Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings per share of $2.95 to $3.05, compared with earlier guidance of $2.90 to $3.05.

A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.

Grace Therapeutics Inc.’s hopes of becoming the first company in decades to update the standard of care in aneurysmal subarachnoid hemorrhage were delayed after the U.S. FDA issued a complete response letter (CRL) for its GTx-104 NDA, citing manufacturing and nonclinical deficiencies rather than concerns over efficacy or safety.

Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.

Biopharma deal value reached $79.22 billion in the first quarter (Q1) 2026, marking a strong start to the year and an increase of about 17% from $67.6 billion in Q1 2025 and similar to $78.93 billion in Q4 2025. The total is the highest first-quarter tally in recent years, and the highest quarter since Q4 2025 brought $80.65 billion.