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Soleno Therapeutics Inc. (NASDAQ: NASDAQ:SLNO) received a reiterated Buy rating and a $74.00 price target from Stifel, following an update from the U.S. Food and Drug Administration (FDA) on the company's diazoxide choline-controlled release (DCCR) treatment for Prader-Willi syndrome (PWS).
The FDA indicated that it does not currently require an advisory committee meeting for DCCR, but noted that the review team might still consider the need for one in the future.
Stifel's reiteration comes as the FDA's decision marks the second instance where an advisory committee has been bypassed for a drug under review, the previous being govorestat for classic galactosemia.
The firm's confidence in the drug's approval prospects remains unchanged, citing a high probability of approval for DCCR based on both industry conversations and their own research.
The announcement had an immediate impact on Soleno's stock, with shares climbing over 10% in pre-market trading. This positive market reaction reflects investor sentiment that the FDA's decision could reduce the potential volatility typically associated with the release of advisory committee briefing documents.
The FDA's review of DCCR is ongoing, with the anticipated Prescription Drug User Fee Act (PDUFA) date set for November 28. Despite the FDA's caveat regarding the possibility of convening an advisory committee in the future, Stifel's stance on Soleno Therapeutics remains firm, with no changes to their investment thesis.
In other recent news, Soleno Therapeutics has received positive updates from the U.S. Food and Drug Administration (FDA) regarding its drug DCCR, which is under review for the treatment of Prader-Willi syndrome.
The FDA has indicated no need for an advisory committee meeting, a development that has been received favorably by Oppenheimer, Piper Sandler, and H.C. Wainwright. These firms have maintained their positive ratings on Soleno, with Oppenheimer reiterating an Outperform rating and Piper Sandler maintaining an Overweight rating. Stifel has also raised the price target for Soleno to $74, citing the potential approval of DCCR and the strength of its market exclusivity.
In addition to these regulatory developments, Soleno has also seen changes in its Board of Directors, with Matthew Pauls becoming the new Lead Independent Director and Dawn Carter Bir joining the board.
The company has also entered into an agreement with Jefferies LLC to potentially sell up to $150 million of its common stock. Furthermore, Soleno has awarded performance-based restricted stock units to its employees, aligning their interests with the company's performance.
InvestingPro Insights
Soleno Therapeutics Inc. (NASDAQ:SLNO) has shown impressive market performance, with InvestingPro data revealing a remarkable 104.6% price total return over the past year. This aligns with the positive market reaction to the FDA's recent decision on DCCR, as mentioned in the article.
InvestingPro Tips highlight that Soleno's net income is expected to grow this year, and analysts predict the company will be profitable. These projections support the optimistic outlook presented in the article regarding DCCR's approval prospects.
However, it's worth noting that Soleno currently holds more cash than debt on its balance sheet, which could provide financial flexibility as it navigates the regulatory process for DCCR. The company's stock price often moves in the opposite direction of the market, potentially offering diversification benefits to investors.
For a more comprehensive analysis, InvestingPro offers 5 additional tips that could provide valuable insights into Soleno's financial health and market position.
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