Amylyx and ALS, Continued ADC Excitement, Dire Drug Shortages

The past two weeks have seen Amylyx lose its only marketed product but receive numerous accolades for its decision to voluntarily withdraw Relyvrio after a failed Phase III trial in amyotrophic lateral sclerosis. Analysts and insiders spoke with BioSpace this week about the company's future and a possible regulatory precedent for other drugs approved based on a single trial.

Elsewhere, antibody-drug conjugates continue to steal the show in oncology. At the American Association for Cancer Research’s annual meeting, Merck and Kelun Biotech presented Phase I/II data showing that their TROP2-directed ADC elicited promising disease control and a potential survival benefit in gastric cancer patients, and Bristol Myers Squibb–backed TORL netted $158 million in an oversubscribed Series B to advance its pipeline of novel ADC candidates.

Finally, drug shortages in the U.S. have reached an all-time high, according to the latest data from the American Society of Health-System Pharmacists, with both basic and life-saving products on the list.