Ciprocopan Wins First-Ever Approval in China, Beating Soliris in Head-to-Head PNH Trial
NVCT has more than doubled off its 52-week low of $5.55.
Summary
Nuvectis's partner Haisco secured Chinese marketing approval for ciprocopan (NXP100) in treatment-naive PNH, making it the first approved once-daily oral Factor B inhibitor. The pivotal Phase 3 data showed clear superiority over standard-of-care Soliris: 59.5% of patients reached a hemoglobin target of 12 g/dL versus 8.3%, with a mean hemoglobin increase of ~5.0 g/dL versus 2.2 g/dL, and 94.6% avoided transfusions versus 69.4%. This is a major de-risking event for the ex-China rights Nuvectis licensed just last month. The strong efficacy and convenience profile positions ciprocopan to capture significant share in the multi-billion-dollar PNH market if approved outside China. The news follows the June licensing deal and the recent $100 million offering that funded the company's development plans. With clinical validation in hand, attention turns to Nuvectis's regulatory strategy in the U.S. and Europe.
At the time of this announcement, NVCT was trading at $19.29 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $608.1M. The 52-week trading range was $5.55 to $29.28. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.