Grupo Ferrer Internacional SA

Acquisition adds complementary dermatology product to the Pelthos portfolio anchored by ZELSUVMI™ Xepi is a novel FDA-approved topical treatment for impetigo that addresses a critical unmet need in antibiotic-resistant skin infections caused by staph and strep infections, most commonly affecting children Impetigo affects approximately 3 million people in the U.S. every year and is among the most common bacterial skin infections seen in pediatric offices Private convertible notes financing will support the acquisition and re-launch of Xepi, accelerate the commercialization of ZELSUVMI for molluscum contagiosum, and for general working capital purposes Nov. 07, 2025 -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos”), today announced it has acquired the U.S. commercialization rights to Xepi® (ozenoxacin) Cream, 1%, from Biofrontera Inc. and Ferrer Internacional S.A. (the “Acquisition”). Xepi is a non-fluorinated quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients two months of age and older. The Company has also closed on an $18 million private convertible notes financing (the “Notes”) with existing investors, including Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) and a group of investors led by Murchinson Ltd (the “Investors”). Under the terms of the Acquisition agreement, Pelthos will pay Biofrontera $3.0 million and Ferrer $1.2 million upfront, with additional payments based on the availability of commercial quantities of Xepi and the achievement of sales-based milestones. Pelthos will pay royalties on U.S. net sales of Xepi to Ferrer and the Investors. “This acquisition represents an excellent investment opportunity and marks an exciting new chapter in the Pelthos growth story,” said Scott Plesha, CEO of Pelthos. “Xepi is well-positioned to address antimicrobial resistance in pediatric dermatology, and we believe it will provide physicians with an important alternative to first-line impetigo treatments. Offering another novel product to the pediatric and dermatology communities creates an increasingly favorable opportunity for Pelthos as it allows us to leverage our current commercial infrastructure to promote multiple innovative brands.” Xepi was developed by Ferrer and Medimetriks Pharmaceuticals, Inc., and approved by the FDA in 2017. At the time of approval, Xepi was the first new novel treatment for impetigo in more than 10 years. Biofrontera has owned the U.S. rights to Xepi since 2019 but has not been actively promoting the product. Pelthos intends to re-launch Xepi in late 2026. Impetigo is a highly contagious bacterial skin infection most often caused by Staphylococcus aureus and/or Group A Streptococcus (Streptococcus pyogenes). It affects approximately 3 million people in the U.S. every year and is most common in children ages 2 to 5.1,2 Impetigo is among the most common bacterial skin infections seen in pediatric offices and spreads easily within families, in crowded settings, such as schools and childcare facilities. “As bacterial resistance continues to rise, particularly to commonly used topical antibiotics like mupirocin, the need for effective alternatives in treating impetigo has never been greater,” said Lawrence A. Schachner, MD, Chair and Professor Emeritus at the University of Miami Department of Dermatology. “Xepi is one of the few treatment options for children that can act against both methicillin-resistant and mupirocin-resistant Staphylococcus aureus. We believe it is a significant therapeutic advancement for clinicians and patients facing infections that no longer respond to traditional therapies.” Pelthos has also closed on an $18 million convertible notes financing with the Investors. The Notes will be secured obligations of Pelthos and will bear interest at a rate of 8.5% per annum, payable quarterly in arrears. The Notes will mature on November 6, 2027, unless earlier repurchased, redeemed or converted into shares of Pelthos common stock in accordance with their terms. The Notes will be convertible at an initial conversion price of $34.442, representing the price that is the lower of (i) the Official Closing Price immediately preceding the signing of the binding agreement or (ii) the average Official Closing Price for the five trading days immediately preceding the signing of the binding agreement. The Company anticipates that the proceeds of the financing will be used to acquire and relaunch Xepi, accelerate the commercialization of ZELSUVMI, and for general working capital purposes. In addition to the Notes, the Investors will be entitled to a low single-digit royalty on U.S. net sales of Xepi and additional milestone payments and royalties on ZELSUVMI net sales in Japan, if ZELSUVMI is approved in Japan. “The convertible notes transaction demonstrates the ongoing confidence of our existing investors. The additional capital from this transaction allows us to add a complementary product to our portfolio, strengthens our balance sheet, and will help support the commercial growth of ZELSUVMI, our novel medicine for molluscum contagiosum,” said Frank Knuettel II, CFO of Pelthos. Sullivan & Worcester LLP and Paul Hastings LLP served as legal counsel to Pelthos. Piper Sandler and Lake Street Capital Markets LLC served as financial advisors to Pelthos on the Notes financing, and Roth Capital Partners, LLC advised Pelthos on the Xepi acquisition. Latham & Watkins LLP served as lead counsel to Ligand. Kelley Drye & Warren LLP and Morgan, Lewis and Bockius LLP represented the group of investors led by Murchinson Ltd. The offer and sale of the Notes and the shares of common stock issuable upon conversion of the Notes, if any, have not been, registered under the Securities Act or the securities laws of any other jurisdiction, and until so registered, may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons, absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer to sell, solicitation of an offer to buy or sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. 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. 1 Holly Hartman-Adams, Christine Banvard, Gregory Juckett. Am Fam Physician. 2014;90(4):229-235 2 https://health.hawaii.gov/docd/disease_listing/impetigo/ The content above comes from the network. if any infringement, please contact us to modify.

The topical cream is indicated to treat impetigo, a bacterial skin infection. Credit: bangoland/Shutterstock.com. Pelthos Therapeutics has secured the rights to market non-fluorinated quinolone antimicrobial, Xepi (ozenoxacin) cream, 1% in the US from Biofrontera and Ferrer Internacional. The topical cream is indicated to treat impetigo, a bacterial skin infection caused by Staphylococcus aureus or Streptococcus pyogenes in both adults and paediatric patients as young as two months. In conjunction with this acquisition, Pelthos also completed a private financing round through convertible notes, bringing in $18m from current investors, including Ligand Pharmaceuticals and a consortium spearheaded by Murchinson. Terms of the latest deal require Pelthos to pay $3m to Biofrontera and $1.2m to Ferrer upfront. Further payments will depend on commercial supply levels of the cream and future sales. The agreement also includes royalty obligations by Pelthos on US net sales to both Ferrer and the investor group. Initially developed by Ferrer in collaboration with Medimetriks Pharmaceuticals, Xepi received approval from the Food and Drug Administration (FDA) in 2017, becoming the first new treatment for impetigo in more than a decade. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Although Biofrontera has held rights to the cream in the US since 2019, there has been little promotion of the product thus far. Pelthos has indicated plans for its relaunch towards the end of 2026. Impetigo is seen among children and is known for its rapid spread, particularly in family households and crowded settings such as schools. The convertible notes secured will accrue interest at 8.5% annually, with payments required every quarter. These notes will mature on 6 November 2027 unless they are earlier rebought, redeemed or converted into ordinary shares of Pelthos under specific provisions. Funds raised are also earmarked for progressing commercial activities for Zelsuvmi and general operational costs. Investors participating in the financing will be entitled to a royalty percentage on US sales of Xepi, along with milestone payments and royalties should Zelsuvmi achieve approval and generate sales in Japan. Legal advice to Pelthos was provided by Sullivan & Worcester and Paul Hastings, with Piper Sandler and Lake Street Capital Markets advising on the financing transaction. Roth Capital Partners provided advice on the Xepi rights acquisition. Latham & Watkins represented Ligand, while Kelley Drye & Warren, along with Morgan, Lewis & Bockius, acted on behalf of Murchinson’s investor group. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

iStock, z_wei Last month, “historic positive results” from uniQure’s gene therapy snapped the Huntington’s community out of years of failure. As the biotech prepares to submit for FDA approval, BioSpace looks at four more candidates on the near horizon. Last month, one of medicine’s most devastating diseases was catapulted back into the spotlight when a Dutch biotech named uniQure reported what one expert called “historic positive results” from a pivotal trial of its gene therapy. That day, Sept. 24, BBC News declared that Huntington’s disease had been successfully treated for the first time. Often described as a combination of dementia, Parkinson’s disease and amyotrophic lateral sclerosis, Huntington’s is caused by a CAG repeat in the first exon of the huntingtin ( HTT ) gene. It strikes patients in the prime of their lives and gets passed down to approximately half of the next generation. UniQure’s three-year data showed that the gene therapy, AMT-130, slowed disease by 75% in 29 patients. Despite the excitement, several experts in the field have urged caution, stressing the small number of evaluable patients in the trial, and the potential risks inherent in the 12–18 hour intracranial surgery, among other remaining questions. Still, Ignacio Munoz-Sanjuan, CEO and chairman at Rumi Scientific and president of the Huntington’s-focused non-profit Factor-H, hailed the results as an important turning point—not just for this one disease but for the neurodegeneration space more broadly. “Beyond Huntington’s, this is the first time that an adult-onset neurodegenerative disease has shown any signs in all of the composite scores,” he told BioSpace . “Even if it takes 10 years, it’s still a significant milestone for the field of neurodegeneration.” Armed with these data, uniQure plans to submit a biologics license to the FDA in the first quarter of 2026 and is aiming to launch what would be the first genetic treatment for Huntington’s later next year. But the company is far from alone. Others—including Prilenia Therapeutics and Wave Life Sciences—are also deep into the clinical development process with therapies. Meanwhile, others, including Sage Therapeutics, have fallen by the wayside since our last pipeline check-in . Here, BioSpace takes a closer look at some of the Huntington’s candidates nearing the regulatory finish line. Wave Life Sciences WVE-003 Wave Life Sciences exemplifies the tenacity intrinsic to a space that has been knocked down countless times since the discovery of the huntingtin gene in 1993 but keeps on getting back up. After shelving two antisense oligonucleotides (ASO) for Huntington’s in March 2021 following disappointing data from two Phase Ib/IIa trials, the Cambridge, Mass.–based biotech is advancing a third ASO dubbed WVE-003, which targets a nucleotide polymorphism present on the mutant huntingtin (mHTT) mRNA while leaving healthy huntingtin—understood to be essential for certain neurological functions—intact. In June 2024, Wave reported that the candidate significantly and selectively reduced levels of the mHTT protein in the Phase Ib/IIa SELECT-HD trial . After 24 weeks, treatment with WVE-003 led to a 46% drop in mHTT levels in patients’ cerebrospinal fluid versus placebo. In an interview with BioSpace earlier this month, Wave CEO Paul Bolno called out this “dramatic decrease,” noting that uniQure did not show this effect on mHTT levels in its most recent readout. Wave is also homing in on a regulatory application. The company has reached alignment with the FDA on a path to accelerated approval, with slowing of caudate atrophy acting as a clinical surrogate endpoint, Bolno said. At CHDI’s 20th annual HD Therapeutics Conference, Wave highlighted results from SELECT-HD showing “a statistically significant correlation between mHTT reduction and slowing of caudate atrophy.” Look for Wave to announce submission of an investigational new drug application to the FDA for a potentially registrational Phase II/III trial of WVE-003 this quarter. Prilenia Therapeutics Pridopidine Prilenia Therapeutics’ chances to bring the first disease-modifying therapy for Huntington’s to market were dashed in July when the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended against marketing authorization for pridopidine. The rejection was not a complete surprise. In April 2023, Prilenia reported topline results from the Phase III PROOF-HD study showing pridopidine, a small molecule agonist of the sigma-1 receptor, a functional regulator of signaling proteins, including in motor neurons, failed to hit the trial’s primary and key secondary endpoints. However, further analysis of the data showed that the candidate elicited clinically meaningful efficacy in patients not taking anti-dopaminergic and chorea medications. In April, Prilenia struck a collaboration and license agreement with Ferrer for the further development and commercialization of pridopidine—which is also being developed for amyotrophic lateral sclerosis—in Europe and other select markets. This month, the partners presented five posters at the 2025 HSG Huntington’s Disease (HD) Clinical Research Congress, including new analyses of two-year data following patients not taking antidopaminergic medicines in PROOF-HD. The data revealed “significant and clinically meaningful slowing of progression and significantly less decline across multiple endpoints of function, cognition and motor features” in pridopidine-treated patients versus both placebo and propensity-matched natural history cohorts, the companies reported . A global confirmatory trial of pridopidine in patients with early-stage Huntington’s is planned for the first half of next year. PTC Therapeutics and Novartis PTC518 Last December, Novartis paid up to $2.9 billion to advance PTC Therapeutics’ PTC518 , a small molecule that reduces the production of mHTT and is able to penetrate the blood brain barrier, according to PTC. The first readout following Novartis’ investment didn’t exactly wow investors. While new data , released in May from the Phase II PIVOT-HD trial, met the trial’s primary endpoint with the lowest dose of PTC518 lowering blood HTT protein levels by 23% in patients with both earlier- and later-stage disease, the results received a mixed reaction. William Blair analysts at the time said that a “question regarding correlation between [huntingtin] reductions and clinical benefit remains.” They further noted that patients with later-stage disease did not show any functional benefit on PTC518 and that protein reduction in cerebrospinal fluid (CSF) was less robust in these patients. Despite these reservations, the analysts wrote that they “believe the biomarker and clinical outcomes data at 12 and 24 months in the [earlier stage] patients are likely sufficient for productive conversations with the FDA regarding a registrational path in patients with less advanced disease.” If PTC518 successfully reaches the market, PTC will be entitled to 40% of U.S. profits while Novartis would take 60%, according to the terms of their deal. Roche and Ionis Tominersen Wave isn’t the only would-be comeback kid in the Huntington’s space. In March 2021—a week before Wave retired its first two Huntington’s candidates—Roche and Ionis discontinued the Phase III GENERATION-HD1 trial of their ASO tominersen after it failed to elicit higher efficacy than placebo. In fact, the drug actually led to worse outcomes when given more frequently. But tominersen is back and being studied by the partners in a Phase II trial for patients with prodromal and early manifest Huntington’s. “Following the decision by the independent data monitoring committee to discontinue dosing in the GENERATION-HD1 trial for tominersen, a post hoc analysis of the data suggested that low-exposure tominersen may benefit younger adult patients with lower disease burden,” Peter McColgan, lead clinical director for the Huntington’s Disease program at Roche, told PharmaVoice in 2022. The trial’s Clinicaltrials.gov page lists an estimated primary completion date of May 31, 2026, and a study completion date of April 1, 2027. Roche lists 2028+ on its pipeline page for an expected filing.