SPARC gains after receiving USFDA's CRL for Xelpros

Sun Pharma Advanced Research Company rose 3.87% to Rs 319.30 at 9:37 IST on BSE after the company said it has received a complete response letter from the US drug regulator for the new drug application for Xelpros Latanoprost BAK-free eyedrops.

The announcement was made before trading hours today, 22 December 2016.

Meanwhile, the BSE Sensex was down 101.44 points, or 0.39%, to 26,140.94.

On the BSE, so far 1.09 lakh shares were traded in the counter, compared with average daily volumes of 69,889 shares in the past one quarter. The stock had hit a high of Rs 328.15 and a low of Rs 313 so far during the day.

 

The stock had underperformed the market over the past 30 days till 21 December 2016, falling 0.87% compared with the 1.08% rise in the Sensex. The scrip had also underperformed the market in past one quarter, falling 10.69% as against Sensex's 8.80% decline.

The mid-cap company has equity capital of Rs 24.69 crore. Face value per share is Rs 10.

Sun Pharma Advanced Research Company (SPARK) said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (USFDA) for the new drug application (NDA) for Xelpros, Latanoprost BAK-free eyedrops.

The CRL references the recent inspection of the Sun Pharmaceutical Industries' Halol manufacturing site by USFDA and indicates that satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Xelpros. There are no requirements of any additional data from USFDA in the CRL.

SPARC had out-licensed Xelpros to a subsidiary of Sun Pharmaceutical Industries in June 2015.

SPARC reported net profit of Rs 14.74 crore in Q2 September 2016 as against net loss of Rs 17.74 crore in Q2 September 2015. Net sales rose 120.06% to Rs 94.89 crore in Q2 September 2016 over Q2 September 2015.

SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.

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