DENVER, Colo., Aug 21, 2025 (247marketnews.com)- From new trials to regulatory approvals, here’s what’s driving early sentiment.
Protagenic Therapeutics (NASDAQ:PTIX) announced that all subjects in the multiple-dose portion of its Phase 1 trial for PT00114 have now received their first injection, with dosing on track to complete by the end of August. Topline safety data is expected in September, paving the way for Phase 2 trials in Q1 2026 targeting stress-related and mood disorders like PTSD and depression.
“Initiating the multiple-dose trial… marks a pivotal step,” said CMO Robert Stein, M.D., Ph.D.
PT00114, based on TCAP, a brain hormone tied to emotional regulation, offers a first-in-class mechanism distinct from traditional symptom-blunting antidepressants.
LIXTE (NASDAQ:LIXT) continues its technical breakout powered by its lead compound, LB-100, which induces “lethal activation” in colon cancer cells. The compound, currently in trials with Roche’s (OTCQX:RHHBY) atezolizumab and GSK’s (NYSE:GSK) dostarlimab, could enhance immunotherapy efficacy in colorectal and ovarian cancers. Momentum is building, both on the charts and in the lab.
Aptorum (NASDAQ:APM) and DiamiR Biosciences announced New York State approval of DiamiR’s APOE Genotyping test, designed to assess genetic risk for late-onset Alzheimer’s disease. The test will be available through DiamiR’s CLIA-certified and CAP-accredited lab.
“This milestone expands access to an important tool…” Alidad Mireskandari, Ph.D., CEO of DiamiR
The news adds momentum to their all-stock merger, expected to close in Q4 2025, with DiamiR becoming a wholly owned subsidiary of Aptorum.
Evoke Pharma (NASDAQ:EVOK) announced that a new U.S. patent for GIMOTI (metoclopramide nasal spray) has been added to the FDA’s Orange Book, extending exclusivity until 2038, eight years beyond the previous patent.
“The listed patent shows our commitment to developing innovative products…” Matt D’Onofrio, CEO
The move strengthens Evoke’s IP portfolio and long-term commercial strategy for treating diabetic gastroparesis.
Tharimmune (NASDAQ:HAR) extended gains after announcing, yesterday, positive pharmacokinetic simulation results for its lead compound TH104, a buccal nalmefene film aimed at proactively protecting against exposure to synthetic opioids like fentanyl. Unlike short-acting naloxone, TH104 may offer 24-hour protection, making it a compelling candidate for military and first responder use.
Aethlon Medical (NASDAQ:AEMD) is gaining early traction after filing to sell common stock and warrants, while also setting sights on completing an oncology trial in Australia by early 2026. The capital raise supports pipeline progress amid rising small-cap biotech interest.
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