Relief Therapeutics Hldg Ag Stock Price, News & Analysis

Relief Therapeutics Holding SA has announced the appointment of Tracy Truong and Kelli Powell as Regional Clinical Specialists for the West and Northeast Regions, effective May 23, 2022. Both specialists bring significant experience in pharmaceutical sales, particularly in rare diseases, having worked for top companies like Alexion and NPS Pharmaceuticals. Their expertise will support the anticipated rollout of PKU GOLIKE and the potential launch of ACER-001 for Urea Cycle Disorders, with a crucial PDUFA date set for June 5, 2022.

Relief Therapeutics Holding SA has submitted Amendment No. 2 to its Registration Statement on Form 20-F to the U.S. SEC, aiming to transition its Level 1 American Depositary Receipt (ADR) program to a Level 2 ADR program. This is part of Relief's goal to list its ADRs on the NASDAQ Stock Market. The effectiveness of the Registration Statement and the subsequent NASDAQ listing remain uncertain. Notably, there are no proceeds from this filing as it does not involve a securities offering.

Relief Therapeutics announced its participation in two significant conferences in May 2022, including Bio€quity Europe and the H.C. Wainwright Global Investment Conference. CFO Jack Weinstein will present at both events, with presentations scheduled for May 17 in Milan and May 24 virtually. Relief is advancing its drug candidate, RLF-100 (aviptadil), for treating respiratory issues linked to COVID-19, while also collaborating on ACER-001 for metabolic disorders. The company's ongoing efforts reflect a commitment to addressing unmet medical needs.

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.