Glenmark Pharma up 1% on US FDA nod to drug's first phase

Shares of Glenmark Pharmaceuticals rose nearly 1 percent intraday on Wednesday as investors cheered the US FDA’s clearance of drug in the first phase. The clearance gives it the go ahead to begin second phase of the study.The US Food and Drug Administration (FDA) cleared the company’s investigational new drug (IND) application to begin a Phase 2 study of GSP 304 (tiotropium bromide) for administration by nebulization for the long term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), according to the company’s filings to the exchanges.Post the clearance, the pharmaceutical major plans to initiate clinical development with a Phase 2 study of GSP 304 in subjects with mild to moderate COPD as determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. “Moving GSP 304 into Phase 2 is a great example of that focus and, if approved, will be the first nebulized form of tiotropium bromide. This milestone further affirms our goal of providing new treatment options that meet significant unmet medical needs,” Fred Grossman D.O., President and Chief Medical Officer of Glenmark Pharmaceuticals said in a statement to the exchanges. The stock has shown weak movements, posting a fall of nearly 4 percent in the past 15 days. At 09:22 hrs, the stock was quoting at Rs 906.00, up Rs 4.40, or 0.49 percent on the BSE. It touched an intraday high of Rs 909.95 and an intraday low of Rs 902.30.