Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T

The St. Louis-based biotech hopes to submit an application for its leukemia and lymphoma therapy in 2027, if all goes well in an ongoing trial. 

By Kristin Jensen • Aug. 27, 2025

Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field

Stealth secured a new agency review of its experimental therapy elamipretide after a rejection this year. The result could carry broader consequences.

By Alexandra Pecci • Aug. 26, 2025

Explore the Trendline➔

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

FDA cancels adcomm on Biohaven drug; Catalent lays off staff

Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff at a gene therapy facility.

By BioPharma Dive staff • Aug. 22, 2025

FDA approves Ionis’ hereditary angioedema drug

Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition. Ionis set its list price at $57,462 per dose.

By Gwendolyn Wu • Updated Aug. 21, 2025

Gilead dives into ‘in vivo’ cell therapy with $350M buyout of Interius

The deal gives Gilead ownership of a technology that can genetically modify immune cells inside the body, an approach could that potentially widen access to CAR-T treatment.

By Jonathan Gardner • Aug. 21, 2025

Sarepta pushes off debt payments in bid to regain financial footing

A refinancing deal will delay the maturity of $700 million in debt until 2030, allowing the company to “fully fund” its pipeline and meet its near-term financial obligations, CEO Doug Ingram said. 

By Kristin Jensen • Aug. 21, 2025

Xoma, a drug royalty specialist, buys another ‘zombie’ biotech

A deal to acquire Alkermes spinout Mural Oncology is Xoma’s fourth since June and the latest evidence of interest in buying and shutting down struggling drugmakers.

By Ben Fidler • Aug. 20, 2025

Viking shares sink as obesity pill misses expectations in key study

The company’s market value was nearly cut in half following trial results showing higher rates of treatment discontinuations among people receiving Viking’s drug. 

By Jonathan Gardner • Aug. 19, 2025

CSL to separate vaccine business, cut jobs

On an earnings call, CSL CEO Paul McKenzie described weakness in the U.S. market for seasonal flu vaccines as “disappointing” and “highly irrational.”

By Delilah Alvarado • Aug. 19, 2025

PTC drug for Friedrich’s ataxia rejected; Lilly sells nearly $7B in bonds

The FDA said data for PTC's drug did not prove "substantial evidence of efficacy." Elsewhere, the FDA delayed its decision on a Regenxbio gene therapy and Skyhawk Therapeutics struck a deal.

By BioPharma Dive staff • Aug. 19, 2025

Omega’s Otello Stampacchia on the ‘reset’ changing biotech for the better

Tough times in the industry are forcing changes in investment and governance that should result in a healthier sector, the Omega Funds founder said.

By Gwendolyn Wu • Aug. 19, 2025

Stealth resubmits rare disease drug to FDA

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency’s concerns and now sees potential for a speedy review.

By Jonathan Gardner • Aug. 18, 2025

Kennedy’s mRNA cuts could set US science back, experts warn

Scientists say HHS’ decision to defund mRNA vaccine research will leave the country less prepared for pandemics, and make it harder to invest in companies advancing the technology.

By Delilah Alvarado • Aug. 18, 2025

Reunion’s psychedelic drug headed to late-stage testing

The drug, which functions similar to psilocybin, scored positive enough results in a mid-stage study that Reunion is now setting up a larger experiment to hopefully secure approval in postpartum depression.

By Jacob Bell • Aug. 18, 2025

Novo’s Wegovy becomes first GLP-1 drug approved for MASH

The FDA clearance sets Novo’s medicine up for a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.

By Ben Fidler • Aug. 18, 2025

Precigen wins immunotherapy approval; Pfizer sickle cell drug fails trial

The FDA’s announcement of Papzimeos’ approval contained an unusual quote from newly reinstated CBER director Vinay Prasad. Elsewhere, Eli Lilly and Superluminal Medicines struck a deal.

By BioPharma Dive staff • Aug. 15, 2025

Vedanta, PureTech’s microbiome startup, to cut staff after study setback

The result marks the latest failure for a microbiome therapy in inflammatory bowel disease, which has long been a top target of Vedanta and other companies like it.

By Ben Fidler • Aug. 14, 2025

PureTech launches new biotech built around lung disease drug

The spinout, known as Celea Therapeutics, will advance what’s designed to be an improved version of the drug pirfenidone for idiopathic pulmonary fibrosis. 

By Delilah Alvarado • Aug. 12, 2025

Bayer buys into KRAS cancer drug; Novartis immune therapy goes 3 for 3

The German pharma will license a KRAS G12D inhibitor from Kumquat Biosciences. Elsewhere, a Biohaven OCD drug missed its study goal, while Biogen and Stoke began a key Phase 3 test.

By BioPharma Dive staff • Aug. 12, 2025

Expedition, a startup searching for drugs from China, cuts its first deal

The startup agreed to pay Fosun Pharma as much as $645 million for a drug in testing for multiple lung conditions, including bronchiectasis.

By Ben Fidler • Updated Aug. 12, 2025

IO Biotech sees path forward for skin cancer vaccine despite study setback

A regimen involving the company’s shot failed a Phase 3 trial “by a hair,” an executive said, leading the company to believe it still could win U.S. approval.

By Jonathan Gardner • Aug. 11, 2025

As gene therapy sales sputter, one biotech aims to defy the odds

With a strong launch underway for a bladder cancer gene therapy, Ferring is finding the kind of commercial success that’s eluded many of its peers.

By Meagan Parrish • Aug. 11, 2025

Vinay Prasad, in surprise reversal, to rejoin FDA after abrupt departure

One analyst speculated that, going forward, Prasad may be less “heavy-handed” in reviewing rare disease therapies given the public backlash to the agency’s confrontation with Sarepta.

By Ben Fidler • Updated Aug. 11, 2025

BioNTech ends patent fight with mRNA rival CureVac ahead of buyout deal

The complex settlement, which hands payouts and royalties to CureVac and partner GSK, comes as BioNTech is inching toward an acquisition of its one-time COVID-19 vaccine competitor.

By Jonathan Gardner • Aug. 8, 2025

Elevidys sales weaken; Neumora gets into obesity

Sarepta reported a quarter-on-quarter dip in sales for its Duchenne gene therapy. Elsewhere, Jazz won FDA approval of a brain cancer drug and Novo decided to advance a Prothena medicine into Phase 3.

By BioPharma Dive staff • Aug. 8, 2025