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RELIEF THERAPEUTICS Holding SA (RLFTY) is a biopharmaceutical company dedicated to developing innovative treatment options for select specialty, unmet, and rare diseases. The company's mission is to provide therapeutic relief to patients through its portfolio of revenue-generating products, proprietary Physiomimic™ and TEHCLO™ platform technologies, and a clinical development pipeline focused on rare skin, metabolic, and respiratory disorders. With a team of experienced industry leaders, Relief Therapeutics aims to optimize patient outcomes and advance treatment paradigms. Headquartered in Geneva, the company is listed on the SIX Swiss Exchange and OTCQB in the U.S.
Relief Therapeutics Holding SA announced that its collaboration partner, NeuroRx, has filed a lawsuit against it in New York, alleging breach of their collaboration agreement and defamation. Relief asserts that the agreement is still valid and disputes NeuroRx's claims. The company believes the lawsuit includes materially inaccurate statements and an illogical damages calculation. Relief plans to respond to the lawsuit and continues to participate in scheduled mediation with NeuroRx.
Relief Therapeutics announced that its partner, NRx Pharmaceuticals, submitted an application to the FDA for emergency use authorization (EUA) of aviptadil to treat COVID-19 patients at high risk of death. This application targets patients who are not eligible for the NIH-sponsored trial and are unresponsive to standard treatments like Remdesivir. Additionally, Relief is currently involved in a lawsuit against NeuroRx and its CEO, Jonathan Javitt, concerning their collaboration on aviptadil. The company remains optimistic about its legal claims and an upcoming mediation in February 2022.
Relief Therapeutics announced its participation in several virtual investor conferences in January 2022. The conferences include the H.C. Wainwright BioConnect Virtual Conference (January 10-13), where CFO Jack Weinstein will present an overview, and the Biotech Showcase 2022 (January 10-13, 17-19) for an additional corporate presentation. Relief's drug candidate, RLF-100, is in late-stage clinical testing for COVID-19 respiratory deficiency. The company is also expanding its pipeline through collaborations and acquisitions.
Relief Therapeutics has announced that its partner, NRx Pharmaceuticals, has filed a provisional patent application for stable compositions of aviptadil, a treatment for COVID-19. The application focuses on shelf-stable formulations of vasoactive intestinal peptide. Relief asserts that NRx has obligations under their collaboration agreement to cross-license related intellectual property to Relief, which plays a crucial role in an ongoing breach of contract lawsuit against NRx. Relief is also advancing its lead candidate RLF-100™ in late-stage clinical testing.
Relief Therapeutics Holding has announced an Extraordinary General Meeting (EGM) for shareholders on January 28, 2022, to be held virtually due to COVID-19 precautions. Key agenda items include:
- Election of Michelle Lock to the Board of Directors.
- Proposal for CHF 2,500,000 in compensation for Board members, up from CHF 1,500,000.
- General revision of Articles of Association, covering various amendments.
Relief Therapeutics announced that its collaboration partner, NRx Pharmaceuticals, has filed for Breakthrough Therapy Designation from the FDA for aviptadil aimed at treating COVID-19 patients experiencing respiratory failure. The BTD request is supported by clinical data showing a 2.8-fold increase in survival odds at 28 days and a 4-fold increase at 60 days for patients treated with aviptadil compared to a placebo. This data may significantly impact Relief's market position and investor sentiment regarding its ongoing clinical programs.
Relief Therapeutics announced that the Swiss Patent Office will conclude its patent application for Vasoactive Intestinal Peptide (VIP) by January 24, 2022. This patent, focusing on the treatment of drug-induced pneumonitis via the inhaled formulation of RLF-100 (aviptadil), underlines the company’s strengthening intellectual property portfolio. Chairman Raghuram Selvaraju emphasized the significance of this patent amidst ongoing clinical studies, which indicate promising results for patients suffering from immune checkpoint inhibitor-related pneumonitis. The patent is expected to be issued a month after the examination procedure concludes.
Relief Therapeutics Holding SA has filed a Registration Statement on Form 20-F with the U.S. SEC, aiming to upgrade its Level 1 American Depositary Receipt (ADR) program to Level 2. This move supports Relief's ambition to list on the NASDAQ during the first half of 2022, pending SEC approval and application. Currently, the company's ordinary shares are traded on the SIX Swiss Exchange under the symbol RLF and on OTCQB under RLFTF. The ADRs represent 150 of Relief's ordinary shares and currently trade as RLFTY.
Relief Therapeutics Holding SA announced that its collaboration partner, NRx Pharmaceuticals, reported a favorable safety update on aviptadil, currently being tested in the ACTIV-3b Critical Care Phase 3 study by the NIH. The Independent Data Safety Monitoring Board reviewed 348 patients and found no new safety concerns, allowing the study to continue enrollment aiming for a total of 640 patients. This update supports Relief's lead candidate, RLF-100 (aviptadil), which is in late-stage testing for respiratory deficiencies due to COVID-19.
Relief Therapeutics reported that its partner, NRx Pharmaceuticals, has established a regulatory pathway with Hungarian Health Officials for the emergency use of aviptadil. This program is expected to commence by the end of 2021. Relief is focused on clinical-stage programs, notably advancing RLF-100 (aviptadil) for COVID-19 related respiratory issues. The company also diversifies its pipeline through agreements like the one with Acer Therapeutics for ACER-001 aimed at treating Urea Cycle Disorders.
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