Amylyx Pharmaceuticals received FDA approval for its ALS drug Relyvrio in September 2022, under a somewhat controversial process that could be considered conditional in spirit, though it was technically a full approval.
Sales Performance and Patient Numbers
Relyvrio hit the market in late 2022 with a list price of $158,000 per year, generating significant revenue in a short period despite its eventual withdrawal. Here’s a breakdown based on available data:
The drug’s rapid uptake was driven by high demand from the ALS community, advocacy efforts (like the ALS Ice Bucket Challenge), and insurance coverage for most patients, though some faced high co-pays or delays. Revenue growth slowed in late 2023, reflecting a tapering of new patient starts, due to skepticism about efficacy and negative feedback regarding side effects.
Projections Made
Before and during Relyvrio’s market tenure, analysts and Amylyx itself made optimistic projections, buoyed by the unmet need in ALS and early sales success:
Outcome and Removal
The PHOENIX trial results, announced in March 2024, showed no significant benefit over placebo, contradicting the Phase 2 findings. This led Amylyx to halt marketing in April 2024, offering the drug free to existing patients while ending new prescriptions. The $380.8 million earned in 2023 fell short of the loftier $500 million+ projections for that year, and the billion-dollar peak potential evaporated with the trial failure. The company’s stock crashed over 80% in March 2024, losing over $1 billion in market value, and 70% of its workforce was cut as it pivoted to other drug candidates. Though had the drug proved effective it shows revenue could easily top 1 Billion US dollars in North America.
So that market is still waiting.
Cheers
(20min delay)