It's All Green For BLUE, HTBX Plunges On Failed Study, Watch Out For BPMC

(RTTNews) - Shares of Blueprint Medicines Corp. (BPMC) gained over 12% in the after-hours session on Wednesday, following encouraging early data from its ongoing phase I trial of BLU-285 in patients with advanced gastrointestinal stromal tumors, or GIST.

According to the trial results, tumor shrinkage was observed in 14 out of 15 PDGFRa-driven GIST patients and in four out of the six KIT-driven GIST patients treated at the higher dose levels, indicating the potential for increased clinical activity with increased dose.

BLU-285 carries the orphan drug tag for the treatment of GIST, and has also been granted Fast Track designation for the treatment of patients with unresectable or metastatic GIST.

BPMC closed Wednesday's trading at $29.37, down 3.20%. In after hours, the stock was up 12.33% to $32.99.

Shares of bluebird bio Inc. (BLUE) rose over 27% in extended trading on Wednesday, following encouraging interim data from its ongoing Phase 1 clinical study of bb2121 in patients with relapsed/refractory multiple myeloma.

According to the trial results, bb2121 demonstrated objective anti-tumor responses in all 6 of the heavily pre-treated patients with multiple myeloma. Two patients achieved stringent complete responses, with 6 and 4 months follow-up. No dose-limiting toxicities or Grade 3 or Grade 4 cytokine release syndrome or Grade 3 or Grade 4 neurotoxicity have been observed to date.

BLUE closed Wednesday's trading at $60.35, down 6.29%. In after-hours, the stock was up 27.59% to $77.00.

Shares of Heat Biologics Inc. (HTBX) tumbled nearly 57% in extended trading on Wednesday, following disappointing results from its phase II study of HS-410 in the treatment of non-muscle invasive bladder cancer.

The trial evaluated HS-410 in combination with standard of care, Bacillus Calmette-Guérin (BCG), and as a monotherapy against placebo. One-year disease free survival was set as the primary endpoint.

According to the trial results, although there were encouraging signs of anti-tumor activity with HS-410, there was no statistically significant difference in the primary endpoint between the vaccine and placebo arms of the trial.

The patients enrolled in the trial will now be monitored for an additional 12 months and based on those results, the company will decide whether or not to advance the trial into phase III testing.

Shares of Heat Biologics had gained over 134% in the last 7 trading days in the run-up to the announcement of the trial results. But with the bladder cancer vaccine candidate failing the mid-stage study, Heat Biologics' rally has come to an end.

HTBX closed Wednesday's trading at $2.87, down 3.69%. In after-hours, the stock plummeted 56.10% to $1.26.

Pfizer Inc.'s (PFE) pivotal study of PF-05280014, a proposed Herceptin biosimilar, met its primary endpoint, demonstrating equivalence in objective response rate in patients with HER2-positive metastatic breast cancer.

The study, dubbed REFLECTIONS B3271002, was a comparative safety and efficacy study of PF-05280014 in combination with chemotherapy drug paclitaxel versus Herceptin in combination with paclitaxel.

Developed by Roche's subsidiary Genentech, Herceptin is a targeted therapeutic antibody treatment for women who have tumors that overexpress the human epidermal growth factor receptor 2 (HER2) protein. The drug generated sales of $6.59 billion in 2015.

Early in November, Mylan N.V. (MYL) submitted a biologics license application for MYL-1401O, a proposed biosimilar to Herceptin. It is the first submission of a proposed biosimilar Herceptin in the U.S.

PFE closed Wednesday's trading at $32.14, up 0.69%.

Protalix BioTherapeutics Inc. (PLX) has enrolled the first patient in its phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. The trial is designed to enroll 20 patients with active mild to moderate ulcerative colitis. The company expects to report data from this clinical trial in the second half of 2017.

A phase II clinical trial of AIR DNase for the treatment of Cystic Fibrosis is underway, and data from this study are anticipated around year-end.

PLX closed Wednesday's trading at $0.55, down 1.79%.

Ultragenyx Pharmaceutical Inc. (RARE) on Wednesday reported positive 78-week data from its phase II study of UX007 in patients with long-chain fatty acid oxidation disorder.

The frequency and duration of major medical events, say, hypoglycemia, cardiomyopathy and rhabdomyolysis were reduced significantly during treatment with UX007, and patients demonstrated improved exercise tolerance and quality of life during the study, according to the company.

RARE closed Wednesday's trading at $78.29, down 7.01%.