“We Think There is a Good Chance of Broad-label Approval”
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© Reuters. “We Think There is a Good Chance of Broad-label Approval” – Needham & Company Bullish on Zealand Pharma (ZEAL) Following Phase 3 DataNeedham & Company analyst Joseph Stringer reiterated a Buy rating and $32.00 price target on Zealand Pharma A/S (NASDAQ:), as the company reported positive Phase 3 results of dasiglugacon.
An analyst commented: “Today, ZEAL has announced positive results from a Ph3-trial evaluating Dasiglugacon In Congenital Hyperinsulinism. (CHI) is an uncommon metabolic disorder that affects infants and children. It met its primary goal of reducing I.V. glucose, a reduction of -55% compared to placebo. According to reports, Dasiglucagon was well tolerated by 11/12 patients who enrolled in the long-term extension. ZEAL will submit an NDA to YE22 by today, which will contain data from a Ph3 CHI study in children. The Ph3 pediatric trial failed to meet its primary endpoint but did show significant improvements on several key secondary endpoints. ZEAL is confident that FDA approval can be obtained with a broad label based upon the entire data. Broad-label approval is possible based upon high unmet demand and the cumulative positive Ph3 results generated by ZEAL. As the regulatory process progresses, more information will be available. Peak sales in CHI are modest at $108M U.S. by 2033. The majority of our valuation and our BUY rating are based upon lead asset glepaglutide for Short Bowel Syndrome. These results will be available in the 3Q22.
An analyst rating summary of Zealand Pharma A/S and a history of ratings can be found here click here. Find out more about Zealand Pharma A/S ratings. click here.
Today’s closing price for shares in Zealand Pharma A/S was $11.70.
By Vlad Schepkov
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