doxorubicin microneedle array (D-MNA) / Medicus Pharma - LARVOL DELTA

Medicus Pharma Ltd. Announces Filing of FDA Commissioner’s National Priority Voucher Application (CNPV) for SKNJCT-003 to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin (GlobeNewswire) - "The FDA plans, in the first year of the program, to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this program, the agency may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval....The Company believes it meets each of the above criteria and seeks inclusion in the CNPV Pilot Program to enable enhanced FDA collaboration and expedited review, accelerating access to a U.S.-developed, cost-effective, cancer therapy that supports national goals of improving access, safety, and quality of care and providing access to Gorlin Syndrome patients that have no available treatment."

FDA event • Basal Cell Carcinoma

Medicus Pharma Ltd. Receives Full United Kingdom Regulatory and Ethical Approvals To Expand Phase 2 Clinical Study (SKNJCT-003) To Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin (ACCESS Newswire) - "The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States can now expand into additional sites in United Kingdom....The SKNJCT-003 clinical study is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 90 subjects presenting with BCC of the skin."

Trial status • Basal Cell Carcinoma

Medicus Pharma Ltd. Receives Positive Feedback From the Food and Drug Adminstration (FDA) Type C Meeting Supporting the Development of Skinject (ACCESS Newswire) - "The FDA agrees that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat basal cell carcinoma (BCC) of the skin using dissolvable Doxorubicin-containing Microneedle arrays (D-MNA)...The purpose of the Type C meeting was to discuss the design, endpoints, and other key protocol elements for the clinical development of doxorubicin containing microneedle array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin....As we plan to complete patient recruitment for SKNJCT-003 before the end this year and request an EOP2 meeting with the FDA in Q1 2026, our confidence is increasing that Skinject may become commercially viable sometime in 2027."

FDA event • Launch US • Trial status • Basal Cell Carcinoma

Medicus Pharma Ltd. To Present at Brookline Capital Markets (ACCESS Newswire) - "Following a company overview from Dr. Raza Bokhari Executive Chairman and CEO of Medicus Pharma, there will be two featured presentations providing updates on the Company's key development programs: Ed Brennan, MD, FACS Chief Scientific Officer & Head of R&D Program, will discuss SkinJect D-MNA novel treatment to non-invasively treat basal cell carcinoma (BCC) of the skin and provide an update on the progress of phase 2 clinical studies; Faisal Mehmud, MD, MRCP, Chief Medical Officer, will provide an update on Teverelix, a next generation GnRH antagonist as a first in class market product to prevent relapse of acute urinary retention (AURr) and high CV risk prostate cancer."

Clinical • Trial status • Basal Cell Carcinoma • Prostate Cancer

Medicus Pharma Ltd. Provides Update on United Arab Emirates (UAE) SKNJCT-004 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC) (ACCESS Newswire) - "Medicus Pharma...has commenced patient recruitment in Cleveland clinic Abu Dhabi (CCAD)...The study is expected to randomize thirty-six (36) patients in four sites in UAE."

Trial status • Basal Cell Carcinoma

The Company…announced that its phase 2 clinical study to non-invasively treat BCC using novel D-MNA (SKNJCT-003) has now randomized more than seventy five percent (75%) of the ninety (90) participants expected to be randomized in the study. (Medicus Pharma Press Release) - "The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA...SKNJCT-003 Phase 2 clinical study is currently underway in nine (9) clinical sites across the United States which commenced randomizing patients in August 2024."

Trial status • Basal Cell Carcinoma

Medicus Pharma Ltd. Provides Update on Doxorubicin Containing Novel Microneedle Array (D-MNA) Clinical Development Program for the Treatment of Basal Cell Carcinoma (BCC) of the Skin (Medicus Pharma Press Release) - "Medicus Pharma Ltd...is pleased to announce, following the acceptance of the Type C meeting request by the United States Food and Drug Administration (the "FDA"), the Company has submitted its queries in writing and expect to receive a response from the FDA before the end of Q3 2025...The Company’s aim is to gain the FDA’s consent to fast-track the clinical development program and seek feedback on future clinical plans for the D-MNA development program."

FDA event • Basal Cell Carcinoma

Medicus Pharma Ltd…Reports Second Quarter 2025 Financial Highlights (Medicus Pharma Press Release) - "The addition of $11.5 million of aggregate net proceeds from financing transactions and the exercise of warrants has bolstered the Company’s already strong balance sheet as it continues to progress its clinical development program while pursuing strategic transactions and building out its core management team...Total operating expenses were $6.0 million for the second quarter compared to $3.6 million for the same period in 2024. Research and development expenses were $1.4 million for the second quarter compared to $1.3 million for the same period in 2024."

Commercial • Basal Cell Carcinoma

Medicus Pharma Ltd…is pleased to announce submission of a comprehensive package to the United States Food and Drug Administration (the ’FDA’) seeking a Type C meeting with the FDA during the week of October 6th, 2025 (Medicus Pharma Press Release) - "The purpose of the Type C meeting is to formally discuss the D-MNA product development and gain further alignment on the clinical pathway...SKNJCT-003 Phase 2 clinical study is currently underway in nine (9) clinical sites across United States which commenced randomizing patients in August 2024...The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. In April 2025, the investigational review board increased the number of participants in SKNJCT-003 to Ninety (90) subjects. The Company also announced expanding clinical trial sites in Europe. The Company also has a clinical design (SKNJCT-004) currently underway in United Arab Emirates (UAE)."

FDA event • New trial • Trial status • Basal Cell Carcinoma

Medicus Pharma Ltd. Announces Pricing of $7.0 Million Public Offering (Yahoo Finance) - "Medicus Pharma Ltd...announced the pricing of its public offering of 2,260,000 units, on a "best-efforts" basis, at a price of $3.10 per unit. Each unit consists of one common share of the Company and one warrant to purchase one common share. The warrants will have an exercise price of $3.10 per share and will expire 5 years from the date of issuance....The offering is expected to close on June 2, 2025, subject to customary closing conditions. The Company intends to use any net proceeds from the offering to fund its Phase 2 proof of concept clinical trial for treatment of basal cell carcinoma using its doxorubicin tip loaded dissolvable microarray needle skinpatch. The Company may also use the net proceeds of the offering to expand its exploratory phase 2 clinical trial to a pivotal trial and/or to expand its trials to cover other non-melanoma skin diseases."

Financing • Basal Cell Carcinoma • Non-melanoma Skin Cancer

Medicus Pharma Ltd Receives Study May Proceed Approval from United Arab Emirates (UAE) Department of Health (DOH) to Commence Phase 2 Clinical Study (SKNJCT-004) to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC) (Yahoo Finance) - "Medicus Pharma Ltd...is pleased to announce that it has received study may proceed approval from the UAE DOH to commence Phase 2 clinical study (SKNJCT-004) to non-invasively treat BCC of the skin. The study is expected to randomize thirty-six (36) patients in four sites in UAE, which are Cleveland Clinic Abu Dhabi (CCAD), Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), and American Hospital of Dubai (AHD)."

New P2 trial • Basal Cell Carcinoma

Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma (BCC) (Medicus Pharma Press Release) - "Medicus Pharma...is pleased to announce that Institutional Review Board (IRB) has approved the increase in number of patients from sixty (60) to Ninety (90). The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States will expand into additional sites in United States, as well as two clinical trial sites in Europe. The Company also announced that it has randomized more the forty-five (45) participants in the study and is on track to submit the package seeking a Type C meeting with the United States Food and Drug Administration (FDA) before the end of Q2 2025....The Company also has submitted a clinical design (SKNJCT-004) to United Arab Emirates (UAE) Department of Health (DOH). The study is expected to randomize 36 patients in four sites in UAE..."

FDA event • New trial • Trial status • Basal Cell Carcinoma

Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma (BCC) (GlobeNewswire) - "Medicus Pharma Ltd....is also pleased to announce that its phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States, has now randomized more than 50% of the 60 patients expected to be enrolled in the study. The Company also announced that it is on track to complete an interim data analysis before the end of Q1 2025 and to submit its findings to the United States Food and Drug Administration (FDA) as part of a package seeking a Type C meeting with the FDA in Q2 2025."

FDA event • P1 data • Trial status • Basal Cell Carcinoma

Medicus Pharma Ltd Announces Positively Trending Interim Analysis for SKNJCT-003 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC) (GlobeNewswire) - P2 | N=60 | NCT06608238 | Sponsor: SkinJect, Inc. | "The interim analysis shows the clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%. The analysis also shows the investigational product, D-MNA was well tolerated for both dose levels, a low-dose group receiving 100ug of D-MNA and a high-dose group receiving 200ug of D-MNA in all participants so far enrolled in the study, with no dose limiting toxicities (DLTs), or serious adverse events (SAEs). In addition, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed."

P2 data • Basal Cell Carcinoma

Medicus Pharma Ltd Announces Submission of Phase 2 Clinical Design (SKNJCT-004) to United Arab Emirates (UAE) Department of Health (DOH) to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC) (GlobeNewswire) - "Medicus Pharma Ltd...is pleased to announce that it has submitted a clinical design (SKNJCT-004) to UAE DOH to non-invasively treat BCC of the skin...The study is expected to randomize thirty-six (36) patients in four sites in UAE, which are Cleveland Clinic Abu Dhabi (CCAD), Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), and American Hospital of Dubai (AHD)...The clinical study, SKNJCT-004, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 36 subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA."

Clinical protocol • New P2 trial • Basal Cell Carcinoma

Medicus Pharma Ltd. Announces Collaboration Agreement to Expand Phase 2 Clinical Study in Asia Pacific Region (GlobeNewswire) - "Medicus Pharma Ltd...is pleased to announce an agreement with Swanielle Inc. ('Swanielle') to explore expansion of Phase 2 clinical study for treatment of Basal Cell Carcinoma (BCC) in the Asia-pacific region...Under the agreement, Swanielle, a bespoke healthcare consulting firm, will help identify a pharmaceutical/biotech company or companies in Southeast Asia to partner with Medicus to expand the Phase 2 clinical study in the Asia Pacific region....The company is also pleased to announce that the phase 2 clinical study (SKNJCT-003) is currently underway in nine (9) clinical sites in United States and has already randomized more than 25% of the 60 patients expected to be enrolled in the study. Medicus is planning to initiate an interim data analysis in Q1 2025 and submit its findings to the United States Food and Drug Administration (FDA) as a part of a package seeking a Type C meeting with the FDA in Q2 2025."

Commercial • FDA event • P2 data • Trial status • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor