Vanda Pharmaceuticals

At the Cantor conference, Vanda presented a growth strategy that expands its commercial portfolio from three to five products and identifies the psychiatry division as the main driver. Management targets a psychiatry revenue potential of $750 million by 2030, assuming approvals, switching rates and payer behavior proceed as planned. Near-term catalysts are BYSANTI (expected improved gross-to-net profile) and the launch of NEREUS with an additional opportunity related to GLP-1‑induced nausea; multiple Phase III readouts are expected in late 2026 to H1 2027. Remaining risks include regulatory hurdles, trial results and reimbursement dynamics. » Más en de.investing.com

The European Commission has granted orphan drug status to Vanda’s investigational treatment imsidolimab for generalized pustular psoriasis (GPP), based on a recommendation from the EMA’s committee for rare diseases. It is the first agent to receive this designation for GPP in the EU; the FDA and Japan had previously awarded orphan status. The FDA is currently reviewing the biologics license application for imsidolimab, with a target decision date of December 12, 2026. Vanda holds an exclusive worldwide license; regulatory and patent exclusivity are expected into the late 2030s, along with benefits such as scientific advice, reduced fees, and market exclusivity. » Más en de.investing.com

Vanda reported an adjusted loss of $1.04 per share in the second quarter versus the $0.60 expected and revenue of $50.5 million (expectation $61.8 million). Strong prescription growth for Fanapt and moderate growth for PONVORY could not offset a sharp decline in HETLIOZ due to generic competition. Operating expenses rose markedly, the net loss widened to $62.5 million, and cash on hand stood at $170 million as of June 30. Vanda reconfirmed its full-year revenue guidance of $240–290 million, expects costs to decline from late 2026/2027, and pointed to several upcoming Phase III milestones and a PDUFA date in December 2026. » Más en de.investing.com