Morning Market Surge: Biotech Bulls Lead Charge with FDA Wins and Breakthrough Trial Data

August 26, 2025

DENVER, Colo., Aug 26, 2025 (247marketnews.com)- Biotechs are lighting up the tape.

Allarity Therapeutics (NASDAQ:ALLR) is charging ahead after announcing FDA Fast Track designation for its dual PARP/WNT inhibitor stenoparib in advanced ovarian cancer. The company recently began enrollment in a Phase 2 study for platinum-resistant or -ineligible patients. With prior data showing some patients staying on treatment for over 22 months, investors are watching closely as the drug targets one of the most difficult oncology indications. The DRP companion diagnostic is expected to further sharpen patient targeting, potentially increasing treatment efficacy.

Marker Therapeutics (NASDAQ:MRKR) delivered breakthrough data from its Phase 1 APOLLO study of MT-601, showing a 66% response rate and 50% complete response among Non-Hodgkin Lymphoma (NHL) patients, many of whom failed CAR-T and bispecifics. Safety data was also favorable, with no ICANS or dose-limiting toxicities observed. The study moves next into dose expansion in DLBCL, while Hodgkin Lymphoma patients also showed 78% response rates.

Serina Therapeutics (NYSE:SER) gained ground following FDA feedback that supports a registrational trial pathway for SER-252 in advanced Parkinson’s disease via the 505(b)(2) NDA track. The POZ-enabled apomorphine aims to offer more consistent motor relief. IND filing is expected in Q4 2025, with U.S. enrollment to begin in Q1 2026, and initial dosing to start in Australia later this year.

LIXTE Biotechnology (NASDAQ:LIXT) is emerging as a compelling small-cap cancer play. Its lead compound LB-100, a PP2A inhibitor, is progressing into trials for ovarian clear-cell carcinoma (OCCC) in partnership with GlaxoSmithKline (NYSE:GSK). With long-life patents and synergy with both chemo and immunotherapy, LIXTE is positioning itself as a precision tool for tackling treatment-resistant tumors.

Momentum Movers:

  • Chemomab Therapeutics (NASDAQ:CMMB) is catching early upside action on speculative buying interest.
  • Americas Silver Corporation (NYSE:USAS) is also on the move, possibly buoyed by rising metals prices and improved mine output expectations.

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