Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
FEATURED STORIES
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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Connect Biopharma Phase II trial on a potential drug for adults with moderate-to-severe ulcerative colitis may have failed to meet its primary endpoint, but the company isn’t giving up yet.
The FDA accepted Bayer’s supplemental New Drug Application for its proposed oral treatment for metastatic hormone-sensitive prostate cancer.
Three long-time FDA officials, Dr. Peter Marks, Dr. Janet Woodcock and Dr. Robert Califf wrote an op-ed in JAMA describing the reality that COVID-19 represents “the new normal.”
Horizon Therapeutics announced its Phase II dazodalibep (HZN-4920) clinical trial has met its primary endpoint. Dazodalibep is a treatment for patients with Rheumatoid Arthritis (RA).
GPH101 is an investigational next-generation gene-edited autologous hematopoietic stem cell (HSC) therapy.
Denali Therapeutics, Inc. has announced that dosing has begun for participants of a Phase II clinical trial that intends to evaluate the potential of SAR443820 (DNL788) in patients with amyotrophic lateral sclerosis (ALS).
Dianthus Therapeutics launched today with $100 million in Series A financing led by 5AM Ventures, Avidity Partners and Fidelity Research and Management. The company plans to tackle severe and rare autoimmune diseases by utilizing antibodies that target complements.
Humacyte’s engineered blood vessels, human acellular vessels, are in a position to take tissue regeneration from a laboratory possibility to a commercial reality.
Therapeutic Solutions International is targeting long COVID with a new stem cell therapy, as Tonix and Pfizer explore their own treatment options.
What sets Verseon apart is its use of molecular physics modeling to enable the atomic-level engineering of new molecules. The company has 14 small molecule drugs in development.