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STAT is a health and science news site; this feed focuses on biotech – covering the discoveries, personalities, and business deals driving the biotech industry.

STAT+: FDA Rejection Is a Reality Check on Agency Rhetoric

The U.S. Food and Drug Administration rejected a rare‑disease cell therapy that had already secured approval in Europe, despite earlier internal support from the agency. The decision comes under the FDA’s new leadership and has sparked debate over whether the agency’s public rhetoric aligns with its regulatory actions. Concurrently, Sarepta Therapeutics announced its CEO’s departure, adding another layer of uncertainty to the biotech sector. The episode underscores the fragile balance between innovation, regulatory scrutiny, and market confidence.

By STAT (Biotech)

News•Feb 26, 2026

STAT+: Rare Disease Advocates Fume over FDA’s Mixed Signals

The FDA has rejected Regenxbio’s gene therapy for mucopolysaccharidosis type 2, citing a need for additional data that could postpone approval by years. This decision adds to at least four other recent rejections of cell or gene therapies targeting deadly rare...

By STAT (Biotech)

News•Feb 26, 2026

STAT+: Sarepta Therapeutics CEO Doug Ingram Will Retire After a Tumultuous Decade

Sarepta Therapeutics CEO Doug Ingram announced his retirement, ending a decade that lifted the biotech to a $15 billion valuation by securing approvals for three Duchenne muscular dystrophy (DMD) therapies. The company’s market value subsequently collapsed amid a safety investigation into...

By STAT (Biotech)

News•Feb 25, 2026

STAT+: A Rare Disease Drug Was Approvable, Then It Wasn’t. Inside a Surprise Rejection by the FDA

An experimental cell therapy for a rare post‑transplant blood cancer, developed by Atara Biotherapeutics and Pierre Fabre, was initially deemed approvable by FDA reviewers but was abruptly rejected in February 2026 over alleged clinical data deficiencies. The disease affects roughly...

By STAT (Biotech)

News•Feb 25, 2026

STAT+: Novo Doubles Down on Oral Peptides

Novo Nordisk announced a major expansion of its oral peptide platform, committing additional capital to bring next‑generation oral GLP‑1 candidates to market within the next few years. At the same time, Alkermes CEO Richard Pops will retire after a 35‑year...

By STAT (Biotech)

Deals•Feb 25, 2026

GSK to Acquire 35Pharma for Under $1B

GlaxoSmithKline (GSK) announced the acquisition of privately held 35Pharma, a developer of a pulmonary arterial hypertension drug. The cash deal is valued at just under $1 billion, expanding GSK’s pipeline in respiratory and immunology.

STAT (Biotech)

News•Feb 24, 2026

STAT+: Drugmakers Lay Out Their Legal Arguments Against Trump’s Drug Pricing Experiments

Pharmaceutical and biotech firms are mobilizing against two Trump administration proposals that would tie Medicare drug prices to those paid in other affluent nations. The initiatives – the GLOBE model for Part B physician‑administered drugs and the GUARD model for Part D...

By STAT (Biotech)

News•Feb 24, 2026

STAT+: New Treatment Approach Could Give IBD Patients Hope, and Be a Bonanza for Drugmakers

A new combination‑therapy approach for inflammatory bowel disease (IBD) aims to boost remission rates beyond the current 30 % success benchmark. By pairing agents that target distinct immune pathways, early trials show remission climbing to roughly 55 % and faster mucosal healing....

By STAT (Biotech)

News•Feb 23, 2026

STAT+: Gossamer Lung Disease Drug Fails Late-Stage Study, but Company Will Still Seek FDA Approval

Gossamer Bio announced that its Phase 3 trial of seralutinib for pulmonary arterial hypertension missed its primary endpoint. Patients on seralutinib walked 13 meters farther than placebo over six minutes, but the difference lacked statistical significance. The trial also reported cough...

By STAT (Biotech)

News•Feb 23, 2026

STAT+: Gilead to Buy Arcellx in Nearly $8B Deal

Gilead Sciences announced a $7.8 billion acquisition of Arcellx, pricing the deal at $115 per share—a 79% premium to the prior close. The agreement includes an additional $5 per share contingent on future sales milestones. Central to the transaction is anito‑cel,...

By STAT (Biotech)

News•Feb 19, 2026

STAT+: Key Study of Grail’s Cancer Detection Test Fails in Setback for Company

Grail’s multi‑cancer blood test Galleri failed to meet its primary endpoint in a large NHS‑partnered study, casting doubt on its early‑detection claims. The test, priced at $1,000, generated $136.8 million from 185,000 units sold in 2025 but remains unapproved by the...

By STAT (Biotech)

News•Feb 19, 2026

STAT+: In First Speech to Her FDA Staff, Høeg Says She’ll Scrutinize RSV Shots and SSRIs in Pregnancy

FDA Commissioner Tracy Beth Høeg, in her inaugural staff address, announced a renewed focus on evaluating the safety of antidepressants prescribed during pregnancy and monoclonal antibody RSV prophylaxis for infants. She highlighted gaps in existing safety monitoring and pledged more...

By STAT (Biotech)

News•Feb 19, 2026

STAT+: What to Expect From Gossamer Bio’s Late-Stage Lung Disease Study

Gossamer Bio is set to announce results from its Phase 3 trial in pulmonary arterial hypertension (PAH) before the end of February. The readout follows a Phase 2 study that delivered modest, sub‑par efficacy, which the company attributes to an...

By STAT (Biotech)

News•Feb 18, 2026

STAT+: The FDA’s Moderna Pirouette Is One More Sign of Chaos at the Agency

The FDA initially issued a refuse‑to‑file letter for Moderna’s mRNA influenza vaccine, then reversed course within a week and agreed to review the product. The agency will now consider two separate pathways: full approval for adults 50‑64 and accelerated approval...

By STAT (Biotech)

News•Feb 18, 2026

STAT+: Biotech Startup Raises $175 Million to Advance Alzheimer’s Antibody Therapy

Korsana Biosciences announced a $175 million financing round led by Fairmount, Venrock, Wellington Management and TCGX to develop its Alzheimer’s antibody candidate KRSA‑028. The startup positions KRSA‑028 as a next‑generation “brain shuttle” designed to clear amyloid plaques more efficiently than existing...

By STAT (Biotech)

Deals•Feb 9, 2026

Aerska Raises $39M in Back-to-Back Financing to Advance Brain Gene‑silencing Therapies

Irish‑British biotech Aerska, developing brain‑shuttle technology to deliver siRNA across the blood‑brain barrier, announced a $39 million financing round. The new funding follows a prior raise just four months earlier and will support development of treatments for neurological diseases. Investors were...

STAT (Biotech)

Deals•Feb 9, 2026

Eli Lilly to Acquire Orna Therapeutics for $2.4 Billion

Eli Lilly announced it will acquire biotech firm Orna Therapeutics for up to $2.4 billion. Orna's in vivo CAR-T and circular RNA technology targets autoimmune diseases, expanding Lilly's cell-therapy pipeline.

STAT (Biotech)

Technology Pulse

STAT (Biotech)

Recent Posts

STAT+: FDA Rejection Is a Reality Check on Agency Rhetoric

STAT+: Rare Disease Advocates Fume over FDA’s Mixed Signals

STAT+: Sarepta Therapeutics CEO Doug Ingram Will Retire After a Tumultuous Decade

STAT+: A Rare Disease Drug Was Approvable, Then It Wasn’t. Inside a Surprise Rejection by the FDA

STAT+: Novo Doubles Down on Oral Peptides

GSK to Acquire 35Pharma for Under $1B

STAT+: Drugmakers Lay Out Their Legal Arguments Against Trump’s Drug Pricing Experiments

STAT+: New Treatment Approach Could Give IBD Patients Hope, and Be a Bonanza for Drugmakers

STAT+: Gossamer Lung Disease Drug Fails Late-Stage Study, but Company Will Still Seek FDA Approval

STAT+: Gilead to Buy Arcellx in Nearly $8B Deal

STAT+: Key Study of Grail’s Cancer Detection Test Fails in Setback for Company

STAT+: In First Speech to Her FDA Staff, Høeg Says She’ll Scrutinize RSV Shots and SSRIs in Pregnancy

STAT+: What to Expect From Gossamer Bio’s Late-Stage Lung Disease Study

STAT+: The FDA’s Moderna Pirouette Is One More Sign of Chaos at the Agency

STAT+: Biotech Startup Raises $175 Million to Advance Alzheimer’s Antibody Therapy

Aerska Raises $39M in Back-to-Back Financing to Advance Brain Gene‑silencing Therapies

Eli Lilly to Acquire Orna Therapeutics for $2.4 Billion

Technology Pulse

STAT (Biotech)

Recent Posts

STAT+: FDA Rejection Is a Reality Check on Agency Rhetoric

STAT+: Rare Disease Advocates Fume over FDA’s Mixed Signals

STAT+: Sarepta Therapeutics CEO Doug Ingram Will Retire After a Tumultuous Decade

STAT+: A Rare Disease Drug Was Approvable, Then It Wasn’t. Inside a Surprise Rejection by the FDA

STAT+: Novo Doubles Down on Oral Peptides

GSK to Acquire 35Pharma for Under $1B

STAT+: Drugmakers Lay Out Their Legal Arguments Against Trump’s Drug Pricing Experiments

STAT+: New Treatment Approach Could Give IBD Patients Hope, and Be a Bonanza for Drugmakers

STAT+: Gossamer Lung Disease Drug Fails Late-Stage Study, but Company Will Still Seek FDA Approval

STAT+: Gilead to Buy Arcellx in Nearly $8B Deal

STAT+: Key Study of Grail’s Cancer Detection Test Fails in Setback for Company

STAT+: In First Speech to Her FDA Staff, Høeg Says She’ll Scrutinize RSV Shots and SSRIs in Pregnancy

STAT+: What to Expect From Gossamer Bio’s Late-Stage Lung Disease Study

STAT+: The FDA’s Moderna Pirouette Is One More Sign of Chaos at the Agency

STAT+: Biotech Startup Raises $175 Million to Advance Alzheimer’s Antibody Therapy

Aerska Raises $39M in Back-to-Back Financing to Advance Brain Gene‑silencing Therapies

Eli Lilly to Acquire Orna Therapeutics for $2.4 Billion