The voluntary removal of ALS drug Relyvrio from the market comes with a corporate restructuring that turns Amylyx Pharmaceuticals’ focus to other neurodegenerative diseases. But the company also has another ALS drug candidate set to begin clinical testing this year.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.
Octave Bioscience, based in Menlo Park, California, just closed a $30 million extension to its Series B funding round.
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.
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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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.
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.
The concept of using protein homeostasis – or proteostasis – as a platform for drug development is a rather new one, but it makes a good amount of sense: Maintaining a proper balance of protein production in the body is critical to a person’s health. Proteostasis makes sure every protein within a cell either is folded […]