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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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In the acquisition, announced Wednesday, Kriya picks up two gene therapy programs focused on epilepsy and trigeminal neuralgia. Financial terms of the deal were not disclosed.
Tricida, Inc. is reducing its headcount by around 57% to improve its financial standing after its lead candidate failed in a Phase III trial, the company revealed in its third-quarter financial results.
AstraZeneca dosed the first patient in a Phase II portion of an ongoing trial assessing a PD-1/TIGIT bispecific antibody, triggering a $7.5 million milestone payment to partner, Compugen.
When Roche announced that gantenerumab failed to meet the primary endpoint in two Phase III studies, several of its competitors saw their stocks rise - including Biogen and Eisai.
RSV, influenza, COVID-19 and monkeypox have dominated vaccine discussions this year, but vaccines are also being developed for a host of other infectious diseases.
Neoleukin Therapeutics plans to slash its workforce by about 40% and drop NL-201, a de novo IL-2/IL-15 agonist currently in Phase I, according to its third-quarter report.
Beam Therapeutics has enrolled the first patient in a Phase I/II trial studying a gene therapy leveraging base editing in adults with severe sickle cell disease.
Two months after selling an immuno-oncology platform developed by Good Therapeutics to Roche, Bonum Therapeutics launched Tuesday with $93 million in Series A financing.
Acrivon Therapeutics announced the pricing of its initial public offering Tuesday, putting all of its 7,550,000 shares of common stock up for sale for $12.50 apiece.
Surrozen announced it paused its Phase I study in Crohn’s disease and ulcerative colitis as several healthy participants showed increased levels of liver enzymes.