Soleno Therapeutics Inc Stock Price, News & Analysis

Soleno Therapeutics announced that the FDA has extended the review period for DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi syndrome (PWS) in patients four years and older with hyperphagia. The new PDUFA target action date is pushed back by three months to March 27, 2025. The extension follows the FDA's determination that responses to recent information requests constituted a major amendment to the NDA. The FDA did not cite any safety, efficacy, or manufacturing concerns. The drug has received Breakthrough, Fast Track, and Orphan Drug Designations.

Soleno Therapeutics (NASDAQ: SLNO) announced two upcoming oral presentations at the 62nd Annual European Society for Paediatric Endocrinology Meeting 2024 in Liverpool, UK. The presentations will showcase data from their DCCR clinical development program for Prader-Willi syndrome (PWS) treatment. The first presentation focuses on food control parameters and hyperphagia reduction, while the second discusses long-term efficacy results from the DESTINY PWS and C602 studies. PWS affects one in 15,000 live births, with hyperphagia as its hallmark symptom, causing intense hunger and food-seeking behavior. Currently, there are no approved therapies for PWS's hyperphagia, metabolic, cognitive, or behavioral aspects.

Soleno Therapeutics (NASDAQ: SLNO) reported key developments in Q3 2024, including FDA acceptance of their New Drug Application for DCCR tablets treating Prader-Willi syndrome, with Priority Review and a PDUFA date of December 27, 2024. The company reported a net loss of $76.6 million ($1.83 per share) compared to $10.9 million in Q3 2023. R&D expenses were $30.1 million, while G&A expenses reached $49.2 million. The company maintains a strong balance sheet with $284.7 million in cash and equivalents, preparing for potential commercial launch.

Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease therapeutics, has announced its participation in three major healthcare investor conferences in November 2024. The company will present at the Guggenheim Healthcare Innovation Conference (Nov 11, 10:00 AM ET), Stifel 2024 Healthcare Conference (Nov 18, 4:45 PM ET), and Jefferies London Healthcare Conference (Nov 20, 8:00 AM GT). Live audio webcasts and replays will be available for the Guggenheim and Jefferies events through the company's website.

Soleno Therapeutics, Inc. (NASDAQ: SLNO) has announced the passing of Ernest Mario, Ph.D., former Chairman of the Board of Directors, at the age of 86. Dr. Mario served as Soleno's Chairman from 2007 through August 2024. The company expressed deep sadness and extended condolences to Dr. Mario's family.

Dr. Mario had a distinguished career in the pharmaceutical industry spanning decades. He held key positions at companies such as Strasenburgh Laboratories, SmithKline, Squibb Corp., and Glaxo plc. As CEO and Deputy Chairman of Glaxo, he oversaw the launch of five major brands, leading the company to become the second-largest pharmaceutical company globally. He later served as CEO of Alza and Chairman and CEO of Reliant Pharmaceuticals.

Soleno Therapeutics acknowledged Dr. Mario's significant contributions to the development of new treatments for various diseases and his commitment to the company's success.

Soleno Therapeutics (NASDAQ: SLNO) has received a regulatory update from the FDA regarding its New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets to treat Prader-Willi syndrome (PWS). The FDA Review Division has determined that an advisory committee meeting does not appear necessary at this time. However, the review team will continue to consider this possibility during their ongoing evaluation.

The DCCR NDA has been designated for Priority Review with a PDUFA target action date of December 27, 2024. Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases.

Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease treatments, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will present on Tuesday, September 17, 2024, at 8:00 AM Eastern Time.

Investors and interested parties can access a live audio webcast of the presentation through Soleno's website. The presentation will also be available for replay in the Investors section at www.soleno.life. This conference provides Soleno with an opportunity to showcase its progress in developing novel therapeutics for rare diseases to a global audience of healthcare industry professionals and investors.

Soleno Therapeutics announced that the FDA has accepted for filing and granted Priority Review to its New Drug Application (NDA) for DCCR (Diazoxide Choline) Extended-Release Tablets for treating Prader-Willi syndrome (PWS) in individuals four years and older with hyperphagia. The PDUFA target action date is set for December 27, 2024. The FDA plans to hold an Advisory Committee meeting to discuss the application.

Priority Review is designated for drugs that could significantly improve treatment of serious conditions. DCCR has Breakthrough and Fast Track Designations in the U.S., and Orphan Drug Designation for PWS in both the U.S. and E.U. This acceptance marks a important milestone for Soleno and the PWS community, highlighting the potential impact of DCCR in addressing this rare and devastating condition.

Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease treatments, has announced inducement grants to six new employees as required by Nasdaq Stock Market rules. The company's independent board members approved non-qualified stock options to purchase 143,850 shares of common stock. These options have exercise prices of $49.52 and $48.44 per share, matching Soleno's closing stock prices on August 13 and 16, 2024, respectively.

The option awards will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter, contingent on continued employment. These grants fall under Soleno's 2020 Inducement Equity Incentive Plan and are designed to attract and retain talent in compliance with Nasdaq Listing Rule 5635(c)(4).