Soleno Therapeutics Inc - SLNO STOCK NEWS

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).

Soleno Therapeutics (NASDAQ: SLNO) announced changes to its Board of Directors. Dawn Carter Bir, a seasoned biotech executive with over 30 years of industry experience, has been appointed to the Board. Ernest Mario, Ph.D. is stepping down as Chair due to health reasons, and Matthew Pauls, J.D., M.B.A. is assuming the role of Lead Independent Director.

Ms. Bir's extensive experience in commercialization, strategic business development, and global operational leadership is expected to be valuable as Soleno prepares for a potential launch of DCCR. She recently served as Executive VP and Chief Commercial Officer at Reata Pharmaceuticals, contributing to the company's first product approval and launch, leading to a $7.3B acquisition by Biogen in 2023.

Soleno Therapeutics (NASDAQ: SLNO) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Submission of a New Drug Application (NDA) to the FDA for DCCR to treat Prader-Willi Syndrome (PWS).
2. Closing of a $158.7 million public offering.
3. Granted Breakthrough Therapy Designation for DCCR by the FDA.
4. Presentation of Study C602 data at ENDO 2024.
5. Inclusion in the Russell 3000® Index.

Financial results show $294.6 million in cash and equivalents as of June 30, 2024. R&D expenses increased to $12.3 million for Q2 2024, up from $5.1 million in Q2 2023. G&A expenses rose to $10.9 million from $3.2 million year-over-year. Net loss for Q2 2024 was $21.9 million or $0.57 per share.

Soleno Therapeutics has submitted a New Drug Application (NDA) to the U.S. FDA for its drug DCCR (diazoxide choline) extended-release tablets, aimed at treating Prader-Willi syndrome (PWS) in individuals aged four and older suffering from hyperphagia.

This submission is a pivotal step for Soleno, offering a potential new therapeutic solution for PWS, a rare condition characterized by life-threatening overeating and other severe symptoms.

DCCR has received Breakthrough, Fast Track, and Orphan Drug designations in the U.S., as well as Orphan Drug designation in the E.U. The FDA will decide on the NDA's acceptance within 60 days, and Soleno has requested Priority Review, which could shorten the review period to six months.

Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare diseases, announced the grant of inducement awards to eight new employees, as required by Nasdaq rules. The Board of Directors approved the issuance of non-qualified stock options for 247,200 shares at an exercise price of $41.15 per share, which matches the closing price on June 21, 2024. These options vest over four years, with 25% vesting after one year and the remaining shares vesting monthly. This grant falls under Soleno's 2020 Inducement Equity Incentive Plan.