H.C. Wainwright analyst reiterated a Buy rating and $70.00 stock target on Soleno Therapeutics Inc. (NASDAQ: NASDAQ:SLNO). The analyst's commentary suggests confidence in DCCR's eventual approval by the new PDUFA date in late March 2025. Following the approval, the analyst expects Soleno to begin generating revenue by mid-2025.
The reiterated Buy rating and 12-month price target reflect the firm's continued positive outlook on Soleno's stock. This optimism is shared broadly across Wall Street, with analyst price targets ranging from $67 to $93 and a strong consensus recommendation of 1.38.
Get deeper insights into Soleno's financial metrics and growth potential with InvestingPro's comprehensive research report, part of its coverage of over 1,400 US stocks. This optimism is shared broadly across Wall Street, with analyst price targets ranging from $67 to $93 and a strong consensus recommendation of 1.38.
Last week, it was announced that the FDA had decided to extend the Prescription Drug User Fee Act (PDUFA) target action date to March 27, 2025. The extension is a result of the FDA considering recent responses to their information requests as a major amendment to the NDA, thus requiring additional time for review.
The three-month extension is intended to allow the FDA to complete its examination of the new data without any safety, efficacy, or manufacturing concerns being raised.
Soleno originally submitted the DCCR NDA in late June 2024, with the FDA granting it Priority Review status. This designation had initially set a PDUFA action date of December 27, 2024. Despite the postponement of the approval decision, the analyst remains optimistic about the drug's long-term prospects and the minimal impact of the delay.
The analyst's commentary suggests confidence in DCCR's eventual approval by the new PDUFA date in late March 2025. Following the approval, the analyst expects Soleno to begin generating revenue by mid-2025. The reiterated Buy rating and 12-month price target reflect the firm's continued positive outlook on Soleno's stock.
In other recent news, Soleno Therapeutics has been the focus of attention due to the FDA's extended review period for the company's New Drug Application for DCCR, a treatment for Prader-Willi syndrome. The FDA has set a new target action date for March 27, 2025, but has not raised any safety or efficacy concerns.
Analyst firms such as Baird, Oppenheimer, Laidlaw, and Stifel maintain a positive outlook on Soleno, with Baird keeping a $72 target and Oppenheimer raising its price target based on updated sales projections.
Soleno Therapeutics has also seen changes in its Board of Directors, with the appointment of Matthew Pauls as the new Lead Independent (LON:IOG) Director and the addition of Dawn Carter Bir.
The company has entered into an agreement with Jefferies LLC to potentially sell up to $150 million of its common stock and has awarded performance-based restricted stock units to its employees. These are recent developments that have been shaping the trajectory of Soleno Therapeutics.
Oppenheimer has updated its revenue model for Soleno, projecting significant growth in U.S. sales from 2025 to 2029. The new estimates are based on an expected rise in diagnosis rates and the anticipated pricing strategy for DCCR. The FDA's decision on DCCR is expected by the end of 2024, marking a critical milestone for Soleno Therapeutics.
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