Deep brain stimulation (DBS) through implanted electrodes has enabled fundamentally new ways of treating certain disorders. More than 100,000 severely ill patients have received an implant to treat Parkinson’s disease, which is DBS’ greatest success story. But even in this greatest success story, Friedhelm Hummel told the audience at the 2026 Congress of the European Academy of Neurology, currently underway in Geneva, only a small minority of patients that might benefit from DBS actually receive it.

Vistagen's SAD slump: lead pherine, fasedienol, fails again

Top-line phase III Palisade-4 results of Vistagen Therapeutics Inc.’s fasedienol showed the intranasal pherine candidate failed to hit primary and secondary endpoints in the acute treatment of social anxiety disorder (SAD), issuing a near death knell as the company’s shares (NASDAQ:VTGN) plunged more than 70% to only 21 cents in early trading June 30. The failure marks the third of four phase III trials to miss the mark. Regardless, the company is holding on to a glimmer of hope in which a post-hoc analysis showed fasedienol achieved a nominal statistically significant improvement on the primary endpoint in very severe SAD patients, with plans to discuss a future, registrational phase III trial with the U.S. FDA, which previously granted fast track designation for the candidate. While the Palisade-4 results “certainly were disappointing,” Vistagen’s President and CEO Shawn Singh said on an investor call, the “multiple post-hoc analysis of the data in patients with very severe social anxiety disorder, amounting to slightly over half of the patients randomized in the trial, demonstrates significant findings we believe are important from the clinical and the regulatory perspectives.”

Deerfield-backed Boulevard, Metis pen $1.6B trispecific TCE deal

A U.S. biotechnology company founded by Deerfield Management Company L.P. licensed exclusive rights to Metis Techbio Co. Ltd.’s preclinical trispecific T-cell engager (TCE) for autoimmune disorders in a potential $1.62 billion deal. Rights to develop, manufacture and commercialize Metis’ trispecific TCE asset, MTS-128, were licensed to Deerfield-affiliated Boulevard Bio Inc., with the biotech paying $20 million up front. Metis will be eligible to receive up to $1.6 billion in development, regulatory and commercial milestone payments, plus tiered royalties based on product sales.

NEJM paper on Tavneos pivotal trial retracted by academic authors

The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded. The re-adjudication, detailed in an ongoing U.S. FDA investigation, was done without the knowledge of the two authors, David Jayne, professor of clinical autoimmunity at Addenbrooke’s Hospital, Cambridge, U.K., and Peter Merkel, chief of rheumatology at the University of Pennsylvania, and is “inconsistent with proper research conduct,” according to the retraction published June 29. The retraction is a further setback for Amgen in its effort to keep Tavneos on the market, in the face of regulatory concerns.

AI, data and wearables transforming health care, clinical trials

AI, data and wearable technologies are transforming health care, giving patients greater access to information about their health and enabling faster, more responsive clinical trials, Anthony Costello, CEO of Medidata Solutions Inc., told BioWorld. As more people use wearable devices to monitor their health, they are increasingly able to react to those insights, while pharmaceutical companies are gaining a clearer picture how patients respond to treatments during clinical trials. Additionally, the U.S. FDA’s real-time clinical trials initiative, could further accelerate drug development by allowing data to be reviewed as it is generated, he added.

Phase III safety data in UC help Abivax recovery 

Shares of Abivax SA (NASDAQ:ABVX) were trading at $131.50, up $35.35, or 36%, after the company rolled out top-line results from the supplemental part 2 of the Abtect phase III maintenance trial in ulcerative colitis (UC) with obefazimod, an oral miR-124 enhancer, in adults with moderately to severely active disease. Leerink analyst Thomas Smith called the response rates “compelling.” Wall Street especially likes that the incidence rates of malignancies, adjusted for patient-year exposure, landed well within the predefined background reference ranges, based on previous UC studies. Abivax’s stock took a hit at the start of the month, dropping to $72.50, when a cancer scare surfaced with the drug. Malignancies other than non-melanoma skin tumors were identified in the 50-mg treatment cohort: one case of prostate cancer, (which was disclosed during the induction period), one breast, and one instance of colonic dysplasia. None turned up in the 25-mg or placebo groups, nor were any evident in phase II investigations.

FDA clears first flight of Precheck Rx manufacturing pilot

The U.S. FDA’s new Precheck Pilot Program is taking flight with seven biopharma companies on board. As part of the Trump administration’s efforts to encourage onshoring of biopharma manufacturing, the program is intended to increase regulatory predictability, facilitate the construction of U.S. manufacturing sites and streamline the FDA’s plant assessments in advance of a specific product application. After screening more than 80 applicants, the agency chose the inaugural cohort based on the products to be manufactured, stage of facility development, anticipated timeline to market, and innovation in facility development and manufacturing operations.

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