Gene Therapy News Monitoring

FDA Approves AAVantgarde’s IND Application for Stargardt Gene Therapy

AAVantgarde Bio, a clinical-stage, biotechnology company specializing in inherited retinal diseases, announced on July 15, 2025, that FDA has cleared the company’s investigational new drug application for AAVB-039, a gene therapy to treat Stargardt disease …

Krystal Biotech Initiates EMERALD-1 Trial: First Patient Dosed in Study of Gene Therapy for Neurotrophic Keratitis

Krystal Biotech has announced the dosing of the first patient in its EMERALD-1 phase 1/2 clinical trial, evaluating KB801, a redosable gene therapy eye drop for the treatment of neurotrophic keratitis (NK). This corneal disease is characterized by …

Sanofi’s Intravitreal Gene Therapy Receives FDA Fast Track Designation for Geographic Atrophy

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAR446597, a one-time intravitreal gene therapy developed by Sanofi for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). This …

CMS Launches Value-Based Gene Therapy Program for Sickle Cell Disease

A new federal payment model launching today will let states offer gene therapies for sickle cell disease at a lower cost by having the federal government negotiate prices with drugmakers. CMS has launched the Cell and Gene Therapy (CGT) Access Model, …

Sarepta Surges After-Hours As It Slashes 500 Jobs Amid FDA Black Box Warning For Gene Therapy — Retail Eyes Rebound

Sarepta Therapeutics shares surged 34% in after-hours trading on Wednesday after the company said it would slash 500 jobs, or 36% of its workforce, as part of its restructuring plan.  The move is expected to decrease costs by $400 million annually starting …

Sarepta Slashes Workforce After Patient Deaths on Gene Therapy

(Bloomberg) -- Sarepta Therapeutics Inc. is cutting more than one-third of its workforce and will add a black box warning label to its gene therapy for a fatal muscle disorder after two patient deaths raised doubts about the future of the company. The …

Fostering Collaboration in Cell and Gene Therapy Research

Helping investigators doing preclinical research on cell and gene therapy to bring their programs to the clinic is a key goal of Mass General Brigham (MGB)’s Gene and Cell Therapy Institute (GCTI). Fostering collaboration between experts in different …

Around the Helix: Cell and Gene Therapy Company Updates – July 16, 2025

The cell and gene therapy sectors are growing exponentially, with new players emerging daily and much progress being made both in and out of the lab. CGTLive®’s Around the Helix is your chance to catch up with the latest news in cell and gene therapies, …

Sarepta to cut 500 jobs, add black-box warning on gene therapy

Audio By Carbonatix By Mariam Sunny (Reuters) -Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients who were …

CMS’ gene therapy access model goes live, with 33 states on board

A total of 33 states, plus the District of Columbia and Puerto Rico, agreed to participate in the U.S. CMS’ voluntary, outcomes-based program aimed at helping state Medicaid programs cover high-priced cell and gene therapies, starting with therapies for …

Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff

After a difficult season that has seen two deaths linked to Sarepta Therapeutics’ Duchenne muscular dystrophy treatment Elevidys, the Cambridge, Massachusetts–based biotech is letting go of more than a third of its workforce and adding a black box warning …

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

Sarepta Therapeutics is laying off roughly 500 employees in an extensive workforce reduction that follows a series of setbacks and the collapse of the company’s share price this year. In a statement Monday, Sarepta said it plans to cut approximately 36% of …

Sarepta to cut 500 jobs after gene therapy setback, shares jump

(Reuters) -Sarepta Therapeutics said on Wednesday it would lay off 36% of its workforce, or about 500 employees, after the recent deaths of two patients who had received its gene therapy Elevidys. Its shares shot up about 40% in extended trading, as the …

Aavantgarde Bio cleared to begin clinical study of Stargardt disease gene therapy in US

Ocular The U.S. FDA has cleared Aavantgarde Bio Srl’s IND application for AAVB-039, the company’s gene therapy program for Stargardt disease, the most common inherited form of macular degeneration. BioWorld Science Regulatory Genetic/congenital Ocular …

Sarepta Therapeutics lays off 500 after gene therapy setback

FDA fast-tracks Sanofi's gene therapy for eye disease GA

Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy (GA), a complication of age-related macular degeneration (AMD), as it prepares to test it in a clinical trial. The SAR446597 gene therapy could provide a one-off …

Nanoscope Therapeutics Puts Rolling BLA for Retinitis Pigmentosa Gene Therapy MCO-010 in Front of FDA

Nanoscope Therapeutics has submitted a rolling biologics license application (BLA) to the FDA for MCO-010 (sonpiretigene isteparvovec), an investigational ambient-light activatable multi-characteristic opsin (MCO) gene therapy, for the treatment of …

Golden Age Health secures rights to promote LX-101 gene therapy in China

Golden Age Health (GAH) has secured exclusive rights to commercialise and promote Innostellar Biotherapeutics' first-in-class gene therapy candidate, LX-101, in mainland China. Golden Age Health (GAH) has secured exclusive rights to commercialise and …

CHA Biotech builds hub for global cell and gene therapy startups in Pangyo

Before hiring a scientist or applying for a grant, Korean biotech startups often face a more basic challenge: finding a place to work. Renting and equipping a lab in the country’s upscale tech districts can cost more than 3 billion won (roughly $2.18 …

Digital Video Advertising Market Growing at 29.6% CAGR | Reach USD 712.6 Billion by 2031 Globally

The global rise in connected TV adoption is pushing brands toward digital video ads, fueling strong growth in the digital video advertising market. WILMINGTON, DE, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Digital video advertising is …

Carrier Details Launches Digital Evidence of Insurance Verification, Boosts Compliance Across Freight Industry

HEBRON, ND, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Carrier Details, a trusted provider of freight carrier data solutions, today announced the official launch of its Digital Evidence of Insurance (EOI) Verification API. The Carrier …

Helical Fusion and Toshiba Team Up on HTS Technology for Fusion Energy

Aiming for the world’s first commercial fusion reactor, the two companies will co-develop current leads for cutting-edge high-temperature superconducting　coils. TOKYO, JAPAN, July 17, 2025 /⁨EINPresswire.com⁩/ -- Helical Fusion Co., Ltd. (“Helical …

ActOne Group introduces AI-enabled Process Automation Platform - Assembly Orchestration

Business outcomes are transformed with AI Agents and human workforce on a unified platform. LOS ANGELES, CA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- ActOne Group's strategic investment in Assembly Industries is transforming how …

Finelo Awarded on Newsweek’s America’s Best Online Platforms 2025 List

Finelo named to Newsweek’s 2025 list of America’s Best Online Platforms, recognizing standout quality, growth, and mobile usability. NEW YORK, NY, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Finelo Named to Newsweek’s List of America’s …

Rocket Propulsion Systems Awarded US Space Force $3M Contract for Orbital Transfer Vehicle

Transport solutions to address the Space Force's need to move critical payloads between orbits KENT, WA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Rocket Propulsion Systems (RPS) LLC announces it has been selected by SpaceWERX for a …

Firm Performance Partners with BigScoots to Offer Clients Enhanced Legal Website Hosting

Firm Performance partners with BigScoots to offer its clients legal website hosting options for optimal security, reliability, and scalability. CHICAGO, IL, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- BigScoots, a site-specific, fully …

Award-Winning Film Studio Delphia Entertainment Begins Production on New NASA Documentary Before the Moon

NASA trained in Warminster. From steamboats to space shuttles, this doc uncovers the hidden innovators who launched America skyward. WARMINSTER, PA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Delphia Entertainment, the acclaimed …

Zyphe Announces New Funding to Accelerate Growth of Its Privacy-First, Decentralized Identity Verification Platform

Zyphe raises new funding to scale its privacy-first, decentralized ID verification platform and fight against data breaches resulting from digital onboarding. SAN FRANCISCO, CA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Zyphe, a leader …

46 Inspiring Connecticut STEM Leaders Selected as 2025 Women of Innovation® Finalists

Recognizing Innovation and Leadership in Academia, Community, Corporate, Entrepreneurship, and Research; Youth Scholarships to be Awarded HARTFORD, CT, CT, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Forty-six accomplished Connecticut …

ViaPath Technologies Launches ViaPath HealthTech™ and Will Be Honored at Teladoc Health Forum with Connected Care Award

ViaPath Technologies launches ViaPath HealthTech™, a HIPAA-compliant healthcare app, winning the 2025 Connected Care Award for innovation in corrections. FALLS CHURCH, VA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- ViaPath Technologies …

Home Brewers Worldwide Compete in iGulu Challenge as Public Voting Begins

iGulu Brew Challenge - Everyone's a Brew Artist LOS ANGELES, CA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- The world of home brewing is undergoing a transformation, as technology and creativity come together in unexpected ways. The …

LoginRadius and Next Reason Partner to Accelerate Akamai Identity Cloud Migrations

Akamai Identity Cloud customers are facing EOL in 2027. LoginRadius, a leading identity platform unveils strategic partnership with migration expert Next Reason VANCOUVER, BRITISH COLUMBIA, CANADA, July 17, 2025 /⁨EINPresswire.com⁩/ -- LoginRadius …

PeopleInsight by HireRoad Receives Silver Stevie Award for HR Technology Solution Provider of the Year

PeopleInsight by HireRoad named Silver winner in 10th annual Stevie® Awards for Great Employers in the category of HR Technology Solution Provider of the Year. BOSTON, MA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Top HR analytics …

Tesla Outsourcing Services Champions Resilience: Pioneering BIM for a Sustainable Infrastructure Future

Tesla Outsourcing Services pioneers resilient infrastructure with BIM for sustainable, future-proof development. FL, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- In a rapidly evolving global landscape marked by increasing urbanization, …

UnitedLayer® Recognized as a Leader in ISG Provider Lens™ 2025 for Private/Hybrid Cloud – Data Center Services

SANTA CLARA, CA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- UnitedLayer®, a leading provider of hybrid colocation, private cloud, and infrastructure services, has been recognized as a Leader in the ISG Provider Lens™ 2025 – Private/ …

Growing at 42.6% CAGR | Device as a Service Market Reach USD 1.8 Trillion by 2031 Globally

WILMINGTON, DE, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Allied Market Research published a new report, titled, “Growing at 42.6% CAGR | Device as a Service Market Reach USD 1.8 Trillion by 2031 Globally.” The report offers an extensive …

Growing at 20% CAGR | Commercial Robots Market Reach USD 85.2 Billion by 2031 Globally

WILMINGTON, DE, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- According to the report published by Allied Market Research, Growing at 20% CAGR | Commercial Robots Market Reach USD 85.2 Billion by 2031 Globally . The report provides an …

California Water Service awards multi-million-dollar design-build contract to Covenant Technical Solutions

Tank mixing and dosing program project will improve and maintain consistent water quality across five Southern California sites DANVILLE, CA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Covenant Technical Solutions™ (CTS™), a leading …

Ainnocence SentinusAI® Demonstrates Consistent Superior Performance in Protein Design, Outperforming Competitors

SAN FRANCISCO, CA, UNITED STATES, July 17, 2025 /⁨EINPresswire.com⁩/ -- Ainnocence’s SentinusAI® protein design platform continues to demonstrate superior performance compared to competitive platforms, maintaining consistent excellence since 2021 …