Drug Development
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
FEATURED STORIES
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
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THE LATEST
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.