Phase II
In a first for the Parkinson’s field, AC Immune’s immunotherapy has stabilized key biomarkers that suggest an effect on the disease’s course.
Structure’s aleniglipron elicited over 11% weight loss in a Phase II trial, sending the biotech’s stock up nearly 103% as markets closed on Monday.
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.
The pharmaceutical supply chain and device development have become intricately linked. Harmonizing formulation development with drug delivery device design—and leveraging a single‐vendor ecosystem—can deliver significant time, cost, and regulatory advantages for US‑focused drug products, according to industry experts.
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.
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.
Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.
NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord injury.
While expressing disappointment, William Blair analysts were unsurprised by the Phase II failure, having assigned the VISTA study a high level of risk given the “mixed” performance of a similar drug in a prior multiple sclerosis study.
Winrevair yielded significant and meaningful clinical benefits for patients with combined post- and precapillary pulmonary hypertension, an indication that, according to BMO Capital Markets, has few treatment options.
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