ALS — amyotrophic lateral sclerosis — is a fatal disease, with about half of those afflicted dying within two years of diagnosis; some 300,000 people worldwide live with the disease, explains Mike Cintolo, growth stock expert and eidtor of Cabot Top Ten Trader.
The Ice Bucket Challenge craze of recent years wasn’t just for show: money gathered by the effort to boost awareness of ALS and helped fund research for, and lobby for approval of, Relyvrio, an oral treatment from Amylyx (AMLX) that dramatically reduces the deterioration of muscles seen in adults with ALS.
The drug was green-lighted by the Food & Drug Administration last month, after clinical trials partially funded by Ice Bucket Challenge grants showed that Relyvrio takers had a median survival period of 23.5 months, 4.8 months more than those on placebo.
The drug is approved in Canada under the brand Albrioza and is nearing approval in the E.U. Until now, Amylyx has been a developmental stage company, posting revenue of just $285,000 in 2021, all from grants, and a net loss of $88 million.
Rollout of Relyvrio has been planned for some time, and will be the main driver of revenue going ahead. It could be significant since, while Amylyx has priced the drug below the levels of other ALS treatments, Relyvrio will still command $158,000 for a year’s treatment. The key will be getting doctors who treat ALS patients to prescribe the drug as it becomes available in the next couple of weeks.
Management says they have a plan to get some 500 doctors specializing in ALS to prescribe the drug early on, which would cover two-thirds of expected prescriptions, a number that hasn’t been publicly disclosed. Analysts see revenue of $185 million next year, but that’s likely a shot in the dark.
Technically, AMLX began to get going in May after a huge decline, though nervousness about the approval caused a big shakeout in early September. That’s behind the stock now, of course, with AMLX gapping up to after the news, forming a base and pushing higher. It’s an interesting speculation — if you want to take a swing at it, look for a pullback into the 25-day line.