8 Major FDA Decisions and Trial Results to Watch for in September

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Array BioPharma

At the end of June 2016, Array BioPharma Inc. (NASDAQ: ARRY) submitted a New Drug Application (NDA) for binimetinib to the FDA. It is planning for an Oncologic Drugs Advisory Committee meeting as part of the regulatory review process. Array is also currently preparing for an Application Orientation Meeting with the FDA in September 2016, which it expects will include a discussion of the NDA package including clinical risk/benefit.

Shares of Array were last trading at $3.52. The consensus price target is $8.00. The 52-week range is $2.38 to $6.01.

Mast Therapeutics

September is when Mast Therapeutics Inc. (NYSEMKT: MSTX) is planning to announce the top-line data from its EPIC study. There are 388 subjects randomized at study sites around the globe. Also EPIC was the largest placebo-controlled study in sickle-cell disease ever concluded. To support its NDA for vepoloxamer, Mast is continuing to enroll patients in EPIC-E, the repeat exposure study for EPIC patients, and in a clinical pharmacokinetics study of vepoloxamer in individuals with varying degrees of renal insufficiency.

Shares last closed at $0.52, in a 52-week range of $0.21 to $0.60. The consensus price target is $2.75.

Novavax

Expectations are that Novavax Inc. (NASDAQ: NVAX) will announce top-line data from its Phase 3 Resolve trial in the third quarter of 2016. This is a pivotal Phase 3 trial of the RSV F vaccine in older adults (60 years of age and older). The Resolve trial is a randomized, observer-blinded, placebo-controlled trial in 11,850 older adults at 60 sites in the United States. The primary efficacy objective is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. Enrollment was completed back in the fourth quarter of 2015.

Shares of Novavax were most recently trading at $6.82, with a consensus price target of $14.49 and a 52-week range of $4.08 to $11.15.

Threshold Pharmaceuticals

Threshold Pharmaceuticals Inc. (NASDAQ: THLD) is planning to report preliminary results from its Phase 2 proof of concept studies with tarloxotinib, a hypoxia-activated epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), which is designed to selectively release an irreversible EGFR-TKI in hypoxic tumors.

Currently, Investigations are continuing in two proof-of-concept, Phase 2 clinical trials in patients with advanced non-small cell lung cancer and patients with metastatic squamous cell carcinoma of the head and neck and skin; the designs of both trials require a minimum response rate for study continuation.

The shares closed on Thursday at $1.05. The consensus price target is $2.00, and the 52-week range is $0.21 to $5.26.

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Vertex Pharmaceuticals

A Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) Phase 3 clinical study has been completed. It was conducted to support the potential approval of Orkambi for children with cystic fibrosis within the past year. The study enrolled 58 children ages 6 to 11 with two copies of the F508del mutation, and the primary endpoint of the study was safety. In May the FDA granted Vertex’s request for a PDUFA Priority Review of this sNDA by the end of September.

Shares of Vertex were last seen at $94.75, within a 52-week range of $75.90 to $136.97. The consensus price target is $110.32.