Why Did Moleculin Biotech Inc. (MBRX) Soar 11.82%?

Generated by AI AgentAinvest Pre-Market Radar
Tuesday, Jul 29, 2025 8:46 am ET1min read
Aime RobotAime Summary

- Moleculin Biotech (NASDAQ: MBRX) surged 11.82% pre-market on July 29, 2025, driven by clinical trial expansions and regulatory approvals.

- The Phase 3 MIRACLE trial expanded to Georgia (RAMPA approval) and secured EU EMA validation, with 7 enrolled patients and 16 new global sites planned by August 31.

- Market optimism stems from potential regulatory pathways and commercialization prospects for the company's therapies following these developments.

Moleculin Biotech Inc. (NASDAQ: MBRX) saw a significant rise of 11.82% in pre-market trading on July 29, 2025. This surge can be attributed to several key developments in the company's clinical trials and regulatory approvals.

Moleculin Biotech has expanded its Phase 3 MIRACLE clinical trial into the country of Georgia, securing approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA). This expansion follows recent EU approval from the European Medicines Agency (EMA), which has bolstered the trial's profile. The enrollment in Part A of the MIRACLE trial has reached seven subjects treated, with one additional subject in screening. Additionally, 16 new clinical sites in Europe and the US are expected to begin recruitment by the end of August, further strengthening the trial's momentum.

These developments have likely contributed to the positive market sentiment surrounding

, driving the stock's pre-market surge. Investors are closely watching the progress of the MIRACLE trial, as successful outcomes could pave the way for regulatory approvals and potential commercialization of the company's therapies.

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