Medicus Pharma Ltd Stock Price, News & Analysis

Medicus Pharma (NASDAQ: MDCX) completed enrollment of 90 patients in its U.S. Phase 2 trial SKNJCT-003 testing Doxorubicin Microneedle Array (D-MNA) to non-invasively treat nodular basal cell carcinoma (BCC) across 9 U.S. sites. The company expects topline results in Q1 2026 and plans to request an End-of-Phase 2 (EOP2) meeting with the FDA in H1 2026. Prior data include a Q1 2025 interim showing >60% clinical clearance in 26 patients and Phase 1 safety/tolerability in 13 participants with 6 complete histologic responses. Recent milestones: positive FDA Type C feedback on a 505(b)(2) pathway, UK regulatory and ethics approvals to expand SKNJCT-003, first patient dosed in SKNJCT-004 UAE, a MoU with HelixNano, acquisition of Antev, and a collaboration with the Gorlin Syndrome Alliance for expanded access.

Medicus Pharma (NASDAQ:MDCX) entered a warrant inducement agreement to accelerate exercise of existing Series A and B warrants issued July 14, 2025. The investor agreed to reduce the warrants' exercise price to $1.92 and to immediately exercise all outstanding warrants to buy 2,680,000 common shares for gross proceeds of approximately $5.1 million before fees.

In exchange, Medicus will issue unregistered Series C and D warrants to purchase an additional 4,020,000 shares at $2.00 per share, exercisable under similar terms and expiring 5.5 years from issuance; registration of resale of those shares is to be filed with the SEC. Closing is expected on or about December 5, 2025, subject to customary conditions.

Medicus Pharma (NASDAQ: MDCX) appointed Carolyn Bonner as Chief Financial Officer in addition to her role as President, effective December 1, 2025, after she served as acting CFO since September 12, 2025.

Key program updates: a Phase 2 U.S. trial SKNJCT-003 reported a March 2025 interim analysis showing >60% clinical clearance after >50% of a 60-patient target were randomized; FDA Type C feedback in September 2025 supported a 505(b)(2) pathway; first patient treated in SKNJCT-004 (UAE) in October 2025; full UK regulatory and ethical approvals for SKNJCT-003 were received in November 2025. The company completed acquisition of Antev in August 2025.

Medicus Pharma (Nasdaq: MDCX) announced clinical and corporate developments on Nov 24, 2025 focused on next‑generation prostate and skin cancer therapies.

Key points: Acquisition of Antev (Aug 2025) advancing Teverelix, a long‑acting GnRH antagonist with Phase 2a data showing 97.5% probability of castrate testosterone suppression (50 patients) and prior FDA written guidance supporting Phase 3 design. The company also reports SkinJect™ microneedle program progress: Phase 1 safety with 6 complete histologic responses (March 2021), ongoing SKNJCT‑003/004 trials, UK regulatory approvals to expand SKNJCT‑003 (Nov 2025), and a GSA collaboration for Expanded Access IND (Oct 2025).

Medicus Pharma (NASDAQ: MDCX) announced it filed a FDA Commissioner’s National Priority Voucher (CNPV) application on Nov 17, 2025 for SkinJect’s SKNJCT-003, a dissolvable doxorubicin microneedle array (D-MNA) to non-invasively treat basal cell carcinoma (BCC).

Key program facts: SKNJCT-003 is a randomized, double-blind Phase 2 trial (started Aug 2024) expanded to 90 subjects, reported a March 2025 interim showing >60% clinical clearance (preliminary), and received positive FDA Type C feedback on a 505(b)(2) pathway in Sept 2025. The company received UK regulatory and ethics approvals in Nov 2025 and began SKNJCT-004 in UAE (36 patients).

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.