Relief Therapeutics Hldg Ag Stock Price, News & Analysis

Relief Therapeutics announced that its partner, NRx Pharmaceuticals, has filed for Breakthrough Therapy Designation with the FDA for aviptadil in patients with Critical COVID-19 who were also treated with remdesivir. The request is based on a post-hoc analysis of around 750 patients and aims to address ongoing respiratory failure. Relief's ongoing collaborations also include a licensing agreement with Acer Therapeutics for another treatment. The PDUFA date for Acer's new drug application is set for June 5, 2022.

Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, RLFTY) presented data on ACER-001 at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting held from April 10-13, 2022. The studies demonstrated that taste-masked sodium phenylbutyrate (ACER-001) is bioequivalent to BUPHENYL® under both fasting and fed conditions, with similar safety profiles. The FDA's PDUFA date for ACER-001 is set for June 5, 2022, with potential benefits for patients with urea cycle disorders (UCDs). The findings highlight ACER-001 as a promising alternative therapy.

RELIEF THERAPEUTICS Holding SA announced that the Swiss Patent Office has granted a patent for Vasoactive Intestinal Peptide (VIP) for treating drug-induced pneumonitis, enhancing the intellectual property for RLF-100 (aviptadil) until at least 2039. This patent covers treatment for checkpoint inhibitor-related pneumonitis and methotrexate-induced pneumonitis. Clinical studies, including the NIH-sponsored ACTIVE-3b/TESICO study, are ongoing. Aviptadil's inhalation method shows promising results, offering rapid and targeted treatment, which can improve patient outcomes significantly.

Relief Therapeutics Holding SA announced that the I-SPY COVID Trial involving its product aviptadil has been halted due to a lack of clinical benefit in critically ill COVID-19 patients. The Phase 2 trial, sponsored by Quantum Leap Healthcare Collaborative, aimed to evaluate potential agents that could improve recovery times. Relief's pipeline includes RLF-100 and a collaboration with Acer Therapeutics for ACER-001, with a new drug application accepted by the FDA. The future of aviptadil’s approval remains uncertain amid ongoing litigation.

Relief Therapeutics reported full-year 2021 results with a net loss of CHF 34.7 million, up from CHF 7.8 million in 2020. The company generated CHF 3.3 million in revenue from marketed products following the acquisition of APR Applied Pharma Research. Relief is positioned for potential growth with plans for U.S. commercialization of ACER-001, pending FDA approval by June 5, 2022. The company ended 2021 with a cash position of CHF 44.8 million, forecasting a cash runway into 2023. Notable acquisitions and product developments are set to enhance its commercial infrastructure.

Relief Therapeutics' subsidiary, APR Applied Pharma Research, published promising in vivo data in the International Journal of Molecular Sciences. The study indicates that its Physiomimic^TM technology may provide prolonged release of amino acids (AAs), beneficial for managing phenylketonuria (PKU). Results show improved nitrogen balance, muscle mass, and strength in animal models. CEO Paolo Galfetti emphasized the potential of PKU GOLIKE(R), a product utilizing this technology, to mimic natural protein absorption. Relief aims for U.S. market entry of PKU GOLIKE(R) in 2022 while pursuing further clinical evidence.

Relief Therapeutics announced that it has received a trademark registration for RLF-100 from the USPTO. This certification is significant as it strengthens the company’s intellectual property position for RLF-100, a drug in late-stage development targeting respiratory issues related to COVID-19 and other conditions. RLF-100 is a synthetic form of Vasoactive Intestinal Peptide with a proven history of safe use in several trials. The company aims to leverage this trademark to enhance its market position as it navigates ongoing clinical testing.

Relief Therapeutics has appointed Christopher Wick as the Senior Director, Head of U.S. Sales, to strengthen its U.S. expansion efforts. Wick, with over 20 years in pharmaceutical sales, previously led successful teams at Alexion Pharmaceuticals and held key roles at GlaxoSmithKline and Novartis. His experience will support the planned launch of pharmaceutical treatments, including ACER-001 for Urea Cycle Disorders, with a PDUFA date of June 5, 2022. The company aims to boost its U.S. market presence driven by its recent acquisitions and strategic collaborations.

Relief Therapeutics announced the filing of Amendment No. 1 to its Registration Statement on Form 20-F with the SEC. This aims to register the company as a reporting entity under the Securities Exchange Act of 1934 and convert its Level 1 ADR program to Level 2, facilitating a future Nasdaq listing. However, there is no assurance that the registration will be effective or that the Nasdaq listing will occur. Notably, the filing does not involve any securities offering, hence no proceeds will be received from this ADR program.