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) 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.
Medicus Pharma (NASDAQ: MDCX) has submitted a Phase 2 clinical design (SKNJCT-004) to UAE's Department of Health for non-invasive treatment of Basal Cell Carcinoma (BCC). The study will randomize 36 patients across four UAE clinical sites, testing two dose levels of D-MNA against placebo.
The trial follows successful Phase 1 results (SKNJCT-001) completed in March 2021, which demonstrated safety and tolerability with no serious adverse events across all dose levels. Notably, 6 participants showed complete responses in treating nodular BCC.
Additionally, Medicus has a parallel Phase 2 study (SKNJCT-003) ongoing in the US across 9 clinical sites, targeting 60 patients, with over 50% already randomized. The company plans an interim data analysis in Q1 2025 and aims to seek FDA's consent for fast-tracking the clinical development program through a Type C meeting in Q2 2025.
Medicus Pharma (NASDAQ: MDCX) reports progress in its Phase 2 clinical study (SKNJCT-003) for treating nodular Basal Cell Carcinoma (BCC). The study has successfully randomized over 50% of the planned 60 patients across nine U.S. clinical sites. The company expects to complete interim data analysis by Q1 2025 and plans to submit findings to the FDA for a Type C meeting in Q2 2025.
The study evaluates two dose levels of D-MNA (100μg and 200μg) against placebo in a 1:1:1 randomization. This follows successful Phase 1 results from March 2021, where the treatment showed safety and tolerability with no serious adverse events, and achieved complete responses in 6 participants with nodular BCC.
Medicus Pharma (NASDAQ: MDCX) has announced two significant developments: First, the company entered into a Standby Equity Purchase Agreement (SEPA) with YA II PN, , managed by Yorkville Advisors Global, LP. This agreement allows Medicus to sell up to US$15 million of common shares over 36 months, with shares priced at 97% of market price during a specified three-day pricing period.
Second, Medicus announced plans to voluntarily delist from the TSX Venture Exchange (TSXV) while maintaining its NASDAQ listing under 'MDCX'. The company cited low TSXV trading volume as the reason for delisting. Medicus will remain a reporting issuer in Canada, continuing to provide disclosure on SEDAR+.
The SEPA includes limitations, capping total issuable shares at 19.99% of outstanding shares, with the Investor's beneficial ownership not exceeding 4.99% at any time. The agreement requires SEC registration for share resale.
Medicus Pharma (NASDAQ: MDCX) has entered into a Standby Equity Purchase Agreement (SEPA) with YA II PN, , allowing the company to sell up to $15 million of common shares over 36 months. The shares will be priced at 97% of the market price during a specified three-day pricing period, with limitations including a 4.99% ownership cap for the investor.
The company also announced plans to voluntarily delist from the TSX Venture Exchange (TSXV) while maintaining its NASDAQ listing under 'MDCX'. The delisting decision was made due to low TSXV trading volume, with NASDAQ representing the majority of trading activity. Medicus will remain a reporting issuer in Canada.
The company's subsidiary, SkinJect, is developing a dissolvable microneedle patch for basal cell skin cancer treatment. Following successful Phase 1 safety studies, a Phase 2 clinical trial (SKNJCT-003) is currently recruiting patients across nine U.S. sites to evaluate two dose levels compared to placebo.
AudioCodes (AUDC) reported its Q4 and full year 2024 financial results. Q4 revenues decreased 3.2% year-over-year to $61.6 million, while full-year revenues slightly declined 0.9% to $242.2 million. However, service revenues showed strong growth, increasing 10.9% in Q4 to $34.2 million and 8.2% for the full year to $130.2 million.
Q4 GAAP net income was $6.8 million ($0.22 per share), while full-year GAAP net income reached $15.3 million ($0.50 per share). The company's Enterprise UCaaS and CX business accounted for 92% of Q4 revenues, with Microsoft business growing 13% in the quarter. The company's ARR reached $65 million, representing 35% year-over-year growth.
AudioCodes declared a semi-annual dividend of 18 cents per share, payable March 6, 2025, and repurchased 634,533 shares for $6.0 million during Q4 2024.
Medicus Pharma (NASDAQ: MDCX) has received Minor Use in Major Species (MUMS) Designation from the FDA for its Doxorubicin-containing microneedle array (D-MNA) patch to treat external squamous cell carcinoma (SCC) in horses. The MUMS status, similar to Orphan Drug designation for human drugs, grants a 7-year exclusive marketing period post-approval.
The D-MNA is a patent-protected dissolvable transdermal patch using cellulose-based microneedles loaded with doxorubicin to penetrate and treat skin tumors. The company plans to target the equine SCC market, which affects 2-3% of the US horse population of 6.6-7.25 million horses, particularly in breeds with white or partially white coats. Medicus aims to have a commercially viable product by 2026.
Medicus Pharma (NASDAQ: MDCX) announced a collaboration with Swanielle to expand its Phase 2 clinical study for Basal Cell Carcinoma (BCC) treatment in the Asia-Pacific region. The ongoing Phase 2 study (SKNJCT-003) has already enrolled 25% of the targeted 60 patients across nine U.S. clinical sites. The company plans an interim data analysis in Q1 2025 and FDA Type C meeting in Q2 2025. The study evaluates two dose levels of D-MNA against placebo, building on successful Phase 1 results that showed complete responses in 6 participants with no serious adverse events.
Medicus Pharma announces key leadership changes with the appointment of Faisal Mehmud, MD as Chief Medical Officer and the promotion of Edward Brennan, MD to Chief Scientific Officer & Head of R&D. Dr. Mehmud brings over 20 years of global pharmaceutical experience from companies like GSK, Pfizer, and BMS. The company is developing a novel dissolvable doxorubicin-containing microneedle array (D-MNA) to treat non-melanoma skin cancer. Their Phase 1 study completed in March 2021 showed safety and tolerability, with six participants achieving complete response. A Phase 2 clinical trial is currently recruiting 60 patients across nine U.S. sites to evaluate two dose levels against placebo.
Medicus Pharma (NASDAQ: MDCX) announced the closing of its US$4.0M initial public offering in the United States, consisting of 970,000 units at US$4.125 per unit. Each unit includes one common share and one warrant with a US$4.64 exercise price, expiring in 5 years. The company's shares and warrants began trading on Nasdaq under 'MDCX' and 'MDCXW'. The proceeds will fund Phase 2 clinical trials for basal cell carcinoma treatment using their doxorubicin microarray needle skinpatch, with potential expansion to other non-melanoma skin diseases. The underwriter exercised an overallotment option for 145,500 additional warrants.