Sanofi SA is taking over Vigil Neuroscience Inc. for $8 per share (NASDAQ:VIGL) plus a non-tradeable contingent value right entitling the holder to potentially collect $2 per share more in cash, payable following the first commercial sale of the phase II-ready small-molecule TREM2 antagonist VG-3927 for Alzheimer’s disease, if achieved within a specific period. The deal represents an equity value of about $470 million on a fully diluted basis. Iluzanebart (VGL-101), Vigil’s monoclonal antibody program, is not being acquired by Sanofi, and will be returned to Amgen Inc., the original licensor. Watertown, Mass.-based Vigil’s stock was trading at $7.94, up $5.64, or 243%.
Adcom Starglo vote could impact universe of trials
This week’s 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma. “We anticipate heightened regulatory risk for any trial relying on Asian enrollment for registration and/or employing a control arm not clearly aligned with the preferred U.S. SOC,” Leerink Partners LLC analyst Daina Graybosch said. In considering the universe of trials that may be at risk, Graybosch noted that numerous phase III trials in first-line, PD-L1 high non-small-cell lung cancer may be vulnerable because their comparator arm doesn’t match the preferred U.S. standard of care.
Chikungunya wins boost Valneva; overall infectious disease stocks fall
Infectious disease stocks stumbled in the early months of 2025, with the BioWorld Infectious Disease Index (BIDI) plunging 17.83% by the end of April, well behind the broader markets. By comparison, the Nasdaq Biotechnology Index slipped just 1.16%, and the Dow Jones Industrial Average declined 4.41%. Valneva SE led the BIDI gainers, up after approvals for its chikungunya virus vaccine Ixchiq.
Annji's phase I/II positive in spinal, bulbar muscular atrophy
Annji Pharmaceutical Co. Ltd.’s rosolutamide (AJ-201, JM-17) achieved positive results in a phase I/II trial in adults with spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s disease. “SBMA is a slowly progressing neuromuscular disorder, and I am greatly encouraged by the positive clinical outcomes observed after a relatively short course of AJ-201 treatment,” Annji CEO Wendy Huang said, noting that she is committed to advancing the program to phase III clinical trials to provide a “much-needed therapeutic option for patients living with SBMA, a disease that currently lacks any FDA-approved treatments.” SBMA, or Kennedy's disease, is a rare X-linked inherited neuromuscular disorder caused by CAG repeat expansion in the androgen receptor gene.
Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ contract development and manufacturing organization (CDMO) operations and Samsung Bioepis’ biosimilar business. Often misperceived as one entity, the holding structure and possible conflict of interest between the two has drawn scrutiny from company clients and investors, according to the Incheon, South Korea-based CDMO.
White House eyes an 11% cut in FDA budget authority for 2026
FDA commissioner Marty Makary’s May 22 appearance at the Senate Appropriations Committee included the expected fireworks regarding reductions in the FDA workforce, but it came without a formal fiscal year 2026 budget proposal for the FDA. Nonetheless, Makary said the Trump administration will propose a reduction in FDA budget authority of 11.5% over the current fiscal year, a proposal that might struggle to gain traction on Capitol Hill as the FY 2026 budget process takes shape.
GAO sees need for FDA guidance for organ-on-a-chip
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office (GAO) has raised the question of whether organ-on-a-chip (OOC) methods are ready to fill the gap. The new leadership at the U.S. Department of Health and Human Services declared earlier this year it will commence with an effort to phase out animal testing for some biologics-based therapies. The private sector has taken interest in the OOC field, such as Organoid Sciences Ltd., of Seongnam, South Korea. The subject is important for medical technology as well, given the FDA’s emphasis on decreased reliance in animal testing for device development.