On Tuesday, Laidlaw reiterated a Buy rating and maintained a $75.00 price target on Soleno Therapeutics Inc. (NASDAQ:), following an update from the company regarding its New Drug Application (NDA) process. The firm’s analyst noted the positive development that the U.S. Food and Drug Administration (FDA) has indicated that there is no need for an advisory committee meeting for the evaluation of DCCR (diazoxide choline) in Prader-Willi Syndrome (PWS).
Soleno Therapeutics reported that the FDA’s decision to forgo an advisory committee meeting is a favorable sign for the NDA process of DCCR in PWS. This decision suggests that the FDA is sufficiently acquainted with the clinical data and other information related to DCCR’s development for treating PWS.
The analyst from Laidlaw expressed optimism about the potential approval of DCCR, stating that the probability of authorization has meaningfully increased. This perspective is based on the implication that the FDA’s familiarity with the drug’s data may streamline the review process.
Soleno Therapeutics is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. DCCR, the drug in question, is currently under review by the FDA for the treatment of PWS, a complex genetic disorder characterized by insatiable appetite and obesity among other symptoms.
The company and its stakeholders are likely to be encouraged by this latest development, as it represents a significant step forward in the drug’s path to potential market approval. The decision by the FDA could potentially expedite the NDA process, bringing DCCR closer to availability for patients with PWS.
In other recent news, Soleno Therapeutics has been a focus of interest for several analyst firms, following updates on the company’s drug candidate DCCR. The U.S. Food and Drug Administration (FDA) has indicated no requirement for an Advisory Committee meeting regarding DCCR, a treatment under review for Prader-Willi Syndrome (PWS).
This regulatory development has been seen as a favorable sign for the drug’s approval process, with Baird maintaining an Outperform rating and a $72.00 price target on Soleno shares. Similarly, Stifel has reiterated a Buy rating and raised the price target to $74.00, expressing confidence in the drug’s approval and future market performance.
Oppenheimer also maintained an Outperform rating and a $65.00 price target, highlighting the potential for significant revenues if DCCR is approved. The FDA’s decision on DCCR, expected by the end of 2024, is a critical milestone for Soleno Therapeutics.
In addition to these regulatory updates, Soleno has 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 and awarded performance-based restricted stock units to its employees.
InvestingPro Insights
Recent data from InvestingPro sheds additional light on Soleno Therapeutics’ (NASDAQ:SLNO) financial position and market performance, offering valuable context to the positive developments in its DCCR drug approval process.
Despite not being profitable over the last twelve months, InvestingPro Tips highlight that Soleno’s net income is expected to grow this year. This aligns with the optimism surrounding the potential approval of DCCR, which could significantly impact the company’s financial outlook. Additionally, the company holds more cash than debt on its balance sheet, providing financial flexibility as it navigates the final stages of the drug approval process.
Soleno’s stock has shown impressive performance, with a high return over the last year and currently trading near its 52-week high. The stock price’s 104.6% total return over the past year reflects investor confidence in the company’s prospects, likely bolstered by the positive developments in the DCCR approval process.
It’s worth noting that analysts predict the company will be profitable this year, which could be a game-changer for Soleno if DCCR receives FDA approval. The company’s market capitalization stands at $2.05 billion, indicating significant investor interest in its potential.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Soleno Therapeutics, providing a deeper understanding of the company’s financial health and market position.
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