Metagenomi, Ovid CEOs step aside; Cogent soars on ‘unprecedented’ stomach cancer data

Metagenomi is laying of 25% of its staff while switching up leadership. Elsewhere, Ovid announced a CEO succession plan and Cogent Biosciences and Galecto saw their shares skyrocket. 

By Ben Fidler • Nov. 12, 2025

Neurocrine chalks up a depression drug failure

Analysts suspected that the mid-stage trial miss wouldn't ding Neurocrine’s share price since expectations around the program were "near-zero."

By Jacob Bell • Nov. 10, 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

Lilly picks up an eye gene therapy in deal with MeiraGTx

The alliance extends a deal streak in genetic medicine for Lilly and hands the company rights to an experimental treatment for an ultra-rare form of childhood blindness.

By Gwendolyn Wu • Nov. 10, 2025

Patient dies in Intellia trial; FDA awards 6 more ‘national priority’ vouchers

The death of a study volunteer further complicates the path forward for Intellia’s on-hold rare disease treatment. Elsewhere, Gilead reported a setback and J&J netted a first-of-its-kind approval.

By BioPharma Dive staff • Nov. 7, 2025

AstraZeneca exercises option to buy an obesity startup

The pharma giant disclosed in an earnings report that it paid $170 million up front to acquire SixPeaks Bio, a weight loss-focused startup it helped launch last year.

By Gwendolyn Wu • Nov. 6, 2025

Moderna leans on cost cuts, pipeline as vaccine sales dip

Despite quarterly revenue totals that were nearly cut in half compared to the same period last year, Moderna still expects to break even financially in 2028 with the help of more disciplined spending. 

By Delilah Alvarado • Nov. 6, 2025

Evommune nabs $150M in IPO amid federal shutdown

The immune drugmaker is the second biotech, along with MapLight Therapeutics, to recently use a workaround in U.S. securities law to price an offering during the shutdown. 

By Gwendolyn Wu • Nov. 5, 2025

Soleno slumps despite sales uptick; Madrigal’s MASH drug continues ascent

Soleno shares fell double digits amid questions about the growth trajectory of its Prader-Willi drug. Elsewhere, a cancer medicine at the center of a $1.9 billion buyout fell short in a key trial. 

By BioPharma Dive staff • Nov. 5, 2025

Braveheart secures $185M to advance challenger to Bristol Myers heart drug

The startup is advancing a drug licensed from China’s Hengrui Pharma that it claims could be “best-in-class” among a group of similar treatments for hypertrophic cardiomyopathy.

By Ben Fidler • Nov. 5, 2025

Vertex’s new pain, blood disorder drugs miss Wall Street expectations

While the launches of Journavx and Casgevy have started to build steam, “investors may not be inclined to look past the clear revenue misses,” wrote a Raymond James analyst.

By Jacob Bell • Nov. 4, 2025

Sarepta Duchenne drugs come up short in confirmatory test

Still, CEO Doug Ingram claimed removing the two drugs, Vyondys 53 and Amondys 45, from market would make “little sense” and that the evidence accrued to date makes a strong case for full approval.

By Ben Fidler • Nov. 4, 2025

Neok Bio launches with $75M to make dual-targeting ADCs

The startup claims its medicines may be able to overcome the limitations of conventional antibody-drug conjugates by simultaneously homing in on “unique pairs” of cancer targets. 

By Delilah Alvarado • Nov. 4, 2025

UniQure dives after FDA’s ‘very surprising’ reversal on Huntington’s gene therapy

The FDA’s abrupt shift on UniQure’s treatment reflects an agency that, under current leadership, is as unpredictable as it's been in years, some analysts said.

By Jacob Bell • Nov. 3, 2025

Caribou results suggest renewed promise for ‘off-the-shelf’ cancer cell therapy

While early, the data support Caribou’s plan to boost its therapies’ effectiveness by using donor cells that are carefully matched to a patient’s immune system. 

By Jonathan Gardner • Nov. 3, 2025

Tidmarsh resigns from CDER; Kenvue to sell to Kimberly-Clark

George Tidmarsh’s short run directing the agency’s principal drug review office reportedly ended in controversy. Elsewhere, Moderna advanced a T-cell engager and Lilly expanded a production push for its GLP-1 pill.

By BioPharma Dive staff • Nov. 3, 2025

Roche taps an AI specialist to craft new brain drugs

For $55 million, Roche gains access to Manifold Bio’s drug discovery technology, which will be used to develop new “shuttles” that can get medicines across the blood-brain barrier.

By Jacob Bell • Nov. 3, 2025

Corporate venture firms stepped in for drug startups during biotech funding pullback

According to a new BioPharma Dive analysis, corporate-related funds such as Novo Holdings, Eli Lilly and Sanofi Ventures have been among the most active investors in biotech startups this year.

By Gwendolyn Wu • Oct. 31, 2025

Earnings roundup: Alnylam’s down day, Neurocrine’s head scratch and Biogen’s ‘low quality’ win

Alnylam and Neurocrine shares tumbled despite upbeat sales reports. Elsewhere, Biogen is dealing with what one analyst called “lackluster” appeal and Bristol Myers’ prized schizophrenia drug again underwhelmed.

By Jacob Bell , Ben Fidler • Oct. 30, 2025

FDA places formal hold on two Intellia CRISPR trials

Two days after Intellia voluntarily paused dosing due to safety concerns, the regulator stepped in with an official hold that makes a longer halt more likely. 

By Delilah Alvarado • Oct. 30, 2025

BridgeBio chalks up another win for its rare disease research

The company reported its second late-stage study success, this time with a drug that could become a new treatment standard for an uncommon endocrine disease.

By Ben Fidler • Oct. 29, 2025

GSK adds to COPD drug push with Empirico deal

GSK is shelling out $85 million up front, and possibly $745 million overall, for an RNA-based therapy it sees helping a "broad spectrum" of people with the chronic lung condition. 

By Kristin Jensen • Oct. 28, 2025

Incyte trims pipeline; Zenas surges on MS drug results

Incyte axed three prospects to focus on “high-value programs,” its CEO said. Elsewhere, MapLight priced an IPO during the federal government shutdown and GSK picked up a cancer drug.

By BioPharma Dive staff • Oct. 28, 2025

Zag Bio emerges with plans to treat immune disease by targeting the thymus

With $80 million in funding from a list of high-profile backers, the startup is developing bifunctional antibodies that drag “tolerizing” antigens to the thymus.

By Gwendolyn Wu • Oct. 28, 2025

BioMarin, following sluggish sales, to offload hemophilia gene therapy

The company intends to divest Roctavian and “remove it from our portfolio,” CEO Alexander Hardy said, after nearly three years of slow uptake for a medicine once viewed as a future blockbuster.

By Ben Fidler • Oct. 27, 2025

Intellia pauses two CRISPR drug studies after safety scare

A study volunteer receiving Intellia’s transthyretin amyloidosis treatment was hospitalized due to severe signs of liver stress, prompting the company to pause enrollment and dosing while evaluating a new safety protocol. 

By Jonathan Gardner • Oct. 27, 2025