Medicus Pharma’s SKNJCT-003: A Breakthrough in Non-Invasive Cancer Treatment?

Investors, buckle up—Medicus Pharma (MEDC) has just fired a rocket into the oncology space with its Phase 2 update for SKNJCT-003, a potential game-changer in treating nodular basal cell carcinoma (BCC). This isn’t just another skin cancer drug; it’s a non-invasive, dissolvable microneedle patch that could upend the $2 billion BCC treatment market. Let’s dive into the data and dissect why this could be a “Cramer Classic” opportunity—or a risky gamble.

The Breakthrough in Non-Invasive Cancer Treatment

Current BCC treatments like Mohs surgery or radiation are invasive, costly, and often leave scars. Medicus’ D-MNA (delivered via its microneedle patch) aims to replace these with a simple, painless outpatient procedure. The Phase 2 trial’s interim data, released in March 2025, shows over 60% of patients achieved complete clinical clearance of nodular BCC, a subtype that accounts for 70% of the 5 million annual U.S. cases. Even better: no serious adverse events or toxicities were reported, aligning with Phase 1’s stellar safety profile.

This isn’t just about comfort—it’s about scale. With 200–400 patients needed for a pivotal trial, Medicus is on track to fast-track approval if the FDA greenlights its plans post-Type C meeting (scheduled for Q2 2025). The company also plans to expand trials in the UAE and Europe, targeting regions where surgical access is limited.

The Regulatory Play: Fast-Track or Bust

Medicus’ big move hinges on its upcoming Type C FDA meeting, where it will pitch converting Phase 2 into a pivotal trial. If the FDA blesses this path, the timeline to market could shrink dramatically. The company is also eyeing a 505(b)(2) NDA, leveraging existing safety data for doxorubicin (the active ingredient), which is already approved for other cancers.

But here’s the kicker: shows volatility, with shares rising 30% on Phase 1 data but falling 15% on macroeconomic fears. Investors need to watch Q2’s FDA meeting outcome closely—positive news could send shares soaring.

Market Opportunity: Tackling a $2 Billion Market

The BCC market is ripe for disruption. With 5 million cases yearly in the U.S. alone, and nodular BCC dominating 70% of cases, D-MNA’s potential is massive. Current treatments cost insurers $5,000–$20,000 per patient; Medicus’ patch could undercut that by 50% while improving adherence. Analysts estimate peak sales of $500 million annually if approved.

But competition looms. Merck’s checkpoint inhibitors and other targeted therapies are in trials, but none offer Medicus’ non-invasive convenience. For now, D-MNA’s unique delivery method gives it a leg up.

Risks and Challenges

This isn’t all roses. The interim data, while promising, is preliminary—final Phase 2 results (due late 2025) must confirm efficacy. There’s also the risk of FDA pushback, especially on the 505(b)(2) pathway, which could delay approval. Plus, manufacturing the microneedle patch at scale could introduce cost or quality hurdles.

Don’t forget: even with fast-track status, pivotal trials could uncover hidden safety issues. And while the UAE trial expands the data set, regulatory hurdles abroad could complicate global launches.

Conclusion: A High-Reward, High-Risk Bet

Medicus Pharma’s SKNJCT-003 has the potential to redefine BCC treatment, offering a safer, cheaper alternative to surgery. With 60% interim efficacy, a clean safety profile, and a clear path to fast-track approval, this stock could be a multi-bagger if Phase 2 success translates to pivotal trial wins.

But investors must stay vigilant. The FDA’s Q2 Type C meeting will be a make-or-break moment—positive news could propel MEDC to $50+ from its current $25 range, while a rejection could tank it. Pair this with the $500 million sales potential and you’ve got a classic “Cramer Call”: high risk, high reward.

For aggressive investors willing to bet on innovation, Medicus is worth watching—just keep an eye on that Type C meeting. As I’d say on Mad Money: “All in? Maybe not. But this is one to own a piece of!”

Data as of April 2025. Always consult a financial advisor before making investment decisions.