“We Think There is a Good Chance of Broad-label Approval”

Needham & 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.

The analyst comments: “Today, ZEAL announced positive results from a Ph3 trial evaluating dasiglugacon in Congenital Hyperinsulinism (CHI), an ultra-rare metabolic disorder affecting infants and children. The trial met the primary endpoint of reduction in I.V. glucose (-55% reduction vs placebo). Dasiglucagon was reportedly well-tolerated, with 11/12 patients entering the long-term extension. With today’s positive result, ZEAL plans to submit an NDA by YE22, which will include data from a previously completed Ph3 CHI trial in pediatric patients. Recall, the Ph3 pediatric trial did not meet the primary endpoint, but showed significant reductions on multiple key secondary endpoints. ZEAL believes it can gain FDA approval with a broad label based on the totality of the data. We think there is a good chance of broad-label approval based on high unmet need and the cumulative positive Ph3 data generated by ZEAL to date, and we await further visibility as the regulatory process unfolds. We have relatively modest peak sales estimates in CHI (~$108M U.S. in 2033). Our BUY rating and the majority of our valuation are based on lead asset glepaglutide in Short Bowel Syndrome, which is set to readout Ph3 results in 3Q22.”

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Shares of Zealand Pharma A/S closed at $11.70 yesterday.

By Vlad Schepkov