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Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Deal-hungry Big Pharmas, a long-sought biotech prize, an infrequent buyer and one serial biotech rabblerouser highlight a busy quarter in biopharma M&A.
In addition to delivering two approved medicines to Biogen’s portfolio, the acquisition of Apellis Pharmaceuticals will support the future launch of the pharma’s own kidney disease asset, currently in multiple Phase 3 trials.
PepGen’s lead candidate for myotonic dystrophy type 1 barely beat the placebo in a Phase 2 trial in terms of fixing incorrect gene splicing, but the biotech attributed the poor result to an outlier.
In the buyout, Eli Lilly picks up Centessa Pharmaceuticals’ lead asset cleminorexton, which could go toe-to-toe with Takeda’s oveporexton, currently under FDA review with a decision expected in the third quarter.
Presentations at the 2026 meeting of the American Academy of Dermatology not only demonstrate the therapeutic potential of next-generation skin drugs but also shed light on how they might fare on the market.
Despite hitting its primary endpoint, Viridian’s thyroid eye disease antibody failed to ease eye bulging to the degree that analysts had been hoping for, and the biotech’s stock price fell by one-third.
Merck is eyeing a quick review for its lipid-lowering drug candidate enlicitide, which in December was awarded a Commissioner’s National Priority Voucher.
Serial biotech investor Kevin Tang previously unsuccessfully tried to buy Kezar Life Sciences via Concentra Biosciences, a biotech consolidation company owned by the venture capital firm he runs.
Takeda’s layoffs include cutting 247 people in Massachusetts. The workforce reduction is meant to help offset investments in areas including a product launch for oral drug candidate zasocitinib, for which the pharma today announced positive Phase 3 data.
While tonlamarsen missed one of two co-primary endpoints, Kardigan says the drug has shown a clinically meaningful effect on blood pressure, supporting advancement into Phase 2b.