Medicus Pharma

MDCX

Market cap $11.5M

Medicus Pharma (NASDAQ:MDCX) said on Monday its chief executive and senior leadership team met with US lawmakers on Capitol Hill to seek support for regulatory and policy measures aimed at advancing its SkinJect therapy for patients with Gorlin syndrome, a rare inherited condition linked to recurrent skin cancers. The biotech company said the discussions focused on securing orphan drug designation for SkinJect for Gorlin syndrome, registrational investigational new drug approval for affected patients, and support for the rare disease pediatric FDA voucher program.

Builds Support for Accelerated Access to SkinJect® for Gorlin Syndrome patients with a Rare Autosomal Dominant Disease Builds Support for Accelerated Access to SkinJect® for Gorlin Syndrome patients with a Rare Autosomal Dominant Disease

Medicus Pharma (NASDAQ:MDCX) earlier this week outlined progress in advancing its Skinject program, highlighting a newly submitted orphan drug designation application with the US Food and Drug Administration targeting Gorlin syndrome, a rare genetic condition with no approved treatments. In an interview with Proactive, CEO Dr Raza Bokhari said the company is positioning 2026 as a “catalyst rich year,” driven by developments across its pipeline, led by Skinject.

Medicus Pharma (NASDAQ:MDCX) said on Friday it has submitted an application to the US Food and Drug Administration seeking orphan drug designation for its SkinJect therapy to treat basal cell carcinoma in patients with Gorlin Syndrome, a rare genetic condition marked by recurring skin cancers. The company said the filing expands its SkinJect program into an area of high unmet medical need, where treatment options are limited and often rely on repeated surgical procedures that can lead to cumulative physical and psychological burden.

Targets rare, high-burden genetic condition with no approved therapies; advances non-surgical treatment strategy for recurrent basal cell carcinoma Targets rare, high-burden genetic condition with no approved therapies; advances non-surgical treatment strategy for recurrent basal cell carcinoma

Medicus Pharma (NASDAQ:MDCX) announced plans to present new early-stage clinical data on its investigational drug candidate, Teverelix, at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026 in Las Vegas later this month. The company said the presentation will include results from two Phase 1 studies evaluating Teverelix, a long-acting gonadotropin-releasing hormone (GnRH) antagonist being developed for hormone-related conditions.

Updated Safety, Efficacy, and Clinical Data Supports Teverelix as Potentially the First Long-Acting Injectable GnRH Antagonist Across Multiple Indications in Women's Health Updated Safety, Efficacy, and Clinical Data Supports Teverelix as Potentially the First Long-Acting Injectable GnRH Antagonist Across Multiple Indications in Women's Health

The company positions Teverelix, a next-generation GnRH antagonist, as a first-in-market product targeting cardiovascular high-risk advanced prostate cancer patients and those with acute urinary retention relapse (AURr) episodes due to enlarged prostate. The company said it collectively represents an approximately $6 billion market opportunity.

Medicus Pharma (NASDAQ:MDCX) earlier this week outlined progress in the development of its investigational therapy Teverelix, confirming that it has submitted an optimized Phase 2 study design to the US Food and Drug Administration targeting acute urinary retention (AUR) relapse prevention. Speaking to Proactive, chief medical officer Dr Faisal Mehmud said the company is refining its clinical approach to improve both efficiency and speed of decision-making.

Medicus Pharma (NASDAQ:MDCX) announced on Monday that it has submitted an optimized Phase 2 clinical study protocol to the US Food and Drug Administration (FDA) for Teverelix, an investigational GnRH antagonist. The study is designed to evaluate the drug's effectiveness in preventing recurrent acute urinary retention (AURr) in men with benign prostatic hyperplasia (BPH) as part of an existing open Investigational New Drug application.