Capricor soars on positive results for Duchenne cell therapy

Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first treatment for heart-related complications of Duchenne.

By Kristin Jensen • Dec. 3, 2025

Pharvaris’ pill succeeds in late-stage trial for rare swelling disorder

Phase 3 data could make the Dutch biotech's drug competitive in the increasingly crowded market of hereditary angioedema treatments.

By Jonathan Gardner • Dec. 3, 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

Janux sinks on ‘overreaction’ to prostate cancer data; RFK Jr. replaces ACIP chair

Janux’s “masked” T cell engager had a lower response rate than reported last year. Elsewhere, Lilly dropped Zepbound’s price and ACIP named a new chairman days before a key vaccine meeting.

By BioPharma Dive staff • Dec. 2, 2025

Belite continues ascent as Stargardt drug hits mark in late-stage trial

The results position Belite, one of the sector’s top-performing companies since 2022, to seek approval of what could be the first marketed medicine for the rare eye condition.

By Ben Fidler • Dec. 1, 2025

With $130M, Protego pushes forward a new type of amyloidosis drug

The startup’s lead prospect stabilizes abnormal proteins in patients with amyloid “light chain” amyloidosis, an approach that could represent a step forward compared to current therapies. 

By Gwendolyn Wu • Dec. 1, 2025

From feedstocks to infrastructure, Indiana’s bioeconomy is on the move

Indiana shows high potential for the state to become the premiere destination to research, commercialize, scale biotechnology processes, platforms and products.  

Dec. 1, 2025

Otsuka gains approval for first-of-its-kind treatment against rare kidney disease

In a rapidly heating market, Otsuka is the first to secure FDA clearance for an "anti-APRIL" therapy targeting IgA nephropathy.

By Delilah Alvarado • Nov. 26, 2025

Biogen strikes deal with Versant-backed biotech to expand immune portfolio

Newly launched Dayra Therapeutics has agreed to identify for Biogen "oral macrocycle candidates" that go after "high-priority immunological targets."

By Delilah Alvarado • Nov. 24, 2025

FDA tests new program to speed drugmaker talks; Bezos-linked AI startup raises $106M

The FDA will now allow biotechs to ask agency staff for “quick clarifications” via email. Elsewhere, Novartis hiked guidance for two top drugs and a startup nearing “unicorn” status secured a megaround.

By BioPharma Dive staff • Nov. 21, 2025

Moderna secures $1.5B lifeline as it looks to break even in 2028

At an analyst day event, Moderna said it wants to invest revenue from a hopefully expanded seasonal vaccine franchise into oncology and rare disease programs, to “set the stage for additional growth in 2027 and 2028.”

By Delilah Alvarado • Nov. 20, 2025

Aspen raises $115M for a Parkinson’s stem cell treatment

The cell therapy maker said Thursday the raise will support an ongoing trial of its experimental treatment for the neurodegenerative condition, as well as plans for building its manufacturing capabilities.

By Gwendolyn Wu • Nov. 20, 2025

Agios shares fall on mixed sickle cell results for blood disease drug

Pyrukynd, which Agios sells for a rare type of anemia, missed one of its main objectives in a study seen as crucial for its commercial outlook and the company’s reinvention as a rare disease specialist.

By Jonathan Gardner • Nov. 19, 2025

Alkermes escalates bidding war; US biotech risks ‘falling behind’ China

A bipartisan report warned Congress about China’s growing control over the pharmaceutical supply chain. Elsewhere, Alkermes sweetened its bid for Avadel and Moderna is investing $140 million in U.S. drug production.

By BioPharma Dive staff • Nov. 19, 2025

RNAi biotech Arrowhead wins first FDA approval

The clearance of Redemplo for a rare genetic disorder marks Arrowhead’s transition, after two decades, into a commercial-stage company and sets up a turf war with Ionis Pharmaceuticals.

By Delilah Alvarado • Updated Nov. 18, 2025

Zymeworks to change course, pursue ‘royalty-driven’ biotech model

On the heels of a data readout suggesting one of its cancer drugs could become a future blockbuster, Zymeworks is adopting a new strategy its CEO says will create “more consistent value for shareholders.”

By Gwendolyn Wu • Nov. 18, 2025

J&J adds to pharma’s M&A spree with $3B buyout of startup Halda

The deal gives J&J access to a pipeline of drugs designed to “hold and kill” tumors, led by a prostate cancer medicine that’s shown promise in early-stage testing. 

By Jonathan Gardner • Nov. 17, 2025

FDA limits Elevidys use; Nxera to lay off staff

Elevidys now has a “boxed” warning and is no longer available for Duchenne patients who can’t walk. Elsewhere, Nuvalent and Zymeworks unveiled data for targeted cancer drugs.

By Ben Fidler • Nov. 17, 2025

Solve lines up $120M to push ADCs into further testing

The startup, which is backed by a dozen investors including Merck & Co., claims its novel “linkers” can help address some of the issues limiting the potential of earlier ADCs. 

By Delilah Alvarado • Nov. 17, 2025

A ‘DNA damage repair’ drugmaker raises $115M for cancer treatments

Artios Pharma, which looking for newer targets that, like PARP inhibitors, affect the way tumors fix themselves, said its Series D round will help advance ongoing mid-stage studies.

By Gwendolyn Wu • Nov. 17, 2025

Sofinnova Partners raises another $750M to back biotech, medtech startups

The new fund will mostly support biotechs making new drugs, with investments spanning from initial financings to follow-on rounds. 

By Gwendolyn Wu • Nov. 16, 2025

Lundbeck sparks bidding war with Alkermes; Pfizer closes Metsera deal

Pfizer quickly consummated the $10 billion buyout after one-upping Novo Nordisk. Elsewhere, Lundbeck submitted a rival offer for Avadel Pharmaceuticals and Zealand Pharma dropped an obesity drug.

By BioPharma Dive staff • Nov. 14, 2025

Medicxi closes sixth fund to back ‘asset-centric’ startups

The European venture firm raised 500 million euros, or about $579 million, for its latest fund, which follows a flurry of recent buyout deals involving portfolio companies like Merus and Vicebio.

By Gwendolyn Wu • Nov. 14, 2025

Day One snaps up ADC maker Mersana in backloaded buyout deal

After multiple clinical setbacks and layoff rounds, Mersana accepted an offer in which the bulk of the payouts will only materialize if its main cancer drug hits a variety of milestones.

By Jonathan Gardner • Nov. 13, 2025

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