Relief Reports that its Collaboration Partner, Acer Therapeutics, Issued a Statement Regarding the PDUFA Target Action Date for ACER-001

Rhea-AI Summary

Relief Therapeutics Holding SA reported that its partner Acer Therapeutics has not received a decision from the FDA on the 505(b)(2) NDA for ACER-001 (sodium phenylbutyrate) aimed at treating urea cycle disorders. The NDA was accepted for review on October 5, 2021, with a PDUFA target action date of June 5, 2022. Currently, the FDA's review is ongoing without a set target date. Relief and Acer will issue a joint release once the FDA decision is made, impacting the prospects of their development and commercialization agreement for ACER-001.

Positive

• Collaboration with Acer Therapeutics for ACER-001 development.
• ACER-001 aims to address unmet needs in urea cycle disorders.

Negative

• No decision from the FDA by the PDUFA target date may indicate potential delays in drug approval.
• Ongoing FDA review without a set target date adds uncertainty to timelines.

GENEVA, SWITZERLAND / ACCESSWIRE / June 8, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet needs, reported today that its collaboration partner, Acer Therapeutics, Inc. ("Acer"), announced that it has not yet received a decision from the U.S. Food and Drug Administration ("FDA") on its 505(b)(2) New Drug Application ("NDA") for ACER-001 (sodium phenylbutyrate), for the treatment of urea cycle disorders ("UCDs"). The NDA for ACER-001 for UCDs was accepted for review by FDA on October 5, 2021, at which time FDA assigned a PDUFA target action date of Sunday, June 5, 2022. According to the press release, the FDA has informed Acer that review for ACER-001 is ongoing and the agency currently does not have a set target date. Acer reported that, under the Prescription Drug User Fee Act (PDUFA), FDA's review performance goal is to review and act on 90 percent of NDA submissions by the target action date. The related Acer press release can be accessed through the following link.

Acer and Relief will issue a joint press release once the FDA has provided its written decision to Acer.

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 has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of inborn errors of metabolism, including urea cycle disorders and Maple Syrup Urine Disease. Relief also continues to study aviptadil for several possible lung related conditions. Finally, Relief's 2021 acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought 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 symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

CONTACT:

RELIEF THERAPEUTICS Holding SA
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 and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer's NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will submit an application for approval of ACER-001 in Europe and the timing of filing such application, (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patients in Europe with UCDs will be approved, and (iv) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission, all of 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/704287/Relief-Reports-that-its-Collaboration-Partner-Acer-Therapeutics-Issued-a-Statement-Regarding-the-PDUFA-Target-Action-Date-for-ACER-001

FAQ

What is the latest update on Relief Therapeutics' ACER-001 FDA application?

Relief Therapeutics reported that its partner Acer Therapeutics has not received a decision from the FDA regarding the ACER-001 NDA.

What are the implications of the FDA's ongoing review for ACER-001?

The ongoing review without a set target date suggests potential delays in the approval process for ACER-001.

When was the NDA for ACER-001 accepted by the FDA?

The NDA for ACER-001 was accepted for review by the FDA on October 5, 2021.

What conditions is ACER-001 intended to treat?

ACER-001 is intended to treat urea cycle disorders.

What is the significance of the PDUFA target action date for ACER-001?

The PDUFA target action date of June 5, 2022, was expected for the FDA's decision on the NDA for ACER-001.