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BioWorld - Tuesday, June 2, 2026
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Pancreas

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

May 1, 2026
By Marian (YoonJee) Chu
No Comments
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.
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Xray showing lung cancer on tablet

How to Summit up? Dis-Harmoni on ivonescimab NSCLC phase III

May 1, 2026
By Randy Osborne
No Comments
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell lung cancer (NSCLC).
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Hypervision Surgical Hyperspectral Intelligence imaging platform

Hypervision secures £17M for surgical hyperspectral imaging platform

May 1, 2026
By Shani Alexander
No Comments
Hypervision Surgical Ltd. raised £17 million (US$23 million) in a series A financing round for its platform technology which combines spectral sensing with cloud-enabled AI analytics, to give surgeons real-time insights into tissue physiology during surgery that were previously impossible to see.
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IPO and digital hologram with business icons

Hemab prices $301M in latest upsized biopharma IPO

May 1, 2026
By Jennifer Boggs
No Comments
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.
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Stock exchange board

Seaport joins Nasdaq as parent Puretech delists, sticks with LSE

May 1, 2026
By Nuala Moran
No Comments
Seaport Therapeutics Inc. joined Nasdaq May 1, raising gross proceeds of $254.9 million, as its parent, Boston-based Puretech Health plc moved to exit the market, opting for a sole listing on the London Stock Exchange (LSE) in order to reduce its cost base and cut bureaucracy.
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Auvelity

Axsome’s Auvelity cleared for large Alzheimer’s agitation market

May 1, 2026
By Karen Carey
No Comments
Axsome Therapeutics Inc. won U.S. FDA approval for Auvelity (AXS-05) to treat Alzheimer’s disease agitation, 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 agency accepted the supplemental NDA under priority review on Dec. 31, 2025, and the breakthrough therapy approval, specifically for agitation associated with dementia due to Alzheimer’s disease, came on the April 30, 2026, PDUFA date.
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Axsome’s Auvelity cleared for large Alzheimer’s agitation market

May 1, 2026
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A preview of the next edition of BioWorld, May 1, 2026
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Biopharma exec settles with SEC over misappropriation claims

April 30, 2026
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The U.S. SEC filed a settlement April 29 that it reached with Anthony Cataldo regarding allegations that the former chairman and CEO of a clinical-stage biopharma company misappropriated about $3.2 million from the company and then concealed the misconduct from the company’s auditors.
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Regulatory actions for April 30, 2026

April 30, 2026
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: 3D Systems, Agitated Solutions, Beone, Chest Wall, CMR, Dr. Reddy, Earflo, Expression, Gilead, Henlius, Hutchmed, Immunome, Norgine, Olympus, Prelude, Ray.
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Other news to note for April 30, 2026

April 30, 2026
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Candel, Circular, Emalex, Eversana, Greywolf, Infinite, Pfizer, Psyga, Teva, XTL.
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