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. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted the opinion specifically for patients without relapses in the last two years, and based on Hercules phase III data in nrSPMS, supported by the Gemini 1 and Gemini 2 phase III studies in relapsing multiple sclerosis. Branded Cenrifki, the drug is an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor that targets smoldering neuroinflammation, a key driver of disability progression.

Grace Therapeutics hits CRL setback with GTx-104 despite positive trial

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. The CRL cited issues related to leachables for product packaging, nonclinical product toxicology risk assessments, and product manufacturing deficiencies at the company’s contract manufacturing organization. Grace said it will request a type A meeting with the FDA to clarify the path forward and determine the appropriate next steps.

Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest

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. UCB SA is the latest to plunk down a significant sum, up to $1.15 billion in total, including $650 million up front and the rest in milestone payments, for epilepsy-focused Neurona Therapeutics, which has NRTX-1001 as its lead asset. But the M&A follows at least four other billion-dollar buyouts for neuro companies this year, and stocks have climbed dramatically as well, some due to positive data and others due to the Trump administration’s commitment to innovation for mental health. Meanwhile, the FDA announced April 24 commissioner’s national priority vouchers for three companies working on psilocybin and methylone candidates.

Edwards raises 2026 guidance on strong TAVR performance

Edwards Lifesciences Corp. raised its full year 2026 guidance after seeing strong sales in the first quarter, particularly 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.

Anaptysbio spinout First Tracks hits the slopes

Anaptysbio Inc. announced in September of 2025 that it would separate its drug development business from the royalties it receives on Jemperli with GSK plc and imsidolimab with Vanda Pharmaceuticals Inc. Just seven months later, well ahead of its “year-end 2026” goal, San Diego-based First Tracks Biotherapeutics Inc., the drug development arm of the company, started trading on April 20, 2026, as a standalone company on Nasdaq under the ticker symbol TRAX. BioWorld examines why the companies separated and where each is headed next.

Ribo, Diagens tally 2 Hong Kong biotech, medtech IPOs in Q1 2026

A first-quarter review by BioWorld found that nearly 30 companies (26 biotech and three medtech) filed a new or renewed application on Hong Kong’s trading board from Jan. 1 to March 31, adding to the influx of life science firms seeking an exit from mainland China last year. Among them, however, less than 20% achieved a stock sale by December 2025.

Xenon spikes, Theravance sinks after phase III readouts in March

Shares of Xenon Pharmaceuticals Inc. spiked 49.6% after the phase III X-Tole2 study testing azetukalner in focal onset seizures yielded better-than-expected data, positioning the drug for an NDA submission later this year. Meanwhile, a phase III failure of Theravance Biopharma Inc.’s norepinephrine reuptake inhibitor ampreloxetine to treat symptomatic neurogenic orthostatic hypotension in patients with the rare disease multiple system atrophy led to the company’s shares sinking by 26%.

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