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Actionable news in RPRX: Repros Therapeutics Inc.,

​Puma PBYI receives FDA Approval; Repros RPRX clinical hold remains in place; NVAX data July 24

Price and Volume Movers

Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the FDA has approved NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer. Approval was based on the placebo controlled ExteNET trial. After two years, invasive disease-free survival (iDFS) was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008). Shares are currently trading up 9% to $93.65 in the after-hours session.

Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced that it met all primary and secondary endpoints in its Phase 3 trial of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Shares are currently trading up 4.2% in the after-hours session to $26.00 after closing up 3.7% during normal trading hours.

Repros Therapeutics Inc., (Nasdaq:RPRX) noted that the FDA has kept in place the clinical hold for Proellex. The FDA also indicated that the company will be required to compile a large pre-approval safety data base to support future development. Shares slumped to close down 33% to $0.385.

Novavax, Inc. (Nasdaq:NVAX) announced it will host a conference on Monday, July 24, 2017, at 4:30 p.m. ET where it will announce top-line data from its Phase 2 safety and...


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