Trouble For CTIC, It's A Thumbs Up For BMY, CYCC On Notice Again, VRTX Snubbed

(RTTNews) - Aralez Pharmaceuticals Inc., formed by the combination of POZEN Inc. (POZN) and Tribute Pharmaceuticals Canada Inc. (TRX.V), is all set to trade on NASDAQ under the ticker symbol "ARLZ" on or about February 8, 2016, and on the Toronto Stock Exchange under the ticker symbol "ARZ" on or about February 10, 2016.

As of Friday's closing, Aralez had roughly 75 million outstanding shares on a fully diluted basis.

Bristol-Myers Squibb Co.'s (BMY) hep C drug virus Daklinza in combination with Gilead Sciences' (GILD) Sovaldi has received expanded FDA approval for the treatment of genotypes 1 and 3 chronic hepatitis C virus patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV.

Daklinza for use with Sovaldi was initially approved last July to treat hepatitis C virus (HCV) genotype 3 infections.

A 12-week regimen of Daklinza costs $63,000 and as you may know, a 12-week treatment course of Sovaldi is $84,000. So the combined 12 week regimen would cost roughly $147,000.

BMY closed Friday's trading at $59.63, down 0.12%.

The FDA has placed a partial hold on clinical studies of CTI BioPharma Corp.'s (CTIC) Pacritinib, its lead drug candidate for primary myelofibrosis, due to excess mortality and other adverse events in a pivotal trial.

The pivotal trial, dubbed PERSIST-1, formed the basis for the company's NDA for Pacritinib, which was submitted to the FDA last month.

Under the partial clinical hold, clinical investigators may not enroll new patients or start Pacritinib as initial or crossover treatment, and patients not deriving benefit after 30 weeks of pacritinib treatment should stop using Pacritinib, according to the company.

Another phase III trial, known as PERSIST-2, evaluating Pacritinib in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, recently completed enrollment. Now that the partial clinical hold has been imposed, patients currently receiving Pacritinib in the PERSIST-2 trial may continue to do so unless they are not deriving benefit after 30 weeks of Pacritinib treatment, and crossover of patients from the control arm to the Pacritinib arm will not be allowed.

CTIC closed Friday's trading at $1.12, down 1.75%.

Cyclacel Pharmaceuticals Inc.'s (CYCC) deadline to regain compliance with the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market expired on February 2, 2016.

The company would be subject to delisting unless it timely requests a hearing before a NASDAQ Listing Qualifications Panel and present its plan to regain compliance.

Cyclacel intends to timely request a hearing before the Panel, which has the discretion to grant the company up to an additional 180 calendar days, or until August 1, 2016, to regain compliance with the minimum bid price requirement.

CYCC closed Friday's trading at $0.36, down 3.90%.

Shares of Immunomedics Inc. (IMMU) rose more than 20% on Friday, following the receipt of FDA's Breakthrough Therapy Designation for the company's lead investigational product sacituzumab govitecan, or IMMU-132, for the treatment of patients with triple-negative breast cancer who have failed at least 2 prior therapies for metastatic disease.

In a phase II study in heavily pre-treated metastatic triple-negative breast cancer patients, IMMU-132 produced an interim objective response rate of 31% in 58 evaluable patients, with 78% of these responding patients being confirmed. The interim median progression free survival was 6.0 months, with 58% of these patients having experienced a PFS event.

IMMU-132 is also in phase 2 trials in patients with advanced, heavily-pretreated, non-small-cell lung cancer, small-cell lung cancer, and urothelial cancers, where encouraging results have been observed.

IMMU closed Friday's trading at $2.20, up 20.88%. In after hours, the stock was up 0.91% to $2.22.

Vertex Pharmaceuticals Inc.'s (VRTX) supplemental New Drug Application for the use of KALYDECO in people with cystic fibrosis ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene has been turned down by the FDA.

Vertex plans to meet with the FDA to determine an appropriate path forward.

KALYDECO is currently approved for the treatment of cystic fibrosis in patients age 2 years and older who have one of the following mutations in their CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H.

The net product revenue from KALYDECO was $632 million in 2015, up 36% over 2014. Looking ahead, the company anticipates KALYDECO net product revenue to range between $670 million and $690 million for full year 2016.

VRTX closed Friday's trading at $86.61, down 5.57%.