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BioWorld - Friday, February 27, 2026
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Brain-computer interface illustration

Nia reports promising results for Smart Neurostimulation System

Jan. 5, 2026
By Shani Alexander
Nia Therapeutics Inc. reported data from an in vivo study of its Smart Neurostimulation System, an AI-based brain-computer interface (BCI), which demonstrated its ability to perform chronic sensing, neural-state decoding and programmable stimulation.
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Eric Shaff, president and CEO, Psithera
Immune

Psithera spun out of Roivant with $47.5M and immune, inflammatory focus

Jan. 5, 2026
By Brian Orelli
No Comments
December 2025 was a big month for announcements from Psithera Inc. The Watertown, Mass.-based newco announced its name change from Psivant Therapeutics, having come out from under the Roivant Sciences Ltd. umbrella – thus the dropping of the “-vant” name. The company also announced a $47.5 million series A financing and disclosed that Eric Shaff had started as the company’s new president and CEO.
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3D illustration of T cells fighting cancer

New year sees Abbvie, Zelgen in $1.1B T-cell engager deal

Jan. 2, 2026
By Tamra Sami
No Comments
Abbvie Inc. signed a $1.1 billion New Year’s Eve deal with China’s Zelgen Biopharmaceuticals Co. Ltd., gaining ex-China rights to Zelgen’s lead oncology asset, alveltamig (ZG-006), a trispecific T-cell engager targeting delta-like ligand 3. Under terms of the deal, Abbvie will pay Zelgen an up-front fee of $100 million, and Zelgen is eligible to receive $60 million in near-term milestones and could receive up to $1.075 billion in additional development, regulatory and commercial milestones, alongside tiered royalties on net sales outside China. Zelgen retains full rights in China.
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Eric Shaff, president and CEO, Psithera

Psithera spun out of Roivant with $47.5M and immune, inflammatory focus

Jan. 2, 2026
By Brian Orelli
No Comments
December 2025 was a big month for announcements from Psithera Inc. The Watertown, Mass.-based newco announced its name change from Psivant Therapeutics, having come out from under the Roivant Sciences Ltd. umbrella – thus the dropping of the “-vant” name. The company also announced a $47.5 million series A financing and disclosed that Eric Shaff had started as the company’s new president and CEO.
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Close-up of eye with digital focus

Missed window? A third CRL sinks Outlook’s ONS-5010

Jan. 2, 2026
By Karen Carey
No Comments
Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.
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Medtronic Hugo platform
The year in review

Robotic-assisted surgical systems gained momentum in 2025

Jan. 2, 2026
By Shani Alexander
In 2025, the momentum behind robotic-assisted surgical systems continued to accelerate on the back of increasing demand for minimally invasive procedures. In many parts of the world, these technologies are reshaping surgical procedures by improving precision and efficiency through high resolution imaging, AI and refined instrument control. This is resulting in fewer complications, faster recovery and improved patient outcomes.
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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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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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IPO line graph
Year in review

Med-tech IPOs shoot for the stars in 2025

Dec. 31, 2025
By Annette Boyle
IPOs top the list of the big stories in 2025 in med tech. Thirty med-tech companies went public, raising nearly $12 billion, two orders of magnitude more than in 2023 and almost 20 times more than raised in 2024.
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