do not respond to standard lines of treatment also relapse or progress within six months of CAR T therapy.

Known as InflaMix (Inflammation Mixture Model), the new tool was developed to assess inflammation, a potential cause of CAR T failure, by testing for a variety of blood biomarkers in 149 patients with NHL. With the help of machine learning, a type of artificial intelligence that uses algorithms to learn from sets of information and draw conclusions from patterns found in that data, the model was able to find an inflammatory biomarker from a series of unique blood tests not usually employed in standard clinical practice.

By analyzing the inflammatory signature that InflaMix identified, the researchers found it was associated with a high risk of CAR T treatment failing, including increased risk of death or disease relapse. InflaMix is an unsupervised model, meaning that it was trained without any knowledge of clinical outcomes.

“These studies demonstrate that by using machine learning and blood tests, we could develop a highly reliable tool that can help predict who will respond well to CAR T cell therapy,” said Marcel van den Brink, M.D., Ph.D. president of City of Hope Los Angeles and City of Hope National Medical Center, the Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D., and a senior author of the paper. “With a rigorous statistical approach, we demonstrated that this is one of the most thoroughly validated tests we have for predicting CAR T outcomes in lymphoma patients and could be used by oncologists everywhere to assess the risk of CAR T in an individual patient.”

According to the team, the machine learning model is very flexible and worked well even when they used only six available blood tests — all of which are typically evaluated for patients with lymphoma — to assess InflaMix’s capabilities with less data. Researchers said this is important because it means this test can be made available for most, if not all, patients with lymphoma.

“Prior studies had hinted that inflammation might be a risk factor for poor CAR T cell efficacy,” said medical oncologist Sandeep Raj, M.D., who specializes in bone marrow transplants at MSK and is lead author of the Nature Medicine paper. “Our goal was to refine this concept and build a robust and reliable clinical tool that characterizes inflammation in the blood and predicts CAR T outcomes.”

Studies of three independent cohorts comprising 688 patients with NHL who had a wide range of clinical characteristics and disease subtypes and used different CAR T products were also used to validate the team’s initial findings.

Next, City of Hope and MSK researchers plan to investigate whether blood inflammation defined by InflaMix directly influences CAR T cell function and learn more about the source of this inflammation.

“InflaMix could be used to reliably identify patients who are about to be treated with CAR T and are at high risk for the treatment not working,” said Dr. Van den Brink. “By identifying these patients, doctors may be able to design new clinical trials that can boost the effectiveness of CAR T with additional treatment strategies.”

City of Hope, a recognized leader in CAR T cell therapies for blood and other cancers, has treated more than 1,700 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world — it currently has about 70 ongoing clinical trials using immune cell products, mostly CAR T, for blood cancers and 15 different solid tumor types. These products include City of Hope-developed therapies and industry-sponsored treatments.

The team’s studies were funded in part by the National Institutes of Health, the National Cancer Institute and an MSK Support Grant. The work was primarily done at MSK where Dr. Van den Brink worked for more than two decades before coming to City of Hope in 2024.

About City of Hope

City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope brings a uniquely integrated model that spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHop^TM. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.

Contacts

Letisia Marquez

626-476-7593

lemarquez@coh.org

Nuage Therapeutics appoints Dr. Stuart Hughes as CEO and Vanessa Malier as Chair




Nuage Therapeutics appoints Dr. Stuart Hughes as CEO and Vanessa Malier as Chair

• Experienced R&D leader and biotech entrepreneur, Stuart Hughes, appointed as Chief Executive Officer
• Life sciences executive and healthcare investor, Vanessa Malier, appointed as Chair of the Board of Directors
• Nuage Therapeutics applying its proprietary technology to advance a pipeline of novel agents targeting oncogenic transcription factors

BARCELONA, Spain–(BUSINESS WIRE)–Nuage Therapeutics S.L. (“Nuage”), a biotech company focused on creating transformational precision therapies by targeting established oncogenic transcription factors, today announced the appointment of Stuart Hughes as Chief Executive Officer (CEO) and Vanessa Malier as Chair of the Board. Dr. Hughes will succeed outgoing and founding CEO, Judit Anido, who is assisting with the leadership transition.

Nuage has developed a set of tools that enables the reconstitution of intrinsically-disordered proteins (IDPs) in a secondary-structured form that renders them amenable to small molecule drug discovery. This has enabled the Company to unlock a wide range of previously intractable but important drug targets with a robust human biological basis for therapeutic intervention.

Dr. Stuart Hughes has broad R&D leadership experience in a range of settings having worked in drug discovery across multiple therapeutic areas. He joins Nuage from Pathios Therapeutics, an immuno-oncology company where he served as CEO and where he built the company from an initial seed investment to a clinical-stage organisation. During this period, he led the completion of a €25m Series B first close, that included the addition of Bristol Myers Squibb as a strategic investor, to support ongoing Phase 1 studies. Previously, he was a Senior Director at the global biotech, Vertex Pharmaceuticals and before then, he was a Principal Research Scientist in CNS disorders at Eli Lilly. He has a MSc in Electrical & Electronic Engineering and a PhD in Neuroscience from Cardiff University.

Commenting on his appointment, Dr. Hughes, new CEO of Nuage, said: “Nuage possesses a highly differentiated suite of technologies that enables the capture of ‘disordered’ proteins in a form that is amenable to small molecule screening and profiling. I believe Nuage represents a game-changing advance in drug discovery and precision medicine, especially where targets have previously been considered undruggable. Allied to a highly skilled team and the support of top-tier investors, Nuage is ideally positioned for growth and success. I look forward to getting started.”

Vanessa Malier is board member and advisor to biotechs, venture capital and private equity firms. She previously spent 10 years as Managing Partner at Kurma Partners and was instrumental in the scale-up of the firm, fund raising Biofund III and the growth fund, completing the deal with Eurazeo and investing in portfolio companies. Prior to Kurma, Vanessa spent 10 years at Ipsen, in a variety of strategic and operational roles including Chief of Staff to the CEO, Adenuric® Lead, VP R&D Strategic Planning and BD. Vanessa is a non-executive director of Sygnature Discovery. She graduated from Pasteur Institute in Immunology and Ecole Normale Supérieure in Biology and Biochemistry.

Maina Bhaman, Partner at Sofinnova Partners, said, “Welcome to Stuart and Vanessa to the respective roles of CEO and Chair of the Board at Nuage. Vanessa has already been helping to shape Nuage over the last year, and now that Stuart has joined, together they can combine their broad and complementary scope of leadership, biotech and VC experience to moving the Company forward. Their appointments are happening at an exciting time for the Company as it looks to usher in a new wave of transformational precision therapies for a range of cancers that currently have limited treatment options.”

Clara Campàs, Managing Partner and co-founder of Asabys Partners, said, “I would also like to warmly welcome Stuart and Vanessa to Nuage, and on behalf of the Board, say thank you to the outgoing CEO, Dr. Anido, for her stewardship to date and her assistance in a smooth transition to Stuart and the team. We have been long term supporters of the Company and its technology since its inception and believe strongly in its truly differentiated approach. Nuage is located within the thriving, rapidly growing biotech and pharma ecosystem in Barcelona and we believe it has all of the ingredients to deliver on its immense promise.”

Notes to Editors

About Nuage Therapeutics

Nuage Therapeutics is a spin-off from the IRB Barcelona and ICREA, that was founded by the researchers Prof. Xavier Salvatella, Prof. Denes Hnisz and Dr. Mateusz Biesaga. Based at the Barcelona Science Park, Nuage deploys a suite of proprietary tools for screening and profiling small molecules against intrinsically disordered proteins (IDPs), a group of proteins that to date have been notoriously difficult to drug. With an initial focus on oncogenic transcription factors, Nuage is developing an internal pipeline of first-in-class programs. The Company is also seeking to establish collaborations and partnerships with key parties with a shared interest in drugging transcription factors and related high-value targets in other disease areas. The Company’s investors are Sofinnova Partners, Asabys Partners and Innvierte, an investment program of CDTI.

For more information, please visit www.nuagetx.com

Contacts

Nuage Therapeutics
Via Vigo Consulting

Vanessa Malier, Chair

Stuart Hughes, CEO

Vigo Consulting (media)

Melanie Toyne-Sewell / Rozi Morris
+44 (0) 7890 022 814 / +44 (0)7740 859962

Nuage@vigoconsulting.com

VectorY Therapeutics Appoints Olga Uspenskaya-Cadoz as Chief Medical Officer




VectorY Therapeutics Appoints Olga Uspenskaya-Cadoz as Chief Medical Officer

~ Appointment Strengthens Clinical Leadership as VectorY Prepares to Submit Investigational New Drug Application for VTx-002 in Sporadic ALS by Year-End 2025 ~

AMSTERDAM & BOSTON–(BUSINESS WIRE)–VectorY Therapeutics, a biotechnology company advancing vectorized antibody therapies for neurodegenerative diseases, today announced the appointment of Olga Uspenskaya-Cadoz, M.D., Ph.D., as Chief Medical Officer (CMO).

Dr. Uspenskaya-Cadoz brings two decades of experience in neurology, gene therapy, and clinical development, enhancing VectorY’s leadership in developing transformative treatments for neurodegenerative conditions. Her appointment comes as the company prepares to submit an investigational new drug (IND) application for its lead candidate, VTx-002, for sporadic amyotrophic lateral sclerosis (ALS) before the end of 2025 and enter clinical development in 2026.

Dr. Uspenskaya-Cadoz joins VectorY from Eli Lilly, where she served as Vice President, Medical, Gene Therapy. In this role, she led clinical development, clinical operations, pharmacovigilance and patient advocacy for central nervous system (CNS) and lysosomal storage genetic medicines. She also was an integral part of the company’s ALS and rare disease strategy team. Prior to Eli Lilly, she served as Vice President of Clinical Development at Prevail Therapeutics, where she played a pivotal role in designing clinical programs for novel gene therapies targeting neurodegenerative disorders.

With a career spanning global biopharmaceutical companies and leading academic institutions, Dr. Uspenskaya-Cadoz has extensive expertise in neurology, neurodegeneration, and translational medicine. She has contributed to large-scale clinical trials in Alzheimer’s disease, ALS, and other CNS disorders at IQVIA, Quintiles, and the University Hospital Pitié-Salpêtrière. She also has a strong research background, having conducted studies on neurochemical biomarkers and neuroimaging in Alzheimer’s disease.

“On behalf of the VectorY team, we welcome Olga at this important stage of our growth,” said Jim Scibetta, chief executive officer of VectorY Therapeutics. “Her deep expertise in neurology and gene therapy, combined with her leadership in clinical development, will be invaluable as we advance our pipeline of vectorized antibody therapies targeting neurodegenerative diseases. With the planned submission of an IND for VTx-002 in sporadic ALS before the end of 2025 and initiation of clinical development in 2026, her leadership will be instrumental in guiding the program toward success.”

Dr. Uspenskaya-Cadoz earned her M.D. and Ph.D. in Neurosciences from First Moscow State Medical University, with additional research training at Ludwig-Maximilians University in Munich and the Sorbonne University of Paris. She has authored more than 20 peer-reviewed publications and contributed to multiple book chapters on neurodegenerative diseases. In addition, she has presented extensively at international conferences and remains actively engaged in the scientific community, shaping the discourse on novel therapeutic approaches for neurodegenerative disorders.

“I am very pleased to join VectorY and contribute to its mission of developing innovative therapies for patients with neurodegenerative diseases,” said Dr. Uspenskaya-Cadoz. “Vectorized antibody approaches have the potential to revolutionize treatment paradigms, and I look forward to working with the team to advance these promising programs.”

About VectorY Therapeutics

VectorY is on a mission to provide patients with neurodegenerative diseases a longer, better life by creating transformative vectorized antibody treatments. Our platform combines the promise of precise therapeutic antibodies with one-time AAV-based delivery to the CNS. Unique in-house expertise in antibodies, AAV vectors, protein degradation, manufacturing and neuroscience drives the rapid development of much needed disease-modifying therapies for neurodegenerative diseases such as ALS. For more information, visit www.VectorYtx.com.

Contacts

VectorY Therapeutics info@vectorytx.com
Jim Scibetta, chief executive officer Tel: +31 681 174 072

Vigo Consulting (Media) VectorY@vigoconsulting.com
Melanie Toyne-Sewell / Rozi Morris +44 207 390 0237 / +44 20 7390 0231

European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease




European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease

• ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for non-pregnant adults aged 18-49

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO^®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:

• Active immunization of individuals 18 years of age and older for the prevention of LRTD caused by RSV
• Passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy

“We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, ABRYSVO’s expanded authorization for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.”

The amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by the thousands of persons vaccinated in clinical trials involving ABRYSVO in this age group.^1,2,3,4 The results of MONeT and other studies have been published in peer-reviewed journals.

ABOUT RSV

Respiratory Syncytial Virus (RSV) is a contagious virus and a common cause of respiratory illness worldwide.⁵ The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.^6,7,8 There are two major subgroups of RSV: RSV-A and RSV-B.⁹ Both subgroups cause disease and can co-circulate or alternate predominance from season to season. In total, RSV causes approximately 158,000 hospital admissions annually among adults aged 18 and older across the EU, with an estimated 13,000 hospitalizations in those aged 18 to 64 years.¹⁰

ABOUT ABRYSVO

ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies.

In August 2023, Pfizer announced that the European Commission granted marketing authorization for ABRYSVO for both adults aged 60 years and older and maternal immunization to help protect infants.

In the U.S in October 2024, the FDA approved ABRYSVO for the prevention of lower respiratory tract disease caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Prior, in May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age and older. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.

In addition to the most recent EU approval, ABRYSVO has received approvals for both indications in multiple countries worldwide.

U.S. INDICATIONS FOR ABRYSVO

ABRYSVO^® is a vaccine indicated in the U.S. for:

• the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
• the prevention of LRTD caused by RSV in people 18 through 59 years of age who are at increased risk for LRTD caused by RSV
• pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

IMPORTANT U.S. SAFETY INFORMATION FOR ABRYSVO

• ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
• An increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with ABRYSVO
• For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
• Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
• Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
• Vaccination with ABRYSVO may not protect all people
• In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain
• In adults 18 through 59 years of age, the most common side effects (≥10%) were pain at the injection site, muscle pain, joint pain, and nausea
• In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea
• In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo)

View the full ABRYSVO Prescribing Information.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE:

The information contained in this release is as of April 1, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about ABRYSVO, including its potential benefits and an approval in the EU to extend the indication to include prevention of LRTD caused by RSV in individuals 18 through 59 years of age, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether ABRYSVO for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

¹ Walsh EE, Falsey AR, Scott DA, et al. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366.

² Schmoele-Thoma B, Zareba AM, Jiang Q, et al. Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2022 Jun 23;386(25):2377-2386. doi: 10.1056/NEJMoa2116154.

³ Baker J, Aliabadi N, Munjal I, et al. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024 May 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16.

⁴ Peterson JT, Zareba AM, Fitz-Patrick D, et al. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine. J Infect Dis. 2022 Jun 15;225(12):2077-2086. doi: 10.1093/infdis/jiab505.

⁵ World Health Organization. Respiratory Syncytial Virus (RSV) disease. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/respiratory-syncytial-virus-disease

⁶ World Health Organization. Respiratory Syncytial Virus (RSV). https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus-(rsv)

⁷ Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. https://www.cdc.gov/rsv/factsheet-older-adults.pdf

⁸ Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/high-risk/infants-young-children.html

⁹ Nuttens C, Moyersoen J, Curcio D, et al. Differences Between RSV A and RSV B Subgroups and Implications for Pharmaceutical Preventive Measures. Infect Dis Ther. 2024;13(8):1725-1742. doi:10.1007/s40121-024-01012-2

¹⁰ Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, et al. Estimation of the Number of Respiratory Syncytial Virus–Associated Hospitalizations in Adults in the European Union. J Infect Dis 2023 May 29;228(11):1539–1548. doi: 10.1093/infdis/jiad189.

Contacts

Media Contact:

PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226

Investor Contact:

IR@Pfizer.com
+1 (212) 733-4848

Aqemia Advances Epitranscriptomics Programs and Expands into Small-Molecule RNA Targeting with $7.4 Million Grant




Aqemia Advances Epitranscriptomics Programs and Expands into Small-Molecule RNA Targeting with $7.4 Million Grant

PARIS & LONDON–(BUSINESS WIRE)–Aqemia announces it is broadening and accelerating its computational platform to target RNAs using its physics-enabled generative AI engine. Building on successes in epitranscriptomics, Aqemia aims to develop novel small-molecule drugs against this emerging and promising class of therapeutic targets. In parallel with advancing RNA-focused initiatives, the company continues to drive innovation in its broader pipeline, including protein-targeting programs.

New Funding

Aqemia has secured a $7.4 million grant as part of the France 2030 plan. This funding will strengthen the company’s generative AI platform to handle highly flexible proteins and RNA targets. For instance, Aqemia plans to experimentally determine various RNA and RNA-modifying targets to refine and iterate its technology.

Why RNAs?

RNAs have long been a promising yet difficult class of therapeutic targets due to their inherently flexible and complex structures. However, their pivotal role in gene regulation and expression—especially in diseases such as cancer—makes them highly strategic for innovative drug discovery efforts.

Progress in Drug Discovery Programs

Aqemia has already advanced several drug discovery programs in RNA targeting, bringing them closer to clinical trials. One such program, in partnership with Novalix, has shown a strong effect on cancer cells and is currently progressing in vivo models.

“This funding enables us to extend the reach of our technology to previously unexplored targets, opening the door to new classes of treatments. Integrating RNA targeting into our platform reinforces our ambition to transform the invention of new therapeutic solutions for patients. We are grateful for the continued support that allows us to push boundaries and tackle critical medical challenges.” – Dr. Maximilien Levesque, CEO and Co-Founder of Aqemia.

About Aqemia

Aqemia is a next-gen TechBio company building one of the world’s fastest-growing drug discovery pipelines. Our mission is to rapidly design innovative drug candidates for critical diseases. What sets us apart is our unique combination of physics-based algorithms and statistical mechanics to power generative AI, enabling us to design novel drug candidates without relying on experimental data.

We have already achieved multiple drug discovery successes, both within our internal pipeline and through collaborations with leading pharmaceutical companies. Our most advanced programs have demonstrated efficacy in animal models for cancer.

For more information, visit Aqemia.com and our LinkedIn.

Contacts

Press Contact
Orianne Bornand

Head of Communications

+33 6 10 04 32 80 I orianne.bornand@aqemia.com

Quanterix Showcases Innovation Powered by Simoa® at AD/PD with Customer Research and New Dried Blood Spot Extraction Kit




Quanterix Showcases Innovation Powered by Simoa® at AD/PD with Customer Research and New Dried Blood Spot Extraction Kit

Simoa^® technology highlighted in more than 80 posters and oral presentations demonstrating its impact on neurodegenerative disease research

BILLERICA, Mass.–(BUSINESS WIRE)–Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced the inclusion of a new dried blood spot extraction (DBS) kit as part of their industry-leading Simoa^® assay kits at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD) in Vienna, Austria. This new extraction kit enables researchers to measure low-concentration biomarkers from dried blood spots using a more cost-effective and less invasive method.

Current Alzheimer’s and neurodegenerative disease tests often require complex sample handling, repeated collections, and offer limited accessibility, particularly in remote or resource-limited settings, due to their reliance on venous blood draws. To address this, Quanterix, leveraging research from its collaboration with the DROP-AD Project at the University of Gothenburg, has developed a downstream DBS extraction kit that includes buffers and a sample preparation protocol, enabling accurate and sensitive measurement of neuro biomarkers from a DBS matrix. Validation studies show that DBS samples from two different devices tested with Simoa ALZpath p-Tau 217 and the Simoa extraction kit demonstrated correlation to venous in simulated CSF spiked samples of 0.75 to 0.86. This advancement lays critical groundwork for the development of scalable, minimally invasive diagnostic tools that can be deployed more broadly and equitably across populations.

“Our new dried blood spot (DBS) extraction kit represents a major step forward in making biomarker testing more accessible,” said Masoud Toloue, PhD, Chief Executive Officer of Quanterix. “By simplifying sample collection, DBS has the potential to expand participation in Alzheimer’s research and clinical trials—especially among under-represented populations. This advancement will deepen our ability to understand the disease and its progression across diverse communities.”

Additionally, Quanterix’s Simoa platform will be featured in over 80 posters, presentations, and sessions at AD/PD, demonstrating its significant role in advancing neurodegenerative disease research. For a full list of research available at AD/PD, please visit AD/PD’s event website.

About Quanterix

From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 3,200 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com.

Contacts

Media Contact:

Marissa Klaassen

(978) 488-1854

media@quanterix.com

Investor Relations Contact:

Joshua Young

(508) 846-3327

ir@quanterix.com