Relief Therapeut Stock Price, News & Analysis

Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, RLFTY) presented data on ACER-001 (sodium phenylbutyrate) at the GMDI Conference on May 5, 2022. The studies demonstrated that ACER-001 is bioequivalent to BUPHENYL under fasting and fed conditions, with no major safety concerns. The companies anticipate a decision from the FDA regarding the new drug application on June 5, 2022, and plan to submit a marketing application in the EU later this year. ACER-001 aims to address unmet needs in Urea Cycle Disorders.

Relief Therapeutics Holding SA has announced its Annual General Meeting (AGM) scheduled for May 31, 2022, which will be held without shareholder presence due to COVID-19. The Board recommends approval of key items including the Annual Report for 2021, carrying forward a loss of CHF 29,553,450, increasing authorized share capital to CHF 22 million, and approving compensation for the Board and Executive Committee totaling CHF 7.5 million. The meeting will also include re-elections for Board members and auditors.

Relief Therapeutics announced that its subsidiary, APR Applied Pharma Research, received a Notice of Allowance for Patent Application No. 15/303,121 from the U.S. Patent and Trademark Office. This patent covers PKU GOLIKE(R) formulations, enhancing dietary management for patients with phenylketonuria (PKU). The patent, valid until at least September 27, 2036, strengthens Relief's intellectual property and supports plans for a U.S. launch of PKU GOLIKE(R) in mid-2022, pending approval. The formulation is designed to mimic natural protein absorption while masking unpleasant flavors.

Relief Therapeutics announces the appointment of Drew Cronin-Fine as Executive Director, Head of U.S. Marketing, effective May 3, 2022. This strategic hire aims to bolster the U.S. commercial team ahead of the anticipated product rollouts for PKU GOLIKE and ACER-001, with a PDUFA date set for June 5, 2022. Cronin-Fine brings extensive experience from her previous roles at Intercept Pharmaceuticals and Cubist Pharmaceuticals, focusing on rare diseases and digital marketing strategies. This move is expected to enhance Relief's capabilities in the evolving rare disease market.

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.