With the wild success of glucagon-like peptide-1 (GLP-1) drugs, Amylyx Pharmaceuticals is looking to explore the field as it has bought out avexitide, a Phase III ready GLP-1 receptor antagonist, for $35 million in an auction last month from bankrupt Eiger BioPharmaceuticals. The company is planning to pursue it for two rare metabolic disorders.
After a busy first half of 2024, several companies are expecting key data readouts in the neuropsychiatric and neurodegenerative disease spaces during the next six months.
Macroeconomic forces can only carry the sector so far, though. Innovative new drugs, and the study data that supports them, are what sustains investors’ attention.
A group of imminent clinical trial readouts, then, could either speed or stall any biotech momentum. Here are 10 to watch:
The biotech reported $98 million in second quarter revenue, a step up from the $71 million it earned between January and March and slightly higher than analysts had forecast.
Shares of Amylyx Pharmaceuticals are falling again, despite the company announcing positive long-term survival analysis data for AMX0035, its experimental amyotrophic lateral sclerosis (ALS) therapy that is up for potential approval from the U.S. Food and Drug Administration next month.
A green light is expected for Bristol’s anti-Lag3 relatlimab next month given its impressive PFS data. The antibody is administered as a fixed dose combination with Opdivo and the phase 2/3 study Relativity-047 in unresectable or metastatic melanoma showed a median PFS of 10.1 months versus 4.6 months for Opdivo alone.
Amylyx’s decision this week to pursue early US approval of its amyotrophic lateral sclerosis project, AMX0035, put the focus back on a field that has seen more than its fair share of disappointment of late.
And surprisingly, the mid-to-late-stage pipeline is looking full, with many different approaches being tested. “I’ve been in the field for about nine years and, during that time, there’s never been as many trials and companies as there are today,” Amylyx’s co-chief executive officer, Josh Cohen, told Evaluate Vantage.
However, he added a note of caution: “I think it’s going to take a lot of shots on goal. We can’t expect every trial to succeed.”