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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].