Zealand Pharma — Maj 2022
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og os:)
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"Based on the trial’s results, Zealand Pharma will engage with the U.S. Food and Drug Administration to discuss the submission of an NDA for marketing approval. Dasiglucagon has the potential to become the first medicine developed specifically for this debilitating, ultra-rare disease in over three decades."
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lyder som gammel Panduro bog: "patienterne" -;)
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Zealand Pharma Announces Positive Results from Phase 3 Trial of Dasiglucagon in Pediatric Patients with Congenital Hyperinsulinism (CHI)
https://www.proinvestor.com/boards/103556 -
Zealand Pharma i kursspurt efter positive testresultater
"På en ellers trist børsdag indleder Zealand Pharma en imponerende spurt efter offentliggørelse af positive resultater fra fase 3 test"
https://borsen.dk/nyheder/investor/zealand-pharma-i-kursspurt-efter-positive-testresultater
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Needham & Company analyst Joseph Stringer reiterated a Buy rating and $32.00 price target on Zealand Pharma A/S (NASDAQ:ZEAL), 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). Dasigluc
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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
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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." -
Det får du nok svar på i Q&A med CEO Adam Steensberg som starter kl. 15.
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