New York, Feb 11, 2026, 05:22 EST — Premarket
- PHIO climbed roughly 10% before the bell, building on Tuesday’s surge.
- The company pointed to an SMC safety wrap-up and refreshed its response numbers from the Phase 1b skin cancer trial.
- Up next: the company is aiming for an FDA submission in Q2 2026, along with key manufacturing milestones on the roadmap.
Shares of Phio Pharmaceuticals Corp jumped 9.8% to $1.23 ahead of the bell Wednesday, buoyed by new safety and response data for its main skin-cancer program. On Tuesday, the stock settled at $1.12, up 24.4%.
This is significant: Phio remains an early-stage play, so a straightforward safety readout can rapidly shift the outlook—and the price action—for these thinly traded microcaps. The company posted the update on Tuesday, after its initial release, according to a filing.
Phio’s Safety Monitoring Committee wrapped up its scheduled review of every treated patient in the Phase 1b PH-762 study. PH-762 relies on small interfering RNA (siRNA) to silence certain genes within cells.
The company said that among 22 patients given four intratumoral shots—meaning the drug went straight into their tumors—there were no dose-limiting toxicities and no serious adverse events. PH-762 moved through five dose-escalation groups, with drug levels increasing twentyfold from the first group to the last.
The company reported that six out of seven patients had a pathological response at the highest dose. That’s determined after doctors remove the treated tissue and check it under a microscope to see the amount of tumor left.
Phio said 13 out of 20 patients with cutaneous squamous cell carcinoma responded pathologically, with nine of those showing complete responses. The company also noted that none of the treated patients experienced disease progression.
Chief Executive Robert Bitterman said, “These results support continued evaluation of this highest dose concentration of PH-762 in the next clinical trial.” According to Investing.com, which cited the company statement, Phio aims to file a proposal with the U.S. Food and Drug Administration in the second quarter of 2026 to get input on the next steps. Investing.com India
PH-762 zeroes in on the PD-1 checkpoint pathway—a key lever for many cancer immunotherapies aiming to help immune cells go after tumors. Merck and Bristol Myers Squibb have already put systemic PD-1 drugs on the market, but Phio is choosing a different route, opting for a local, gene-silencing method.
Traders are watching to see if Tuesday’s surge in interest sticks around after the bell, or if it fizzles when initial buyers pull back. With microcap biotech names, tight floats and all-or-nothing news often send shares whipping around.
Still, this readout comes from a limited trial, and the company noted that full results are awaiting official review. Delays on timing, disappointing follow-up numbers, or a fresh cash raise could all weigh on the stock.
Eyes are on the FDA filing, slated for the second quarter, along with any news on chemistry and manufacturing progress. API material is on deck for March, and cGMP production is penciled in for the back half of 2026.
