Topic
Corp Fin leadership has signaled that staff time may be better spent listening to earnings calls than reviewing routine shelf filings, and a recent comment letter exchange shows why. For life sciences companies, whose calls routinely cover program-level spend, clinical data, and cash runway, inconsistencies between the call and the filings are a potential source of staff comments.
On August 3, 2026, the California Supreme Court held in Gilead Tenofovir Cases (Aug. 3, 2026, S283862) ___ Cal.5th ___ (slip opn.), that a drug manufacturer owes no duty of care to users of a non-defective drug when deciding whether and when to commercialize an allegedly safer alternative drug. The Court reached that conclusion on…
On February 18, 2026, FDA Commissioner Martin Makary and Vinay Prasad, then-Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, published a landmark policy announcement in the New England Journal of Medicine that a single adequate and well-controlled pivotal trial — supplemented by confirmatory evidence — is now the…
In re BioAge Labs, Inc., Securities Litigation, No. 25-cv-00196, 2025 WL 3038991 (N.D. Cal. Oct. 30, 2025) Case Highlights In October 2025, a federal district court dismissed securities claims against a biopharmaceutical company, BioAge Labs, Inc., arising from disclosures in connection with its initial public offering (“IPO”) concerning the safety of the company’s lead drug…
What began as a series of demand letters in July 2025 has evolved into something significantly more consequential. By February 2026, sixteen of the seventeen largest pharmaceutical manufacturers have signed Most-Favored-Nation (MFN) pricing agreements with the Trump administration, which commit them to Medicaid price parity, MFN pricing on new product launches, and participation in TrumpRx.gov…
As public companies prepare their third quarter Form 10-Q filings, the rapidly shifting policy landscape has created new disclosure challenges for the life sciences sector. The recently announced pharmaceutical tariffs and ongoing government shutdown both carry potential financial and operational implications that warrant close attention. For biotech companies, these developments underscore the need for clear,…