$MDCX

Medicus Pharma (NASDAQ:MDCX) said the FDA cleared its Phase 2b registration-enabling trial for SkinJect in Gorlin syndrome. The crossover study will enroll up to 50 patients, with recruitment expected before year-end and first enrollment possibly in early next year. SkinJect is a microneedle array for basal cell carcinoma; success could support an NDA for the Gorlin indication.

Friday’s US market ended higher, with the Nasdaq up about 1% to 25,373, the S&P 500 up 0.7% to 7,489, and the Dow up 0.5% to 52,485, led by a tech rebound. The article cites company updates including Roblox, Strategy (MSTR), Rivian, Reddit, and Coinbase after their Q2 results, plus clinical and rare-earth project news for several smaller firms.

Medicus Pharma (NASDAQ:MDCX) said the UAE Department of Health Abu Dhabi granted IND authorization for its Phase 2a PRECISION-E2 trial of Teverelix in moderate-to-severe symptomatic endometriosis. The randomized, placebo-controlled study will enroll about 84 women in the UAE with four dosing arms (60 mg SC, 90 mg SC, 90 mg IM, placebo). Primary endpoint is maintaining serum estradiol in the 20-50 pg/mL Barbieri window for at least 14 days.

Medicus Pharma Ltd. (NASDAQ:MDCX) on Friday secured regulatory clearance from the United Arab Emirates Department of Health – Abu Dhabi for its PRECISION-E2 Phase 2a clinical study. The trial evaluates Teverelix in women with moderate-to-severe symptomatic endometriosis, an estrogen-dependent disease affecting roughly 10% of reproductive-age women globally.

U.S. stocks ended mixed Monday. The Dow rose 263 points (0.5%) to 52,210, the S&P 500 edged up to 7,413, and the Nasdaq fell 44 points (0.2%) to 24,932 as semiconductor shares slid. Nvidia dropped more than 4%. Oil fell over 9% on hopes for diplomacy. ASML fell after reports of China mass-producing DUV lithography machines. Earnings included Applied Digital after the close; Boeing, Coca-Cola, PayPal and UPS before the open.

Medicus Pharma (NASDAQ:MDCX) said the FDA issued a “Study May Proceed” letter allowing it to start its NDA-enabling Phase 2b registrational SkinJect study in Gorlin syndrome. The open-label trial will enroll up to 50 patients using SkinJect 200 mcg. The FDA requested protocol changes, including biopsy confirmation and longer follow-up.

Medicus Pharma (NASDAQ:MDCX) said its redesigned Teverelix clinical study received Institutional Review Board approval and was accepted by the FDA with operational observations. CEO Raza Bokhari said the program was acquired via Medicus’ purchase of UK firm Antev. The protocol cut planned patients from 390 to 126 and may reduce cost from over $30M to under $10M.

Wall Street ended lower Thursday as a semiconductor selloff hit the Nasdaq. The Nasdaq fell 387 points, or 1.5%, to 25,882, with the Philadelphia Semiconductor Index dropping as investors questioned AI infrastructure returns. Nvidia, Micron and Broadcom declined. Netflix earnings are due after the close, with Jefferies and Bank of America keeping Buy ratings and $110 and $125 targets.

Medicus Pharma (NASDAQ:MDCX) said it received US FDA feedback and central IRB approval for an optimized Phase 2 study of Teverelix (ANT-2111-02) in men after a first acute urinary retention episode. The trial will enroll about 126 patients in the US and Europe, down from ~390, and evaluate Teverelix DP on prostate volume and urinary function. FDA comments were operational, and the IRB approval runs for one year.

Medicus Pharma (MDCX) said it received written FDA feedback and central IRB approval for an optimized Phase 2 redesign of Teverelix (ANT-2111-02) in men with first-episode acute urinary retention. The randomized, double-blind, placebo-controlled multicenter trial will assess Teverelix DP on prostate volume and urinary function, with planned enrollment cut to about 126 from ~390. MDCX shares closed at $0.34.