Welcome to our dedicated page for Medicus Pharma news (Ticker: MDCX), a resource for investors and traders seeking the latest updates and insights on Medicus Pharma stock.
Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech and life sciences company whose news flow centers on clinical trial progress, regulatory milestones, strategic collaborations and capital markets activity. The company describes itself as a precision guided biotech/life sciences organization focused on advancing SkinJect™, an investigational microneedle therapy for basal cell carcinoma (BCC) of the skin, and Teverelix, a long-acting GnRH antagonist for hormone-driven conditions.
News updates frequently cover the SkinJect™ program, including Phase 2 study SKNJCT-003 in the United States, regulatory and ethics approvals to expand into the United Kingdom, and SKNJCT-004 in the United Arab Emirates. Releases also highlight interactions with the U.S. Food and Drug Administration (FDA), such as Type C meeting feedback supporting a 505(b)(2) regulatory pathway and the filing of an FDA Commissioner’s National Priority Voucher (CNPV) application for SKNJCT-003.
Another major theme in MDCX news is the Teverelix pipeline, added through the acquisition of Antev Limited. Company communications describe prior Phase 1 and Phase 2a data, FDA guidance on Phase 3 design, and plans to use AI-enabled analytics—via an engagement with Reliant AI Inc.—to support upcoming Teverelix clinical studies. Additional coverage includes Phase 1 data in healthy female volunteers and acceptance of Teverelix research for presentation at a leading endocrinology conference.
Investors following MDCX news will also see announcements on collaborations, such as the Gorlin Syndrome Alliance partnership for compassionate access to SkinJect™ and a non-binding memorandum of understanding with Helix Nanotechnologies, Inc. around thermostable infectious disease vaccines. Capital markets updates, including warrant inducement agreements, standby equity purchase activity and debenture financings, are disclosed through press releases and Form 8-K filings.
This news page aggregates these developments so readers can review Medicus Pharma’s clinical, regulatory, partnering and financing announcements in one place.
Medicus Pharma (NASDAQ:MDCX) reported Q3 2025 corporate and financial updates including clinical progress, an acquisition, patient-access initiatives, and financing activity.
Key points: SKNJCT-003 (Phase 2 D-MNA for basal cell carcinoma) has randomized >75% of a 90-patient target and received FDA Type C feedback supporting a 505(b)(2) pathway; UK MHRA/HRA/WREC approvals were received to expand the study and the first patient was treated in a UAE SKNJCT-004 study. Medicus completed the acquisition of Antev (Teverelix) in August 2025. Q3 cash was $8.7M after $10.4M aggregate net proceeds; Q3 operating expenses were $15.4M and net loss was $16.0M.
Medicus Pharma (NASDAQ:MDCX) received full United Kingdom regulatory and ethical approvals (MHRA, HRA, WREC) to expand its Phase 2 study SKNJCT-003 evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC).
The randomized, double-blind, placebo-controlled study will enroll up to 90 subjects (1:1:1 placebo, 100μg, 200μg); the company reports >75% of the 90 participants have been randomized and an earlier interim analysis showed >60% clinical clearance. The 200μg dose matches the Phase 1 maximum; SKNJCT-001 (n=13) reported safety, tolerability and 6 complete responses. The company also completed the Antev acquisition (Aug 2025) and announced a collaboration with the Gorlin Syndrome Alliance for expanded access to SKINJECT™.
Medicus Pharma (NASDAQ: MDCX) announced a collaboration with the Gorlin Syndrome Alliance to pursue an FDA Expanded Access IND pathway enabling physician‑supervised access to SKINJECT™, an investigational doxorubicin microneedle array for patients with Gorlin syndrome.
Key program facts: a Phase 2 study (SKNJCT-003) expanded to 90 subjects with >75% randomized and a reported interim analysis in March 2025 showing >60% clinical clearance; FDA Type C feedback in Sept 2025 indicated a 505(b)(2) regulatory route. The company completed the Antev acquisition in Aug 2025 and runs a 36‑patient SKNJCT-004 study in the UAE.
Medicus Pharma (NASDAQ:MDCX) announced the first patient enrolled in the UAE for its SKNJCT-004 Phase 2 randomized, double-blind, placebo-controlled study to non-invasively treat basal cell carcinoma (BCC) using dissolvable Doxorubicin-containing microneedle arrays (D-MNA).
The 36-subject UAE study will run across six sites including Cleveland Clinic Abu Dhabi and is coordinated by IROS. Medicus also reported ongoing U.S. Phase 2 SKNJCT-003 with a March 2025 interim showing >60% clinical clearance and FDA Type C feedback supporting a 505(b)(2) pathway. In August 2025 Medicus completed acquisition of Antev, adding Teverelix TFA for advanced prostate cancer.
Medicus Pharma (NASDAQ:MDCX) is pursuing three independent programs: Skinject (doxorubicin microneedle for basal cell carcinoma), the acquired Teverelix GnRH antagonist for prostate cancer with cardiovascular risk, and a non-binding HelixNano microneedle+mRNA collaboration.
Key facts: FDA Type C feedback in Sept 2025 confirmed Skinject may use the 505(b)(2) pathway; SKNJCT-003 enrollment expanded 60→90 with >75% randomized and an interim >60% clinical clearance; recruitment expected complete by Q4 2025 and EOP2 meeting targeted for Q1 2026. Teverelix acquired Aug 2025, formulated for six-week dosing. Cash on hand was $9.7M as of Q2 2025.
Medicus Pharma (NASDAQ:MDCX) will present at the Maxim Growth Summit on October 22-23, 2025 in New York City, where CEO Dr. Raza Bokhari will participate in a fireside chat and meet institutional investors.
The company reported clinical progress for Skinject (SKNJCT-003): a Phase 2, double-blind, placebo-controlled study expanded to 90 subjects with randomization >75% complete and a March 2025 interim analysis showing >60% clinical clearance (preliminary). In September 2025 the FDA provided positive Type C feedback supporting a 505(b)(2) pathway. Medicus completed the August 2025 acquisition of Antev, adding Teverelix TFA, a long-acting GnRH antagonist with six-week dosing for advanced prostate care.
Medicus Pharma (NASDAQ:MDCX) will present at the Family Office Summit in Dubai on October 9, 2025, with CEO Dr. Raza Bokhari speaking on biotech innovation, AI in drug development, and the UAE Genomic project.
Medicus is conducting a Phase 2 study of SKNJCT-003 across 9 US sites, expanded to 90 subjects with >75% randomized after randomization began in August 2024; a March 2025 interim analysis showed >60% clinical clearance but results are preliminary. The company received positive FDA Type C feedback in September 2025 indicating a possible 505(b)(2) pathway for Skinject. Medicus also runs a 36-patient UAE trial (SKNJCT-004) and completed the acquisition of Antev (August 2025), adding Teverelix TFA, a long-acting GnRH antagonist with a six-week dosing interval.
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) 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 Ltd. (NASDAQ:MDCX) announced its upcoming participation in a live fireside chat hosted by Brookline Capital Markets on September 29, 2025. The company will present updates on two key development programs: SkinJect™ D-MNA for basal cell carcinoma treatment and Teverelix, a GnRH antagonist for urinary retention and prostate cancer.
The company's Phase 2 clinical study SKNJCT-003 has shown promising interim results with over 60% clinical clearance and has expanded to include 90 participants across U.S. sites. A parallel study, SKNJCT-004, is ongoing in the UAE across 6 medical centers. Additionally, Medicus recently acquired Antev, gaining access to Teverelix TFA, which offers a unique six-week dosing interval. These programs collectively represent a $8 billion market opportunity.