‘RevoAb™’, A New Service for Antibody Developability Engineering

‘RevoAb™’, A New Service for Antibody Developability Engineering




‘RevoAb™’, A New Service for Antibody Developability Engineering

SENDAI, Japan–(BUSINESS WIRE)–RevolKa Ltd. (RevolKa), a venture-backed biotech company providing a cutting-edge AI-driven protein engineering technology platform, called aiProtein® is pleased to announce the launch of a new contract research service, ‘RevoAb™’. This service engineers antibodies to improve physicochemical properties while protecting antigen binding affinity.


About RevoAb™

Since December 2023, RevolKa has offered contract research services for antibody engineering using aiProtein®, its AI-driven protein engineering technology, through FUJIFILM Wako Pure Chemical Corporation in Japan.

RevoAb™ is a new online service for antibody developability engineering based on “RevolKa’s Refined Naturalness Design concept,” This refines antibody framework sequences to be close to those in naturally occurring antibodies. The pilot version was released in Japan in July 2025. Based on customer feedback, we are now launching an upgraded RevoAb™ world-wide.

With RevoAb™, users can instantly access multiple antibody sequences with potential improvement in properties, such as expression levels, stability, solubility, etc., at low prices.

For more details, please visit.:

https://revoab.revolka.com/en/

Story behind RevoAb™ Development.

Antibodies are proteins that provide immune protection by recognizing and binding to substances (antigens) from infecting bacteria and viruses. They are widely used in industries, such as therapeutics and diagnostics. However, antibodies are often fragile for industrial applications, and enhancing their properties typically requires significant time and resources.

RevolKa has successfully engineered many proteins using aiProtein® in collaboration with customers. For antibodies, we identified that part of aiProtein® could become a valuable tool for scientists struggling with suboptimal physicochemical properties. It is engineering of framework sequences of antibody by using RevolKa’s Refined Naturalness Design concept. We developed RevoAb™ to provide research scientists with “Winning Antibody Sequences” instantly online.

Fees

Target

Origins

Price per target

Remarks

Fragment of variable regions(Fv)

Human

Rabbit

Mouse

Rat

USD700

One target: one heavy chain sequence + one light chain sequence.

 

Humanized Fv considered as human.

Others

USD350

Variable heavy domain of heavy chain(VHH)

Camelids

USD350

Humanized VHH not supported.

Registration

Please review and agree to the terms of use and privacy policy before filling out the form on the landing page.

Contacts

Inquiries Regarding RevoAb™
For any question, please contact us at support-revotune@revolka.co.jp

A.forall expands US generics portfolio

A.forall expands US generics portfolio




A.forall expands US generics portfolio

Four FDA-approved products strengthen portfolio and reaffirm commitment to global reach


ANDERLECHT, Belgium–(BUSINESS WIRE)–#FocusToGrow–A.forall is pleased to announce the acquisition of four FDA-approved injectable generics and two late-stage pipeline assets from Provepharm’s US portfolio. With this acquisition, A.forall considerably extends its marketed portfolio in the US, marking a significant expansion of its US footprint and a key milestone in the company’s sharpened focus on high-quality generics worldwide.

Strengthening Essential Healthcare

The acquired portfolio includes four well-established hospital products that address critical therapeutic needs:

  • Dihydroergotamine Mesylate (neurology – for the treatment of migraine and cluster headaches)
  • Piperacillin/Tazobactam (infectious disease – broad-spectrum antibiotic for hospital-acquired infections)
  • Tranexamic Acid (hematology – to control bleeding in surgical and trauma settings)
  • Phenylephrine Hydrochloride (anesthesiology – to manage hypotension during surgery)

These medicines are widely integrated in US hospital protocols and marketed via established pharmaceutical distributors and group purchasing organizations, ensuring strong clinical familiarity among healthcare professionals. The newly acquired products will be commercialized through A.forall’s US subsidiary, Milla Pharmaceuticals Inc.

The two late-stage pipeline products target complementary therapeutic areas and are expected to launch in the coming years.

Steen Vangsgaard, CEO of A.forall, comments: “This acquisition fits perfectly with our renewed strategy to develop, commercialize and add value to medicines, increasing their availability where they matter most. These products expand our US relevance and give us immediate access to a robust portfolio that meets essential therapeutic needs. It’s a strategic investment that delivers scale, diversification and valuable cross-selling opportunities.”

Strategic US Focus

For A.forall, the US is a strategic priority. With a dedicated team on the ground, strong partnerships and a robust pipeline, the company continues to invest in one of the world’s most competitive and complex healthcare environments.

Since 2017, six products of A.forall were registered successfully in the US market, demonstrating consistent growth and commitment to American healthcare providers.

“By integrating this portfolio with our existing capabilities, we focus to reach further into markets where high-quality generic medicines make the greatest difference,” Vangsgaard adds. “This acquisition strengthens our brand recognition and significantly expands our commercial presence in the world’s largest pharmaceutical market.”

This acquisition follows the recent decision to divest A.forall’s Retail & Hospital division and focus entirely on generics: a strategy that gives the company a sharper scope, stronger momentum and a clear direction for growth.

About A.forall

A.forall is a Belgian pharmaceutical group with headquarters in Anderlecht and offices in Ireland and the United States. At current, the company employs over 144 people and distributes a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and retirement homes. A.forall is also a global player in the generics market, now with 35+ molecules on the European and U.S. market and a fully stocked pipeline of mainly injectable generics and value-added products covering various therapeutic areas.

Driven by one mission #MakingAffordableMedicinesAvailableToAll, A.forall focuses 100% on the development, licensing and commercialization of generic medicines worldwide.

A.forall is part of The Riverside Company’s portfolio, a global investment firm focused on the smaller end of the middle market that has invested in more than 220 healthcare companies since 1988.

For more information, visit: www.aforallpharma.com.

Contacts

We’re happy to provide additional context or answer any questions you may have.

For media inquiries or more information, please contact:

A.forall Group NV

Communication Department

communications@aforallpharma.com
+32 2 526 64 14

New Arizona’s Bioscience Roadmap Details How the State Becomes a Nationally Recognized Bioscience Hub

New Arizona’s Bioscience Roadmap Details How the State Becomes a Nationally Recognized Bioscience Hub




New Arizona’s Bioscience Roadmap Details How the State Becomes a Nationally Recognized Bioscience Hub

  • The Flinn Foundation has commissioned a new Arizona’s Bioscience Roadmap to guide discovery, innovation, and economic growth through 2030
  • The strategic plan was first launched more than two decades ago and includes goals for accelerating commercialization, empowering startups, and developing and retaining workers
  • Developed by SRI International of Menlo Park, Calif., the plan will be launched at stakeholder events statewide and online the week of Sept. 8, 2025

PHOENIX–(BUSINESS WIRE)–#AZBioRoadmap–A new blueprint for Arizona’s emerging bioscience ecosystem lays out a plan for the state to capitalize on more than two decades of momentum and become a nationally recognized leader in the space.


The next iteration of Arizona’s Bioscience Roadmap, which will be unveiled the week of Monday, Sept. 8, builds on Arizona’s skilled talent base, world-class research, and entrepreneurial spirit to improve the economy as well as Arizonans’ health and quality of life.

The report analyzes Arizona’s strengths and challenges, acknowledging the uncertainty around federal funding for bioscience research and how that may impact the state going forward.

More than 140,000 people are employed in bioscience companies and hospitals in Arizona. On average, their salaries are 30% higher than private-sector salaries statewide. Crossover opportunities with semiconductor manufacturing and other tech-heavy industries provide a key opportunity for growth in the next five years, the Roadmap concludes.

Medical device manufacturing, neuroscience, oncology, and precision medicine are among the areas of particular excellence and promise in Arizona.

“With the right vision, strategies, determination, and courage — and with its rapidly growing resources, existing and potential strengths, and remarkable collaborative spirit — Arizona has a chance to make transformational contributions to bioscientific research and clinical care, with a profound impact on people here in Arizona and around the world,” said Dr. Eric Reiman, chair of the Flinn Foundation board of directors.

“The Flinn Foundation is excited to help in that endeavor.”

The Bioscience Roadmap is the longest-running statewide bioscience strategic plan in the nation. It was launched by the Flinn Foundation in 2002. Since then, the Foundation has tracked and publicly reported performance metrics from the six subsectors that make up the Arizona biosciences:

  • Agricultural feedstock and industrial biosciences
  • Bioscience-related distribution
  • Medical devices and equipment
  • Pharmaceuticals
  • Research, testing, and medical laboratories
  • Hospitals

The most recent report from April 2025 showed Arizona’s growth rate continues to outpace the nation in several categories, including bioscience jobs, National Institutes of Health funding, and university research and development, and included several record highs for the state.

The new Roadmap, developed by SRI International in collaboration with Arizona leaders and commissioned by the Flinn Foundation, establishes five goals:

1. Amplify the collaborative gene: Arizona’s collaborative culture is something to be celebrated and leveraged. Unlike more entrenched regions, Arizona organizations and participants see how facilitating one another’s individual success helps the entire ecosystem. Collaboration can also accelerate innovation across technology sectors.

2. Accelerate research into impact: Arizona will increase the scale, speed, and success of commercialization of discoveries that address critical needs. Getting new treatments and products to patients quickly is vital, especially where they enable transformative improvements in quality of life.

3. Elevate Arizona’s startup ecosystem: The state will nurture and empower entrepreneurs and startups, providing resources and support to launch, scale, and retain bio ventures. An increasingly vibrant startup community will attract investors and global-scale bioscience firms.

4. Strengthen talent and career pathways: Arizona will attract, develop, and retain top professionals and skilled workers. A large, skilled and sustained talent pool is necessary to help home-grown startups thrive and attract out-of-state companies to Arizona.

5. Tell Arizona’s bioscience story: Arizona will be recognized nationally for its contributions to health outcomes and economic growth and a competitive policy environment.

The plan emerged from more than a year of research, interviews, and focus groups throughout the state.

“The Roadmap was shaped by the people of Arizona and belongs to the people of Arizona,” said Tammy McLeod, Ph.D., Flinn Foundation president and CEO.

“This plan is more than just a well-researched document; it serves as a living guide and inspiration for our leading researchers, entrepreneurs, policymakers, and educators as well as the students who can see a future for themselves in the biosciences here in Arizona.”

Christiana McFarland is the director of SRI’s Center for Innovation Strategy and Policy, which produced the report.

“Executing this Roadmap will require focus and collaboration among key partners. Doing so will strengthen Arizona’s economy, improve health outcomes, and cement the state’s place as a vital contributor to bioscience in the United States and beyond,” McFarland said.

Read the full Arizona’s Bioscience Roadmap report and executive summary: https://www.flinn.org/bioscience/arizonas-bioscience-roadmap/about-the-roadmap/

About the Flinn Foundation

The Flinn Foundation is a privately endowed, philanthropic grantmaking organization established in 1965 by Dr. Robert S. and Irene P. Flinn to improve the quality of life in Arizona to benefit future generations. Based in Phoenix, the Foundation supports the advancement of the biosciences in Arizona as well as the merit-based Flinn Scholarship, arts and culture, and the Arizona Center for Civic Leadership.

Contacts

Stacy Sullivan, Vice President, Communications, Flinn Foundation, 602-320-1762, ssullivan@flinn.org

Brian Powell, Communications Manager, Flinn Foundation, 602-744-6806, bpowell@flinn.org

Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors

Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors




Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors

NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson (NYSE: JNJ) announced today that John Morikis, retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, has been elected to its Board of Directors.




“We are pleased to welcome John to our Company’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “He is a proven leader of a large multinational organization who possesses a strong understanding of global markets and complex supply chains. His unique perspective and ability to harness technology to drive innovation will be an incredible asset to Johnson & Johnson as we continue to deliver the next generation of healthcare innovation for patients.”

“I’ve long admired Johnson & Johnson for its innovation, leadership in healthcare and commitment to patients around the world,” said John Morikis. “I’m honored to join Johnson & Johnson’s Board and look forward to working with management and fellow directors to support the Company’s long-term strategy of delivering breakthrough treatments to patients and creating value for shareholders.”

About John Morikis

Mr. Morikis is the retired Executive Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, a global leader in the manufacture, development distribution and sale of paint, coatings, and related products.

He joined Sherwin-Williams in 1984 as a management trainee in the Paint Stores Group. Over the next four decades, he advanced through key leadership roles, including Division President and Group President. From 2006 to 2016, Mr. Morikis served as President and Chief Operating Officer before being appointed Chief Executive Officer, a position he held for eight years.

As CEO, Mr. Morikis led Sherwin-Williams through a strategic transformation that strengthened its market leadership and positioned the company for long-term success. He spearheaded a company-wide overhaul to differentiate Sherwin-Williams from industry commoditization by emphasizing world class talent, breakthrough innovation, customer-driven solutions, and a focus on value-added products and services. Under his leadership, the company expanded its global presence to 123 countries, optimized its supply chain, and invested in technology to enhance the customer experience and operational efficiency. These efforts reinforced Sherwin-Williams’ competitive edge, culminating in its inclusion in the Dow Jones Industrial Average and further solidifying its status as a global industry leader.

Mr. Morikis currently serves on the Board of Directors of United Parcel Service, Inc., General Mills, Inc. and Whirlpool Corporation and as Chairman of the Board of Directors for University Hospitals Health System, Inc.

He earned bachelor’s degrees in Business Administration and Psychology from Saint Joseph’s College in Rensselaer, Indiana, and a master’s degree in Business from National Louis University in Evanston, Illinois.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Contacts

Media contact:
media-relations@its.jnj.com

Investor contact:

investor-relations@its.jnj.com

Corner Therapeutics Research Opens Path to Universal, Long-Lasting Flu Vaccine and Signals Promise for Oncology

Corner Therapeutics Research Opens Path to Universal, Long-Lasting Flu Vaccine and Signals Promise for Oncology




Corner Therapeutics Research Opens Path to Universal, Long-Lasting Flu Vaccine and Signals Promise for Oncology

WATERTOWN, Mass.–(BUSINESS WIRE)–Corner Therapeutics, an in vivo T cell modulation and immunotherapy company pioneering novel approaches to cancer and infection, today published research in mBio, a leading microbiology journal, showing that a novel technology to generate T cells in vivo significantly outperforms standard influenza vaccine adjuvants.


The study shows that the technology elicits a broadly acting immune response that targets all strains of influenza present in the commercial quadrivalent influenza vaccine Afluria. This finding may open the door for the development of a universal flu vaccine that could eliminate the need for annual immunization. Beyond influenza, the study serves as proof-of-concept for Corner’s technologies for oncology, where the generation of robust and durable T cell responses is critical for treating cancer.

In this study, the scientists at Corner discovered a new class of drugs, called hyperactivators, which engage nature’s T cell engineers in vivo, the dendritic cells. When used in vaccine settings in non-human primates, the influenza vaccine Afluria was converted into a universal formulation capable of targeting all virus strains – all while maintaining excellent safety margins.

“Our hyperactivator technology addresses a fundamental challenge for vaccines: how to protect people from broad strains of a virus while providing a durable, lifelong immune response,” said Jonathan Kagan, Distinguished Scientist at Corner Therapeutics. “This research validates a central dogma in immunology, that dendritic cells are the best conduit to robust T cell responses and immunity. This work not only moves us one step closer to a universal influenza vaccine that could eliminate the need for annual shots, but also provides proof-of-concept for our approach to cancer immunotherapies, where T cell activities are key to tumor eradication.”

Revolutionary Approach to Vaccine Enhancement

Corner’s hyperactivator technology was tested in both mice and non-human primates, where it enhanced cross-strain antibody responses and generated robust T cell memory. Unlike existing adjuvants such as aluminum hydroxide (Alum), Corner’s hyperactivators do not kill dendritic cells, but rather instruct these apex regulators of immunity to generate long term memory. This innovative approach represents a fundamental shift in how immunotherapies can be optimized for maximum health.

Corner Therapeutics aims to begin clinical trials of its hyperactivator technology by the end of 2027.

In addition to the hyperactivator technology, Corner Therapeutics is advancing its DCITE (Dendritic Cell Initiated T cell Engineering) platform to instruct dendritic cells to stimulate durable T cell immunity. Using lipid nanoparticle formulations to deliver mRNA encoding specific antigens directly to dendritic cells, DCITE enables the in vivo generation of tumor-specific CD8+ T cells to treat existing cancers and infections.

About Corner Therapeutics

Corner Therapeutics is the in vivo T cell modulation and immunotherapy company pioneering novel approaches to cancer and infection. Using its novel dendritic cell stimuli platforms, Corner teaches the immune system to engineer its own long-lived, disease-fighting T cells. With its antigen-agnostic platform, Corner is revolutionizing care for an exceptionally wide range of diseases. For more information about Corner Therapeutics, visit https://cornertx.com/

Contacts

Media: Mission North cornertherapeutics@missionnorth.com

Aptar Increases Quarterly Dividend by Nearly 7% Signaling Continued Momentum and Long-Term Strength

Aptar Increases Quarterly Dividend by Nearly 7% Signaling Continued Momentum and Long-Term Strength




Aptar Increases Quarterly Dividend by Nearly 7% Signaling Continued Momentum and Long-Term Strength

Following an increase of almost 10% a year ago

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–AptarGroup, Inc. (NYSE:ATR), a global leader in drug delivery, consumer product dosing, dispensing and protection technologies, today declared a quarterly cash dividend of $0.48 per share, an almost 7% increase from the previous dividend amount, bringing the new annualized dividend to $1.92 per share. The payment date is November 13, 2025, to stockholders of record as of October 23, 2025.


Stephan B. Tanda, Aptar President and CEO, commented, “Given the strength of our business outlook, the sustained long-term growth we anticipate from our Pharma segment, and our continued strong performance across all key financial metrics, the Board of Directors has approved an increase in the quarterly dividend. Since 2020, we’ve returned over $1 billion to shareholders through dividends and share repurchases, and we remain on track to achieve our 32nd consecutive year of increasing our total annual dividend.”

As previously announced, Aptar will hold its biennial Investor Day on Tuesday, September 9, 2025. The event will begin at 9:00 a.m. EDT. Presentations by members of executive management followed by a moderated Q&A session are expected to conclude at approximately 12:00 p.m. EDT. The general public can access the event and listen live by registering for the webcast.

About Aptar

Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.

This press release contains forward-looking statements, including regarding our annualized dividends. Expressions or future or conditional verbs such as “will” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: the successful integration of acquisitions; the regulatory environment; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-Ks and Form 10-Qs. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Investor Relations Contact:
Mary Skafidas

mary.skafidas@aptar.com
+1 347-351-6407

Media Contact:
Katie Reardon

katie.reardon@aptar.com
+1 815-479-5671

DiaMedica Therapeutics to Participate in Upcoming Investor Conferences

DiaMedica Therapeutics to Participate in Upcoming Investor Conferences




DiaMedica Therapeutics to Participate in Upcoming Investor Conferences

MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction, and acute ischemic stroke, today announced that Rick Pauls, President and CEO, and Dave Wambeke, Chief Business Officer, will participate in two upcoming investor conferences in New York City.


Details

H.C. Wainwright 27th Annual Global Investment Conference

Date: September 8-10, 2025

Participation: One-on-one meetings and corporate presentation

Presentation Date & Time: Tuesday, September 9, 2025, from 2:30-3 p.m. ET

Lake Street Capital Markets Best Ideas Growth Conference Big 9

Date: September 11, 2025

Participation: One-on-one meetings only

About DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company’s website at www.diamedica.com.

Contacts

Scott Kellen

Chief Financial Officer

Phone: (763) 496-5118

skellen@diamedica.com

For Investor Inquiries:
Mike Moyer

Managing Director, LifeSci Advisors, LLC

Phone: (617) 308-4306

mmoyer@lifesciadvisors.com

Media Contact:
Madelin Hawtin

LifeSci Communications

mhawtin@lifescicomms.com

Newron to present data and updates on its clinical program evaluating evenamide as an add-on treatment for schizophrenia at the 2025 World Congress of Biological Psychiatry (WCBP)

Newron to present data and updates on its clinical program evaluating evenamide as an add-on treatment for schizophrenia at the 2025 World Congress of Biological Psychiatry (WCBP)




Newron to present data and updates on its clinical program evaluating evenamide as an add-on treatment for schizophrenia at the 2025 World Congress of Biological Psychiatry (WCBP)

  • The importance of glutamate release modulation by evenamide used as an add-on therapy for patients with schizophrenia inadequately responding to their second-generation antipsychotics, including clozapine (study 008A) – oral and poster presentation
  • The key features of a landmark, potentially pivotal, randomized, double-blind, placebo-controlled study designed to demonstrate the short and long-term efficacy and tolerability of evenamide as an add-on treatment to current second-generation antipsychotic(s) in Treatment Resistant Schizophrenia (TRS) (study ENIGMA-TRS 1) – poster presentation
  • The safety and tolerability of new antipsychotics, demonstrating the relevance of the preclinical mechanism of action – poster presentation

MILAN–(BUSINESS WIRE)–$NWRN #schizophrenia–Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announced that it will present three posters and give an oral presentation at the upcoming 17th World Congress of Biological Psychiatry (WCBP) taking place September 9-12, 2025, at the Estrel Berlin Hotel & Conference Center, in Berlin, Germany.


The results of Study 008A indicate for the first time that glutamate modulation, in this case through addition of evenamide, is associated with clinically meaningful and statistically significant efficacy. In addition, this trial is the first to demonstrate that the addition of one antipsychotic to another is associated with an improvement in efficacy. Study 008A was an international, randomized, double-blind, placebo-controlled study of evenamide as an add-on to a second-generation antipsychotic (SGA) in patients with symptomatic schizophrenia not responding adequately to their current antipsychotic medication, including clozapine. Evenamide was extremely well tolerated in this study without the occurrence of any typical antipsychotic adverse events and with a minimal dropout rate.

The ENIGMA-TRS 1 (EveNamIde’s Glutamate Modulation Ameliorates TRS 1) study’s unique design aims to address previous trials’ limitations by assessing evenamide’s (15 and 30 mg bid) response as an add-on to current SGA medication(s) in patients with TRS, as defined by the TRRIP Working Group Consensus Guidelines, in a blinded, placebo-controlled setting. Patients’ eligibility is reviewed by an Independent Eligibility Assessment Committee and SGA plasma concentration measurements are monitored pre- and post-randomization to ensure participants’ antipsychotic treatment compliance. This potentially pivotal landmark study plans to enroll more than 600 subjects at around 50 sites in 20 countries and will assess both short-term and long-term efficacy (at week 12, 26 and 52).

The favorable safety and tolerability profile of evenamide will be compared with that of three recently approved antipsychotics. The analysis will focus on the relative risk of each drug compared to placebo in relation to their different modes of action.

Oral and poster presentation

Wednesday, September 10, 2025

1:30 pm – 3:00 pm CEST (oral)

6:15 pm – 7:45 pm CEST (poster)

  • Glutamate Modulation as Adjunctive Therapy in Patients with Schizophrenia Not Adequately Responding to Second-Generation Antipsychotics: Clinical Benefits of Evenamide in a Phase 2/3, International, Randomized, Double-Blind, Placebo-Controlled Trial

Poster presentation

Thursday, September 11, 2025

6:15 pm – 7:45 pm CEST

  • Evenamide, a Glutamate Release Modulator, as Add-On to Second-Generation Antipsychotics in Treatment-Resistant Schizophrenia: Updates from a Phase 3, Potentially Pivotal, International, Randomized, Double-Blind, Placebo-Controlled Trial
  • Mechanism of Action of Antipsychotics and their Impact on Tolerability and Safety

About treatment-resistant schizophrenia (TRS)

A significant proportion of patients with schizophrenia show virtually no beneficial response to antipsychotics (APs) despite adequate treatment, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no, or inadequate, symptomatic relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. About 15% of patients develop TRS from illness onset, and about one-third of patients overall. Increasing evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of benefit of most typical and atypical antipsychotics.

About evenamide

Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system.

Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable safety profile, which is uncommon for available antipsychotic medications.

Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea.

Newron has a proven track record in bringing CNS therapies to market. Its Parkinson’s disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika.

For more information, please visit: www.newron.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Contacts

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
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Nature Medicine Publishes Phase 3 Data on Pridopidine in Early-Stage Huntington’s Disease, Highlighting Impact on Clinical Progression

Nature Medicine Publishes Phase 3 Data on Pridopidine in Early-Stage Huntington’s Disease, Highlighting Impact on Clinical Progression




Nature Medicine Publishes Phase 3 Data on Pridopidine in Early-Stage Huntington’s Disease, Highlighting Impact on Clinical Progression

Treatment with pridopidine slowed clinical progression and maintained function, cognition, and motor performance in pre-defined analyses of a subgroup of early-stage Huntington’s disease (HD) patients who were not taking antidopaminergic medicines (ADMs). The PROOF-HD study did not meet its overall primary or secondary endpoints in the full population

In the group of patients who were not taking ADMs, pridopidine demonstrated clinically meaningful improvement from baseline for one year, and slowing of decline thereafter, as measured by cUHDRS

ADMs may cause side effects that cannot be distinguished from HD progression and can negatively impact clinical outcome measures and confound treatment-related effects in a clinical triali

This randomized, double-blind, placebo-controlled study represents the first Phase 3 trial in HD to deliver a consistent pattern of meaningful benefits across multiple outcome measures of efficacy including cognition (SWR) and motor function (Q-Motor), in a subgroup of subjects, as well as a favorable safety profile

A planned confirmatory study in early HD patients, designed to confirm pridopidine’s effects and support global regulatory approval pathway discussions, is expected to start next year

NAARDEN, Netherlands & WALTHAM, Mass. & BARCELONA, Spain–(BUSINESS WIRE)–Prilenia Therapeutics B.V. and Ferrer today announced the publication, in the journal Nature Medicine, of a manuscript entitled “Pridopidine in Early-Stage Manifest Huntington Disease: A Phase 3 Trialii. The publication describes data showing that treatment with pridopidine slowed clinical progression in Huntington’s disease (HD) patients not taking antidopaminergic medicines (ADMs).


The published data, from pre-defined analyses of a subgroup of patients not taking ADMs from pridopidine’s Phase 3 PROOF-HD trial, show that treatment with pridopidine achieved a clinically meaningful improvement from baseline for one year and slowing of decline thereafter, as measured by cUHDRS, with change vs placebo of ­0.46, ­0.45, ­0.41 and ­0.27 at 26, 39, 52 and 65 weeks (the end of the double-blind trial). Annual reductions in cUHDRS of 0.1–0.3 points have been associated with a clinically meaningful benefit in HDiii.

Importantly, the benefits in cUHDRS in this subgroup of subjects with HD were seen across domains of function, cognition, and motor performance. Pridopidine also achieved similar maintenance of cognition with no deterioration, as measured by Stroop Word Reading Test (SWR), and motor performance, as measured by Quantitative Motor (Q-Motor).

Ralf Reilmann, MD, FAAN, Founding Director, George Huntington Institute and publication lead author, said: “The published data represents the first Phase 3 HD trial to deliver consistent and meaningful benefits on progression across multiple clinical domains of HD such as function, cognition and motor performance, while also confirming pridopidine’s favorable safety and tolerability profile. Upcoming studies can now refine patient selection and account for the impact of ADM exposure, which obscured the true drug-related benefits. Appropriate stratification and dosage strategies will control for this confounding factor and allow demonstration of pridopidine’s positive treatment effects on clinical progression of symptoms. I would like to express my gratitude for the continued commitment of everyone working to support the next data-driven steps to making this well-tolerated and easily administered treatment option available to HD patients.”

Dina de Sousa, European Huntington Association (EHA) Board member, remarked: “We have no options to help slow down our decline. Nothing to help people feed themselves a little longer, button a shirt a little longer, walk a little longer, or maybe even dance a little longer. Treatment options are needed now that can enable maintenance of independence for as long as possible. These results provide hope that there are therapies that can go further than just symptom control, and hope that we can take a step forward toward availability of a disease-modifying treatment able to slow down the inexorable march of this dreadful disease.”

“These data provide a clear path forward for next year’s planned global confirmatory study in early HD patients, aimed at confirming pridopidine’s effect and supporting ongoing global regulatory discussions,” said Dr. Michael R. Hayden, CEO of Prilenia.

“Nature Medicine is one of the world’s leading peer-reviewed medical journals, and this important publication adds to the weight of evidence in support of the sigma-1 receptor agonist approach and the development of pridopidine for the treatment of neurodegenerative diseases such as HD and ALS,” said Oscar Pérez, Chief Scientific Officer at Ferrer.

About pridopidine

Pridopidine (45 mg twice daily) is a potent and selective, orally administered sigma-1 receptor (S1R) agonist which stimulates key neuroprotective mechanisms impaired in neurodegenerative diseases such as HD and ALSiv.

Pridopidine’s extensive development program involved approximately 1,600 people, demonstrating a favorable safety and tolerability profile.

In addition to HD, pridopidine is in late-stage clinical development for ALS, with Prilenia and Ferrer planning to initiate a single, pivotal Phase 3 trial in ALS early in 2026, building on the findings in the population with early and rapid progressing disease from the Phase 2 HEALEY ALS Platform Trial.

Pridopidine has Orphan Drug designation in HD and ALS in the US and EU, and FDA Fast Track designation for the treatment of HDv.

About Huntington’s Disease

Huntington’s disease (HD) is a rare, inherited, autosomal dominant, neurodegenerative disease that results in functional, motor, cognitive and behavioral symptoms. HD is caused by a mutation in the huntingtin genevi, and each child of a parent with HD has a 50 percent chance of developing the disease.vii

HD affects approximately 4.88 out of 100,000 people around the world with an additional 300,000 people at risk of developing HDviii,ix. It is usually diagnosed between the ages of 30 and 50, although HD can occur at any age, including in children and young adults (known as juvenile onset HD or JHD). The disease progresses slowly over 15 to 20 years, with patients slowly losing their ability to work, communicate, manage day-to-day life and take care of themselves. This increasing disability leads to full reliance on a caregiver and, ultimately, death.

The only currently available treatments for HD focus on symptomatic relief and palliative care, with nothing impacting measures of overall progression.

About Prilenia

Prilenia is a private biopharmaceutical company driven by an unwavering commitment to scientific excellence and accelerating progress for people affected by Huntington’s disease (HD), amyotrophic lateral sclerosis (ALS) and other children and adults with neurodegenerative disorders. Our mission is simple but urgent: to develop and provide sustainable access to transformative medicines for people affected by devastating neurodegenerative diseases.

Prilenia is partnered with Ferrer for the commercialization and co-development of pridopidine in Europe and other select markets, retaining full commercialization and development rights to pridopidine in North America, Japan and Asia Pacific.

The company is incorporated in the Netherlands and backed by leading life sciences investors.

For more information, please visit www.prilenia.com and connect with us on LinkedIn or X (Twitter).

About Ferrer

At Ferrer we use business to fight for social justice. We have long been a company that wants to do things differently; instead of maximizing shareholder returns, we reinvest much of our profit in initiatives that give back to society. Back where it belongs. We go beyond compliance and are guided by the highest standards of sustainability, ethics and integrity. As such, since 2022, we are a B Corp.

Founded in Barcelona in 1959, Ferrer offers transformative solutions for life-threatening diseases in more than one hundred countries. In line with our purpose, we have an increasing focus on pulmonary vascular and interstitial lung diseases and rare neurological disorders in adults and children. Our 1,800-strong team is driven by a clear conviction: our business is not an end in itself, but a way to change lives.

We are Ferrer. Ferrer for good. www.ferrer.com

_____________________________

i Tedroff J, Waters S, Barker RA, Roos R, Squitieri F; EHDN Registry Study Group. Antidopaminergic Medication is Associated with More Rapidly Progressive Huntington’s Disease. J Huntingtons Dis. 2015;4(2):131-40. doi: 10.3233/JHD-150143. PMID: 26397894.

Geva M, Goldberg YP, Schuring H, Tan AM, Long JD, Hayden MR. Antidopaminergic Medications and Clinical Changes in Measures of Huntington’s Disease: A Causal Analysis. Mov Disord. 2025 May;40(5):928-937. doi: 10.1002/mds.30164. Epub 2025 Mar 18. PMID: 40099482; PMCID: PMC12089908.

ii https://www.nature.com/articles/s41591-025-03920-3
iii Schobel SA, Palermo G, Auinger P, Long JD, Ma S, Khwaja OS, Trundell D, Cudkowicz M, Hersch S, Sampaio C, Dorsey ER, Leavitt BR, Kieburtz KD, Sevigny JJ, Langbehn DR, Tabrizi SJ; TRACK-HD, COHORT, CARE-HD, and 2CARE Huntington Study Group Investigators. Motor, cognitive, and functional declines contribute to a single progressive factor in early HD. Neurology. 2017 Dec 12;89(24):2495-2502. doi: 10.1212/WNL.0000000000004743. Epub 2017 Nov 15. PMID: 29142089; PMCID: PMC5729794.

iv Naia, L., Ly, P., Mota, S.I. et al. The Sigma-1 Receptor Mediates Pridopidine Rescue of Mitochondrial Function in Huntington Disease Models. Neurotherapeutics 18, 1017–1038 (2021). https://doi.org/10.1007/s13311-021-01022-9
v Cudkowicz, M. AAN Annual Meeting, April 6-9, 2025, San Diego, CA

vi Eddings CR, Arbez N, Akimov S, Geva M, Hayden MR, Ross CA. Pridopidine protects neurons from mutant-huntingtin toxicity via the sigma-1 receptor. Neurobiol Dis. 2019 Sep;129:118-129. doi: 10.1016/j.nbd.2019.05.009. Epub 2019 May 17. PMID: 31108174; PMCID: PMC6996243.

vii Myers RH. Huntington’s disease genetics. NeuroRx. 2004 Apr;1(2):255-62. doi: 10.1602/neurorx.1.2.255. PMID: 15717026; PMCID: PMC534940.)

viii Medina et al., Prevalence and Incidence of Huntington’s Disease: An Updated Systematic Review and Meta-Analysis. Mov Disord. 2022 Dec;37(12):2327-2335.

ix Jiang, A., Handley, R. R., Lehnert, K., & Snell, R. G. (2023). From Pathogenesis to Therapeutics: A Review of 150 Years of Huntington’s Disease Research. International Journal of Molecular Sciences, 24(16), 13021. https://doi.org/10.3390/ijms241613021

Contacts

Media Contacts:
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Communications Team

info@prilenia.com

Ferrer Contact
Alba Soler, Director of Communication

asolerc@ferrer.com

New Data for Genentech’s Vabysmo Reinforce Its Efficacy, Safety and Durability in Wet Age-Related Macular Degeneration (AMD)

New Data for Genentech’s Vabysmo Reinforce Its Efficacy, Safety and Durability in Wet Age-Related Macular Degeneration (AMD)




New Data for Genentech’s Vabysmo Reinforce Its Efficacy, Safety and Durability in Wet Age-Related Macular Degeneration (AMD)

– In AVONELLE-X, the largest long-term extension trial in wet AMD, disease control and durability were maintained over 4 years, with nearly 80% of patients on extended dosing by study end –

– Over 60% of people with a difficult-to-treat form of wet AMD showed no signs of damaging lesions in the SALWEEN study, and clinically meaningful vision improvements were observed –

– Vabysmo was well tolerated with a consistent long-term safety profile in wet AMD in both studies –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data from the AVONELLE-X and SALWEEN studies of Vabysmo® (faricimab-svoa), presented at the 25th Euretina Congress in Paris, France. Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in wet age-related macular degeneration (AMD), a leading cause of vision loss. In the single-arm SALWEEN study, Vabysmo showed clinically meaningful vision gains and retinal drying over one year in polypoidal choroidal vasculopathy (PCV), a vision-threatening subtype of wet AMD that is especially common in Asia.


“The robust SALWEEN findings in PCV highlight Vabysmo’s potential to deliver clinically meaningful improvements and help mitigate vision loss,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Alongside the long-term AVONELLE-X results in wet AMD, these findings support our mission to develop and deliver impactful medicines for people with difficult-to-treat eye diseases.”

In new one-year data from the single-arm, open-label Phase IIIb/IV SALWEEN study of Vabysmo for the treatment of people with PCV in Asia, patients experienced a clinically meaningful gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44 and 48. At year 1, more than 50% of patients were assigned to extended five-month dosing. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with these lesions completely resolving in more than 60% of patients and inactivation of polypoidal lesions in the majority (86%) of eyes. Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in wet AMD.

The AVONELLE-X study was a two-year open-label extension of the two-year Phase III TENAYA and LUCERNE studies of Vabysmo in wet AMD. Vision remained stable throughout the two years of AVONELLE-X, and anatomic improvement from the parent trials was sustained through AVONELLE-X. Results showed that after up to four years of treatment with Vabysmo, nearly 80% of patients had extended their treatment intervals to every three or four months, reinforcing the results seen in TENAYA and LUCERNE. Vabysmo was well tolerated, and safety data were consistent with its known safety profile in wet AMD.

To date, Vabysmo is approved in more than 100 countries for wet AMD and diabetic macular edema (DME), and in more than 60 countries for macular edema following retinal vein occlusion (RVO). More than eight million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.

About Wet Age-Related Macular Degeneration (AMD)

Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading. It is a leading cause of blindness for people aged 60 and over in the U.S. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss. Approximately 20 million people in the U.S. have some form of AMD, and of those, about 1.5 million have late-stage AMD, which includes wet AMD.

Wet AMD is caused by growth of abnormal blood vessels, also referred to as choroidal neovascularization (CNV), into the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years.

Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Vabysmo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or https://www.Genentech-Access.com.

Visit https://www.Vabysmo.com for additional information.

About polypoidal choroidal vasculopathy

Polypoidal choroidal vasculopathy (PCV) is a subtype of wet AMD that is more prevalent in people of Asian or African descent than European descent. It accounts for up to 60% of wet AMD cases in people of Asian descent, and up to 20% in people of European descent.

PCV is characterized by abnormal blood vessels in the choroid, a thin layer of tissue between the sclera (the whites of the eyes) and the retina. These abnormal vessels can leak fluid or blood, leading to retinal damage and vision loss. People with PCV often experience blurred vision or a blind spot in or near the center of their vision in one or both eyes. Early diagnosis and treatment are important to help restore vision and prevent further vision loss.

About AVONELLE-X

AVONELLE-X (NCT04777201) was an open-label, multicenter, two-year extension study of Vabysmo in 1,029 patients with wet AMD who completed one of the two Phase III studies, TENAYA (NCT03823287) or LUCERNE (NCT03823300).

Patients in TENAYA and LUCERNE were treated with either 6 mg Vabysmo or 2 mg aflibercept. During AVONELLE-X, all patients were treated with Vabysmo on a treat-and-extend regimen, where the time between Vabysmo treatments could be adjusted based on retinal fluid levels and visual acuity.

About SALWEEN

SALWEEN was a Phase IIIb/IV multicenter, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV. It enrolled 135 patients aged 50 years and over from 38 sites across nine markets in Asia, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand. Patients received four loading doses of Vabysmo 6 mg over 12 weeks. After that, their treatment schedule was adjusted based on their progress, with doses given every 8, 12, or 16 weeks. From weeks 44 to 104, patients followed a personalized treatment plan with doses spaced out as far as every 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40-48.

About Vabysmo® (faricimab-svoa)

Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.

Vabysmo U.S. Indications

Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

Important Safety Information

Contraindications

Vabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo.

Warnings and Precautions

  • Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.
  • Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the injection.
  • Although not common, Vabysmo patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with Vabysmo reported such an event. In clinical studies for RVO during 6 months, 7 out of 641 patients treated with Vabysmo reported such an event.
  • Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Vabysmo. Healthcare providers should discontinue treatment with Vabysmo in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Reactions

The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and blood on the white of the eye (conjunctival hemorrhage, 8%). These are not all the possible side effects of Vabysmo.

Pregnancy, Lactation, Females and Males of Reproductive Potential

  • Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo.
  • It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo.

Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full Vabysmo Prescribing Information or visit https://www.Vabysmo.com.

About Genentech in Ophthalmology

Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact: Nicole Burkart, (650) 467-6800

Advocacy Contact: Meg Harrison, (617) 694-7060

Investor Contacts: Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284