Biotech News Brief

Biotech news for Sunday, May 10, 2026, ranked by our 5-dimension investment framework — regulatory, technology, commercial, manufacturing, and narrative.

May 8, 2:52 AM EDT

Biogen says FDA extends review of Leqembi alzheimer’s injection

BIIBESALF

hapabapa Biogen ( BIIB ) and Eisai ( ESALF ) Friday said that the FDA has extended its review by three months of the supplemental application for the Leqembi IQLIK subcutaneous injection as an initial treatment option for early

May 8, 2:22 AM EDT

Stoke outlines Q1 2027 rolling NDA start as EMPEROR enrollment targets June, backed by $411M cash balance

STOK

Earnings Call Insights: Stoke Therapeutics (STOK) Q1 2026 Management View "On today's call, we will review recent progress with our business" and management highlighted a Phase III and launch timeline, with CEO Ian Smith saying Jason Hoitt will discuss plannin…

May 8, 1:53 AM EDT

PTC outlines 2026 product revenue guidance of $750M-$850M driven by Sephience launch momentum

PTCT

Earnings Call Insights: PTC Therapeutics (PTCT) Q1 2026 Management View Dr. Matthew Klein said the company “had a record quarter of product revenue,” reporting total revenue of $273 million and product revenue of $226 million, and added, “we are raising our 20…