Chip stocks fall with Nvidia after data center rev disappointment
On Tuesday, Soleno Therapeutics Inc. (NASDAQ:SLNO) maintained its Outperform rating and $65.00 price target following the U.S. Food and Drug Administration's (FDA) acceptance of the New Drug Application (NDA) for its drug candidate DCCR. The FDA has granted the application Priority Review status, and a Prescription Drug User Fee Act (PDUFA) date has been set for December 27, 2024, which is notably earlier than the anticipated timeline.
The announcement was made today that the FDA's acceptance is accompanied by plans for an advisory committee meeting to discuss the NDA for DCCR. Although the date for this meeting has not been scheduled, expectations are high for a positive outcome that will support both the approval and the commercial potential of DCCR. This optimism is based on the strength of the clinical data and the support from the patient community.
DCCR is being developed as a treatment for Prader-Willi Syndrome, a complex genetic disorder. If approved, it would become the first therapy to fundamentally improve the lives of patients with this condition and their families. The anticipation for the advisory committee meeting is a significant milestone for Soleno Therapeutics as it moves closer to potentially bringing this innovative treatment to market.
Analysts project a robust future for DCCR, with estimated sales reaching approximately $1 billion in the U.S. by 2030. Moreover, there is a considerable opportunity for DCCR in markets outside the United States. The early PDUFA date and the expected favorable advisory committee meeting are seen as key catalysts for the company's growth and the drug's potential impact on Prader-Willi Syndrome patients.
InvestingPro Insights
As Soleno Therapeutics Inc. (NASDAQ:SLNO) continues to generate interest following the FDA's acceptance of its New Drug Application for DCCR, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Soleno holds a market capitalization of $1.86 billion, underscoring the significant growth potential perceived by the market. However, the company's P/E ratio stands at -23.31, reflecting its current lack of profitability. Despite this, Soleno's stock has experienced an astronomical one-year price total return of 815.28%, highlighting the high investor confidence in the company's future, particularly as it approaches the PDUFA date for DCCR.
InvestingPro Tips suggest that Soleno has more cash than debt on its balance sheet, which is a positive sign for financial stability. Moreover, analysts predict that the company will turn profitable this year, which could be a pivotal moment for investors. With the stock trading near its 52-week high and a fair value estimate from analysts at $65, compared to InvestingPro's fair value estimate of $28.62, there is a divergence in valuation perspectives that investors may want to consider. For those seeking additional insights, InvestingPro offers more tips on Soleno Therapeutics, which can be found at: https://www.investing.com/pro/SLNO.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.