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) said CEO Dr. Raza Bokhari and leadership met with senior members of the House Energy & Commerce Committee on April 27, 2026 to seek support for Orphan Drug designation, a registrational IND for SkinJect® in Gorlin Syndrome, and rare-disease pediatric voucher access.
Meetings included outreach with advocates and the Gorlin Syndrome Alliance and outline plans for regulatory and clinical development toward expedited access for high-burden patients.
Medicus Pharma (NASDAQ: MDCX) submitted an Orphan Drug Designation (ODD) application to the U.S. FDA on April 17, 2026 for SkinJect (D-MNA) to treat basal cell carcinoma in patients with Gorlin Syndrome.
SkinJect is a doxorubicin-containing dissolvable microneedle array evaluated in Phase 1/2 with reported lesion clearance and histologic complete responses; the company estimates ~11,000 U.S. patients and highlights potential benefits including localized delivery, repeat use, and possible 7-year U.S. exclusivity if approved.
Medicus Pharma (NASDAQ: MDCX) will present Phase 1 data for Teverelix at AACE 2026 (poster on April 24, 11:40 AM PT). Two studies (N=48 healthy premenopausal women) showed dose-dependent estradiol suppression, long-acting PK (t1/2 ~14–23 days), favorable bone markers (≤10% change), and acceptable safety.
The company plans precision-genomics development in endometriosis with Omics Labs and notes several non-binding collaborations and LOIs.
Medicus Pharma (NASDAQ: MDCX) submitted an optimized Phase 2 protocol to the U.S. FDA for Teverelix to prevent recurrent acute urinary retention (AURr) in men with BPH. The design targets ~126 patients across the U.S. and Europe, a mechanism-driven primary endpoint of percent change in total prostate volume at Week 12, a single-dose, four-arm randomized design, and an interim analysis after ~50% of patients complete Week 12 to inform dose and route selection.
The study duration is 52 weeks (28-week treatment, 24-week follow-up), and the company cites an approx. $2 billion addressable AURr market.
Medicus Pharma (NASDAQ: MDCX) clarified topline results from its Phase 2 SKNJCT-003 study in nodular basal cell carcinoma, emphasizing the program will be driven by active treatment arms rather than the device-only arm.
The 200µg D-MNA cohort showed the strongest activity (Clinical Clearance 73% and Histological Response 40% at Day 57) and will be the focus of a planned registrational strategy and an End-of-Phase 2 meeting with FDA.
Medicus Pharma (NASDAQ: MDCX) reported independent KOL validation of its Phase 2 SKNJCT-003 SkinJect dataset on March 30, 2026. The 200µg cohort showed ~80% overall response rate, 73% clinical clearance, and 40% histological clearance at Day 57, supporting selection of the 200µg lead dose.
Dr. Babar Rao described the results as clinically meaningful and supportive of continued development and regulatory engagement for a potential non-surgical BCC treatment.
Medicus Pharma (NASDAQ: MDCX) will host a business update on March 26, 2026, highlighting Phase 2 SkinJect data and AI plans. The 200µg cohort showed an 80% overall response rate (ORR) at Day 57, with 73% clinical clearance and 40% histological complete response.
The company plans an End-of-Phase 2 FDA discussion, is advancing an agentic AI clinical platform, and reported $8.7 million in cash at year-end 2025 after raising ~$31.9 million in 2025.
Medicus Pharma (NASDAQ:MDCX) reported FY2025 results and a corporate update on March 25, 2026, highlighting a completed 90-patient Phase 2 SkinJect study with up to 73% clearance in the 200µg cohort and strengthened capital via ~$31.9M financing proceeds.
FY2025 financials: cash $8.7M, operating expenses $34.4M, net loss $35.4M, and disclosed substantial doubt about going concern; 2026 catalysts include an End-of-Phase 2 FDA meeting and initiation of Teverelix Phase 2b studies.
Medicus Pharma (NASDAQ:MDCX) will host a live fireside chat on March 19, 2026 to review positive Phase 2 SkinJect (SKNJCT-003) topline results.
Key data: 73% clinical clearance in the 200-µg D-MNA arm at Day 57 versus 38% in the device-only P-MNA control, supporting further development and regulatory discussions.
Medicus Pharma (NASDAQ: MDCX) announced that Dr. Babar K. Rao will provide clinical interpretation of positive Phase 2 SkinJect (SKNJCT-003) topline data during a business webcast on March 26, 2026. The randomized, double-blind study showed 73% clinical clearance in the 200-µg D-MNA arm vs 38% in the device-only arm at Day 57, with 40% histological clearance in the active cohort. Management views the dataset as decision-grade evidence to pursue regulatory discussions and potential strategic partnerships.