Healthcare Business

4 Major FDA Decisions Expected by June

AstraZeneca PLC (NYSE: AZN) has a potential best-in-class treatment for hyperkalaemia, a condition associated with increased mortality in patients with chronic kidney disease, diabetes mellitus and chronic heart failure.

Currently the treatment, ZS-9, or saxagliptin/dapagliflozin, is under regulatory review by the FDA with a PDUFA goal date in late May. AstraZeneca also has a submission for European Marketing Application Authorisation that is also progressing as planned.

AstraZeneca shares closed Friday at $27.96, with a consensus price target of $35.41 and a 52-week range of $27.68 to $35.34.

Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) is gearing up for the American Society of Clinical Oncology (ASCO) annual meeting, where the company will present data on its Phase 2 ALTA trial of brigatinib. The annual meeting is set to start on June 3.

In addition to an anticipated data presentation at ASCO, Ariad believes that it is on track to file for approval of brigatinib in the United States in the third quarter of this year. Brigatinib has received breakthrough-therapy designation from the FDA.

Be advised that Ariad had once been considered a potential buyout target, but that has been about a year ago. Its shares were also closer to $10.00 back at that time.

Shares of Ariad closed Friday at $6.98, with a consensus price target of $8.25 and a 52-week range of $4.37 to $10.07.

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced this past week that the European Medicines Agency (EMA) granted the request for accelerated assessment for the Marketing Authorization Application for cerliponase alfa. However, the company expects to submit cerliponase alfa for a Biologics License Application to the FDA by mid-year.

Analysts recently weighed in on BioMarin after its earnings:

  • BMO Capital Markets raised its price target to $108 from $107.
  • Cowen has an Outperform rating with a $150 price target.
  • JPMorgan has an Overweight rating and raised its price target to $120 from $117.
  • Oppenheimer maintained a Perform rating with a $99 price target.

Shares of BioMarin closed Friday at $80.80, with a consensus analyst target of $114.79 and a 52-week range of $62.12 to $151.75.