Phase II
Dyne is eyeing an accelerated approval filing for DYNE-251 in early 2026 that would pit the asset against Sarepta’s Exondys 51 in a patient population amenable to exon 51 skipping.
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year.
Gilead plans to go straight to Phase III studies for once-yearly lenacapavir, while GSK and ViiV will push forward with their long-acting antivirals after touting positive early-stage results.
BEAM-302 “has set the bar for efficacy in this space,” William Blair analysts wrote in an investor note on Monday.
Mineralys’ shares got a more than 50% boost Monday morning as new data showed its hypertension drug reduced blood pressure in a pair of clinical trials.
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
Biohaven in recent months has reported a clinical stumble in spinal muscular atrophy, alongside a Phase I readout for its protein degrader candidate that investors found underwhelming.
After failing to hit the primary endpoint in a Phase III trial, Neumora is remixing study parameters in two replicate trials, with data expected in the first half of 2026.
Despite not differentiating itself from placebo, the Texas-based company said it plans to push pilavapadin into Phase III trials before long.
While Kallyope’s drugs are mechanistically unique, the biotech is competing in a crowded space, with other therapies that appear to elicit superior weight-loss.
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