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On Tuesday, Soleno Therapeutics Inc. (NASDAQ:SLNO) received a Buy rating from H.C. Wainwright.
The firm set a 12-month price target of $70 per share for the biopharmaceutical company, which is currently focused on developing treatments for rare metabolic disorders.
Soleno's leading product, diazoxide choline extended-release tablets (DCCR), has undergone multiple trials for Prader-Willi Syndrome (PWS), a rare genetic condition that impacts metabolic, endocrine, and neurological systems.
PWS is known for causing hyperphagia and a range of behavioral issues including irritability, anger, and anxiety, contributing to a reduced lifespan due to uncontrolled weight gain and the ingestion of harmful substances. Soleno has taken a significant step forward by submitting a New Drug Application (NDA) for DCCR to the U.S. Food and Drug Administration (FDA), which has been accepted for review.
The FDA has granted Priority Review to the DCCR NDA, with a Prescription Drug User Fee Act (PDUFA) action date set for December 27, 2024. The agency plans to hold an Advisory Committee meeting to discuss the application's supporting data, anticipated to take place early in the next quarter.
"We expect the AdCom outcome to be highly supportive of DCCR approval, given the strength of the clinical data generated to date. Assuming approval, we expect Soleno to start generating revenue in 1H25," analysts at the firm said.
In other recent news, Piper Sandler also expressed a positive outlook, highlighting the treatment's comprehensive benefits and clean safety profile. The firm anticipates a potential upside as the company approaches the NDA decision.
In addition to these developments, Soleno Therapeutics has seen significant changes in its Board of Directors, with Matthew Pauls stepping in as the new Lead Independent Director and biotech veteran Dawn Carter Bir joining the board.
Moreover, the company has entered into an agreement with Jefferies LLC to potentially sell up to $150 million of its common stock, aiming to bolster its financial flexibility. Soleno Therapeutics has also awarded performance-based restricted stock units to its employees, aligning their interests with the company's performance.
InvestingPro Insights
In light of the recent Buy rating and optimistic forecast from H.C. Wainwright for Soleno Therapeutics Inc. (NASDAQ:SLNO), it's worth noting some financial metrics and insights from InvestingPro that could be relevant for investors considering this opportunity. With a market capitalization of around $1.9 billion, Soleno is a significant player in the biopharmaceutical space. Despite not being profitable over the last twelve months, analysts predict that the company will turn a profit this year, which aligns with the positive outlook on its DCCR NDA.
InvestingPro Tips suggest that Soleno holds more cash than debt on its balance sheet, which could provide financial flexibility in its operations and drug development efforts. Additionally, Soleno's liquid assets exceed its short-term obligations, indicating a strong short-term financial position. These tips, among others available on InvestingPro, offer valuable insights for investors looking to make informed decisions.
InvestingPro Data reveals a high Price / Book ratio of 6.78 as of the last twelve months leading up to Q2 2024, which suggests that the market values the company's assets quite optimistically. The significant one-year price total return of 882.93% also reflects the market's strong positive sentiment towards Soleno's stock. Furthermore, with a fair value estimate from analysts at $67, compared to the InvestingPro Fair Value of $30.24, there appears to be a divergence in valuation perspectives, which could warrant further investigation by potential investors.
For those interested in a deeper analysis, InvestingPro offers additional tips that can help assess Soleno's prospects more thoroughly.
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