On Thursday, BofA Securities adjusted its outlook on Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX), reducing the price target from $4.00 to $3.50 while maintaining a Neutral rating on the stock. The adjustment follows the release of interim data from the phase 2 HELIOS study of AMX0035, also known as Relyvrio, in adults with Wolfram syndrome.
The study, which evaluated eight out of twelve participants, reported a positive change in C-peptide response, a primary endpoint, at week 24. In addition to this primary outcome, improvements were also observed in several secondary measures. The majority of patients exhibited better HbA1c levels, visual acuity, and positive clinician/patient reported outcomes.
Despite the promising results, the analyst expressed caution, noting the open-label nature of the study, its small sample size, and the short follow-up period. These factors are believed to likely dampen investor sentiment until more conclusive phase 3 data becomes available.
The commercial potential for AMX0035 in treating Wolfram syndrome, an ultra-rare disease, is estimated to be between $100-250 million per year. According to the analyst, this limited market opportunity has influenced the revised price target.
Amylyx's management has announced intentions to reveal topline data for all twelve study participants in the second half of 2024. Discussions with regulatory authorities regarding the next phases of the drug's development are expected to follow this disclosure.
InvestingPro Insights
In light of recent developments at Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX), investors might find the latest metrics from InvestingPro particularly informative. The company currently boasts a market capitalization of $166.74 million and an attractive P/E ratio of 3.79, which adjusts slightly to 4.09 when considering the last twelve months as of Q4 2023. Notably, Amylyx has experienced a staggering revenue growth of 1612.94% over the same period, a testament to the company's expanding financial footprint.
Furthermore, the company's gross profit margin stands at a healthy 59.66%, with an operating income margin of 10.19%, indicating a solid operational efficiency. However, it's worth noting the company's stock performance has seen significant volatility, with a 1-month price total return of -29.21% and a 1-year price total return of -90.81%, reflecting investor uncertainty and market reactions to clinical trial data and earnings projections.
InvestingPro Tips suggest considering the company's robust gross profit and the potential for AMX0035, as these could be pivotal in Amylyx's value proposition. There are additional tips available on InvestingPro that could further guide investment decisions. For those interested, use the coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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