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Amylyx's (AMLX) ALS Drug Fails Pivotal Study, Stock Down 82%
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Shares of Amylyx Pharmaceuticals (AMLX - Free Report) nosedived 82.2% on Mar 8 after management announced topline results from the phase III PHOENIX study evaluating Relyvrio (AMX0035) for the treatment of amyotrophic lateral sclerosis (“ALS”). The study did not meet its primary or secondary endpoints.
The PHOENIX study failed to achieve statistical significance in the primary endpoint of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score following 48 weeks of treatment with Relyvrio. The ALSFRS-R is a disease-specific severity score that reflects motor impairment and functional deterioration in ALS patients.
The study also failed to achieve statistical significance in secondary endpoints, which include quality of life patient-reported outcome assessments, overall survival, and respiratory function.
While management did not disclose any numerical data/figures from this study, it intends to present the data at an upcoming medical meeting and also publish it in a medical journal later this year.
We remind investors that the FDA approved Relyvrio in September 2022 to treat ALS in adults. The drug was also approved in June 2022 in Canada, where it is marketed under the trade name Albrioza.
Following the PHOENIX study failure, Amylyx will discuss the results with the regulatory authorities to decide whether to voluntarily withdraw Relyvrio from the U.S. and Canadian markets. Until the final decision, management has decided to pause all medication promotions.
Investors were massively disappointed with the study results. Currently, Relyvrio is the only marketed drug in Amylyx’s portfolio. Last month, management announced that it generated around $381 million from Relyvrio product sales in 2023 - its first full year on the market – which also helped it turn around earnings per share of 73 cents against the year-ago period loss of $3.39.
With the PHOENIX study failure, there is a high probability that the drug will likely be withdrawn from the market, leaving the company without a marketed drug and turning it back again to a loss-making clinical-stage pharmaceutical company. Even if management does not withdraw the drug, doctors are unlikely to prescribe the drug due to the PHOENIX study results. This potential loss in both the top and the bottom line was most likely the reason for the massive downfall in share price.
In the year so far, Amylyx’s stock has lost 77.2% compared with the industry’s 0.1% fall.
Image Source: Zacks Investment Research
Management also informed investors that it will continue to conduct other clinical studies on Relyvrio in other neurodegenerative diseases. Currently, Amylyx is evaluating Relyvrio in the phase III ORION study in patients with progressive supranuclear palsy (PSP) and the phase II HELIOS study in Wolfram syndrome.
The FDA approval of Relyvrio/Albrioza in 2022 was based on data from the controversial phase II CENTAUR study wherein treatment with AMX0035 showed a significant slow-down of ALS progression and functional decline. Prior to granting this approval, the agency held two advisory committee meetings in 2022 – the first one held in March, which voted 6:4 against approving the drug and another one held in September, which voted 7:2 favoring the drug’s approval after Amylyx submitted additional data analyses from clinical studies on AMX0035.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 18 cents to 30 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 40.3%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPShave risen from $4.06 to $4.40. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.01. Year to date, shares of ANIP have risen 22.3%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, estimates for GSK’s 2024 EPS have risen from $3.87 to $4.03. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.20 to $4.39. Year to date, shares of GSK have risen 16.4%.
GSK's earnings beat estimates in three of the trailing four quarters while missing the mark on one occasion. On average, GSK’s four-quarter earnings surprise was 7.59%.
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Amylyx's (AMLX) ALS Drug Fails Pivotal Study, Stock Down 82%
Shares of Amylyx Pharmaceuticals (AMLX - Free Report) nosedived 82.2% on Mar 8 after management announced topline results from the phase III PHOENIX study evaluating Relyvrio (AMX0035) for the treatment of amyotrophic lateral sclerosis (“ALS”). The study did not meet its primary or secondary endpoints.
The PHOENIX study failed to achieve statistical significance in the primary endpoint of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score following 48 weeks of treatment with Relyvrio. The ALSFRS-R is a disease-specific severity score that reflects motor impairment and functional deterioration in ALS patients.
The study also failed to achieve statistical significance in secondary endpoints, which include quality of life patient-reported outcome assessments, overall survival, and respiratory function.
While management did not disclose any numerical data/figures from this study, it intends to present the data at an upcoming medical meeting and also publish it in a medical journal later this year.
We remind investors that the FDA approved Relyvrio in September 2022 to treat ALS in adults. The drug was also approved in June 2022 in Canada, where it is marketed under the trade name Albrioza.
Following the PHOENIX study failure, Amylyx will discuss the results with the regulatory authorities to decide whether to voluntarily withdraw Relyvrio from the U.S. and Canadian markets. Until the final decision, management has decided to pause all medication promotions.
Investors were massively disappointed with the study results. Currently, Relyvrio is the only marketed drug in Amylyx’s portfolio. Last month, management announced that it generated around $381 million from Relyvrio product sales in 2023 - its first full year on the market – which also helped it turn around earnings per share of 73 cents against the year-ago period loss of $3.39.
With the PHOENIX study failure, there is a high probability that the drug will likely be withdrawn from the market, leaving the company without a marketed drug and turning it back again to a loss-making clinical-stage pharmaceutical company. Even if management does not withdraw the drug, doctors are unlikely to prescribe the drug due to the PHOENIX study results. This potential loss in both the top and the bottom line was most likely the reason for the massive downfall in share price.
In the year so far, Amylyx’s stock has lost 77.2% compared with the industry’s 0.1% fall.
Image Source: Zacks Investment Research
Management also informed investors that it will continue to conduct other clinical studies on Relyvrio in other neurodegenerative diseases. Currently, Amylyx is evaluating Relyvrio in the phase III ORION study in patients with progressive supranuclear palsy (PSP) and the phase II HELIOS study in Wolfram syndrome.
The FDA approval of Relyvrio/Albrioza in 2022 was based on data from the controversial phase II CENTAUR study wherein treatment with AMX0035 showed a significant slow-down of ALS progression and functional decline. Prior to granting this approval, the agency held two advisory committee meetings in 2022 – the first one held in March, which voted 6:4 against approving the drug and another one held in September, which voted 7:2 favoring the drug’s approval after Amylyx submitted additional data analyses from clinical studies on AMX0035.
Amylyx Pharmaceuticals, Inc. Price
Amylyx Pharmaceuticals, Inc. price | Amylyx Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Amylyx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and GSK plc (GSK - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 18 cents to 30 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 40.3%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPShave risen from $4.06 to $4.40. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.01. Year to date, shares of ANIP have risen 22.3%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, estimates for GSK’s 2024 EPS have risen from $3.87 to $4.03. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.20 to $4.39. Year to date, shares of GSK have risen 16.4%.
GSK's earnings beat estimates in three of the trailing four quarters while missing the mark on one occasion. On average, GSK’s four-quarter earnings surprise was 7.59%.