DATA GRAPHICS | Data Byte
EMA agency suggests pulling Translarna, BlenRep from market
CHMP’s September opinions also include approval of seven new medicines and label extensions for 11
September 16, 2023 12:46 AM UTC
The recommendations by EMA’s CHMP to approve seven new therapies, including a biosimilar, and label extensions for 11 others were overshadowed by the committee’s decision to recommend against renewing the conditional approval of PTC Therapeutic’s DMD therapy Translarna.
Shares of PTC Therapeutics Inc. (NASDAQ:PTCT) fell $11.13 (30%) to $26.26 Friday, knocking $838.6 million off the company’s market cap, after CHMP concluded the condition approval of Translarna ataluren should neither be converted to full approval nor renewed as conditional, following “full re-evaluation of the benefits and risks of the medicine,” including new data from study 041 that “failed to confirm Translarna's effectiveness.” ...