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What Does Jazz Pharma's Latest FDA Approval Mean?

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The US FDA granted marketing approval for Defitelio® [defibrotide sodium] for the treatment of adult and pediatric patients with hepatic VOD, also known as sinusoidal obstruction syndrome [SOS], with renal or pulmonary dysfunction following HSCT. Jazz Pharmaceuticals plc - Ordinary Shares (NASDAQ: JAZZ) will ship to distribution within a week.

Northland Capital Markets’ David Buck maintained an Outperform rating for the company, with a price target of $175, saying that Defitelio had received its first FDA approval for severe liver disease and its launch was “imminent.”

Analyst David Buck expects Defitelio to be a key growth driver and to reach 8 percent of the company’s 2016 revenue estimate of $122M, versus 5.3 percent in 2015. He wrote, “With double-digit volume growth, 2016 EU sales should be low-$80M so guidance of $100-$125M (Northland- $122M) appears an achievable target.”

Severe VOD has a fatality rate of about 84 percent at Day +100, after stem-cell transplant. “Based on Defitelio's FDA-approved label, expected survival rates at Day +100 for non-Defitelio-treated patients are just 21% to 31%,” the analyst mentioned. He added that for the US launch, significant efforts would probably be made to educate physicians on diagnosis and importance of early intervention.

Latest Ratings for JAZZ

DateFirmActionFromTo
May 2021HC Wainwright & Co.MaintainsBuy
Apr 2021StifelMaintainsBuy
Apr 2021Morgan StanleyMaintainsEqual-Weight

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