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Dec 30, 2024
Soleno Therapeutics Q4 2024 Earnings Report
Soleno Therapeutics reported its financial results for the fourth quarter and full-year ended December 31, 2024.
Key Takeaways
Soleno Therapeutics reported a net loss of $55.982 million for the fourth quarter of 2024, with total assets of $330.972 million. The company's New Drug Application for DCCR for Prader-Willi syndrome was accepted by the FDA and granted Priority Review, with an updated PDUFA target action date of March 27, 2025. Commercial readiness activities are well underway.
New Drug Application (NDA) for DCCR for Prader-Willi syndrome (PWS) accepted by the U.S. Food and Drug Administration (FDA) and granted Priority Review in August 2024.
FDA extended the review period and assigned an updated Prescription Drug User Fee Act (PDUFA) target action date of March 27, 2025.
Breakthrough Therapy Designation granted by the FDA for DCCR for the treatment of adults and children ages four years and older with genetically confirmed PWS who have hyperphagia in April 2024.
Continued strengthening commercial organization in preparation for anticipated U.S. launch of DCCR, with strategic investments in key commercial and medical affairs programs underway.
Soleno Therapeutics
Soleno Therapeutics
Forward Guidance
Soleno Therapeutics is entering 2025 with strong momentum, awaiting potential approval of DCCR for PWS. The company is diligently working to ensure readiness for launch and continues to work with the FDA as their review progresses. Extensive commercial preparations, supported by a strong balance sheet, are expected to enable a successful launch of DCCR, if approved, and make a meaningful difference in the lives of those with PWS.
Positive Outlook
- Anticipated FDA approval of DCCR for Prader-Willi syndrome.
- Strong balance sheet to support successful launch of DCCR.
- Extensive commercial preparations are well underway.
- All leadership and majority of other positions within Commercial and Medical Affairs organizations hired.
- Strategic investments in key commercial and medical affairs programs, including disease state and payor education, data analytics, and supporting infrastructure well underway.
Challenges Ahead
- The timing of any regulatory process or ultimate approvals is subject to risks and uncertainties.
- The company's ability to make a meaningful difference in the lives of those with PWS is contingent on DCCR approval.
- Future financial performance is dependent on the successful launch and adoption of DCCR.
- The cadence of research and development expenditures will fluctuate depending upon the state of the Company's clinical programs.
- The final $50 million of the loan and security agreement may be made available only upon the mutual consent of Soleno and Oxford.