Radiopharmaceutical specialist Aktis seeks an IPO

The startup’s filing comes during a broader biotech recovery that’s made some industry watchers optimistic IPOs could rebound next year.

By Ben Fidler • Dec. 22, 2025

Cytokinetics set to battle Bristol Myers as FDA approves heart drug

The clearance is the first in Cytokinetics’ lengthy history and pits its drug Myqorzo against Bristol Myers’ Camzyos, which is on its way to topping $1 billion in sales this year.

By Ben Fidler • Dec. 21, 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

BioMarin to buy rare disease drugmaker Amicus for $4.8B

Analysts said the deal makes sense for BioMarin, as it offers a late-stage clinical asset as well as two marketed therapies that generated nearly $450 million over the first nine months of this year.

By Jacob Bell • Dec. 19, 2025

Novo files for CagriSema approval; Merck and Pfizer’s trial win

Novo Nordisk's application for CagriSema comes at the same time as competitor Eli Lilly's ask for its obesity drug orforglipron. Elsewhere, Merck & Co. and Pfizer succeeded in a bladder cancer study.

By BioPharma Dive staff • Dec. 19, 2025

Galapagos TYK2 drug hits goal in one trial, misses in another

The Belgian biotech is still on the hunt for partners after reporting that its drug succeeded against an inflammatory skin and muscle disorder but missed in a lupus study.

By Jonathan Gardner • Dec. 19, 2025

Moderna gets funding for H5 pandemic influenza vaccine

The fresh capital provides another shot for Moderna's candidate against bird flu, which earlier this year lost its government funding.

By Delilah Alvarado • Dec. 18, 2025

Takeda says $4B TYK2 drug succeeds in large psoriasis studies

The results position Takeda, which acquired its therapy in one of the industry’s larger single-drug acquisitions, to challenge Bristol Myers Squibb’s Sotyktu.

By Ben Fidler • Dec. 18, 2025

Orum, a biotech marrying ADCs with protein degraders, captures $100M in funding

The financing follows a strategic shift for Orum, which shelved its original lead program and is now pursuing a potential blood cancer treatment. 

By Gwendolyn Wu • Dec. 18, 2025

Peanut allergy patch succeeds in late-stage study 5 years after FDA rejection

DBV Technologies plans to use the latest Phase 3 results in a new submission to U.S. regulators in 2026.

By Kristin Jensen • Dec. 17, 2025

RA Capital backs drug for rare kind of chronic pain

The investment firm co-led a $125 million Series A round for Ambros Therapeutics, a Vivek Ramaswamy co-founded company with a medicine nearing pivotal testing.

By Jacob Bell • Dec. 17, 2025

Addition emerges with $100M to make gene therapies for chronic and rare diseases

Backed by a handful of prominent investors including the Gates Foundation, the startup is pursuing an approach it believes can sidestep issues seen with traditional gene therapy technology.

By Gwendolyn Wu • Dec. 17, 2025

Nektar sees silver lining as autoimmune drug ‘narrowly’ misses in alopecia study

Despite being unable to declare statistical success, the company claimed its therapy showed enough promise to support moving into late-stage testing. 

By Kristin Jensen • Dec. 16, 2025

FDA ‘proactively’ hands J&J a voucher; Pfizer issues 2026 forecasts

The FDA contacted J&J right after ASH to discuss using a special fast pass on a multiple myeloma regimen. Elsewhere, a new cell therapy player emerged with $60 million in Series A funding.

By BioPharma Dive staff • Dec. 16, 2025

‘Zombie’ biotech buyer Xoma to acquire Generation Bio

The gene therapy developer has lost most of its value since going public in 2020 and saw a long road ahead for a delivery technology that had shown promise in preclinical tests.

By Gwendolyn Wu • Dec. 16, 2025

Argenx falters in effort to expand immune drug’s use

The company will stop two trials testing its blockbuster therapy Vyvgart in thyroid eye disease after treatment was judged to be ineffective at an interim checkpoint.

By Jonathan Gardner • Dec. 15, 2025

Sobi snaps up gout drug in $950M deal for startup Arthrosi

The deal revolves around a drug Sobi claimed could become the “therapy of choice” for people whose gout symptoms persist despite initial therapy. 

By Ben Fidler • Dec. 14, 2025

Arcus cancels work on Gilead-partnered cancer combo after trial setback

A study using TIGIT and PD-1 drugs for gastrointestinal disease was canceled for “futility” at an early checkpoint, another blow to research on a once-promising target.

By Jonathan Gardner • Dec. 12, 2025

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

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