
Capricor Therapeutics shares jumped as much as 94% intraday after the US Food and Drug Administration signalled willingness to review additional data for deramiocel, the company's experimental therapy for Duchenne muscular dystrophy.…
Capricor Therapeutics shares jumped as much as 94% intraday after the US Food and Drug Administration signalled willingness to review additional data for deramiocel, the company's experimental therapy for Duchenne muscular dystrophy. NDTV Profit reports the surge followed the FDA's indication to consider fresh evidence from the drug's clinical programme. Duchenne muscular dystrophy is a rare genetic disorder causing progressive muscle degeneration. Deramiocel, formerly known as CAP-1002, is a cell therapy being developed for the condition.
An FDA rethink on a single experimental drug sends a small biotech stock 94% higher in a day. This exaggerates the idea that regulatory nods are binary, all-or-nothing events. The real picture is more nuanced, the agency simply agreed to review additional data, not grant approval. Watch whether deramiocel's phase 3 results actually meet the FDA's efficacy standards. That number, not today's meme stock frenzy, will decide the drug's fate and the stock's real value.
Source: ndtvprofit.com
This story was synthesised by AI from the source linked above.