Sun Pharma Advanced Research Company (SPARC) skids 2.21% to Rs 170 after the company said that the US drug regulator has ruled against its appeal related to Taclantis, its under-development product for the treatment of breast cancer.
The Office of New Drugs (OND) of the U.S. Food and Drug Administration (USFDA) has denied the company’s appeal of the Complete Response Letter in relation to the New Drug Application (NDA) for Taclantis.
Taclantis is a novel formulation of paclitaxel developed with SPARC’s proprietary Nanotecton technology. Paclitaxel is one of the most widely used cytotoxic agent and is approved for the treatment of breast cancer, ovarian cancer, non small cell lung cancer and pancreatic cancer.
In its Appeal Denied letter, the OND requested the conductofa new Phase 3 study in metastatic breast cancer patients to support any potential re-submission of the Taclantis NDA. The company will review FDA’s response and decide on appropriate next steps soon.
On a standalone basis, SPARC reported a net loss of Rs 67.62 crore in Q3 December 2020 as compared to a net loss of Rs 55.51 crore in Q3 December 2019. Net sales jumped 11.3% to Rs 21.81 crore in Q3 December 2020 over Q3 December 2019.
SPARC is engaged in research and experimental development on natural sciences and engineering. The company operates through pharmaceuticals research and development segment.
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