Praxis tees up another approval filing; Geron turns to layoffs

“Collaborative discussions” with the FDA encouraged Praxis to submit early next year an approval filing for its epilepsy drug. Elsewhere, Rezolute shares plunged and Centessa announced a new CEO.

By BioPharma Dive staff • Dec. 12, 2025

Biotech venture firm Apple Tree goes bankrupt amid dispute with billionaire backer

An unusual tussle over the availability of funds for Apple Tree’s startups led the firm to seek protection from creditors while it restructures.

By Gwendolyn Wu • Updated Dec. 11, 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 or in reprogramming cells inside the body.

By BioPharma Dive staff

Prolynx banks $70M for longer-lasting obesity drugs

Using a novel linker technology, the startup is developing versions of incretin and non-incretin therapies that can be administered monthly or quarterly. 

By Gwendolyn Wu • Dec. 11, 2025

A Roivant spinout bets on AI-designed drugs for immune conditions

PsiThera, formerly Psivant Therapeutics, raised just over $47 million for oral drugs targeting “diseases long-constrained by injectable-only approaches."

By Gwendolyn Wu • Dec. 10, 2025

FDA raises CAR-T approval standards; Novartis bets on an AI startup

CAR-T cancer therapies now need to succeed in randomized, controlled trials to earn approvals. Elsewhere, a drug from Bristol Myers Squibb and BioNTech proved effective in breast cancer patients.

By BioPharma Dive staff • Dec. 9, 2025

Terns drug shows potential to challenge Novartis’ blockbuster leukemia treatment

While early, study results presented at ASH show Tern’s drug could surpass Novartis’ Scemblix and “raise the bar in efficacy” for chronic myeloid leukemia medicines, the company’s CEO said.

By Jonathan Gardner • Dec. 8, 2025

Mirum gains a hepatitis D drug in $620M buyout of startup Bluejay

The deal, which includes another $200 million in potential payouts, hands the California biotech a candidate in late-stage testing for the most severe form of viral hepatitis. 

By Gwendolyn Wu • Dec. 8, 2025

Dyne to seek Duchenne drug approval; Kymera, Wave and Structure shares soar

Dyne is readying a competitor to Sarepta’s Exondys 51. Elsewhere, a pair of obesity drugs showed promise and Kymera’s protein-degrading medicine displayed “biologic-like or better efficacy,” according to one analyst.

By Ben Fidler • Dec. 8, 2025

Vertex CRISPR therapy hits early goal in children with blood disorders

Casgevy, now a "national priority" drug, helped kids with sickle cell and beta thalassemia, results which may help toward a label expansion and stronger commercial uptake.

By Jonathan Gardner • Dec. 6, 2025

RFK Jr.’s hand-picked panel questions childhood vaccine schedule

After weakening an endorsement for the hepatitis B vaccine, ACIP began debating the merits of the protocol used to inoculate U.S. children against many infectious diseases.

By Delilah Alvarado • Dec. 5, 2025

Praxis soars higher; Bristol Myers’ CAR-T therapy wins broader use

Praxis shares climbed another 40% on a pair of positive updates on two different drugs. Elsewhere, Bristol Myers’ Breyanzi was cleared for its fifth cancer indication and AstraZeneca expanded a rare disease deal.

By BioPharma Dive staff • Dec. 5, 2025

An Arch-backed biotech raises $53M to fight neurodegeneration

SciNeuro Pharmaceuticals represents the latest in a string of Arch investments directed at the nervous system, a notoriously challenging area of drug development.

By Jacob Bell • Dec. 4, 2025

UniQure slides further on outlook for Huntington’s gene therapy

Finalized minutes from a late-October meeting with the FDA confirm the agency doesn't see the data collected so far as enough to support an approval filing.

By Jacob Bell • Dec. 4, 2025

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

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