RELIEF THERAPEUTICS HLDG - RLFTF STOCK NEWS

Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, received notice from the FDA denying Breakthrough Therapy Designation for aviptadil. While this designation could have expedited the review process, it is not a requirement for drug approval. The FDA had previously granted priority and rolling review under Fast Track Designation. NRx emphasized that potential approval remains viable, but acknowledges the need for improved scientific alignment. Relief continues to advance its clinical programs, including RLF-100 for COVID-19 respiratory issues.

Relief Therapeutics announced the effectiveness of its Form F-6 registration statement, launching a Level 1 American Depositary Receipt (ADR) program in the U.S. on November 18, 2021. The ADRs, trading under the symbol RLFTY, will represent 150 ordinary shares of Relief, enabling U.S. investors to trade seamlessly. Although Relief will not generate any immediate proceeds from this program, it aims to transition to a Level 2 or Level 3 ADR program with a potential listing on the Nasdaq in the first half of 2022, though success is not guaranteed.

Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, received a positive response from the U.S. FDA regarding updated manufacturing information for aviptadil. This allows for high-volume production and extends the shelf life of aviptadil from 62 days to 150 days. Relief's lead drug candidate, aviptadil, aims to treat respiratory deficiency in COVID-19 patients and is in late-stage clinical testing. The company also has a diverse development pipeline following recent acquisitions.

Relief Therapeutics provided a corporate update regarding its clinical developments and regulatory activities. The company is advancing RLF-100(TM) (aviptadil) for COVID-19 related respiratory complications, with ongoing trials in Europe and the U.S. Recently, it received authorization for a phase 2 trial for pulmonary sarcoidosis. Relief is also preparing to market its PKU GOLIKE(R) product in the U.S. and expects a decision on ACER-001 by June 2022. Relief holds CHF45 million in cash, projecting to cover operations into late 2023 and aiming for positive cash flow by 2024.

Relief Therapeutics announces the appointment of Anthony M. Kim as Senior Vice President and Head of U.S. Commercial Operations, effective December 1, 2021. Kim, a seasoned biotech executive, brings extensive U.S. commercial launch experience, aiming to bolster the company's product availability in the U.S., including the PKU GOLIKE(R). Meanwhile, Chris Stijnen will depart the company, with Paolo Galfetti assuming his responsibilities in Europe. The company highlights strategic growth from collaborations with Acer Therapeutics and acquisitions of APR and AdVita in 2021.

Relief Therapeutics Holding SA announced that its U.S. partner, NRx Pharmaceuticals, has had its request for Emergency Use Authorization for IV aviptadil declined by the FDA. This decision impacts Relief's lead drug candidate, RLF-100, which is being tested for treating respiratory failure due to COVID-19. The company's portfolio also includes collaboration with Acer Therapeutics for ACER-001 aimed at Urea Cycle Disorders. This development raises concerns about the approval timeline and market potential for Relief's key therapies.

Relief Therapeutics Holding SA has taken initial steps to launch a Level 1 American Depositary Receipt (ADR) program in the U.S., filing a registration statement on Form F-6 with the SEC. This program will allow U.S. investors to trade shares without cross-border transactions. Each ADR will represent 150 ordinary shares. Although Relief will not receive proceeds from this program, it aims to progress to a Level 2 or Level 3 ADR program, potentially listing on NASDAQ in H1 2022. The success of this transition is uncertain.

Relief Therapeutics (OTCQB: RLFTF) announced a positive safety update regarding aviptadil from its U.S. partner, NRx Pharmaceuticals, as part of the NIH-sponsored ACTIV-3b study. The Independent Data Safety Monitoring Board analyzed over 300 patients and found no new safety concerns, recommending continued enrollment to reach 640 patients. Relief's lead drug, RLF-100(TM), aims to treat respiratory deficiency due to COVID-19. The company also broadened its portfolio through recent acquisitions and collaborations.

Relief Therapeutics Holding SA has announced positive interim results from a clinical trial of its nasal spray Sentinox for SARS-CoV-2 infected patients. Conducted by APR Applied Pharma Research, the study confirmed Sentinox's safety and tolerability, suggesting it may effectively reduce viral load in nasal mucosa. Out of 30 patients, all treated with Sentinox tested negative for the virus by Day 21, while 10% of the control group remained positive. The study aims to confirm these promising results across a larger cohort.