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.
Merck’s acquisition of Caraway Therapeutics adds programs for genetically defined neurodegenerative diseases. One of those programs addresses a target that was the focus of a different startup purchased by Merck in 2019.
A month after an FDA advisory committee voted against recommending approval of BrainStorm Cell Therapeutics’ stem cell therapy for ALS, the company is preparing to try again with a new Phase 3 study. To help pay for it, the biotech is restructuring and laying off 30% of its staff.
NurOwn, BrainStorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
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.
The Biogen amyotrophic lateral sclerosis drug, Qalsody, treats patients whose disease is driven by mutations to a gene called SOD1. It’s the first drug approved to target a genetic cause of ALS.
Cytokinetics drug reldesemtiv has failed a pivotal clinical trial in amyotrophic lateral sclerosis. The small molecule had previously failed in Phase 2, but the biotech believed adjustments could lead to better results in Phase 3.
Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.
BrainStorm Cell Therapeutics’ stem cell therapy for amyotrophic lateral sclerosis received an FDA refuse-to-file letter, correspondence that informs a company its application seeking approval is incomplete. The notice means BrainStorm might need to run another clinical trial.
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In pricing its new amyotrophic lateral sclerosis drug Relyvrio, Amylyx Pharmaceuticals chose a sum that’s just below the current cost of the last ALS drug to win FDA approval. But a drug price watchdog group argues that prices should be set based on therapeutic value, not according to the price of existing medications.
An Amylyx Pharmaceuticals drug developed to slow the progression of amyotrophic lateral sclerosis is now approved, making it just the third FDA-approved treatment for the disease. Amylyx will market its new product under the name “Relyvrio.”
A Biogen drug designed for a genetically defined form of amyotrophic lateral sclerosis led to patient improvement at a 12-month analysis, according to data now published in the New England Journal of Medicine. Biogen had already filed an application seeking FDA approval of the ALS drug, tofersen; a regulatory decision is expected by January.
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.
Three life science companies unveiled Series B rounds of funding Thursday, early Christmas gifts that top $219 million combined. Along with Verge Genomics, the other companies that raised new capital are Tasso and Brainomix.