BPC December 28 update

Fortress (FBIO) shares spike 50% on previously released data; Cempra (CEMP) yet to release PDUFA outcome

Price and Volume Movers

EDIT: Please note Cempra Inc (NASDAQ:CEMP) was issued a CRL pre-market on December 29, 2016 - more details in Thursday's newsletter.

Today's newsletter was delayed in anticipation that Cempra Inc (NASDAQ:CEMP) would release news regarding its two New Drug Applications for Solithera. Investors were keenly awaiting the outcome of its two assigned PDUFA dates of December 27 and 28, 2016. However, as of 9:20pm EST no news had been released by the company.

Fortress Biotech, Inc. (NASDAQ: FBIO) shares spiked to close up 50% to $3.43 in the after-hours session following its press release that a case study from a Phase 1 trial of MB-101 for the treatment of glioblastoma (GBM) will be published in the December 29 edition of the New England Journal of Medicine. The publication will note that one patient had a clinical response continued for 7.5 months. In a press release on November 21, the company noted the same data.

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) shares closed up 9% to $113.59 on 3x average volume on speculation that Novartis (NYSE: NVS) is interested in a takeover of the company. No official news was released by the company.

Galena Biopharma, Inc. (NASDAQ:GALE) shares jumped today to close up 21% to $2.38 on 48x average volume following confirmation that it will initiate a Phase 3 trial of GALE-401 (Anagrelide Controlled Release) in patients with essential thrombocythemia (ET) under a 505(b)(2) regulatory pathway. Such a pathway allows for some of the safety and efficacy information of the drug candidate to come from trials not conducted by the company, allowing for potentially a less expensive and much faster route to approval, compared to a traditional 505(b)(1) development path.

Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH), which announced after hours on Tuesday that it did not meet the primary endpoint in its Phase 3 SOLUTION trial of Sollpura, saw its shares close down 63% to $0.74 on 10x average volume.

EnteroMedics Inc. (NASDAQ: ETRM) enforced a 1-for-70 reverse stock split today. Shares of the company closed down 15% to $2.46.

Other major price movers (+10%):


Protalix Biotherapeutics Inc (NYSEMKT:PLX): $0.385; +9%; 3x average volume.

Recro Pharma Inc (NASDAQ:REPH): $8.16; +10%.


Moleculin Biotech Inc (NASDAQ:MBRX): $2.37; -14%; 2x average volume.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $5.28; -14%; 3x average volume.

AEterna Zentaris Inc. (NASDAQ:AEZS): $3.55; -12%; 2x average volume.

Dicerna Pharmaceuticals Inc (NASDAQ:DRNA): $3.03; -11%; 2x average volume.

No pipeline updates today.