Relief Reports U.S. Collaboration Partner's Emergency Use Authorization Request for ZYESAMI/RLF-100 (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure was Declined by U.S. FDA

Rhea-AI Summary

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.

Positive

• Acquisitions of APR Applied Pharma Research and AdVita Lifescience expand Relief's pipeline.
• Collaboration with Acer Therapeutics for ACER-001 diversification strategy.

Negative

• FDA declined Emergency Use Authorization for IV aviptadil, affecting Relief's lead drug and clinical prospects.
• Uncertainty regarding future regulatory approval for aviptadil in the U.S.

GENEVA, SWITZERLAND / ACCESSWIRE / November 5, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) ("NRx"), has issued a press release announcing that it was declined Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the use of IV aviptadil for the treatment of acute respiratory failure due to critical COVID-19. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100^TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

CONTACT:
RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com

FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

SOURCE: Relief Therapeutics Holdings AG

View source version on accesswire.com:
https://www.accesswire.com/671343/Relief-Reports-US-Collaboration-Partners-Emergency-Use-Authorization-Request-for-ZYESAMIRLF-100-aviptadil-for-Patients-with-Critical-COVID-19-with-Respiratory-Failure-was-Declined-by-US-FDA

FAQ

What was the outcome of FDA's decision regarding IV aviptadil for Relief Therapeutics?

The FDA declined the Emergency Use Authorization request for IV aviptadil, impacting its development for COVID-19.

How does the FDA decision affect Relief Therapeutics' stock symbol RLFTF?

The decline of the EUA may negatively affect investor sentiment and the stock value of RLFTF.

What are the implications of Relief Therapeutics' acquisitions for its business?

The acquisitions of APR Applied Pharma Research and AdVita Lifescience diversify Relief's drug pipeline, which could enhance its market position.

What drug is Relief Therapeutics focusing on for COVID-19 treatment?

Relief Therapeutics is focusing on RLF-100 (aviptadil) for treating respiratory failure due to COVID-19.