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Biohaven's stock dropped more than 10% Thursday after the company disclosed that the FDA has placed a partial hold on its experimental epilepsy drug opakalim. The agency requested additional data on a metabolite identified in rodent studies and instructed Biohaven to pause recruitment in the ongoing Phase 3 RISE-2 trial, though dosing continues for existing participants. The hold does not affect the fully enrolled RISE-3 trial, which is expected to produce results later this year. Biohaven recently licensed opakalim to SK Biopharmaceuticals in a deal worth up to $795 million, receiving an immediate $350 million payout. Analysts note the hold may delay a readout necessary for approval and adds risk, but SK was aware of the data before the deal.
A Wall Street niche is booming as private biotechs increasingly use reverse mergers with public shells to access Nasdaq investors, with roughly two dozen deals announced by August 2026—more than double all of 2025. The strategy, once stigmatized, has gained legitimacy through Fairmount Funds' model of pairing fallen biotechs with well-financed private companies. While IPOs are also rebounding, reverse mergers offer speed and certainty, attracting institutional investors and Chinese-originated assets. However, the supply of high-quality shells may become a bottleneck, potentially affecting which companies get funded and which medicines get developed.
The Trump administration has installed permanent leaders at the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Michael Davis, formerly acting director of CDER, and Karim Mikhail, who led CBER on an interim basis, will take on the roles permanently. The administration also created a new position for Jared Seehafer as the first deputy commissioner for technology and artificial intelligence, and named Bret Koplow as director of the Center for Tobacco Products. The appointments follow a period of turbulence at the FDA, including the resignation of Commissioner Marty Makary and turnover in key positions. Analysts see the permanent appointments as a sign of continuity and stability that may ease concerns about major policy shifts.
BrainChild Bio, a cell therapy developer focused on CAR-T treatments for children with rare brain cancers, has raised $116 million in a venture financing round. The company, spun out of Seattle Children's Hospital three years ago, is developing two brain cancer cell therapies specifically for children. Its lead candidate, BCB-276, is in Phase 2 testing for diffuse intrinsic pontine glioma (DIPG), a rare and deadly brain stem tumor. Another treatment, BCB-214, is in preclinical development for glioblastoma and is expected to begin human testing next year. The financing round was led by an unnamed private family fund and foundation, with participation from Seattle Children's and the venture arm of the Washington Research Foundation.
AbbVie announced that its dual-acting bispecific antibody etentamig met the main goal of a Phase 3 trial in multiple myeloma, reducing the risk of progression or death by 60% versus standard therapies. The drug also demonstrated a favorable safety profile, with low rates of cytokine release syndrome and ICANS, potentially allowing broader use in community oncology settings. AbbVie plans to discuss results with regulators and present data at the International Myeloma Society Annual Meeting.
On September 3, AbbVie announced that its bispecific antibody etentamig met the primary endpoint in the Phase III CERVINO trial for relapsed/refractory multiple myeloma, significantly extending patients' progression-free survival. Safety data showed that etentamig had lower rates of severe immune-related adverse events compared to similar marketed drugs, which may support its broader use in community oncology centers. Although the drug is launching four years later than J&J's Tecvayli, its differentiated safety profile could help it secure a position in the highly competitive market.
This week's charts show licensing deals between Chinese biotechs and Western drugmakers have surpassed 100 since early 2025, peaking in Q1 2026 with major upfront payments from AstraZeneca, AbbVie, and Roche. Eli Lilly leads 2026 biopharma M&A with a dozen acquisitions, paying at least $31.5 billion, double the next busiest acquirer Gilead. Meanwhile, Alumis and Ultragenyx saw sharp share price drops after mid-stage and rare disease trial failures, respectively.
This week, licensing deals between Chinese biotech companies and Western pharmaceutical firms remained active, Eli Lilly accelerated its M&A pace, while Alumis and Ultragenyx saw stock declines due to clinical trial failures.
This week's pharmaceutical industry highlights: FDA approved Ionis's Zanvastro for the rare disease Alexander disease; Pfizer signed an ADC co-development agreement with Medicus Pharma; Climb Bio reported positive early data for CLYM116; Revolution Medicines' Rasonque study was published in NEJM; Typewriter Therapeutics secured $56 million in funding; Tscan Therapeutics announced a 75% workforce reduction.
NeuroGT, a clinical-stage gene therapy company, announced that the U.S. FDA has cleared the IND application for NGT-104. NGT-104 is an AAV9 gene replacement product intended for the treatment of MPS IIIB (Sanfilippo syndrome type B). The approved Phase I/II human clinical trial is expected to begin patient enrollment in January 2027.