Pelthos Therapeutics Launches Moms Against Molluscum Movement to Unite Families Affected by Molluscum Contagiosum

Rhea-AI Summary

Pelthos Therapeutics (NYSE: PTHS) on Oct 9, 2025 launched the Moms Against Molluscum movement and MomsAgainstMolluscum.com to unite families affected by molluscum contagiosum and share resources.

The company highlights its prescription topical ZELSUVMI (berdazimer) 10.3% gel, launched in July 2025 and described as a once-daily, at-home nitric oxide-releasing treatment. ZELSUVMI received a Novel Drug designation from the FDA in Jan 2024. The release cites disease burden: an estimated 16.7 million Americans affected and up to 6 million new U.S. incidents annually, mostly children.

Positive

• ZELSUVMI launched in July 2025 for molluscum treatment
• ZELSUVMI received Novel Drug designation from FDA in Jan 2024
• First prescription therapy approved for at-home patient/caregiver use
• Campaign targets families to increase awareness and treatment uptake

Negative

• None.

Insights

Commercial and Medical Affairs Analyst

Pelthos launches a caregiver-focused awareness movement tied to the July 2025 commercial availability of ZELSUVMI, a novel at‑home molluscum treatment.

The campaign links disease education to a newly available prescription product, ZELSUVMI (berdazimer) topical gel 10.3%, which the text says Pelthos launched in July 2025 and that received a Novel Drug designation from the FDA in January 2024. The release highlights the large addressable burden—an estimated 16.7 million affected Americans, up to 6 million new incidents annually, and household transmission of about 41%—which frames the product as relevant to parents and pediatric care settings.

The primary dependencies and risks called out are adoption and education: success depends on clinical acceptance, caregiver willingness to seek prescription treatment, and the reach of the social and educational campaign. The content notes convenience and at‑home use as differentiators, but provides no uptake, prescribing, or reimbursement data, so commercial impact remains conditional. Watch near‑term metrics such as prescription volume, caregiver engagement on MomsAgainstMolluscum.com and social channels, and any stated coverage or formulary developments over the next several quarters for clearer commercial signal.

• The Moms Against Molluscum movement aims to empower families impacted by molluscum to share their personal stories and encourage others to join the conversation
• Molluscum is a highly contagious skin infection affecting 16.7 million Americans, mainly children
• MomsAgainstMolluscum.com will offer new resources to support moms, parents, and other caregivers of molluscum patients
  

DURHAM, N.C., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos”), today announced the launch of Moms Against Molluscum, a movement to unite mothers, parents, and other caregivers navigating molluscum contagiosum. The Moms Against Molluscum movement encourages people managing this highly contagious skin infection to visit MomsAgainstMolluscum.com to share their stories and access information about new treatment options, including ZELSUVMI™ (berdazimer) topical gel, 10.3%.

Molluscum is a poxvirus and one of the most common skin infections seen by dermatologists, pediatric dermatologists, and pediatricians. This highly contagious viral skin condition afflicts an estimated 16.7 million people, with up to 6 million new incidents every year in the United States, most of them children.^1,2,3 Approximately 41% of children will transmit molluscum to another person in their household, and if left untreated, lesions may persist for months to years.^4,5,6,7

“I commend the team at Pelthos for bringing families and caregivers together to discuss the emotional, logistical, and social burden of this highly contagious skin infection. I have seen firsthand the toll molluscum takes on parents, especially when it spreads within families. I hope this movement will encourage people to talk to their physicians about new treatment options,” said Stephen W. Stripling, MD, Pediatrician, at The Medical University of South Carolina.

Pelthos launched ZELSUVMI for the treatment of molluscum in adults and pediatric patients one year of age and older in July 2025. ZELSUVMI is a novel, topical nitric oxide-releasing gel for the treatment of molluscum. The once-daily prescription medication is effective, well-tolerated, and convenient for at-home or on-the-go application and can be used to treat molluscum infections on the body, including sensitive areas such as the face, groin, or underarms. ZELSUVMI received a Novel Drug designation from the U.S. Food and Drug Administration in January 2024 and is the first and only prescription therapy approved for use at home by patients, parents, and caregivers to treat molluscum infections.

“Preventing the spread of molluscum can be a significant burden on parents and caregivers. We hope that this movement will spark more discussions about this skin infection and educate families about ZELSUVMI, the first FDA-approved at-home treatment for molluscum,” said Scott Plesha, CEO of Pelthos.

“This is about putting an end to the wondering, the waiting and the loneliness that comes with a diagnosis of molluscum,” said Toni Morgan, a parent. “Now that we can take action and treat the condition conveniently, at home or on the go, treating molluscum is something we can work on together. I don’t want other parents to have to deal with this alone, as I have in the past. We are now able to build a supportive, positive community around this experience.”

Pelthos is running an educational campaign on social media to elevate the discussion on molluscum and to educate families about ZELSUVMI. For more information on the Moms Against Molluscum movement, visit www.momsagainstmolluscum.com. To share your stories on social media, use the hashtag #MomsAgainstMolluscum.

About Molluscum Contagiosum

Molluscum is a poxvirus and one of the most common skin infections seen by dermatologists, pediatric dermatologists, and pediatricians. This highly contagious viral skin condition afflicts an estimated 16.7 million people, with up to 6 million new incidents reported every year in the United States, most of them in children. Individuals with compromised immune systems are at an elevated risk of contracting molluscum, with the condition impacting approximately 20% of HIV patients.⁸ Molluscum infections spread to others through contact with infected persons or contaminated objects like towels, toys, furniture, swimming pools, and other surfaces. Molluscum infections present with raised, flesh-colored or red bumps that can appear anywhere on the body, including the face, hands, trunk, genitals, back of the knees, armpits, and other sensitive areas. People with molluscum may suffer discomfort from itching, secondary bacterial infections from scratching, or atopic dermatitis, as well as immense social stigma from having visible molluscum lesions that may persist for months to years. It is estimated that 30% of children will have lesions that persist beyond 18 months.⁹ Up to 73% of children with molluscum go untreated.

About ZELSUVMI™ (berdazimer) topical gel, 10.3%

ZELSUVMI (berdazimer) topical gel, 10.3% is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adults and pediatric patients one year of age and older. ZELSUVMI received a novel drug designation from the U.S. Food and Drug Administration in 2024 and is the first and only approved topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician's office, or other medical setting to treat this highly contagious viral skin infection. The product was developed using the proprietary nitric oxide-based technology platform, NITRICIL™, now owned by Ligand Pharmaceuticals Incorporated. Complete prescribing information and important safety information is available at www.zelsuvmi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: None.

Warnings: Application site reactions, including, allergic contact dermatitis occurred. Discontinue ZELSUVMI and initiate appropriate therapy.

Adverse Reactions: The most commonly reported adverse reactions (≥1%) are application site reactions including pain such as burning or stinging sensations (18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%).

About Pelthos Therapeutics
Pelthos Therapeutics is a biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. The company’s lead product ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum, was approved by the U.S. Food and Drug Administration in 2024. More information is available at www.pelthos.com. Follow Pelthos on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, regarding Pelthos’ current expectations. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, references to our expectations regarding (i) our belief that the commercial launch of ZELSUVMI marks a significant advancement for patients with molluscum and their caregivers,; (ii) our belief that the Moms Against Molluscum movement and Buddy Program will foster a supportive community that encourages earlier treatment initiation and improves patient and caregiver engagement throughout the treatment journey; and (iii) our hope that the Moms Against Molluscum movement will educate families about ZELSUVMI. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ materially from those set forth in such forward-looking statements include, but are not limited to, risks and uncertainties related to changes in general economic conditions, including as a result of war, conflict, epidemic diseases, the implementation of tariffs, and ongoing or future litigation could expose us to significant liabilities and have a material adverse effect on us. These and other risks and uncertainties are described more fully in our filings with the U.S. Securities and Exchange Commission. The information in this press release is provided only as of the date of this press release, and we undertake no obligation to update any forward-looking statements contained in this press release based on new information, future events, or otherwise, except as required by law.

Contacts

Investors:
Mike Moyer
LifeSci Advisors, LLC
Managing Director
mmoyer@lifesciadvisors.com

Media:
KWM Communications
Kellie Walsh
pelthos@kwmcommunications.com
(914) 315-6072

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¹ ZELSUVMI. Prescribing information. EPIH SPV, LLC. 2024.
² Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878.
³ Han H, Smythe C, Yousefian F, Berman B. Molluscum contagiosum virus evasion of immune surveillance: a review. J Drugs Dermatol. 2023;22(2):182-189.
⁴ Olsen JR, Gallacher J, Finlay A, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15:190-195.
⁵ Molluscum contagiosum: overview. American Academy of Dermatology. Accessed December 9, 2024. https://www.aad.org/public/diseases/a-z/molluscum-contagiosum-overview
⁶ Meza-Romero R, Navarrete-Dechent C, Downey C. Molluscum contagiosum: an update and review of new perspectives in etiology, diagnosis, and treatment. Clin Cosmet Investig Dermatol. 2019;12:373-381.
⁷ Cartwright M, Maeda-Chubachi T, Enloe C, Stripling S, Hebert A. How are pediatricians treating molluscum contagiosum? Results from in-depth interviews. Open J Pediatr Child Health. 2024;9(1):040-044
⁸ Neal Bhatia, Adelaide A Hebert, James Q Del Rosso. Comprehensive Management of Molluscum Contagiosum: Assessment of Clinical Associations, Comorbidities, and Management Principles. Journal of Clinical and Aesthetic Dermatology. 2023 Aug;16(8 Suppl 1):S12–S17.
⁹ Olsen JR, Gallacher J, Finlay A, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15:190-195

FAQ

What did Pelthos (PTHS) announce on Oct 9, 2025 about molluscum?

Pelthos launched the Moms Against Molluscum movement and website to unite caregivers and share information about molluscum and treatment options.

When was ZELSUVMI (berdazimer) launched and what is its indication for PTHS?

ZELSUVMI was launched in July 2025 as a once-daily topical gel for treating molluscum in adults and pediatric patients one year and older.

What regulatory milestones has ZELSUVMI achieved for Pelthos (PTHS)?

ZELSUVMI received a Novel Drug designation from the FDA in January 2024 and is described as the first prescription at-home therapy for molluscum.

How common is molluscum according to Pelthos's announcement?

The announcement cites an estimated 16.7 million Americans affected and up to 6 million new U.S. incidents annually, mostly children.

How can families engage with the Moms Against Molluscum movement from PTHS?

Families can visit MomsAgainstMolluscum.com, share stories, access resources, and use the hashtag #MomsAgainstMolluscum on social media.