Relief Therapeutics

Biophytis obtains FDA Authorization to initiate the SARA-31 phase 3 study in sarcopenia

Retrieved on: 
Saturday, September 16, 2023

This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study.

Key Points: 
  • This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study.
  • The company still needs to obtain authorizations from ethics committees in the countries before launching this study.
  • The effective start of the study is scheduled for 2024, and will depend on the conclusion of partnership agreements and the Company's financial resources.
  • Stanislas Veillet, Chief Executive Officer of Biophytis, commented: "FDA approval suggests authorities may be increasingly aware of the growing need for effective therapeutics against a major disease in an aging society.

Relief Therapeutics to Participate in the H.C. Wainwright 25th Annual Global Investment Conference

Retrieved on: 
Friday, September 1, 2023

Relief Therapeutics to Participate in the H.C. Wainwright 25th Annual Global Investment Conference

Key Points: 
  • Relief Therapeutics to Participate in the H.C. Wainwright 25th Annual Global Investment Conference
    Relief Therapeutics to Participate in the H.C. Wainwright 25th Annual Global Investment Conference
    GENEVA (SEPT. 1, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF , OTCQB: RLFTF , RLFTY ) (Relief Therapeutics), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that Jack Weinstein, chief executive officer, will present a company overview during the H.C. Wainwright 25th Annual Global Investment Conference taking place September 11-13, 2023 at the Lotte New York Palace hotel in New York.
  • Location: Lotte New York Palace Hotel, 455 Madison Avenue at 50th Street, New York, NY 10022
    Management will host one-on-one meetings during the event.
  • Institutional investors who are registered for the conference can log into www.hcwevents.com to request a meeting with the company.
  • A live webcast of the Relief Therapeutics presentation can be found at the following link: https://journey.ct.events/view/6db5b681-f490-4229-8384-6ac135554cfc and will be archived for a period of 90 days after the conference.

Zevra Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio and Adding Commercial Product

Retrieved on: 
Thursday, August 31, 2023

Zevra has also purchased Acer’s secured debt at a discount from Nantahala Capital (Nantahala) through a series of transactions in capital efficient structure.

Key Points: 
  • Zevra has also purchased Acer’s secured debt at a discount from Nantahala Capital (Nantahala) through a series of transactions in capital efficient structure.
  • In addition, Zevra has agreed to provide Acer with a bridge loan facility for up to $16.5 million, subject to certain terms and conditions.
  • The merger is expected to expand Zevra's rare disease portfolio, as well as increase and diversify its revenues with the addition of a U.S. commercial asset, OLPRUVA, indicated for the treatment of UCDs.
  • Pillsbury Winthrop Shaw Pittman LLP served as legal advisor to Acer, and William Blair & Company, LLC served as exclusive financial advisor to Acer.

Acer Therapeutics Reacquires Worldwide Development, Commercialization and Economic Rights to OLPRUVA™ from Relief Therapeutics, Excluding the Geographical Europe

Retrieved on: 
Wednesday, August 30, 2023

OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).

Key Points: 
  • OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).
  • Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe.
  • Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™.
  • For additional Important Safety Information, see full Prescribing Information , Patient Package Insert and discuss with your doctor.

Relief Therapeutics Announces Extension of Distribution Agreement for PKU GOLIKE® in the U.S. with Pentec Health

Retrieved on: 
Wednesday, July 19, 2023

This enables Relief Therapeutics to broaden distribution of PKU GOLIKE® across an expanded commercial payor base, ensuring more patients living with PKU will have access to the PKU GOLIKE® family of products to help them manage their condition.

Key Points: 
  • This enables Relief Therapeutics to broaden distribution of PKU GOLIKE® across an expanded commercial payor base, ensuring more patients living with PKU will have access to the PKU GOLIKE® family of products to help them manage their condition.
  • “Working together, Pentec Health, ZOIA Pharma and Relief Therapeutics are helping to solve problems in the rare disease world to improve the health of people with these conditions,” said Matthew Deans, president and chief executive officer of Pentec Health.
  • “The combined forces of Pentec Health and Zoia Pharma is one of the most consequential developments in the past decade for the distribution of medical foods,” said Chris Wick, U.S. country lead of Relief Therapeutics.
  • “The expanded reach and capabilities will enable us to serve more patients in the PKU community with PKU GOLIKE® for years to come.”

Relief Therapeutics Announces Swissmedic Approval and Operation of New Good Manufacturing Practice-Compliant Laboratory

Retrieved on: 
Monday, May 15, 2023

Swissmedic is the national authorization and supervisory authority for drugs and medical products and devices.

Key Points: 
  • Swissmedic is the national authorization and supervisory authority for drugs and medical products and devices.
  • The next-generation laboratory in Balerna, Switzerland is run by Relief Therapeutics’ subsidiary APR Applied Pharma Research SA (APR) and offers a comprehensive suite of analytical and development services for internal projects and provides external clients with data and full documentation to meet current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and international regulatory authority requirements.
  • “GMP compliance is a critical achievement for our laboratory, enabling us to create, safeguard and supply high-quality products to patients and healthcare providers as well as enable the future submissions of product files to regulatory authorities,” said Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR.
  • “We are excited that our new GMP-compliant lab in Balerna, where innovation is driven by our experienced and highly talented employees, is now Swissmedic-approved and operational,” said Jack Weinstein, chief executive officer of Relief Therapeutics.

Relief Therapeutics Announces Implementation Timeline for Reverse Split of Ordinary Shares

Retrieved on: 
Wednesday, May 3, 2023

GENEVA (May 3, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF , OTCQB: RLFTF , RLFTY ) (Relief Therapeutics), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced the implementation timeline for the reverse split of its ordinary shares, which was approved by shareholders at the Extraordinary General Meeting held on April 28, 2023.

Key Points: 
  • GENEVA (May 3, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF , OTCQB: RLFTF , RLFTY ) (Relief Therapeutics), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced the implementation timeline for the reverse split of its ordinary shares, which was approved by shareholders at the Extraordinary General Meeting held on April 28, 2023.
  • As previously communicated, shareholdings will be rounded down to the next lower whole number of new merged shares by applying the 400 to 1 exchange ratio.
  • The resulting fractions will be compensated in cash at a fixed price corresponding to the three-day volume-weighted average price of the Relief Therapeutics share on the SIX Swiss Exchange prior to the reverse split.

Relief Therapeutics Announces Results of Extraordinary General Meeting of Shareholders

Retrieved on: 
Monday, May 1, 2023

The share consolidation is an important step to bringing us closer to our goal of listing on the Nasdaq,” said Jack Weinstein, chief executive officer of Relief Therapeutics.

Key Points: 
  • The share consolidation is an important step to bringing us closer to our goal of listing on the Nasdaq,” said Jack Weinstein, chief executive officer of Relief Therapeutics.
  • There can be no assurance that Nasdaq will approve the Relief Therapeutics listing application.
  • If Relief Therapeutics' shares are successfully listed on Nasdaq, the ADRs will be exchanged against ordinary registered shares.
  • The voting results of the EGM are available on the same page of the Relief Therapeutics website.

Relief Therapeutics Announces Availability of New PKU GOLIKE BARs in Europe

Retrieved on: 
Thursday, March 16, 2023

Developed with the Company’s proprietary Physiomimic Technology™ platform, the PKU GOLIKE family of products are next-generation, prolonged-release amino acid medical foods for the dietary management of phenylketonuria (PKU).

Key Points: 
  • Developed with the Company’s proprietary Physiomimic Technology™ platform, the PKU GOLIKE family of products are next-generation, prolonged-release amino acid medical foods for the dietary management of phenylketonuria (PKU).
  • The new PKU GOLIKE BARs come in tropical and red fruit flavors and contain natural ingredients and real fruit.
  • To learn more about the features of the new PKU GOLIKE BARs, watch the following video: https://youtu.be/tI_UxCRCedw
    “Our team has spent the past four years conducting focus groups and qualitative research, working directly with patients, caregivers and healthcare providers in the PKU community to develop the new PKU GOLIKE BARs,” said Jack Weinstein, chief executive officer of Relief Therapeutics.
  • “The new PKU GOLIKE BARs were developed with patients and for patients to address the needs expressed by patients.

Relief Therapeutics Recognizes Rare Disease Day and Announces U.S. Availability of New PKU GOLIKE Bars

Retrieved on: 
Tuesday, February 28, 2023

Relief Therapeutics Recognizes Rare Disease Day and Announces U.S.

Key Points: 
  • Relief Therapeutics Recognizes Rare Disease Day and Announces U.S.
  • Availability of New PKU GOLIKE Bars
    Relief Therapeutics Recognizes Rare Disease Day and Announces U.S.
  • My oldest son Riccardo was born with PKU, a rare, lifelong metabolic disease I had never heard of before his birth.
  • More flavors of the bars and other forms of PKU GOLIKE are currently in development.