Medicus Pharma Ltd Stock Price, News & Analysis

Medicus Pharma (NASDAQ: MDCX) has submitted a product development plan to the FDA for treating external squamous cell carcinoma (SCC) in horses using their novel Doxorubicin-containing microneedle array (D-MNA) patch. The company received MUMS designation (similar to Orphan Drug status) in December 2024, granting 7-year exclusive marketing rights post-approval. The clinical study SKNJCT-004 will involve 50 horses in a randomized, double-blind trial comparing two D-MNA dose levels against placebo. The market opportunity is estimated at $250 million. The D-MNA technology has shown promising results in human trials, with a Phase 1 study completed in March 2021 showing safety and efficacy, and an ongoing Phase 2 study (SKNJCT-003) demonstrating over 60% clinical clearance in interim analysis. The company is also expanding trials to Europe and UAE, and recently announced plans to acquire Antev Ltd., a UK biotech company developing treatments for prostate cancer.

Medicus Pharma (NASDAQ: MDCX) has successfully closed a $7.0 million public offering of 2,260,000 units at $3.10 per unit. Each unit includes one common share and one warrant exercisable at $3.10 with a 5-year expiration. The proceeds will primarily fund Phase 2 clinical trials for their innovative doxorubicin tip loaded dissolvable microarray needle skinpatch for basal cell carcinoma treatment. The company, through its subsidiary SkinJect, has already completed Phase 1 safety studies with promising results, showing complete response in six participants. Additionally, Medicus recently announced plans to acquire Antev Ltd., a UK biotech company developing Teverelix for prostate cancer and urinary retention treatment, though the deal remains subject to due diligence and final agreements.

Medicus Pharma (NASDAQ: MDCX) has announced a public offering of 2,260,000 units priced at $3.10 per unit, aiming to raise $7.0 million. Each unit includes one common share and one warrant with a 5-year expiration and $3.10 exercise price. The proceeds will primarily fund Phase 2 clinical trials for their basal cell carcinoma treatment using a doxorubicin-loaded dissolvable microarray needle skinpatch. The company may also expand trials to other non-melanoma skin diseases. The offering, led by Maxim Group LLC with co-placement agents Brookline Capital Markets and D. Boral Capital, is expected to close on June 2, 2025. Additionally, MDCX recently announced plans to acquire Antev Ltd., a UK biotech developing Teverelix for prostate cancer and urinary retention treatment, subject to due diligence and approvals.

Medicus Pharma Ltd (NASDAQ: MDCX) has received approval from the UAE Department of Health to begin a Phase 2 clinical study (SKNJCT-004) for treating Basal Cell Carcinoma (BCC) of the skin. The study will involve 36 patients across four UAE medical centers, including Cleveland Clinic Abu Dhabi.

The randomized, double-blind trial will evaluate two dose levels of D-MNA (100μg and 200μg) against a placebo. This follows successful Phase 1 results from March 2021, where the treatment showed safety and tolerability with 6 participants achieving complete responses. The company is also conducting a Phase 2 study (SKNJCT-003) in the US, which showed positive interim results with over 60% clinical clearance.

Additionally, Medicus recently announced plans to acquire Antev Ltd., a UK biotech company developing Teverelix for prostate cancer and urinary retention treatment.

Medicus Pharma (NASDAQ: MDCX) has announced a binding letter of intent to acquire Antev in a share exchange transaction valued at approximately US$75 million. The deal includes Antev shareholders receiving a ~19% equity stake (2,666,600 shares) in Medicus and up to US$65 million in contingent payments tied to FDA approvals.

Antev is developing Teverelix, a next-generation GnRH antagonist, targeting two key markets:

• Acute Urinary Retention (AUR) prevention, with a Phase 2b study planned for 390 men, addressing a US$2B annual market
• Advanced Prostate Cancer treatment for patients with high cardiovascular risk, with a Phase 2b study planned for 40 men, targeting a US$4B annual market

The transaction is expected to close by June 2025, subject to due diligence, definitive agreements, and regulatory approvals.

Medicus Pharma (NASDAQ: MDCX) announces significant expansion of its Phase 2 clinical study (SKNJCT-003) for treating nodular Basal Cell Carcinoma (BCC). The Institutional Review Board has approved increasing patient enrollment from 60 to 90 participants. The study, currently active in nine U.S. clinical sites, will expand to additional U.S. locations and two European sites.

The trial has already randomized more than 45 participants, with interim analysis showing promising results: over 60% complete clinical clearance rate. The study evaluates two dose levels of D-MNA (100μg and 200μg) against placebo, with both doses demonstrating good tolerability with no serious adverse events or dose-limiting toxicities.

The company plans to submit a Type C meeting request to the FDA before Q2 2025 end. Additionally, Medicus is pursuing global validation with pending approval in Abu Dhabi and potential collaboration in the Asia-Pacific region.

Medicus Pharma (NASDAQ: MDCX) has successfully closed its Tier II Regulation A offering, raising $4.2 million through the sale of 1,490,000 units at $2.80 per unit. Each unit includes one common share and one warrant with a 5-year expiration and $2.80 exercise price.

The proceeds will primarily fund the company's Phase 2 proof of concept clinical trial for basal cell carcinoma treatment using their innovative doxorubicin tip loaded dissolvable microarray needle skinpatch. Additional funds may support expanding to a pivotal trial and exploring other non-melanoma skin diseases.

The company's previous Phase 1 safety study (SKNJCT-001) completed in March 2021 demonstrated both safety and tolerability, with six participants showing complete response. Their upcoming Phase 2 study (SKNJCT-003) will evaluate two dose levels (100 and 200 ug) of D-MNA versus placebo across nine U.S. sites, targeting 60 patients.

Medicus Pharma (NASDAQ: MDCX) has announced pricing of a $4.2 million Regulation A offering of 1,490,000 units at $2.80 per unit. Each unit includes one common share and one warrant with a 5-year expiration period.

The proceeds will fund the company's Phase 2 proof of concept clinical trial for basal cell carcinoma treatment using their doxorubicin tip loaded dissolvable microarray needle skinpatch. Additional funds may support expanding the exploratory phase 2 trial to a pivotal trial and cover other non-melanoma skin diseases.

The company previously completed a Phase 1 safety study in March 2021, which met its primary objectives and showed complete response in six participants. Their Phase 2 IND clinical protocol, submitted in January 2024, involves a randomized, controlled, double-blind study across nine U.S. sites, targeting 60 patients to evaluate two dose levels of D-MNA versus placebo.

Medicus Pharma (NASDAQ: MDCX) has announced positive interim results from its SKNJCT-003 Phase 2 clinical study for treating basal cell carcinoma (BCC) non-invasively. The study, conducted across 9 U.S. clinical sites with a target of 60 patients, shows over 60% complete clinical clearance in interim analysis.

The trial evaluates two dose levels of D-MNA (100μg and 200μg) against placebo, with patients randomized 1:1:1. Both dose levels demonstrated good tolerability with no dose-limiting toxicities or serious adverse events. The company plans to submit these findings to the FDA and seek a Type C meeting in Q2 2025 to discuss expediting clinical development.

Additionally, Medicus has submitted a clinical design (SKNJCT-004) to UAE's Department of Health, planning to randomize 36 patients across four UAE medical facilities.