Gene Therapy News Monitoring

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 …

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 …

Sarepta Therapeutics lays off 500 after gene therapy setback

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 …

Genascence’s GNSC-001 for knee osteoarthritis receives US FDA regenerative medicine advanced therapy designation

Palo Alto-headquartered Genascence Corporation, a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, announced that the US Food and Drug Administration has granted the Regenerative …

BUSINESS HEADLINES

Audio By Carbonatix Trump signs new stablecoin regulations into law, a major milestone for crypto industry WASHINGTON (AP) — President Donald Trump has signed the GENIUS Act into law, setting new regulations for stablecoins, a type of cryptocurrency tied …

FDA investigating risk of acute liver failure with Sarepta gene therapies

As of July 18, 2025, the Food and Drug Administration said it has received three reports of fatal acute liver failure following treatment of patients with Sarepta (SRPT) AAVrh74 gene therapies that appear to have been caused by the gene therapy products as …

FDA Wants Elevidys Off the Market. Sarepta Said No.

The FDA has asked Sarepta Therapeutics to stop shipping Elevidys (delandistrogene moxeparvovec), its gene therapy for Duchenne muscular dystrophy, but according to regulatory officials, Sarepta leaders refused. “Based on our comprehensive scientific …

STAT+: Sarepta Therapeutics crisis is huge blow to Duchenne families, company

Sarepta Therapeutics confronted one of the most serious crises in its history on Friday, rebuffing a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular dystrophy over safety issues, even as patients …

Sarepta downgraded to Sell from Hold at Deutsche Bank

Deutsche Bank downgraded Sarepta (SRPT) to Sell from Hold with a price target of $9, down from $25. The shares traded down sharply after a cascade of negative news that culminated with media reports that the FDA is requesting the company voluntarily halt …

Sarepta says will continue to ship Elevidys to ambulant population

Sarepta (SRPT) Therapeutics issued a statement which reads in part: “Shortly after 2:30 p.m. ET today, Sarepta received an informal request from the U.S. Food and Drug Administration to voluntarily halt shipment of Elevidys, our gene therapy for Duchenne …

Opinion: We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress

They say death is one of life’s few certainties. For a boy or young man living with Duchenne muscular dystrophy, that certainty has a cruel twist: the anticipation of dying young. As mothers of children with this disease, we have wept helplessly in recent …

End-To-End Solutions in Pharma Logistics Creating Difference

There is no shred of doubt that every stage of the pharmaceutical supply chain happens to be critical if the life-saving drugs are to make it to the market and patients who need them, all on time. It is well to be noted that the global challenges continue …

Jaya Biosciences receives patent notices of allowance in Singapore, Japan & China to treat neurological diseases ...

Jaya Biosciences Inc, a privately held early-stage life-sciences company developing CNS-directed gene therapies for unmet needs in the neurodegenerative diseases, announced official patent notices of allowance in Singapore, Japan and China on July 6th, …

Houzeo’s Latest Mobile App Feature Transforms the Home Searching Process in Colorado

From Denver to Aspen to Grand Junction, Houzeo’s new Intuitive Filters feature helps buyers across Colorado find the right home smartly with a click. DENVER, CO, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- Houzeo, America’s Real Estate …

Houzeo's Latest Mobile App Feature Makes Home Search Easy for New York Buyers

New York buyers get a game-changing tool to help them search for homes smartly using interactive filters. NEW YORK CITY, NY, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- Houzeo, America’s Real Estate Super App, has a new mobile app feature …

Houzeo’s New Advanced Search Filters Enables Buyers to Do Home Searches in Ohio Smartly

Houzeo’s new ‘Intuitive Filters’ feature lets Ohio buyers use advanced map-based filters to search for their dream homes without endless scrolling. COLUMBUS, OH, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- Houzeo, America’s Real Estate …

Houzeo Unveils New Search Filters on its Mobile App for Quicker Home Searches in Missouri

New map-based filters let Missouri buyers search for new homes in Kansas City or find investment opportunities in Joplin without stepping out of their homes. ST. LOUIS, MO, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- Houzeo, America’s …

Houzeo's Mobile App Gets a New Feature to Streamline Home Search in South Carolina

Houzeo’s new map-based feature lets homebuyers find relevant homes like a pro, with just a click on their mobile phones. CHARLESTON, SC, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- Houzeo, America’s Real Estate Super App, now has …

Breaking barriers: Novel fatty acid solution preparation improves cellular lipid research

GA, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- Fatty acids (FAs) are pivotal to numerous cellular processes, from energy storage to signaling. However, their insolubility in water has long posed a challenge for researchers. A new method …

Next-gen GNSS delivers real-time positioning with centimeter accuracy

GA, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- In an era of growing demand for real-time precision navigation, researchers have unveiled a powerful leap forward in satellite-based positioning. Leveraging new-generation Global Navigation …

Irish Systemization Firm Helps Over 50 Global Business Owners Cut Their Workload by 80%

GALWAY, IRELAND, July 19, 2025 /⁨EINPresswire.com⁩/ -- A growing number of overworked business owners across six countries are reclaiming their time and rebuilding their lives thanks to an Irish firm that promises — and guarantees — a business that …

Gaming Industry Veterans Launch Gardigaming Platform to Address Coverage Crisis

Expert hub consolidates reviews, news, and guides across all gaming platforms, including PC, console, mobile, and emerging technologies. NEW MEADOWS, ID, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- Gardigaming, a comprehensive gaming …

Cryptopolitan's Newly Released Report Reveals Whether Web3 is Fragmenting or Maturing

LONDON, UNITED KINGDOM, July 20, 2025 /⁨EINPresswire.com⁩/ -- Cryptopolitan, a leading multilingual Web3 media platform and research desk, announced today the release of its latest in-depth Web3 report. "Modular Mania: Is Web3 Fragmenting or …

Cure-in enters global medical device market with ‘MR-SON,’ an MRI-guided automated breast biopsy robot

Targeting U.S. and European markets with precision and convenience-enhancing automation PANGYO, GYEONGGI-DO, SOUTH KOREA, July 19, 2025 /⁨EINPresswire.com⁩/ -- Cure-in Inc. (co-CEOs Yung-Ho Jo and Samuel Byeongjun Park), a medical robotics company …

From Students to Seniors: PanBrain EC2 Blue Cognitive Enhances Focus, Memory, and Sleep

Boost focus, sharpen memory, and enhance mental clarity anytime, anywhere with the most advanced all-in-one brain training device. WA, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- If you’ve ever found yourself zoning out during an …

ITSC Group Presents Research on Bias in AI-Generated Language Assessments Featured at NCSA 2025

ITSC presented research on AI bias in language testing at NCSA 2025, highlighting the need for equity-minded, human-guided assessment design. DENVER, CO, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- ITSC Group was selected to present at …

MyBTCX.com Adds Google Pay for Instant Global Crypto Purchases

Android & Chrome users in 50+ countries can now buy Bitcoin and other crypto in seconds with Google Pay on MyBTCX.com a fast, secure, non-custodial experience. SAN FRANCISCO, CA, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- MyBTCX.com …

AI CERTs® Launches AI+ Engineer™ Certification to Build the Next Generation of Scalable AI Solutions

NEW YORK, NY, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- As industries worldwide race to embed artificial intelligence (AI) into the core of their operations, AI CERTs®, a leading global provider of vendor-aligned, role-focused …

Equator Launches EZ 4650 CV Marine Combo Washer-Dryer for Onboard Laundry Efficiency

HOUSTON, TX, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- Equator Advanced Appliances has introduced the EZ 4650 CV Marine Combo Washer-Dryer, engineered specifically for marine environments. With a compact footprint and advanced corrosion- …

AI CERTs® Launches AI+ Developer™ Certification to Upskill Global Talent in Applied AI Development

NEW YORK, NY, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- AI CERTs®, a leading global provider of vendor-aligned, role-focused certifications in artificial intelligence (AI), has officially launched its AI+ Developer™ certification program …

AI CERTs® Unveils AI+ Architect™ Certification to Power Scalable, Future-Ready AI System Design

NEW YORK, NY, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- AI CERTs®, a leading global provider of vendor-aligned, role-focused certifications in artificial intelligence, has announced the launch of its latest advanced credential, AI+ …

Chime V5 Achieves Microsoft 365 Certification, Validating Commitment to Security, Compliance, and Customer Trust

PORTSMOUTH, NH, UNITED STATES, July 18, 2025 /⁨EINPresswire.com⁩/ -- Instant Technologies, a leader in AI-powered service desk software, proudly announces that its flagship application, Chime V5, is now officially Microsoft 365 Certified. This …

leagend Introduces Battery Remote Monitoring Solution to Power in Energy Storage and Data Center Infrastructure

leagend SOLUTIONS has unveiled its Battery Remote Monitoring Solution for both energy storage systems (ESS) and data center UPS infrastructures. NEW YORK, NY, UNITED STATES, July 19, 2025 /⁨EINPresswire.com⁩/ -- As the world becomes increasingly …