Medicus Pharma Ltd. Receives Positive Feedback From the Food and Drug Adminstration (FDA) Type C Meeting Supporting the Development of Skinject
Medicus Pharma (NASDAQ:MDCX) received positive FDA feedback from a Type C meeting regarding Skinject, their novel doxorubicin-containing microneedle array (D-MNA) treatment for basal cell carcinoma. The FDA supported the 505(b)(2) regulatory pathway, which could accelerate development and reduce costs.
The company's Phase 2 study SKNJCT-003 has shown promising interim results with over 60% clinical clearance and has expanded to 90 participants across multiple sites. Medicus plans to complete patient recruitment in Q4 2025 and request an End-of-Phase 2 meeting in Q1 2026, targeting potential commercialization in 2027.
Additionally, Medicus recently acquired Antev, a UK biotech company developing Teverelix, a next-generation GnRH antagonist for prostate cancer patients with cardiovascular risks.
Medicus Pharma (NASDAQ:MDCX) ha ricevuto feedback positivo dalla FDA a seguito di un incontro di tipo C riguardo Skinject, la loro innovativa array di microneedle contenente doxorubicina (D-MNA) per il carcinoma basocellulare. La FDA ha supportato il percorso regolatorio 505(b)(2), che potrebbe accelerare lo sviluppo e ridurre i costi.
Lo studio di fase 2 SKNJCT-003 ha mostrato risultati provvisori incoraggianti con oltre il 60% di clearance clinica ed è stato esteso a 90 partecipanti in più siti. Medicus intende completare il reclutamento entro Q4 2025 e richiedere un End-of-Phase 2 meeting nel Q1 2026, puntando a una possibile commercializzazione nel 2027.
Inoltre, Medicus ha recentemente acquisito Antev, una biotech del Regno Unito che sviluppa Teverelix, un antagonista GnRH di nuova generazione per pazienti con cancro alla prostata ad alto rischio cardiovascolare.
Medicus Pharma (NASDAQ:MDCX) recibió comentarios positivos de la FDA tras una reunión de tipo C sobre Skinject, su innovador arreglo de microneedles que contiene doxorrubicina (D-MNA) para el carcinoma de células basales. La FDA apoyó la vía regulatoria 505(b)(2), lo que podría acelerar el desarrollo y reducir costos.
El estudio de fase 2 SKNJCT-003 ha mostrado resultados interinos prometedores con más del 60% de aclaramiento clínico y se ha ampliado a 90 participantes en múltiples sitios. Medicus planea completar el reclutamiento de pacientes en Q4 2025 y solicitar una reunión End-of-Phase 2 en Q1 2026, con miras a una posible comercialización en 2027.
Además, Medicus adquirió recientemente Antev, una biotecnológica del Reino Unido que desarrolla Teverelix, un antagonista de GnRH de próxima generación para pacientes con cáncer de próstata y riesgos cardiovasculares.
Medicus Pharma(NASDAQ:MDCX)는 피부의 피부 삽입형 미세바늘 어레이(D-MNA) 치료법인 Skinject에 대해 FDA로부터 Type C 회의에서 긍정적인 피드백을 받았습니다. FDA는 505(b)(2) 규제 경로를 지지했으며, 이는 개발을 가속하고 비용을 감소시킬 수 있습니다.
회전 2상 연구 SKNJCT-003은 임상적 제거율 60% 이상의 유망한 중간 결과를 보여주었고, 다수의 사이트에서 90명의 참가자로 확대되었습니다. Medicus는 2025년 4분기(Q4 2025)까지 환자 모집을 마치고 2026년 1분기(Q1 2026)에 End-of-Phase 2 회의를 요청하여 2027년의 상용화를 목표로 하고 있습니다.
또한 Medicus는 최근 영국의 생명공학 회사 Antev를 인수했으며, 이 회사는 심혈관 위험이 있는 전립선 암 환자를 위한 차세대 GnRH 길항제 Teverelix를 개발하고 있습니다.
Medicus Pharma (NASDAQ:MDCX) a reçu des retours positifs de la FDA lors d’une réunion de type C concernant Skinject, leur nouvelle matrice de microneedles contenant de la doxorubicine (D-MNA) pour le carcinome basocellulaire. La FDA a soutenu la voie réglementaire 505(b)(2), qui pourrait accélérer le développement et réduire les coûts.
L’étude de phase 2 SKNJCT-003 a montré des résultats préliminaires prometteurs avec plus de 60% d’éclaircissement clinique et a été étendue à 90 participants répartis sur plusieurs sites. Medicus prévoit de finaliser le recrutement des patients en Q4 2025 et de demander une réunion End-of-Phase 2 au Q1 2026, envisageant une commercialisation potentielle en 2027.
Par ailleurs, Medicus a récemment acquis Antev, une biotech britannique développant Teverelix, un antagoniste GnRH de prochaine génération pour les patients atteints d’un cancer de la prostate présentant des risques cardiovasculaires.
Medicus Pharma (NASDAQ:MDCX) erhielt positives Feedback der FDA bei einem Type-C-Meeting zu Skinject, ihrer neuartigen Mikroneedle-Array-Behandlung mit Doxorubicin (D-MNA) gegen Basalzellkarzinom. Die FDA unterstützte den 505(b)(2)-Regulierungsweg, der die Entwicklung beschleunigen und Kosten senken könnte.
Die Phase-2-Studie SKNJCT-003 zeigte vielversprechende Zwischenresultate mit über 60% klinischer Clearance und wurde auf 90 Teilnehmer an mehreren Standorten erweitert. Medicus plant, die Rekrutierung der Patienten bis Q4 2025 abzuschließen und in Q1 2026 ein End-of-Phase-2-Meeting zu beantragen, mit dem Ziel einer möglichen Markteinführung im Jahr 2027.
Zusätzlich hat Medicus kürzlich Antev übernommen, ein britisches Biotech-Unternehmen, das Teverelix entwickelt, einen GnRH-Antagonisten der nächsten Generation für Prostatakrebspatienten mit kardiovaskulären Risiken.
Medicus Pharma (NASDAQ:MDCX) تلقت تغذية راجعة إيجابية من FDA خلال اجتماع من النوع C بخصوص Skinject، جهاز الميكروسنادلات الخلوي الذي يحتوي على دوكسوروبايسين (D-MNA) لعلاج سرطان الخلايا القاعدية. دعمت FDA مسار التنظيم 505(b)(2)، مما قد يسرّع التطوير ويخفض التكاليف.
أظهرت دراسة المرحلة 2 SKNJCT-003 نتائج حُرّية مبكرة واعدة مع أكثر من 60% إزالة سريرية وتم توسيعها إلى 90 مشاركاً عبر مواقع متعددة. تخطط Medicus لإكمال تجنيد المرضى في الربع الرابع من 2025 وطلب اجتماع End-of-Phase 2 في الربع الأول من 2026، مستهدفة احتمال التسويق في 2027.
بالإضافة إلى ذلك، استحوذت Medicus مؤخرًا على Antev، وهي شركة بيوتكنولوجي من المملكة المتحدة تطور Teverelix، وهو مضاد GnRH من الجيل التالي لمرضى سرطان البروستاتا المعرضين لمخاطر قلبية وعائية.
Medicus Pharma (NASDAQ:MDCX) 在关于 Skinject 的 Type C 会议中获得 FDA 的正面反馈，这是他们用于治疗基底细胞癌的新型含阿霉素的微针阵列(D-MNA)。FDA 支持505(b)(2) 路径，这可能加快开发进程并降低成本。
其二期研究 SKNJCT-003 显示出有前景的中期结果，临床清除率超过60%，已扩展至在多个中心的90名受试者。Medicus 计划在2025年第四季度完成患者招募，并在2026年第一季度申请阶段末会议 End-of-Phase 2，目标于2027年实现潜在商业化。
此外，Medicus 近期收购了Antev，一间英国生物科技公司，开发 Teverelix——一种面向前列腺癌患者、具有心血管风险的下一代 GnRH 拮抗剂。
- FDA supports 505(b)(2) regulatory pathway, potentially reducing development time and costs
- Positive interim analysis showing >60% clinical clearance in Phase 2 trial
- Successfully expanded trial enrollment from 60 to 90 participants
- Market opportunity estimated at $2 billion
- Strategic acquisition of Antev expands pipeline with late-stage prostate cancer treatment
- FDA recommends additional optimization of formulation and microneedle design
- Commercial launch not expected until 2027
- Multiple clinical trials still ongoing with pending results
Insights
FDA's support for 505(b)(2) pathway significantly accelerates Skinject's development, potentially bringing a $2B non-invasive skin cancer treatment to market by 2027.
The FDA's feedback on Medicus Pharma's Skinject represents a substantial regulatory milestone. The agency's agreement to pursue the 505(b)(2) regulatory pathway is particularly significant as it will allow Medicus to leverage existing safety data for doxorubicin rather than generating entirely new datasets. This accelerates development by potentially 2-3 years and reduces costs by millions compared to the traditional NDA pathway.
The Type C meeting yielded critical alignments on primary endpoints, patient population criteria, and study design for the treatment of basal cell carcinoma (BCC). The FDA's acceptance of the proposed randomized, double-blind, placebo-controlled design validates Medicus's clinical approach. Their recommendation to optimize the microneedle design and incorporate an adhesive layer and applicator suggests the agency views this as a viable product moving toward commercialization.
The interim analysis showing >60% clinical clearance in SKNJCT-003 is promising, though preliminary. The expansion from 60 to 90 participants and the addition of European sites indicates confidence in the treatment approach. With 75% of participants already randomized, they appear on track to meet their Q4 2025 recruitment completion target.
Medicus has strategically positioned Skinject to address the non-invasive BCC treatment market estimated at ~$2 billion. Their timeline projects commercial availability by 2027, which seems achievable given the 505(b)(2) pathway and current trial progress. The international expansion of trials in the UAE further diversifies their regulatory strategy and potential market access.
The development of Skinject (D-MNA) addresses a significant unmet need in non-invasive treatment options for basal cell carcinoma. Current BCC treatments primarily involve surgical excision, which can be disfiguring for visible lesions, or topical therapies that have limited efficacy in certain tumor types.
The >60% clinical clearance rate observed in the interim analysis is clinically meaningful for a non-invasive approach. For context, topical treatments like imiquimod typically show complete clearance rates of 43-75%, but often with significant local skin reactions. If Skinject maintains this efficacy in the completed trial with a favorable side effect profile, it could become a preferred treatment option.
The microneedle array delivery system represents an innovative approach to localized chemotherapy administration. By directly delivering doxorubicin to the tumor site through dissolvable microneedles, this technology potentially maximizes local drug concentration while minimizing systemic exposure, addressing a key limitation of traditional chemotherapy.
The FDA's recommendations for formulation optimization, adhesive integration, and applicator development indicate recognition of the technology's promise but also highlight technical refinements needed before pivotal trials. These improvements would enhance consistency of drug delivery and user experience, critical factors for eventual adoption.
The expansion to 90 participants and addition of international sites will strengthen the statistical power of the results and potentially accelerate the path to market. With 75% of participants already randomized, the study appears to be progressing efficiently, supporting the company's timeline for an End-of-Phase 2 meeting in early 2026.
The FDA agrees that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat basal cell carcinoma (BCC) of the skin using dissolvable Doxorubicin-containing Microneedle arrays (D-MNA) representing ~
The Company plans to complete patient recruitment for SKNJCT-003 before the end of Q4 2025 and to request End-of-Phase 2 (EOP2) with the FDA in Q1 2026
PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 29, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce positive feedback from Type C meeting with United States Food and Drug Administration (FDA).
The purpose of the Type C meeting was to discuss the design, endpoints, and other key protocol elements for the clinical development of doxorubicin containing microneedle array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.
The FDA provided clarity and further alignment that a relative bioavailability study with the Company's D-MNA product to treat BCC administered under certain conditions could provide support towards establishing a clinical bridge for the 505(b)(2) regulatory pathway as well as help satisfy the bioavailability requirement of the Company's D-MNA product as stated in 21CFR320.21. More specifically, the FDA provided positive and constructive feedback on a number of topics for the continued development of Skinject including, but not limited to: the appropriate primary endpoint for the next study; proposed patient population definition, including tumor size limits, location restrictions, and histological confirmation requirements; proposed randomized, double-blind, placebo-controlled, study design for future studies that are intended to demonstrate the effectiveness of D-MNA in treating BCC; and current safety assessments for the proposed study.
In anticipation of future pivotal studies, the FDA also provided recommendations to continue to optimize formulation and microneedle design, integrate an adhesive layer to affix the microneedle system to the body, and incorporate the use of an applicator to consistently apply the product to the application site.
"Establishing 505(b)(2) as a regulatory pathway to bring to market our novel, non-invasive Skinject D-MNA treatment to cure BCC of the skin, is a game changer" stated Dr. Raza Bokhari, Medicus's Executive Chairman & CEO, "by leveraging existing doxorubicin safety data, we will not only realize substantial drug development cost savings but also time savings compared to a traditional full development program. As we plan to complete patient recruitment for SKNJCT-003 before the end this year and request an EOP2 meeting with the FDA in Q1 2026, our confidence is increasing that Skinject may become commercially viable sometime in 2027".
The Company is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States which commenced randomizing patients in August 2024. In March 2025, the Company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more than
The Company also has a clinical study (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), Rashid Hospital (RH), Clemenceau Medical Center (CMC) and American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.
In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
For further information contact:
Carolyn Bonner, President and Acting Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicspharma.com
About Medicus Pharma Ltd.
Medicus Pharma Ltd. (Nasdaq:MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries, spread over three continents.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd., is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates.
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the "MoU") with Helix Nanotechnologies, Inc. ("HelixNano"), a Boston Based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.
In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than
In January 2023, the FDA, reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This milestone supports the Company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.
In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.
In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr and high CV risk prostate cancer, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano's proprietary mRNA vaccine platform with Medicus's proprietary microneedle array (MNA) delivery platform, the Company's aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as "may", "on track", "aim", "might", "will", "will likely result", "could," "designed," "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", "potential" or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2024 (the "Annual Report"), and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. . Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
SOURCE: Medicus Pharma Ltd
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FAQ
What was the outcome of Medicus Pharma's (MDCX) FDA Type C meeting for Skinject?
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What is significant about Medicus Pharma's acquisition of Antev?
