Bluebird extends deal deadline; Affimed files for insolvency

Shareholders in Bluebird now have a choice of two offers from would-be acquirers Carlyle and SK Capital. Elsewhere, Cytokinetics shared more aficamten data and BridgeBio started a new kind of Attruby trial.

By BioPharma Dive staff • May 14, 2025

Galapagos backtracks on planned split

Having now appointed Henry Gosebruch as CEO of the intact company, Galapagos says its priorities are exploring strategic options and “transformative” deals.

By Jacob Bell • May 13, 2025

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

iTeos, GSK to shelve TIGIT drug after study setback

The failure is the latest stumble for a cancer drug class that hasn’t lived up to expectations. iTeos will begin a strategic review in response. 

By Ben Fidler • May 13, 2025

FDA follows EMA in limiting use of Valneva shot

Reports of severe adverse events in some people who received the chikungunya vaccine have spurred regulators in Europe and now the U.S. to suspend use in older adults pending an investigation.

By Delilah Alvarado • May 12, 2025

Innovating a healthier tomorrow: Entering a new era of medicine

Explore the cutting-edge of science and learn how Danaher is advancing healthcare innovation

May 12, 2025

Eli Lilly extends Purdue alliance; EMA investigates Valneva shot

The big pharma will spend up to $250 million over the next eight years of the collaboration. Elsewhere, CRISPR Therapeutics unveiled new data and Vivo Capital raised funds.

By BioPharma Dive staff • May 9, 2025

4 more biotechs cut staff amid market tumult

Vor Bio, Korro Bio, Insitro and Rallybio revealed plans to lay off chunks of their respective workforces in the latest job cuts for a sector struggling to hold its financial footing. 

By Ben Fidler • May 8, 2025

Haya banks $65M to scour the ‘dark genome’ for new drugs

The startup’s first prospect is a heart medicine that works differently than the hypertrophic cardiomyopathy drugs developed by Bristol Myers and Cytokinetics.

By Ben Fidler • May 8, 2025

Sarepta shares plummet as lower sales outlook adds to gloom over FDA’s new biologics hire

Already facing headwinds caused by a patient’s death and treatment delays, the biotech now may have to contend with a less friendly FDA.

By Kristin Jensen • May 7, 2025

Bluebird pleads for deal support; Unity, Mersana lay off staff

Bluebird urged shareholders to back a take-private deal that could close imminently. Elsewhere, Unity Biotechnology began a strategic review and Mersana announced plans to cut more than half its workforce.

By BioPharma Dive staff • May 6, 2025

PTC stock slides on new data for Huntington’s drug

While updated study results confirmed the drug lowers a target protein, the therapy's effect on clinical outcomes was less clear-cut.

By Ned Pagliarulo • May 5, 2025

AI specialist Recursion trims pipeline in latest shakeup

The cuts to three advanced drug programs were “inevitable” given the company’s “unsustainable cash burn,” one analyst wrote in a note to investors. 

By Delilah Alvarado • May 5, 2025

Deerfield secures more than $600M for its next biotech venture fund

The firm, a prolific backer of drug startups, will use the cash to back companies working on therapeutics, medical devices and healthcare services.

By Ben Fidler • May 5, 2025

Cytokinetics reveals unexpected delay; AstraZeneca combo therapy hits in asthma

The FDA pushed back its decision date on Cytokinetics’ heart drug. Elsewhere, Repare Therapeutics licensed its drug discovery work, intellectual property and certain other assets into a newly launched startup.

By BioPharma Dive staff • May 2, 2025

Moderna combination flu, COVID shot delayed amid FDA scrutiny

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

By Delilah Alvarado • May 1, 2025

Arvinas, Entrada cut staff; Merck builds US hub for Keytruda

Arvinas is laying off about a third of its workforce, while Entrada is focusing more on Duchenne research. Elsewhere, Biogen talked down tariff impacts and Merck earmarked $1 billion for a biologics production plant.

By BioPharma Dive staff • May 1, 2025

Madrigal’s MASH drug sales again top Wall Street projections

Rezdiffra sales reached $137 million for the quarter, beating consensus analyst estimates by more than $20 million and continuing a faster-than-expected drug launch.

By Kristin Jensen • May 1, 2025

Siren, a gene therapy startup, tests unconventional alternative to venture funding

Siren Biotechnology is trying to raise $5 million via the type of crowdfunding round that’s rarely used by young drugmakers.

By Gwendolyn Wu • May 1, 2025

Novartis to acquire Regulus in deal for kidney disease drug

The pharma will pay $800 million for the biotech, which was launched nearly two decades ago by Alnylam and Ionis to advance microRNA technology.

By Gwendolyn Wu • April 30, 2025

BridgeBio sales of new heart drug outstrip expectations

In its first full quarter, Attruby made more headway than analysts anticipated in its competition with Pfizer’s market-leading drug.

By Kristin Jensen • April 30, 2025

Acelyrin should liquidate instead of merging with Alumis, investor says

Trium Capital is the latest firm to push a biotech “zombie” to shut down, claiming in a regulatory filing there is more upside to a liquidation than Acelyrin’s planned merger. 

By Ben Fidler • April 29, 2025

FDA misses approval deadline for biotech’s rare disease drug

The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.

By Gwendolyn Wu • Updated April 29, 2025

Novavax says vaccine application still ‘approvable,’ despite FDA delay

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” requiring additional clinical study.

By Delilah Alvarado • April 28, 2025

New Akeso, Summit data stir debate on PD-1/VEGF drugs

Interim results from a study in China suggest ivonescimab may reduce the risk of death versus Keytruda, but the difference wasn’t statistically significant.

By Ben Fidler • April 28, 2025

Biohaven stock slides on withdrawal of European marketing application

Currently under review in the U.S. for a rare genetic disorder, the drug is seen by some investors as critical to Biohaven’s future. Shares bounced back somewhat on Monday. 

By Jacob Bell • April 25, 2025