RELIEF THERAPEUTICS S/ADR - RLFTY STOCK NEWS

Relief Therapeutics announced that the U.S. SEC has declared effective its Registration Statement on Form 20-F, allowing the company to become a reporting entity under the Securities Exchange Act. This move is part of an effort to list its ADRs on the NASDAQ. While the company plans to file its application soon, success is contingent on meeting listing requirements and receiving NASDAQ approval. The company will not receive proceeds from the ADR program at this stage.

Relief Therapeutics announced that its partner, Acer Therapeutics, has resubmitted the New Drug Application (NDA) for ACER-001 to the FDA for treating urea cycle disorders (UCDs). This resubmission addresses issues raised in the previous Complete Response Letter (CRL) issued in June 2022, primarily concerning the inspection of a third-party contract packaging facility. Relief notes that Acer believes no other approvability issues remain. The FDA has already provided orphan drug designation for ACER-001, a sodium phenylbutyrate formulation under development for UCDs and Maple Syrup Urine Disease (MSUD).

Relief Therapeutics has appointed Serene Forte, Ph.D., MPH, as Senior Vice President, Head of Genetic Medicine, effective July 18, 2022. This strategic move aims to advance the company's initiatives in genetic medicine, particularly focusing on developing therapies for rare diseases. Dr. Forte's extensive experience in gene therapy, including leadership roles at Krystal Biotech and PTC Therapeutics, is expected to enhance Relief's commercial and medical strategies. The company aims to leverage Dr. Forte's expertise to evaluate prospective assets in this new field.

Relief Therapeutics has acquired the worldwide rights to a novel therapeutic product aimed at managing phenylketonuria (PKU), excluding the UK. This acquisition complements their existing PKU GOLIKE portfolio. Financial terms were undisclosed. The company plans to conduct clinical studies and submit an Investigational New Drug (IND) application for U.S. FDA approval, with a potential market launch in 2024. The product is expected to cater to the pediatric population by offering better dosage precision.

Relief Therapeutics has filed Amendment No. 4 to its Registration Statement on Form 20-F with the SEC to register as a reporting company under the Securities Exchange Act. This is part of its program to transition its Level 1 ADR to a Level 2 ADR and aims for a potential NASDAQ listing, although no assurance of success is provided. The filing does not involve an offering of securities, and Relief will not receive any proceeds from its current ADR program. The company's focus includes clinical-stage programs and partnerships for drug development.

Relief Therapeutics Holding SA reported on July 4, 2022, that the FDA has declined to issue an Emergency Use Authorization (EUA) for aviptadil concerning a subgroup of patients also receiving remdesivir. This decision impacts the company as it collaborates with NRx Pharmaceuticals, whose subsidiary, NeuroRx, is involved with aviptadil's development. Relief is involved in clinical-stage programs aimed at serious unmet medical needs, including various metabolic disorders. The firm has also expanded its pipeline through recent acquisitions.

Relief Therapeutics has filed Amendment No. 3 to its Registration Statement on Form 20-F with the SEC to transition its Level 1 American Depositary Receipt program to a Level 2 program, facilitating a potential listing on NASDAQ. The filing does not generate any proceeds for the company and is part of an ongoing effort to enhance its market presence. The effectiveness of the Registration Statement remains under review, and there is no guarantee of a successful listing. Relief continues focusing on clinical-stage programs, including collaborations for drug development.

Relief Therapeutics Holding SA announced that its parent company, NRx Pharmaceuticals, Inc., faced a setback as the FDA denied its application for Breakthrough Therapy designation for aviptadil. This rejection could have significant implications for the drug's further development, particularly in treating serious lung conditions, including COVID-19. Relief maintains its focus on clinical-stage programs and has a collaboration with Acer Therapeutics for developing ACER-001.

Relief Therapeutics Holding SA reported that its partner Acer Therapeutics has not received a decision from the FDA on the 505(b)(2) NDA for ACER-001 (sodium phenylbutyrate) aimed at treating urea cycle disorders. The NDA was accepted for review on October 5, 2021, with a PDUFA target action date of June 5, 2022. Currently, the FDA's review is ongoing without a set target date. Relief and Acer will issue a joint release once the FDA decision is made, impacting the prospects of their development and commercialization agreement for ACER-001.