Vanda Pharmaceuticals Q2 revenue up 27% to $29.3 mln, Bysanti NDA accepted for filing.
PorAinvest
jueves, 31 de julio de 2025, 7:33 am ET1 min de lectura
VNDA--
Key highlights from the quarterly report include:
1. Fanapt® Sales Growth: Fanapt® net product sales surged by 27% to $29.3 million, marking a significant increase from the $23.2 million reported in the second quarter of 2024 [2].
2. Regulatory Milestones: The company achieved substantial regulatory milestones with the acceptance for filing of Bysanti™ New Drug Application (NDA) for bipolar I disorder and schizophrenia, with a PDUFA target action date of February 21, 2026, and Tradipitant NDA for motion sickness, with a PDUFA target action date of December 30, 2025 [2].
3. Pipeline Advancements: Imsidolimab Biologics License Application (BLA) for generalized pustular psoriasis is expected to be submitted to the FDA in 2025, further strengthening Vanda's clinical pipeline [2].
4. Financial Guidance: Vanda reiterated its 2025 financial guidance, expecting total revenues to range between $210 million and $250 million, and end-year cash to be between $280 million and $320 million [2].
The company's management expressed optimism about the continued growth of Fanapt® sales, attributing it to the expansion of sales efforts and a broad direct-to-consumer brand awareness campaign [2]. This campaign has significantly elevated brand awareness for both Fanapt® and PONVORY®, contributing to the overall financial performance.
Reference List:
[1] https://www.defenseworld.net/2025/07/30/vanda-pharmaceuticals-vnda-projected-to-post-earnings-on-thursday.html
[2] https://www.marketscreener.com/news/vanda-pharmaceuticals-reports-second-quarter-2025-financial-results-ce7c5fdddb88f422
• Fanapt net sales up 27% to $29.3 million in Q2 2025 • Bysanti NDA accepted for filing; PDUFA target action date Feb. 21, 2026 • Tradipitant NDA accepted for filing; PDUFA target action date Dec. 30, 2025 • Imsidolimab BLA submission expected in 2025 for generalized pustular psoriasis • Fanapt sales growth expected to continue in coming quarters • Broad direct to consumer brand awareness campaign underway
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) reported its second-quarter 2025 financial results on Thursday, July 31, 2025, highlighting significant growth in its core product, Fanapt®. The company's net product sales from Fanapt® increased by 27% to $29.3 million compared to the same period last year, driven by a robust direct-to-consumer brand awareness campaign [2].Key highlights from the quarterly report include:
1. Fanapt® Sales Growth: Fanapt® net product sales surged by 27% to $29.3 million, marking a significant increase from the $23.2 million reported in the second quarter of 2024 [2].
2. Regulatory Milestones: The company achieved substantial regulatory milestones with the acceptance for filing of Bysanti™ New Drug Application (NDA) for bipolar I disorder and schizophrenia, with a PDUFA target action date of February 21, 2026, and Tradipitant NDA for motion sickness, with a PDUFA target action date of December 30, 2025 [2].
3. Pipeline Advancements: Imsidolimab Biologics License Application (BLA) for generalized pustular psoriasis is expected to be submitted to the FDA in 2025, further strengthening Vanda's clinical pipeline [2].
4. Financial Guidance: Vanda reiterated its 2025 financial guidance, expecting total revenues to range between $210 million and $250 million, and end-year cash to be between $280 million and $320 million [2].
The company's management expressed optimism about the continued growth of Fanapt® sales, attributing it to the expansion of sales efforts and a broad direct-to-consumer brand awareness campaign [2]. This campaign has significantly elevated brand awareness for both Fanapt® and PONVORY®, contributing to the overall financial performance.
Reference List:
[1] https://www.defenseworld.net/2025/07/30/vanda-pharmaceuticals-vnda-projected-to-post-earnings-on-thursday.html
[2] https://www.marketscreener.com/news/vanda-pharmaceuticals-reports-second-quarter-2025-financial-results-ce7c5fdddb88f422
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