AGRX At FDA Altar Again, AZN Falls As MYSTIC Fails, VBIV Delivers A Good Shot

Today’s Daily Dose brings you news about Agile’s regulatory catalyst for this year; AstraZeneca’s disappointing results from MYSTIC trial; Tetraphase’s stock offering and VBI Vaccines’ positive interim data from its preventative cytomegalovirus vaccine study.

Read on…

Agile Therapeutics Inc.’s (AGRX) New Drug Application for Twirla, an investigational low-dose combined hormonal contraceptive patch, has been accepted for review by the FDA – with a decision date set for December 26, 2017.

Twirla was turned down by the FDA in 2013. Will second time prove the charm for Twirla?

AGRX closed Thursday’s trading at $4.60, down 3.56%.

Amgen’s (AMGN) supplemental Biologics License Application for Repatha to include data on reducing risk of cardiovascular events has been accepted for priority review by the FDA – with a decision date set for December 2, 2017.

Repatha is indicated for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

A second application seeking to expand the lipid-lowering indication of Repatha to include additional patient populations studied has also been accepted by the FDA.

The drug received its first approval in August 2015. The global sales of Repatha totaled $141 million in 2016 – its first full year in market.

AMGN closed Thursday’s trading at $172.15, down 2.13%.

Shares of AstraZeneca PLC (AZN) took a beating on Thursday, following disappointing results from its checkpoint inhibitor combo trial, dubbed MYSTIC.

The MYSTIC trial, which is a phase III study, evaluated Imfinzi monotherapy or Imfinzi in combination with investigational Tremelimumab versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer.

Imfinzi and Tremelimumab both belong to a class of drugs known as checkpoint-inhibitors. Imfinzi was granted accelerated approval by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma as recently as May of this year. Tremelimumab is an investigational drug, and it was licensed from Pfizer in 2011.

According to the study results, Imfinzi plus Tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy. Also, as a secondary endpoint, although not formally tested, Imfinzi monotherapy…

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