Latest news with #RLF-TD011
Globe and Mail
22-05-2025
- Business
- Globe and Mail
Micro-Cap Biotech Skyrockets on FDA Pediatric Disease Nod
FDA approvals are often market-moving events, and today a micro-cap biotech company saw its shares surge after receiving Rare Pediatric Disease designation from the FDA. Relief Therapeutics Holding SA (OTCQB:RLFTF) (OTCQB:RLFTY) announced this morning that the U.S. FDA has granted Rare Pediatric Disease (RPD) designation to its drug candidate RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic skin disorder. This follows a previous Orphan Drug Designation for the same condition. RLF-TD011 is a hypotonic acid-oxidizing solution containing hypochlorous acid, developed to offer antimicrobial and anti-inflammatory effects while promoting a healing wound environment. The company has reported encouraging clinical results, highlighting the drug's potential to improve EB wound care by modulating the wound microbiome and reducing harmful bacterial colonization. "The FDA's decision to grant Rare Pediatric Disease designation to RLF-TD011 underscores both the critical need for new options for patients living with EB and the potential of our investigational therapy," said Giorgio Reiner, chief scientific officer of Relief. "We look forward to continued engagement with the FDA and to sharing the next steps in our development plan following our upcoming pre-IND meeting." The FDA grants RPD designation to product candidates targeting serious or life-threatening diseases that primarily affect individuals aged 18 years or younger and impact fewer than 200,000 people in the U.S. Companies that receive marketing approval for an RPD-designated indication may be eligible-subject to certain conditions, including congressional reauthorization of the program for designations granted after December 20, 2024-to receive a Priority Review Voucher (PRV), which grants expedited FDA review for a future marketing application. These vouchers are transferable; in May 2025, a PRV awarded following the approval of a treatment for a rare form of EB was sold for $155 million. Shares of RLFTF are surging on the news, currently up 49.62% at $3.89 while shares of RLFTY trade up 40.34% at $4.07 in late-morning trading. Copyright © 2025 All rights reserved. Republication or redistribution of content is expressly prohibited without the prior written consent of shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. View more of this article on About Media, Inc.: Founded in 1999, is one of North America's leading platforms for micro-cap insights. Catering to both Canadian and U.S. markets, we provide a wealth of resources and expert content designed for everyone—from beginner investors to seasoned traders. is rapidly gaining recognition as a leading authority in the micro-cap space, with our insightful content prominently featured across numerous top-tier financial platforms, reaching a broad audience of investors and industry professionals. Want to showcase your company's story to a powerful network of investors? We can help you elevate your message and make a lasting impact. Contact us today. Contact: Media, Inc.
Yahoo
22-05-2025
- Business
- Yahoo
Relief Therapeutics Receives FDA Rare Pediatric Disease Designation for RLF-TD011
GENEVA, SWITZERLAND / / May 22, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic skin disorder characterized by fragile skin and chronic wounds. The FDA had previously granted Orphan Drug Designation to RLF-TD011 for the same indication. RLF-TD011 is a differentiated, hypotonic acid-oxidizing solution formulated with hypochlorous acid, designed to deliver potent antimicrobial and anti-inflammatory activity while creating a wound microenvironment conducive to healing. The Company previously reported promising clinical findings supporting RLF-TD011's potential to meaningfully advance EB wound care by modulating the wound microbiome and reducing pathogenic colonization without disrupting beneficial bacteria. "The FDA's decision to grant Rare Pediatric Disease designation to RLF-TD011 underscores both the critical need for new options for patients living with EB and the potential of our investigational therapy," said Giorgio Reiner, chief scientific officer of Relief. "We look forward to continued engagement with the FDA and to sharing the next steps in our development plan following our upcoming pre-IND meeting." The FDA grants RPD designation to product candidates targeting serious or life-threatening diseases that primarily affect individuals aged 18 years or younger and impact fewer than 200,000 people in the U.S. Companies that receive marketing approval for an RPD-designated indication may be eligible-subject to certain conditions, including congressional reauthorization of the program for designations granted after December 20, 2024-to receive a Priority Review Voucher (PRV), which grants expedited FDA review for a future marketing application. These vouchers are transferable; in May 2025, a PRV awarded following the approval of a treatment for a rare form of EB was sold for $155 million. ABOUT EPIDERMOLYSIS BULLOSAEpidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin's layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB. ABOUT RLF-TD011RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief's proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. Relief's acid-oxidizing solution has previously demonstrated efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In an investigator-initiated trial (NCT05533866), RLF-TD011 has also shown promising results in infection control and wound healing in EB patients with the most severe forms of the disease. RLF-TD011 aims to address unmet needs in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. The U.S. Food and Drug Administration has granted RLF-TD011 both Orphan Drug and Rare Pediatric Disease designations for EB, and Relief plans to seek Qualified Infectious Disease Product (QIDP) designation for extended market exclusivity. ABOUT RELIEFRelief is a commercial-stage biopharmaceutical company dedicated to advancing treatment paradigms and improving the lives of patients with rare and debilitating diseases. With core expertise in drug delivery systems and drug repurposing, Relief's clinical pipeline includes innovative treatments designed to address critical unmet medical needs in rare dermatological, metabolic and respiratory conditions. The Company has also successfully brought several approved products to market through licensing and distribution partnerships. Headquartered in Geneva, Relief 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 CONTACTRELIEF THERAPEUTICS Holding SAJeremy MeinenChief Financial Officercontact@ DISCLAIMERThis press release contains forward-looking statements, which may be identified by words such as "believe," "assume," "expect," "intend," "may," "could," "will," or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise. SOURCE: Relief Therapeutics Holding SA View the original press release on ACCESS Newswire Sign in to access your portfolio
Associated Press
22-05-2025
- Business
- Associated Press
Relief Therapeutics Receives FDA Rare Pediatric Disease Designation for RLF-TD011
GENEVA, SWITZERLAND / ACCESS Newswire / May 22, 2025 / RELIEF THERAPEUTICS Holding SA (SIX: RLF )(OTCQB: RLFTF )(OTCQB: RLFTY ) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic skin disorder characterized by fragile skin and chronic wounds. The FDA had previously granted Orphan Drug Designation to RLF-TD011 for the same indication. RLF-TD011 is a differentiated, hypotonic acid-oxidizing solution formulated with hypochlorous acid, designed to deliver potent antimicrobial and anti-inflammatory activity while creating a wound microenvironment conducive to healing. The Company previously reported promising clinical findings supporting RLF-TD011's potential to meaningfully advance EB wound care by modulating the wound microbiome and reducing pathogenic colonization without disrupting beneficial bacteria. 'The FDA's decision to grant Rare Pediatric Disease designation to RLF-TD011 underscores both the critical need for new options for patients living with EB and the potential of our investigational therapy,' said Giorgio Reiner, chief scientific officer of Relief. 'We look forward to continued engagement with the FDA and to sharing the next steps in our development plan following our upcoming pre-IND meeting.' The FDA grants RPD designation to product candidates targeting serious or life-threatening diseases that primarily affect individuals aged 18 years or younger and impact fewer than 200,000 people in the U.S. Companies that receive marketing approval for an RPD-designated indication may be eligible-subject to certain conditions, including congressional reauthorization of the program for designations granted after December 20, 2024-to receive a Priority Review Voucher (PRV), which grants expedited FDA review for a future marketing application. These vouchers are transferable; in May 2025, a PRV awarded following the approval of a treatment for a rare form of EB was sold for $155 million. ABOUT EPIDERMOLYSIS BULLOSA Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin's layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB. ABOUT RLF-TD011 RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief's proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. Relief's acid-oxidizing solution has previously demonstrated efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In an investigator-initiated trial (NCT05533866), RLF-TD011 has also shown promising results in infection control and wound healing in EB patients with the most severe forms of the disease. RLF-TD011 aims to address unmet needs in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. The U.S. Food and Drug Administration has granted RLF-TD011 both Orphan Drug and Rare Pediatric Disease designations for EB, and Relief plans to seek Qualified Infectious Disease Product (QIDP) designation for extended market exclusivity. ABOUT RELIEF Relief is a commercial-stage biopharmaceutical company dedicated to advancing treatment paradigms and improving the lives of patients with rare and debilitating diseases. With core expertise in drug delivery systems and drug repurposing, Relief's clinical pipeline includes innovative treatments designed to address critical unmet medical needs in rare dermatological, metabolic and respiratory conditions. The Company has also successfully brought several approved products to market through licensing and distribution partnerships. Headquartered in Geneva, Relief 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 CONTACT RELIEF THERAPEUTICS Holding SA Jeremy Meinen Chief Financial Officer [email protected] DISCLAIMER This press release contains forward-looking statements, which may be identified by words such as 'believe,' 'assume,' 'expect,' 'intend,' 'may,' 'could,' 'will,' or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise. SOURCE: Relief Therapeutics Holding SA press release
Yahoo
22-05-2025
- Business
- Yahoo
Relief Therapeutics Receives FDA Rare Pediatric Disease Designation for RLF-TD011
GENEVA, SWITZERLAND / / May 22, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic skin disorder characterized by fragile skin and chronic wounds. The FDA had previously granted Orphan Drug Designation to RLF-TD011 for the same indication. RLF-TD011 is a differentiated, hypotonic acid-oxidizing solution formulated with hypochlorous acid, designed to deliver potent antimicrobial and anti-inflammatory activity while creating a wound microenvironment conducive to healing. The Company previously reported promising clinical findings supporting RLF-TD011's potential to meaningfully advance EB wound care by modulating the wound microbiome and reducing pathogenic colonization without disrupting beneficial bacteria. "The FDA's decision to grant Rare Pediatric Disease designation to RLF-TD011 underscores both the critical need for new options for patients living with EB and the potential of our investigational therapy," said Giorgio Reiner, chief scientific officer of Relief. "We look forward to continued engagement with the FDA and to sharing the next steps in our development plan following our upcoming pre-IND meeting." The FDA grants RPD designation to product candidates targeting serious or life-threatening diseases that primarily affect individuals aged 18 years or younger and impact fewer than 200,000 people in the U.S. Companies that receive marketing approval for an RPD-designated indication may be eligible-subject to certain conditions, including congressional reauthorization of the program for designations granted after December 20, 2024-to receive a Priority Review Voucher (PRV), which grants expedited FDA review for a future marketing application. These vouchers are transferable; in May 2025, a PRV awarded following the approval of a treatment for a rare form of EB was sold for $155 million. ABOUT EPIDERMOLYSIS BULLOSAEpidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin's layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB. ABOUT RLF-TD011RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief's proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. Relief's acid-oxidizing solution has previously demonstrated efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In an investigator-initiated trial (NCT05533866), RLF-TD011 has also shown promising results in infection control and wound healing in EB patients with the most severe forms of the disease. RLF-TD011 aims to address unmet needs in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. The U.S. Food and Drug Administration has granted RLF-TD011 both Orphan Drug and Rare Pediatric Disease designations for EB, and Relief plans to seek Qualified Infectious Disease Product (QIDP) designation for extended market exclusivity. ABOUT RELIEFRelief is a commercial-stage biopharmaceutical company dedicated to advancing treatment paradigms and improving the lives of patients with rare and debilitating diseases. With core expertise in drug delivery systems and drug repurposing, Relief's clinical pipeline includes innovative treatments designed to address critical unmet medical needs in rare dermatological, metabolic and respiratory conditions. The Company has also successfully brought several approved products to market through licensing and distribution partnerships. Headquartered in Geneva, Relief 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 CONTACTRELIEF THERAPEUTICS Holding SAJeremy MeinenChief Financial Officercontact@ DISCLAIMERThis press release contains forward-looking statements, which may be identified by words such as "believe," "assume," "expect," "intend," "may," "could," "will," or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise. SOURCE: Relief Therapeutics Holding SA View the original press release on ACCESS Newswire
Associated Press
06-03-2025
- Business
- Associated Press
Relief Therapeutics Announces Conclusion of Merger Discussions with Renexxion
GENEVA, SWITZERLAND / ACCESS Newswire RELIEF THERAPEUTICS Holding SA (SIX: RLF)(OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that discussions regarding a potential merger with Renexxion, Inc. (Renexxion) have been terminated. After signing a non-binding letter of intent in November 2024, both companies engaged in discussions to form a combined entity with an expanded therapeutic pipeline. However, key conditions necessary to finalize the transaction were not met within the required timeframe. As a result, both parties have mutually agreed to discontinue negotiations. 'While we ultimately decided not to proceed with Renexxion, Relief remains well-positioned to advance its strategic objectives independently. In recent months, we have made meaningful progress across our core development programs and continue to build momentum. With a robust pipeline and around CHF 15 million in cash reserves, along with a CHF 50 million undrawn equity facility from our largest shareholder GEM, we are confident in our ability to execute our development strategy while continuing to explore opportunities to maximize shareholder value,' said Dr. Raghuram Selvaraju, chairman of the board of directors of Relief. The Company also announced that it will provide a comprehensive business update in its 2024 Annual Report, scheduled for publication on April 10, 2025. ABOUT RELIEF Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief's portfolio includes revenue-generating products, commercialized through licensing and distribution partnerships, and a targeted clinical development pipeline. Relief's pipeline consists of risk-mitigated assets in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. Key development programs include RLF-TD011, a stabilized hypochlorous acid solution designed to improve wound healing and infection control in epidermolysis bullosa, and RLF-OD032, a ready-to-use liquid formulation of sapropterin dihydrochloride aimed at enhancing treatment adherence in phenylketonuria patients. Headquartered in Geneva, Relief 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 CONTACT: Jeremy Meinen Chief Financial Officer DISCLAIMER This press release contains forward-looking statements, which may be identified by words such as 'believe,' 'assume,' 'expect,' 'intend,' 'may,' 'could,' 'will,' or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
