Pelthos Therapeutics Announces Expanded Formulary Coverage for ZELSUVMI® (berdazimer) Topical Gel, 10.3%

The new pharmacy benefit manager coverage does not require prior authorization for ZELSUVMI.

Rhea-AI Summary

Pelthos Therapeutics (PTHS) signed a pharmacy benefit manager agreement expanding ZELSUVMI formulary access to an additional 24 million covered lives. The pharmacy benefit manager, which administers prescription drug benefits, added ZELSUVMI to its national list of covered medicines without prior authorization, effective October 1, 2026.

A separate regional commercial health plan update, effective in September, enhanced access for approximately 3 million covered lives. ZELSUVMI now has formulary coverage across 127 million, or 69%, of commercially covered lives, alongside Medicaid coverage of more than 70 million, or 100%, of covered lives. Pelthos launched the topical treatment in July 2025 for molluscum contagiosum, a viral skin infection, in adults and children one year of age and older.

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Positive

• Moderate pointNew pharmacy benefit manager agreement adds 24 million covered lives without prior authorization, effective October 1, 2026.
• Minor pointCommercial formulary coverage now reaches 127 million lives, or 69% of commercially covered lives.
• Minor pointRegional health plan update enhanced access for approximately 3 million covered lives, effective in September.

Negative

• None.

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Details

Market move: PTHS +7.22% vs previous close. PBM formulary partnership

$20.50 – $22.61 Day Range

$84.15M Market Cap

On Oct 6, the day this news came out, the latest delayed price for PTHS is 7.22% above the previous close. Our momentum scanner has recorded 6 alerts for this stock so far that day. The latest delayed price is $21.98.

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Key Figures

New PBM covered lives: 24 million covered lives Regional health plan coverage: Approximately 3 million covered lives Commercially covered lives: 127 million covered lives +4 more

New PBM covered lives

24 million covered lives

New national formulary agreement

Regional health plan coverage

Approximately 3 million covered lives

Enhanced formulary access

Commercially covered lives

127 million covered lives

Total ZELSUVMI formulary coverage

Commercial coverage

69%

Share of commercially covered lives

Medicaid coverage

More than 70 million covered lives

ZELSUVMI Medicaid coverage

Medicaid covered lives

100%

Share of covered lives

National formulary effective date

October 1, 2026

PBM coverage without prior authorization

Key Terms

pharmacy benefit manager, formulary, prior authorization, molluscum contagiosum

4 terms

pharmacy benefit manager financial

"a major Pharmacy Benefit Manager (“PBM”)"

A pharmacy benefit manager (PBM) is a company that manages prescription drug plans for health insurance providers, employers, and other organizations. They negotiate prices with drugmakers, decide which medicines are covered, and handle the distribution of prescriptions. For investors, PBMs are important because they influence healthcare costs and profit margins in the pharmacy industry.

formulary medical

"signed an agreement with a major Pharmacy Benefit Manager"

A formulary is a list of prescription drugs that a health insurer, hospital system, or government program has approved for coverage and payment. Think of it like an approved menu or shopping list that determines which medicines patients can get with financial help. For investors, formulary placement affects a drug maker’s potential sales, pricing power and market access, so being included—or excluded—can materially change a company’s revenue outlook.

prior authorization medical

"without requiring prior authorization"

Prior authorization is a process where a health insurance company requires approval before covering certain medical services or medications. It functions like a pre-approval step, ensuring that the treatment is necessary and appropriate before expenses are paid. For investors, understanding prior authorization is important because delays or denials can impact healthcare costs, provider operations, and the financial stability of related companies.

molluscum contagiosum medical

"treatment of molluscum contagiosum in adults and pediatric patients"

Molluscum contagiosum is a common viral skin infection that causes small, painless bumps or lesions on the skin. While it primarily affects children and healthy adults, it can spread easily through skin contact. For investors, understanding health conditions like this highlights the importance of healthcare companies involved in treatments and the potential impact of infectious diseases on public health and economic stability.

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Company secures new formulary coverage with a major Pharmacy Benefit Manager, reaching an additional 24 million covered lives

Pelthos gains enhanced commercial coverage through a regional commercial health plan representing approximately 3 million covered lives

Formulary coverage for ZELSUVMI increases to 127 million commercially covered lives

DURHAM, N.C., Oct. 06, 2026 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos” or the “Company”), today announced that it signed an agreement with a major Pharmacy Benefit Manager (“PBM”) to open access to ZELSUVMI^® (berdazimer) topical gel, 10.3%, covering 24 million covered lives. The Company also received a formulary update enhancing access to ZELSUVMI with a regional health plan that covers approximately 3 million lives. These significant updates have expanded patient access to ZELSUVMI, an important priority for Pelthos. ZELSUVMI now has formulary coverage across 127 million or 69% of commercially covered lives and strong Medicaid coverage of more than 70 million or 100% of covered lives.

“Expanding patient access to ZELSUVMI has been a top priority for Pelthos since we launched the product last July,” said Sai Rangarao, Chief Commercial Officer at Pelthos. “We are pleased with our progress and remain focused on making this effective, convenient treatment available to patients and families affected by molluscum contagiosum.”

This formulary agreement affects one of the largest PBMs in the U.S., which manages prescription drug benefits for employers, health plans and government programs. The PBM serves roughly one in three Americans and added ZELSUVMI to its national formulary without requiring prior authorization, effective October 1, 2026. The second formulary update, which took effect in September, serves roughly 3 million members.

Pelthos launched ZELSUVMI for the treatment of molluscum contagiosum 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 contagiosum 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.

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.^1,2,3 Individuals with compromised immune systems are at an elevated risk of contracting molluscum, with the condition impacting approximately 20% of HIV patients.⁴ 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.⁵ 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%).

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 new pharmacy benefit manager agreement will expand patient access to ZELSUVMI, (ii) our plans for continued commercial growth and increased coverage for ZELSUVMI, and (iii) the Company’s future opportunities, strategy and plans in the market. 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 our reliance on third-party partners for market access and distribution; the possibility that ZELSUVMI may not achieve market acceptance or broad formulary coverage; our ability to maintain regulatory approvals; and 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.

About Pelthos Therapeutics
Pelthos Therapeutics is a commercial-stage biopharmaceutical company focused on building and advancing a portfolio of differentiated cutaneous infectious disease products that address unmet patient needs. ZELSUVMI^® (berdazimer) topical gel, 10.3%, the company’s lead product, is the first and only prescription therapy approved for use at home by patients, parents, and caregivers to treat molluscum contagiosum. The company’s portfolio of assets includes XEPI^® (ozenoxacin) Cream, 1%, a topical treatment for impetigo, and XEGLYZE^® (abametapir), a topical treatment for head lice. More information is available at www.pelthos.com. Follow Pelthos on LinkedIn and X.

Contacts

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

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

__________________________________
¹ ZELSUVMI. Prescribing information. LNHC, Inc. 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 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
⁵ 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

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How much commercial formulary coverage does Pelthos Therapeutics' ZELSUVMI now have?

ZELSUVMI now has formulary coverage across 127 million, or 69%, of commercially covered lives. A new pharmacy benefit manager agreement added access for 24 million covered lives, while a regional commercial health plan update enhanced access for approximately 3 million covered lives.