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Despite the late-stage fail, Vistagen will nevertheless continue to push its drug candidate forward and meet with the FDA to align on a potential registrational path.
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At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Alixorexton’s Phase II performance sets it up for late-stage success, according to analysts at Truist Securities. Alkermes expects to launch a global late-stage program early next year for narcolepsy type 2.
The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed.
The back-heavy deal includes a $5 million upfront payment for two novel T cell engagers, though the companies have yet to disclose priority indications.
In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
Nearly two dozen life sciences companies that were awarded Massachusetts tax incentives to create and retain about 1,000 combined jobs hit just 13% of that target in 2024. Ten awardees had reported layoffs last year, including Charles River Laboratories and Moderna.
While most BioSpace LinkedIn poll respondents believe the job market won’t improve until at least 2027, two industry experts are optimistic a turnaround could start sooner. They discuss early signals of recovery and challenges that remain.
After the FDA rejected its spinocerebellar ataxia treatment, Biohaven missed out on a $150 million payment from Oberland Capital. Now the company is reshuffling its pipeline to stay alive.
In 2025, landmark obesity drug deals, China’s biotech surge, and AI’s deeper integration into pharma operations drove a year of transformation and renewed momentum for life sciences.
The strategic initiative will extend Metagenomi’s cash runway into the fourth quarter of 2027. That same year, the company expects to generate initial Phase I data for its lead asset MGX-001 in hemophilia A.