Home Most Popular Investing Biotech Stocks Experience Setbacks and Updates: ALDX, EVLO, SRRK, and More

Biotech Stocks Experience Setbacks and Updates: ALDX, EVLO, SRRK, and More

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Biotech Stocks Experience Setbacks and Updates: ALDX, EVLO, SRRK, and More

It was an eventful week for the biotech sector leading up to the third-quarter earnings. While major players remained quiet, there were significant pipeline and regulatory updates from several other biotech companies.

Recap of the Week’s Most Important Stories:

Aldeyra Plummets on Setback: Aldeyra Therapeutics, Inc. (ALDX) saw its shares plummet after receiving a setback in its new drug application for reproxalap, which is intended to treat the signs and symptoms of dry eye disease. The FDA identified review issues and requested additional data to support the drug’s efficacy. As a result, Aldeyra will need to conduct an additional clinical study, leading to potential delays and extra costs.

Annovis Up on Study Updates: Annovis Bio, Inc. (ANVS) announced positive interim analysis results from its Alzheimer’s Disease study. The study evaluated the effectiveness of buntanetap, an experimental drug for neurotoxic aggregating proteins. The analysis indicated that the trial should continue as planned, with patients showing positive response to treatment after just six weeks.

Updates from Scholar Rock: Scholar Rock Holding Corporation (SRRK) gained momentum after revealing its plans to expand into the cardiometabolic disorders space and pricing details for its public offering. The company aims to advance SRK-439, a novel investigational myostatin inhibitor, to treat obesity. Additionally, Scholar Rock plans to initiate a phase II study with apitegromab in combination with GLP-1 RA to further enhance its pipeline.

Evelo Down on Study Failure: Evelo Biosciences, Inc. (EVLO) experienced a decline in its stock price following disappointing results from its mid-stage study on EDP2939 for the treatment of moderate psoriasis. The study did not achieve its primary endpoint, leading Evelo to discontinue the development of EDP2939. The company is now exploring strategic alternatives for its other candidate, EDP1815, and its small intestinal axis platform.

Setback for Amylyx: Amylyx Pharmaceuticals, Inc. (AMLX) faced a setback as the European Medicines Agency maintained its negative opinion on the Marketing Authorisation Application for AMX0035, a potential treatment for amyotrophic lateral sclerosis (ALS). Amylyx will focus on completing the phase III PHOENIX study, which will provide additional data on the drug’s efficacy and safety profile. Depending on the study’s results, the company may seek approval in the EU.

Performance

The Nasdaq Biotechnology Index has experienced a slight decline in the past five trading sessions, while Gilead has seen a 5.94% increase. However, Moderna’s shares have plunged by 40.04% over the past six months.

What’s Next in Biotech?

Stay tuned for more pipeline updates.

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