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Shares of Sun Pharma hit 5-month high as the USFDA has accepted the company's new drug application. The stock climbed as much as 6.4 per cent to Rs 576, highest since July 27
Following a strong open at Rs 545 against the previous close of Rs 540.45, the scrip touched an intraday high of Rs 590 and a low of Rs 543.15. In terms of equity volume, 15.77 lakh shares exchanged hands in the evening trade. The company shares ended higher by 6.89 per cent at Rs 577.70. The company’s market valuation advanced by Rs 8,934.64 crore to Rs 1,38,604.64 crore.
More than 14 million shares changed hands, over three times the 30-day average of around 4 million shares. The stock was the top percentage gainer on both the NSE index and the BSE index, and recorded its biggest intraday percentage gain since March 14. The stock had shed 14.1 per cent this year as of Tuesday's close, bigger than Nifty Pharma index's 8.3 per cent fall.
According to a BSE filing, the US Food and Drug Administration has accepted a new drug application, filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution) 0.09 per cent, a novel nanomicellar formulation of cyclosporine A 0.09 per cent in a clear, preservative-free aqueous solution. OTX-101 is now under review for approval by the US FDA, marking an important developmental milestone for Sun Pharma’s dry eye candidate.
Post the US FDA approval, OTX-101 will be commercialised in the US by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary, based in Princeton, New Jersey. Sun Ophthalmics, founded in 2015, currently markets BromSite® (bromfenac ophthalmic solution) 0.075 per cent to eye care practitioners across US, the filing added.
Sun Pharma MD Dilip Shanghvi said: “OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing under-served and dynamic dry eye market. When approved, it will be a milestone for millions of dry eye patients across the globe that are yet to find relief for their condition.”
(With inputs from Reuters)
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