Drug Development
The mid-stage disappointment in Alzheimer’s disease delivers another blow to Neuphoria Therapeutics, which in November last year was forced to launch a strategic business review after a Phase 3 trial in social anxiety disorder failed.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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Despite the late-stage miss, analysts maintained confidence in the Epkinly program, with Truist Securities saying the result “doesn’t waver our optimism” regarding the bispecific antibody’s ongoing frontline trial.
With inspections always on the table, LOTTE Biologics is pushing a proactive, quality first culture across its dual hubs in Syracuse and Songdo, backing its new single‑use ADC facility with rigorous training, self‑audits and real‑time regulatory surveillance.
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.
After J.P. Morgan, biotech’s bold promises meet real-world challenges. In 2026, success starts with a CDMO partner who accelerates timelines and anticipates every manufacturing hurdle. Learn how AGC Biologics offers tailored cell line solutions for complex molecules.
Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.
Venture funds attending the J.P. Morgan Healthcare Conference said mounting funding pressures and Chinese competition have sharpened their focus on leadership qualities, from regulatory expertise and industry experience to the ability to scale—or step aside—as companies mature.
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.
AbbVie and Novartis strike billion-dollar pacts while attendees at the J.P. Morgan Healthcare Conference await that one big M&A deal and Merck teases limitless buying capacity; Eli Lilly readies for potential orforglipron launch while Novo Nordisk laments compounders; the IPO window cracks open; and the FDA concludes that GLP-1s do not pose a suicide risk.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.