Medicus Pharma Ltd Stock Price, News & Analysis

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.

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.