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Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.

Praxis Precision Medicines has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug candidate ulixacaltamide, for which an approval application is slated for early 2026.

Innovation drives speed in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions integrate advanced formulation design, real-time dose flexibility, and cutting-edge CMC expertise to transform complexity into clarity. By uniting science, technology, and strategy, biotechs can move faster, smarter, and with confidence—turning obstacles into opportunities for breakthrough success.

Pioneering liquid biopsy platform for early lung cancer detection strengthens IP and accelerates commercial strategy in China and Japan diagnostic markets.

Although still in Phase I, Wave Life Sciences’ injectable RNA weight loss treatment achieved results that impressed analysts, with 4% fat reduction after three months, beating Novo Nordisk’s semaglutide at a similar time point.

Arcturus is extending its cash runway into 2028 by discontinuing its early-stage vaccine candidates.

Dyne’s exon-skipping therapy zeleciment rostudirsen resulted in an approximately sevenfold increase in dystrophin levels at six months and elicited functional improvements that are the “best ever” for this treatment class, Stifel analysts said.

Analysts at Jefferies see blockbuster potential in zorevunersen in Dravet syndrome, with sales potentially reaching $1 billion to $4 billion.