Silence Therapeutics (NASDAQ:SLN) shares jumped 16.2% in pre-market trading on Monday as investors positioned ahead of a conference call covering topline results from the Phase 2 SANRECO trial of divesiran, the company’s lead siRNA candidate for polycythemia vera.
The clinical-stage biotechnology company announced over the weekend that it would present and discuss the results through a conference call and webcast scheduled for 8:00 a.m. EDT on Monday.
The readout represents one of the most important near-term milestones for Silence Therapeutics, with management previously identifying the Phase 2 results as a potentially defining event for the company and the future development of divesiran.
SANRECO trial puts divesiran efficacy in focus
The Phase 2 SANRECO study enrolled 48 patients with phlebotomy-dependent polycythemia vera in a randomised, double-blind, placebo-controlled trial.
Divesiran was evaluated using two dosing schedules, with treatment administered either every six weeks or every 12 weeks. The primary endpoint assessed the proportion of patients able to maintain haematocrit below 45% without requiring phlebotomy between weeks 18 and 36.
Investor expectations ahead of the results have been supported by encouraging findings from the earlier Phase 1 programme. Those data showed that the number of required phlebotomy procedures fell from 80 during the six months before treatment to just five during the active treatment period, with the therapeutic effect continuing beyond the final dose.
FDA designations strengthen divesiran profile
Divesiran has also received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration, adding to investor interest in the programme and potentially supporting its future regulatory development.
The combination of encouraging early-stage evidence and the regulatory designations has made the Phase 2 results particularly significant for assessing whether divesiran can maintain its earlier clinical profile in a larger and more rigorous study.
The broader equity market offered little explanation for the scale of Monday’s move. The Nasdaq was up around 0.4% and the S&P 500 gained just 0.1%, indicating that the 16.2% pre-market advance in Silence Therapeutics was predominantly linked to the upcoming clinical update rather than a wider biotechnology or market rally.
Clinical progress drives sharp recovery in SLN shares
Silence Therapeutics shares reached $13.88 in pre-market trading, representing a substantial recovery from a 52-week low of $4.19.
The sharp increase reflects the significance investors are attaching to the SANRECO results. With a long-awaited Phase 2 readout, encouraging Phase 1 evidence and FDA regulatory designations converging around divesiran, the latest clinical update could prove an important inflection point for Silence Therapeutics and the future value of its lead programme.
Silence Therapeutics stock price
