Amy­lyx to move for­ward with ALS pro­gram in Eu­rope, but FDA wants an­oth­er look; Hu­ma­cyte adds $50M in debt fi­nanc­ing

Amy­lyx is one of sev­er­al com­pa­nies look­ing to break through in the tough ALS field, and Wednes­day they an­nounced they’re mov­ing for­ward with reg­u­la­to­ry plans.

The Cam­bridge, MA-based biotech said they’re sub­mit­ting a mar­ket­ing ap­pli­ca­tion to the EMA for their AMX0035 pro­gram by the end of 2021. Wednes­day’s news comes a few weeks af­ter they re­vealed sim­i­lar plans to move for­ward with Cana­di­an health reg­u­la­tors by June 30.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER