Medicus Pharma Ltd. Receives Positive Feedback From the Food and Drug Administration (FDA) Type C Meeting Supporting the Development of Skinject
Medicus Pharma (NASDAQ:MDCX) received positive FDA feedback from a Type C meeting regarding their Skinject development program, a novel treatment for basal cell carcinoma (BCC) using doxorubicin-containing microneedle arrays (D-MNA). The FDA confirmed the 505(b)(2) regulatory pathway viability, representing a $2 billion market opportunity.
The company is advancing two clinical trials: SKNJCT-003 in the US with 90 participants (75% enrolled) and SKNJCT-004 in the UAE with 36 patients across six sites. An interim analysis showed over 60% clinical clearance in the SKNJCT-003 study. Medicus plans to complete patient recruitment by Q4 2025 and request an End-of-Phase 2 meeting in Q1 2026.
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 ottenuto feedback positivi dalla FDA durante un incontro di Type C sul programma Skinject, una terapia innovativa per il carcinoma basocellulare (BCC) che utilizza array di microneedle contenenti doxorubicina (D-MNA). La FDA ha confermato la fattibilità del percorso regolatorio 505(b)(2), rappresentando un’opportunità di mercato superiore ai 2 miliardi di dollari.
L’azienda sta avanzando due studi clinici: SKNJCT-003 negli Stati Uniti con 90 partecipanti (75% reclutati) e SKNJCT-004 negli Emirati Arabi Uniti con 36 pazienti distribuiti su sei siti. Un’analisi intermedia ha mostrato una clearance clinica superiore al 60% nello studio SKNJCT-003. Medicus prevede di completare l’arruolamento dei pazienti entro il quarto trimestre 2025 e di richiedere un End-of-Phase 2 meeting nel primo trimestre 2026.
Inoltre, Medicus ha recentemente acquisito Antev, una biotech britannica che sviluppa Teverelix, un antagonista GnRH di nuova generazione per pazienti affetti da cancro alla prostata con rischi cardiovascolari.
Medicus Pharma (NASDAQ:MDCX) obtuvo comentarios positivos de la FDA tras una reunión de tipo C sobre su programa Skinject, un tratamiento novedoso para el carcinoma de células basales (BCC) que utiliza matrices de microneedles que contienen doxorubicina (D-MNA). La FDA confirmó la viabilidad de la vía regulatoria 505(b)(2), que representa una oportunidad de mercado de más de 2 mil millones de dólares.
La empresa avanza con dos ensayos clínicos: SKNJCT-003 en EE. UU. con 90 participantes (75% reclutados) y SKNJCT-004 en los EAU con 36 pacientes en seis centros. Un análisis interino mostró más del 60% de aclaramiento clínico en el estudio SKNJCT-003. Medicus planea completar el reclutamiento de pacientes para el cuarto trimestre de 2025 y solicitar una reunión End-of-Phase 2 en el primer trimestre de 2026.
Además, Medicus adquirió recientemente a Antev, una biotech británica que desarrolla Teverelix, un antagonista GnRH de próxima generación para pacientes con cáncer de próstata con riesgos cardiovasculares.
Medicus Pharma (NASDAQ:MDCX)는 피부주사 개발 프로그램 Skinject에 대한 Type C 회의에서 FDA로부터 긍정적인 피드백을 받았으며, 도로소루비신(Doxorubicin)을 함유한 미크로니들 배열(D-MNA)을 이용한 기저세포암(BCC) 치료제의 가능성을 확인했습니다. FDA는 505(b)(2) 규제 경로의 타당성을 확인했으며, 이는 20억 달러를 상회하는 시장 기회를 나타냅니다.
회사는 두 건의 임상시험을 진행 중입니다: 미국의 SKNJCT-003은 90명의 참가자(등록률 75%)를 대상으로 하고, UAE의 SKNJCT-004는 6개 사이트에서 36명의 환자를 모집합니다. 중간 분석에서 SKNJCT-003 연구의 임상 해제율이 60%를 넘는 것으로 나타났습니다. Medicus는 2025년 4분기까지 환자 모집을 완료하고 2026년 1분기에 End-of-Phase 2 회의를 요청할 계획입니다.
또한 Medicus는 Teverelix를 개발하는 영국의 바이오테크 기업 Antev를 최근에 인수했습니다. Teverelix는 심혈관 위험이 있는 전립선암 환자를 위한 차세대 GnRH 차단제입니다.
Medicus Pharma (NASDAQ:MDCX) a reçu des retours positifs de la FDA lors d’une réunion Type C concernant son programme Skinject, un traitement novateur pour le carcinome basocellulaire (BCC) utilisant des matrices de microneedles contenant de la doxorubicine (D-MNA). La FDA a confirmé la viabilité de la voie réglementaire 505(b)(2), représentant une opportunité de marché de plus de 2 milliards de dollars.
L’entreprise avance sur deux essais cliniques : SKNJCT-003 aux États‑Unis avec 90 participants (75% recrutés) et SKNJCT-004 aux Émirats arabes unis avec 36 patients répartis sur six sites. Une analyse intermédiaire a montré plus de 60% de clairance clinique dans l’étude SKNJCT-003. Medicus prévoit de terminer le recrutement des patients d’ici le troisième trimestre 2025 et de demander une réunion End-of-Phase 2 au premier trimestre 2026.
Par ailleurs, Medicus a récemment acquis Antev, une biotech britannique qui développe Teverelix, un antagoniste GnRH de prochaine génération pour les patients atteints de cancer de la prostate présentant des risques cardiovasculaires.
Medicus Pharma (NASDAQ:MDCX) erhielt positives Feedback der FDA nach einem Type-C-Meeting zu Skinject, einer neuartigen Behandlung für das Basalzellkarzinom (BCC), die mikroneedling-Arrays mit Doxorubicin (D-MNA) verwendet. Die FDA bestätigte die Durchführbarkeit des regulatorischen Wegs 505(b)(2), was eine Marktchance von mehr als 2 Milliarden US-Dollar bedeutet.
Das Unternehmen treibt zwei klinische Studien voran: SKNJCT-003 in den USA mit 90 Teilnehmern (75% rekrutiert) und SKNJCT-004 in den VAE mit 36 Patienten über sechs Standorte verteilt. Eine Zwischenanalyse zeigte in der SKNJCT-003-Studie eine klinische Clearance von über 60%. Medicus plant, die Rekrutierung der Patienten bis zum vierten Quartal 2025 abzuschließen und im ersten Quartal 2026 ein End-of-Phase-2-Meeting zu beantragen.
Zudem hat Medicus kürzlich Antev übernommen, ein britisches Biotech-Unternehmen, das Teverelix entwickelt, einen GnRH-Antagonisten der nächsten Generation für Prostatakrebspatienten mit kardovaskulären Risiken.
تلقت Medicus Pharma (ناسداك:MDCX) تغذية راجعة إيجابية من FDA خلال اجتماع من النوع C بشأن برنامج Skinject، وهو علاج مبتكر لسرطان الخلايا القاعدية (BCC) يستخدم مصفوفات إبر دقيقة تحتوي على دوكسوروبسين (D-MNA). أكدت FDA جدوى مسار التنظيم 505(b)(2)، مما يمثل فرصة سوقية تفوق قيمتها 2 مليار دولار.
تتقدم الشركة في تجربتين سريريتين: SKNJCT-003 في الولايات المتحدة مع 90 مشاركاً (75٪ مُسجَّل) و SKNJCT-004 في الإمارات العربية المتحدة مع 36 مريضا عبر ستة مواقع. أظهرت تحليلًا في منتصف الطريق انخفاضًا سريريًا يزيد عن 60٪ في دراسة SKNJCT-003. تخطط Medicus لإكمال تجنيد المرضى بحلول الربع الرابع من 2025 وطلب اجتماع End-of-Phase 2 في الربع الأول من 2026.
بالإضافة إلى ذلك، قامت Medicus مؤخرًا بالاستحواذ على Antev، وهي شركة بيوTech بريطانية تطور Teverelix، وهو مضاد GnRH من الجيل التالي للمرضى المصابين بسرطان البروستاتا مع مخاطر قلبية وعائية.
Medicus Pharma（NASDAQ:MDCX）在一次 Type C 会议后获得 FDA 对其 Skinject 开发计划的积极反馈，这是一种使用含多柔昔菌素的微针阵列（D-MNA）的基底细胞癌（BCC）治疗新方法。FDA 确认了 505(b)(2) 监管路径的可行性，代表着超过 20 亿美元的市场机会。
公司正在推进两项临床试验：在美国的 SKNJCT-003，90 名参与者（已入组 75%），以及在阿联酋的 SKNJCT-004，六个地点共有 36 名患者。中期分析显示 SKNJCT-003 研究的临床清除率超过 60%。Medicus 计划在 2025 年第四季度前完成患者招募，并在 2026 年第一季度申请 End-of-Phase 2 会议。
此外，Medicus 最近收购了英国生物科技公司 Antev，该公司正在开发 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 for Skinject, potentially accelerating development and reducing costs
- Interim analysis shows >60% clinical clearance rate in SKNJCT-003 trial
- 75% of targeted 90 participants already enrolled in SKNJCT-003 study
- Strategic acquisition of Antev expands pipeline with Teverelix for prostate cancer treatment
- $2 billion market opportunity for BCC treatment
- FDA recommends additional optimization of formulation and microneedle design
- Commercial availability not expected until 2027
- Multiple clinical trials still ongoing with no guaranteed success
Insights
FDA's 505(b)(2) approval for Medicus's Skinject is strategically significant, potentially cutting years off development timeline while targeting a $2B market.
The FDA's agreement that Medicus can pursue the 505(b)(2) regulatory pathway for their doxorubicin-containing microneedle array (D-MNA) represents a critical regulatory milestone. This pathway is significantly more efficient than traditional approval routes because it allows the company to leverage existing safety data for doxorubicin rather than generating entirely new datasets. For investors, this translates to potentially reduced development costs and accelerated timelines - likely saving years compared to conventional development programs.
The agency's feedback on clinical trial design elements is equally consequential. The FDA has provided clarity on primary endpoints, patient population parameters, and study design for demonstrating effectiveness - essentially creating a regulatory roadmap that reduces uncertainty and risk. The constructive feedback on randomized, double-blind, placebo-controlled studies suggests the agency views this development program favorably.
With 75% of participants already randomized in their expanded SKNJCT-003 trial and preliminary data showing over 60% clinical clearance, Medicus is positioned to complete recruitment by Q4 2025 and secure an End-of-Phase 2 meeting in Q1 2026. The company's global expansion of trial sites to Europe and the UAE demonstrates a comprehensive clinical development strategy. If development proceeds as projected, commercial availability by 2027 appears feasible, targeting what the company estimates as a $2 billion market opportunity for non-invasive treatment of basal cell carcinoma.
Medicus's microneedle array technology could transform BCC treatment by offering a non-invasive alternative to surgery with promising efficacy signals.
The development of a non-invasive treatment option for basal cell carcinoma represents a potential paradigm shift in dermatological oncology. Basal cell carcinoma is the most common form of skin cancer, typically treated with surgical excision, which can be disfiguring particularly when lesions occur on visible areas like the face. Skinject's microneedle technology delivers doxorubicin (a proven cytotoxic agent) directly to tumor sites without traditional injection or surgical intervention.
The interim analysis showing >60% clinical clearance is promising, though still preliminary. This level of response in a Phase 2 study suggests meaningful clinical activity, especially for a topically applied treatment. The expansion of the trial from 60 to 90 participants indicates confidence in the treatment's potential and will provide more robust data for regulatory discussions.
The FDA's recommendations to optimize formulation, incorporate an adhesive layer, and develop a consistent applicator suggest they see merit in this approach but want to ensure reliable drug delivery before pivotal trials. These are solvable technical challenges rather than fundamental efficacy concerns. If successful, this technology could offer significant advantages over current standard-of-care for appropriate BCC patients, including reduced scarring, less pain, and potentially lower overall treatment costs. The international expansion of clinical sites should accelerate enrollment and provide diverse patient data to strengthen the eventual marketing application.
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
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