Relief Therapeutics Hldg Ag Stock Price, News & Analysis

Relief Therapeutics announced positive 12-month stability data for RLF-100 ^®, an investigational formulation of aviptadil acetate for inhaled and intravenous administration. Both formulations demonstrated high purity levels after one year across various temperature conditions, confirming previous findings at three and six months. In response to these results, Relief plans to amend its provisional patent application, potentially extending exclusivity until 2042, factoring in possible Hatch-Waxman extensions.

CEO Jack Weinstein emphasized the commercial potential of the stable formulation, aiming to establish RLF-100 ^® as a standard treatment for respiratory failure. The FDA previously granted Orphan Drug designation for RLF-100 ^® targeting pulmonary sarcoidosis.

Relief Therapeutics Holdings SA reported its financial results for the full year ending December 31, 2022, highlighting significant advances in its transformation to a commercial-stage biopharmaceutical company. The company secured FDA approval for OLPRUVA™, aimed at treating urea cycle disorders, with a launch anticipated in July 2023. Additionally, the launch of the PKU GOLIKE™ line in the U.S. started in October 2022, with the PKU GOLIKE BAR™ introduced in early 2023. The company also revealed stability data for RLF-100™, enhancing its clinical potential. Relief appointed key leaders for its genetic medicine initiative and is pursuing a dual listing on the Nasdaq. The 2022 annual report is available for download on its website.

Relief Therapeutics announced the departure of Dr. Nermeen Varawalla, the Chief Medical Officer, effective Q2 2023. Dr. Varawalla leaves to pursue other opportunities, and the medical affairs team will report to COO Paolo Galfetti until a replacement is found. The company emphasizes that clinical development will be supported by existing consultants. CEO Jack Weinstein praised Varawalla's contributions and reaffirmed the strength of their medical affairs and R&D teams as they focus on advancing their pipeline in metabolic, connective tissue, and pulmonary rare diseases.

Relief Therapeutics Holding SA has announced an extraordinary general meeting (EGM) scheduled for April 28, 2023, in Geneva to vote on a proposed 400-for-1 reverse stock split. This action aims to facilitate a listing of its shares on the Nasdaq Stock Market. The consolidation will not impact the overall market capitalization or shareholders' equity percentages, aside from compensating fractional shares in cash. CEO Jack Weinstein emphasized that this listing would enhance liquidity and access to capital for the company’s development pipeline. Full details of the proposal are available in the EGM invitation and further information can be found on the company's website.

Relief Therapeutics has appointed Guangping Gao, Ph.D., a renowned gene therapy expert, as the chair of its new scientific advisory board (SAB). Dr. Gao's expertise includes the discovery of adeno-associated virus (AAV) serotypes, crucial for gene therapy advancements. His role will focus on providing strategic guidance for the company's genetic medicine initiatives aimed at treating rare diseases. Relief Therapeutics aims to develop potentially curative therapies leveraging Dr. Gao's extensive experience in gene therapy.

Relief Therapeutics announced the presentation of preclinical study results on its PKU GOLIKE product, a prolonged-release amino acid supplement developed with Physiomimic Technology, at the Society for Inherited Metabolic Disorders 44th Annual Meeting in Salt Lake City (March 18-21, 2023). This study shows promising improvements in muscle anabolism and function, critical for patients with Phenylketonuria (PKU), a rare metabolic disorder affecting over 450,000 individuals globally. The findings, indicating enhanced amino acid utilization, will help shape future clinical research. Detailed results will be available on Relief Therapeutics' website after the presentation.

Relief Therapeutics has announced the launch of its new PKU GOLIKE BARs in Europe, designed for patients with phenylketonuria (PKU). These prolonged-release amino acid medical foods come in tropical and red fruit flavors and are made with natural ingredients. Each box contains either 20 bars with 5g protein or 10 bars with 10g protein. The company has eliminated exposure to Credit Suisse and has no funds with closed U.S. banks, mitigating risks from recent banking sector issues. PKU affects over 450,000 patients globally, necessitating strict dietary management to avoid severe health consequences.

Acer Therapeutics reports that preliminary launch activities for OLPRUVA™ are progressing well, with commercial and medical teams being built to support the U.S. launch expected in Q2 2023. The drug is anticipated to be available by early July 2023. Acer has introduced the OLPRUVA™ Navigator service to assist patients and is negotiating access with major payers. The pricing strategy aims for a competitive position, significantly lower than current products like RAVICTI®. Acer will also present a survey on treatment preferences for urea cycle disorders at SIMD 2023.