Soleno Therapeutics Secures FDA Approval for VYKAT XR
Deal News | Mar 26, 2025 | Abingworth LLP
Soleno Therapeutics, a biopharmaceutical firm, received U.S. FDA approval for VYKAT XR, a therapeutic designed to treat hyperphagia in Prader-Willi syndrome. This approval marks a significant milestone, providing the first FDA-approved treatment for hyperphagia, a severe aspect of the disease. The approval was based on robust clinical trials, showing significant improvement in symptoms compared to placebo. Soleno worked alongside various advocacy groups, emphasizing the communal effort in achieving this milestone. VYKAT XR is anticipated to be available in the U.S. from April 2025, bringing hope to patients and families grappling with this disorder. The company will host a conference to discuss this development, underlining its impact on the PWS community.
Sectors
- Biopharmaceuticals
- Healthcare
Geography
- United States – The FDA's approval of VYKAT XR in the United States is central to the article, with plans for availability in the U.S. market.
Industry
- Biopharmaceuticals – The article centers on Soleno Therapeutics, which develops novel biopharmaceutical products for treating rare diseases.
- Healthcare – The article discusses advancements in treatment for Prader-Willi Syndrome, reflecting the healthcare industry's role in addressing rare genetic disorders.
Financials
Participants
| Name | Role | Type | Description |
|---|---|---|---|
| Soleno Therapeutics, Inc. | Target Company | Company | A biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. |
| Abingworth LLP | Private Equity Firm | Company | A private equity firm invested in Soleno Therapeutics. |
| U.S. Food and Drug Administration (FDA) | Regulatory Body | Government | The FDA provided the regulatory approval for VYKAT XR. |
| Foundation for Prader-Willi Research (FPWR) | Advocacy Group | Charity | Supported the approval of VYKAT XR. |
| Prader-Willi Syndrome Association | USA (PWSA | USA) | Advocacy Group | Charity | Advocates for individuals with Prader-Willi Syndrome, supported the drug's approval. |