neurodegenerative diseases
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After ALS Drug Fails in Phase 3, Amylyx Weighs Pulling the Product From Market
Amylyx Pharmaceuticals co-CEO Justin Klee previously said the company would withdraw ALS drug Relyvrio from the market if it failed its Phase 3 clinical trial. The biotech has set an eight-week timeline to evaluate its next steps.
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Sanofi, Denali Neuro Drug Fails Mid-Stage Trial in ALS; MS Study Is Continuing
Sanofi, which is leading development of the Denali Therapeutics-partnered molecule, disclosed little about the clinical trial results in ALS. But this Phase 2 failure follows the 2020 clinical trial pause of a different partnered molecule that addresses the same target.
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Startup Fundraising Spotlight: Octave Bioscience
Octave Bioscience, based in Menlo Park, California, just closed a $30 million extension to its Series B funding round.
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Amylyx Pharma’s IPO lands $190M as ALS drug begins FDA review
It’s the first week of the new year, and the life sciences sector continued the IPO momentum of 2021 as Wall Street welcomed three new biotech companies. Here’s a look at the IPOs of Amylyx Pharmaceuticals, CinCor Pharma, and Vigil Neuroscience, which raised a combined $482 million to support work on drugs addressing neurodegenerative and cardiovascular disorders.
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FDA sets decision date for Amylyx Pharma ALS drug that improves neuron survival
The FDA has accepted Amylyx Pharmaceuticals’ submission for amyotrophic lateral sclerosis drug AMX0035 and it expects to issue a regulatory decision by late June. A lot will happen before then. Amylyx recently filed for an IPO and the company’s drug is slated for an advisory committee meeting ahead of an FDA decision.
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Biotech startup AviadoBio emerges with $80M for neuro disorder gene therapies
AviadoBio’s gene therapies are designed to achieve widespread distribution throughout the central nervous system. The company’s lead program on track to begin human testing as a treatment for frontotemporal dementia.
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Biohaven drug licensed from AstraZeneca fails Phase 3 test in rare neuro disorder
Biohaven’s bet on an AstraZeneca drug for multiple system atrophy does not pan out, failing a pivotal study in the rare, neurodegenerative disorder. But a separate Phase 3 study evaluating verdiperstat in amyotrophic lateral sclerosis is still moving forward.