ZELSUVMI™ (berdazimer) topical gel

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Pelthos Therapeutics to Participate in the 2025 Wells Fargo Healthcare Conference
Globenewswire· 2025-09-02 12:00
Management’s presentation will take place on Wednesday, September 3rd, 2025 at 1:30 pm (ET)DURHAM, N.C., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company (“Pelthos” or the “Company”) committed to commercializing innovative therapeutic products for high unmet patient needs, today announced that Scott Plesha, CEO, and Frank Knuettel, CFO, will participate in the Wells Fargo Healthcare Conference. Management’s presentation will take place on Wednes ...
Pelthos Therapeutics Launches ZELSUVMI™ (berdazimer) Topical Gel 10.3%, the First and Only FDA-Approved At-Home Treatment for Molluscum Contagiosum
Globenewswire· 2025-07-10 12:00
Core Insights - Pelthos Therapeutics Inc. has launched ZELSUVMI™ (berdazimer) topical gel, a novel treatment for molluscum contagiosum, which is the first prescription therapy approved for at-home use by patients and caregivers [1][7][10] - The product received Novel Drug designation from the U.S. FDA in January 2024 and is aimed at addressing a significant unmet medical need for patients suffering from this highly contagious viral skin condition [1][7][10] Company Overview - Pelthos Therapeutics is a biopharmaceutical company focused on commercializing innovative therapeutic products to meet high unmet patient needs [10] - The company’s lead product, ZELSUVMI, was approved by the U.S. FDA in 2024 and is designed to be safe and effective for treating molluscum contagiosum [10] Product Details - ZELSUVMI is a once-daily topical gel that releases nitric oxide, indicated for the treatment of molluscum contagiosum in patients aged one year and older [7][10] - The product was validated through a Phase 3 clinical trial involving 891 patients, showing nearly 33% complete clearance of lesions at week twelve compared to 19.7% in the control group [2][7] Market Need - Molluscum contagiosum affects an estimated 16.7 million people in the U.S., with up to 6 million new cases annually, primarily among children [4][5] - Many parents delay treatment due to the inconvenience of current procedural options, highlighting the need for an effective at-home treatment like ZELSUVMI [3][4] Commercial Strategy - Pelthos has initiated the ZelsuvmiGo patient support program to facilitate patient onboarding and provide resources for caregivers [3] - The company has hired 50 sales territory managers to promote ZELSUVMI to physicians treating high volumes of molluscum patients and has implemented extensive digital outreach efforts [3][5]
Pelthos Therapeutics Completes Merger with Channel Therapeutics and Closes $50.1 Million Private Placement
GlobeNewswire News Room· 2025-07-02 11:00
Core Viewpoint - The merger between Channel Therapeutics Corporation and LNHC, Inc. has been completed, leading to the formation of Pelthos Therapeutics Inc., which will focus on launching ZELSUVMI™ for treating molluscum contagiosum infections starting July 2025 [1][2]. Company Overview - Pelthos Therapeutics Inc. is a biopharmaceutical company dedicated to commercializing innovative therapeutic products for high unmet patient needs [1][7]. - The company will trade on the NYSE American exchange under the ticker symbol "PTHS" beginning July 2, 2025 [1]. Merger Details - The merger involved CHRO Merger Sub Inc., a subsidiary of Channel Therapeutics, merging with LNHC, Inc., a subsidiary of Ligand Pharmaceuticals, with LNHC continuing as a subsidiary of Channel [1]. - The merger is seen as a significant milestone for Pelthos, facilitating the launch of ZELSUVMI™ and creating shareholder value [2][5]. Financial Aspects - Concurrent with the merger, Pelthos closed a $50.1 million equity private placement from strategic investors, which includes the cancellation of approximately $18.8 million in bridge capital previously advanced to support ZELSUVMI™'s commercial launch [3][5]. - The private placement involves investments in Series A Convertible Preferred Stock and common stock [3]. Product Information - ZELSUVMI™ (berdazimer) is a topical gel approved for treating molluscum contagiosum in adults and pediatric patients aged one year and older [4][6]. - It is the first and only prescription medication for this condition that can be administered at home, making it a novel treatment option [4][6]. - The product was developed using Pelthos' proprietary nitric oxide-based technology platform, NITRICIL™ [6]. Market Opportunity - Molluscum contagiosum is a common skin infection affecting an estimated 16.7 million people in the United States, indicating a significant market opportunity for ZELSUVMI™ [4].