Relief Therapeut Stock Price, News & Analysis

Relief Therapeutics has appointed David McCullough as the Senior Director and Head of U.S. Market Access, effective August 22, 2022. This newly created role is aimed at enhancing market access strategies for the company's products. McCullough brings over 20 years of experience from various biopharmaceutical companies, including Mirum Pharmaceuticals and Novartis Gene Therapies. His expertise will be pivotal as Relief prepares for the October 2022 launch of PKU GOLIKE. This appointment signifies a milestone in Relief's growth and commitment to patient access.

Relief Therapeutics announced promising three-month stability data for a new formulation of RLF-100 (aviptadil), indicating it may have clinical use for rare lung diseases. The formulation shows potential for stability during shipping and long-term storage. Relief plans to file for additional patent protection and initiate a phase 2b study for pulmonary sarcoidosis in 2023. The FDA pre-IND meeting will confirm efficacy and safety. RLF-100 has a history of safe use in various conditions, with ongoing development for multiple lung diseases.

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.