Biotech
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Vaccines
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 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging 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 -
Emerging biotech
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 -
Pain drugs
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 -
Startup launches
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 -
News roundup
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 -
Biotech zombies
‘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 -
Emerging biotech
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 -
News roundup
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 -
Emerging biotech
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 -
Emerging biotech
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 -
Startup launches
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 -
News roundup
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 -
Emerging biotech
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 -
News roundup
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 -
Vaccines
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 -
News roundup
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 -
Emerging biotech
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