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On Tuesday, Stifel reaffirmed its positive stance on Soleno Therapeutics Inc. (NASDAQ:SLNO), maintaining a Buy rating and a $59.00 price target for the company's stock. This endorsement follows the recent submission of a New Drug Application (NDA) for diazoxide choline-controlled release (DCCR) in the treatment of Prader-Willi syndrome (PWS), which is a significant step forward for the company.
The analyst from Stifel noted that the timely submission of the NDA, along with the breakthrough therapy designation previously granted by the FDA, should alleviate investor concerns that had caused stock weakness last Friday. The confirmation of the NDA submission is seen as a positive development that could provide some reassurance to the market.
Furthermore, the FDA has granted DCCR a priority review status, with a Prescription Drug User Fee Act (PDUFA) date set for December 27. The priority review indicates the FDA's recognition of the unmet medical need in PWS and its receptivity to the treatment. Additionally, the FDA plans to convene an advisory committee to review the drug, a process that allows for a thorough examination of the data and includes input from patients, parents, and caregivers.
The Stifel analyst expressed a heightened sense of optimism due to these developments, suggesting that the discussions during the advisory committee meeting could further bolster the case for DCCR. In light of the recent news, Soleno Therapeutics' shares have seen a pre-market increase of 3%.
Stifel's continued support for Soleno Therapeutics reflects their belief in the potential for the stock to reach the low-to-mid $50s range as the advisory committee meeting approaches. The firm reiterated its Buy rating, signaling confidence in the stock's future performance.
InvestingPro Insights
As Soleno Therapeutics Inc. (NASDAQ:SLNO) advances with its New Drug Application for DCCR, investors are closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, Soleno Therapeutics holds a market capitalization of $1.83 billion. Despite the challenges reflected in a negative P/E ratio of -23.31, the company has made strides with a noteworthy one-year price total return of 815.28%, indicating a significant increase in stock value over the past year. This surge aligns with the InvestingPro Tip that Soleno's stock has seen a high return over the last year, which could be a point of interest for investors looking at the company's growth trajectory.
InvestingPro Tips also highlight that Soleno has more cash than debt on its balance sheet, which may provide a degree of financial stability and flexibility. Additionally, analysts predict that the company will be profitable this year, which, if realized, could further bolster investor confidence. For those interested in a deeper analysis, InvestingPro offers additional tips on Soleno Therapeutics, providing a comprehensive perspective on the company's financial standing and future outlook.
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