Sun Pharma Among Nifty’s Biggest Losers After USFDA Put Partial Clinical Trial on Deuruxolitinib Drug

Sun Pharma's investigational derma drug trial has been put on hold by the USFDA.

Shares of Sun Pharmaceutical Industries fell more than 1% on May 2 after the US Food and Drug Administration (USFDA) suspended part of its clinical application for an experimental dermatology drug due to a possible thrombotic event.

“Following a recent submission to the USFDA, we held a conference call with the agency to discuss pulmonary embolism (a serious adverse event) at the 12 mg BID dose in a long-term open-label extension (OLE) study,” the company said in a regulatory filing. “Therefore, the agency has placed the drug on partial clinical hold due to the possibility of a thrombotic event,” it added.

Shares of the company were trading down 1% at Rs 976.65 on the BSE at 12:12 pm.

The company said no thromboembolic events were observed during the phase 2 or 3 trials while adding that it remained confident in deuruxolitinib’s potential to treat patients with alopecia areata. USFDA is expected to address those concerns in a formal letter within the next 30 days.

The company’s website reads that Concert Pharmaceuticals is developing deuruxolitinib, an oral inhibitor of the Janus kinases JAK1 and JAK2, as a potential treatment for alopecia areata.

The company completed its acquisition of Concert Pharmaceuticals on March 6, adding deuruxolitinib to its global dermatology portfolio. The acquisition cost was $576 million ($8 per share).

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