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

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Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

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

Gilead leans on HIV drugs as oncology sales slow

The company is looking to the highly anticipated launch of a closely watched HIV medicine to offset weakening demand for Trodelvy and its cancer cell therapies.

By Delilah Alvarado • April 25, 2025

Halozyme sues Merck; FDA blames cuts for Vanda delay

Halozyme claims Merck infringed on patents in developing a subcutaneous form of Keytruda. Elsewhere, Vanda’s challenge to an FDA rejection dragged on, while Sanofi revealed an immune drug setback. 

By BioPharma Dive staff • April 25, 2025

Caribou, in reversal, scraps autoimmune cell therapy and cuts staff

The CRISPR company is laying off about a third of its employees and stopping work on an experimental lupus treatment in a bid to focus resources on a pair of cancer cell therapies.

By Ben Fidler • April 25, 2025

Versant startup Granite debuts with $100M and 2 immune drugs

The young biotech, sprung out of a Versant incubator in Switzerland, has a pair of antibody drugs it claims to have the potential to treat multiple autoimmune conditions.

By Gwendolyn Wu • April 24, 2025

Etiome, a new Flagship startup, looks to catch disease before it strikes

The biotech is using AI and a trove of health data to better understand why certain conditions progress and intervene beforehand with a targeted medication. 

By Gwendolyn Wu • April 24, 2025

German antibody maker valued at $1.6B in blank-check merger

The startup, Veraxa, has $253 million in cash and is raising a crossover funding round to support a pipeline of T-cell engagers and antibody-drug conjugates for cancer. 

By Kristin Jensen • April 23, 2025

Roche looks to a Flagship startup in search of new immune drugs

Repertoire Immune Medicines will get $35 million upfront, and possibly $730 million more, in a deal to help Roche’s Genentech division unearth T-cell targeting therapies for inflammatory diseases.  

By Gwendolyn Wu • April 23, 2025

Akeso claims another PD-1/VEGF win; FDA requests more data from Novavax

An ivonescimab-chemotherapy combination succeeded in a study in China. Elsewhere, the FDA asked Novavax for more COVID vaccine data and Regeneron boosted its manufacturing capabilities.

By BioPharma Dive staff • April 22, 2025

RFK Jr. is remaking HHS. Track the changes here.

Following an executive order from President Trump, the FDA plans to “aggressively deploy its available enforcement tools” to police direct-to-consumer drug ads.

By BioPharma Dive staff • Updated Aug. 28, 2025

Former Neumora CEO to lead Galapagos spinout

Henry Gosebruch is now chief executive of the spinout, which has roughly $2.5 billion and plans to use dealmaking to build a research pipeline targeting cancer, viruses and the immune system.

By Jacob Bell • April 22, 2025

An investment fund sets out to free biotech’s ‘trapped capital’

Alis Biosciences says its goal is to return to investors billions of dollars stuck on the balance sheets of “moribund” biotech companies that have suffered significant setbacks.  

By Gwendolyn Wu • April 18, 2025

Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales potential compared to other emerging medicines for the condition.

By Ben Fidler • April 18, 2025

GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

U.K. regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, RNA editing startup Airna tapped a former Sarepta executive to oversee its pipeline.

By BioPharma Dive staff • April 18, 2025