Axsome Therapeutics Inc. won U.S. FDA approval for Auvelity (AXS-05) to treat Alzheimer’s disease agitation (ADA), a condition that affects up to three-quarters of patients, gaining access to a $1 billion-plus market and a clean label that counters the boxed warning of a competitor. The approval came on the April 30 PDUFA date. Auvelity first gained FDA approval in 2022 for major depressive disorder. It will be launched in June for ADA at a wholesale acquisition cost of $1,248 for a 30-day supply. Auvelity is now the second approved drug for ADA, following the 2023 approval of Rexulti (brepiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S, which earned $970 million in 2025, but has a boxed warning for increased mortality risk in elderly patients with dementia.

Seaport joins Nasdaq as parent Puretech delists, sticks with LSE

Seaport Therapeutics Inc. joins Nasdaq today, May 1, raising gross proceeds of $254.9 million, as its parent, Boston-based Puretech Health plc moves to exit the market, opting for a sole listing on the London Stock Exchange in order to reduce its cost base and cut bureaucracy. Delisting from Nasdaq is one element of a refined strategy, which also will see Puretech spin out clinical programs into independent companies financed by third parties earlier in the development cycle. Nasdaq will continue to be a source of capital for Puretech, which owns 35.1% of Seaport as the neuropsychiatric drugs specialist goes public listing under the ticker symbol SPTX.

Hemab prices $301M in latest upsized biopharma IPO

Continuing biopharma’s IPO resurgence in 2026, Hemab Therapeutics Holdings Inc. priced an upsized offering of 16.75 million shares at $18 per share, the high end of its proposed price range, for gross proceeds of $301.5 million. Another $45 million could come if underwriters exercise their full overallotment. The company, which targets coagulation disorders such as Glanzmann thrombasthenia and von Willebrand disease, is set to start trading on Nasdaq May 1 under the apt ticker COAG.

Hypervision secures £17M for surgical hyperspectral imaging platform

Hypervision Surgical Ltd. raised £17 million (US$23 million) in a series A financing round for its platform technology that combines spectral sensing with cloud-enabled AI analytics to give surgeons real-time insights into tissue physiology during surgery that they were previously unable to see. Michael Ebner, CEO and co-founder, told BioWorld that the company has created “a kind of a superhuman retina in a camera, which we believe is the future.” Just as imaging evolved from black and white to color, he said, the next step is beyond color to spectral imaging, unlocking diagnostic insights invisible to the human eye.

Sonire starts US study of cancer HIFU system after $18M series A

Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15. “Treatment for pancreatic cancer is limited. We aim to build clinical evidence and establish a new treatment as a standard of care,” Tohru Satoh, president and CEO of Sonire Therapeutics Inc., told BioWorld. “Our device uses focused ultrasound and does not require invasive procedures or anesthesia.” Palo Alto, Calif.-based Sonire (pronounced “so-near”) is advancing the HIFU system as a noninvasive tool to selectively ablate (burn) tumors in patients with advanced pancreatic cancer, a condition with a five-year survival rate of about 12%.

Summit waits for final phase III PFS analysis with ivonescimab in NSCLC

Shares of Summit Therapeutics Inc. (NASDAQ:SMMT) were trading at $16.09, down 25%, or $5.37, after the Miami-based firm provided a financial and clinical update. Leerink analyst Daina Graybosch called the adverse market reaction “reasonable” given Summit’s disclosure with regard to the Harmoni-3 phase III trial with PD-1/VEGF bispecific antibody ivonescimab in first-line squamous non-small-cell lung cancer. The company is continuing the sub-study of ivonescimab plus chemotherapy vs. Keytruda (pembrolizumab, Merck & Co. Inc.) plus chemo to the final progression-free survival (PFS) analysis, after not reaching statistical significance at the interim PFS peek. The drug is partnered with Akeso Pharmaceuticals Inc., of Hong Kong.

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