Ponesimod

2024 mixed for biotech; sector down 14% due to Q3 results, guidance cuts, pipeline setbacks, and vaccine skeptic nominee. Despite challenges, biotech remains attractive for innovation and M&A activity. Recommended stocks: Allogene Therapeutics (ALLO), Rezolute (RZLT), Vanda Pharmaceuticals (VNDA), all under $10 with strong Zacks Rank and ABR.

Vanda Pharmaceuticals' Q3 2024 10-Q filing shows total revenues up to $47.7M, driven by PONVORY® and Fanapt® sales. Fanapt® sales rose 12% to $23.9M, HETLIOZ® up 2% to $17.9M, and PONVORY® contributed $5.9M. Despite increased R&D and SG&A expenses, the company reported a net loss of $5.3M. Cash and equivalents totaled $376.3M. Vanda continues to focus on product development and commercialization.

Vanda Pharmaceuticals reports Q3 2024 revenue of $47.7 million, up 23% YoY. Financial guidance for 2024 is revised upwards. Fanapt® launch in bipolar I disorder sees new patient starts increase by over 90% YoY. Fanapt® long-acting injectable program to start in Q4 2024. Milsaperidone NDA for schizophrenia and bipolar I disorder expected in early 2025. PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024. PONVORY® IND applications for psoriasis and ulcerative colitis expected in Q4 2024. Tradipitant NDA for motion sickness to be submitted in Q4 2024.

FDA declined Vanda Pharmaceuticals' NDA for tradipitant to treat gastroparesis symptoms, despite evidence from studies and patient experience. Vanda plans to pursue marketing authorization and file another NDA for motion sickness prevention.

Vanda Pharmaceuticals' stock rose 1.8% since April, lagging the S&P 500's 7% gain. Fanapt, approved for bipolar 1 disorder, faces market challenges due to lack of differentiation from generic antipsychotics. Upcoming catalysts include FDA decisions on tradipitant for gastroparesis and motion sickness, and a Phase I study for a CFTR inhibitor to treat cholera. Vanda's cash position is strong, but its product pipeline is weak, with potential revenue declines from Hetlioz and Fanapt due to generic competition. The company rejected takeover bids, emphasizing the need for strategic cash management.