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BioWorld - Wednesday, June 3, 2026
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Holiday notice

Jan. 2, 2026
BioWorld's offices were closed Thursday, Jan. 1. No issue was published.
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3D rendering of antibody drug conjugated with cytotoxic payload
The year in review

ADCs’ breakout 2025 and their still-unfinished potential

Jan. 2, 2026
By Coia Dulsat
No Comments
Over the course of the year, and continuing into the latest scientific meetings, an extraordinary breadth of new antibody-drug conjugate (ADC) designs was reported, with innovations spanning targets, linkers, payloads, conjugation chemistries and overall architectures. Once defined by a simple “one target, one payload” model, the field is lately expanding into a more versatile and diverse therapeutic space.
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Auvelity

Axsome’s Auvelity for Alzheimer’s agitation gets priority review

Dec. 31, 2025
By Karen Carey
No Comments
On the last day of the year, shares of Axsome Therapeutics Inc. rose 22% on news that the U.S. FDA accepted and granted priority review of the company’s supplemental NDA for AXS-05 to treat Alzheimer’s disease agitation, a $1 billion-plus opportunity, scheduling the PDUFA date for April 30.
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Blue dollar sign on white background

Blossomhill advancing EGFR, CLK inhibitors with series B extension

Dec. 31, 2025
By Brian Orelli
No Comments
Wife-and-husband team, J. Jean Cui and Y. Peter Li, launched Blossomhill Therapeutics Inc. in mid-2020 to focus on next-generation, macrocyclic inhibitors against oncology targets. The couple had planned to take some time off to rest and do a little traveling, but then the pandemic hit. “This was a great time [to start a new company],” Cui told BioWorld. “Nothing to do but reading and thinking.”
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FDA icons

Corcept looks to ovarian cancer as relacorilant gets CRL in Cushing

Dec. 31, 2025
By Jennifer Boggs
No Comments
The U.S. FDA dashed hopes that Corcept Therapeutics Inc. might be able to launch its selective glucocorticoid receptor antagonist in two indications in 2026, issuing a complete response letter for relacorilant for use in patients with hypertension secondary to hypercortisolism, also known as Cushing syndrome. Focus is now on the July 2026 PDUFA date, as Corcept seeks approval for the same drug as a treatment for patients with platinum-resistant ovarian cancer.
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Woman on boat with motion sickness

Vanda stock jumps with FDA approval of motion sickness drug

Dec. 31, 2025
By Lee Landenberger
No Comments
The U.S. FDA has approved its first pharma treatment in more than 40 years for motion sickness. The green light for Nereus (tradipitant), from Vanda Pharmaceuticals Inc., was based on three clinical studies, all pivotal, including two phase III real-world trials with patients on boats and another supporting study.
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Holiday notice

Dec. 31, 2025
BioWorld's offices will be closed Thursday, Jan. 1. No issue will be published.
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Vanda stock jumps with FDA approval of motion sickness drug

Dec. 31, 2025
No Comments
A preview of the next edition of BioWorld, Dec. 31, 2025
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Regulatory actions for Dec. 31, 2025

Dec. 31, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Cogent, Hutchmed, Unicycive.
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Other news to note for Dec. 31, 2025

Dec. 31, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Hyloris, Nido, Rosemont, Takeda, Xoma.
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