VNDA News & Events

AnaptysBio (ANAB) provided an update on the potential spin-off of its biopharma operations. Intention to separate biopharma operations from substantial royalty assets on track for Q2, potentially as early as late-April. The royalty management company will initially retain the name AnaptysBio and will manage the financial collaborations from Jemperli with GSK (GSK) and imsidolimab with Vanda (VNDA). While specific decisions regarding board composition, leadership and financial operations will be disclosed at a later time, Daniel Faga is anticipated to be the initial CEO. First Tracks will be a public company focused on the development and potential commercialization of innovative immunology therapeutics for autoimmune and inflammatory diseases, including ANB033, rosnilimab and ANB101. Form 10 registration statement has been publicly filed in connection with the planned spin-off. Initial board of directors for First Tracks Biotherapeutics is expected to include certain current members of Anaptys' board. Initial executive leadership team for First Tracks Biotherapeutics will include Daniel Faga, CEO, Paul Lizzul, CMO and Ben Stone, CBO. Additional executives will be disclosed at a later time. Upon completion of the spin-off, First Tracks Biotherapeutics will launch with adequate capital to fund operations through significant potential product milestones. "We are approaching a defining inflection point for Anaptys, as we plan to spin-off in Q2 2026 our wholly owned biopharma portfolio into a public company, to be called First Tracks Biotherapeutics, to unlock and amplify value for investors across two distinct sets of assets," said Daniel Faga, president and chief executive officer of Anaptys. "In our royalty portfolio, Jemperli exited Q4 2025 on a ~$1.4 billion annualized run rate, reinforcing GSK's peak sales guidance of far more than $2.7 billion2 in monotherapy indications. At the same time, our biopharma portfolio is advancing multiple attractive, high-potential assets, including ANB033, which has pipeline-in-a-product potential, initially in a Phase 1b trial for both celiac disease and eosinophilic esophagitis."

Vanda Pharmaceuticals announced that the U.S. FDA has granted the company's request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research's proposal to refuse approval of Vanda's supplemental new drug application for Hetlioz in the treatment of jet lag disorder. The FDA confirmed the decision to grant a hearing in a letter from the Office of the Commissioner dated March 2, 2026. The hearing will proceed under 21 CFR Part 12, after which the presiding officer will issue an initial decision pursuant to 21 CFR Section 12.120. Granting a formal evidentiary public hearing in response to a proposed refusal to approve a drug application is a rare and highly significant regulatory step. Publicly available records and historical accounts indicate that the FDA has not granted such a hearing under 21 CFR Part 12 in the context of drug approvals for decades-potentially over 40 years-underscoring the gravity of the legal and scientific issues raised by Vanda.