Medicus Pharma Ltd Stock Price, News & Analysis

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.

Medicus Pharma (NASDAQ:MDCX) has secured an $8.0 million non-dilutive debenture financing through a purchase agreement with Yorkville Advisors Global's investment fund. The debenture carries an 8% annual interest rate and matures in 12 months, with monthly installment payments.

The financing refinances approximately $1.7 million of existing debentures from May-June 2025, resulting in net proceeds of $5.7 million. The company plans to use the funds to accelerate the development of Teverelix, a next-generation GnRH Antagonist targeting Acute Urinary Retention and high CV risk Prostate Cancer markets, with an estimated $6 billion market opportunity.

Medicus Pharma (NASDAQ:MDCX) has initiated patient recruitment for its SKNJCT-004 Phase 2 clinical study at Cleveland Clinic Abu Dhabi (CCAD) to treat Basal Cell Carcinoma (BCC) of the skin. The study will enroll 36 participants across multiple UAE sites in a randomized, double-blind, placebo-controlled trial evaluating two dose levels of D-MNA.

The company's parallel U.S. study, SKNJCT-003, has already enrolled 75% of its 90 targeted participants and showed promising interim results with over 60% clinical clearance. This represents a potential $2 billion market opportunity. Additionally, Medicus recently acquired UK-based Antev Limited and entered a non-binding MoU with Helix Nanotechnologies for potential mRNA platform development.