SCLN Settles FCPA Charges, OGXI On Cost Discipline Mode, Shire To Face FDA

(RTTNews) - Amgen's (AMGN) approved leukemia drug, Blincyto, has met the primary endpoint of improved overall survival in a phase III study in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Blincyto was granted accelerated approval by the FDA to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia in December 2014.

Now that Blincyto has demonstrated overall survival benefit in the phase III study, the company will work with regulatory authorities towards a full approval for the drug.

AMGN closed Thursday's trading at $149.91, down 0.52%.

China-based Wuhan Dangdai Science & Technology Industries Group Inc. is all set to take a 19.4% stake in Cellular Biomedicine Group Inc. (CBMG) by investing $43.13 million in 2.27 million shares of the company, at $19 per share.

CBMG closed Thursday's trading at $18.50, up 7.50%.

Dipexium Pharmaceuticals Inc.'s (DPRX) two phase III trials of Locilex for the treatment of patients with mild infections of diabetic foot ulcers have reached the 75% enrollment milestone.

The trials, dubbed OneStep-1 and OneStep-2, are designed to enroll 180 patients per clinical trial, and are being conducted under a Special Protocol Assessment agreement with the FDA.

The trials are expected to be completed in the second half of 2016. The submission of Locilex NDA is planned for the first half of 2017 and a Marketing Authorization Application submission for the second half of 2017.

DPRX touched a 52-week low of $6.63 on Thursday, before closing the day's trading at $7.00, down 11.05%.

ImmunoGen Inc. (IMGN) has entered into a clinical research collaboration with Merck (MRK).

The collaboration aims to assess ImmunoGen's Mirvetuximab soravtansine, which is in early clinical testing, with Merck's Keytruda for the treatment of patients with FRa-positive ovarian cancer.

Merck's Keytruda is approved for the treatment of metastatic melanoma and metastatic non-small cell lung cancer.

ImmunoGen is conducting a phase 1b/2 clinical trial, dubbed FORWARD II, that evaluates Mirvetuximab soravtansine for FRa-positive ovarian cancer used in doublet combination with other anticancer agents. The assessment of Mirvetuximab soravtansine with Keytruda will be added to this trial, with Merck supplying the Keytruda.

ImmunoGen expects this cohort to open for patient enrollment in the second half of 2016.

IMGN closed Thursday's trading at $7.98, up 4.72%.

Merck's (MRK) single-dose EMEND for injection in combination with other antiemetic agents has received FDA expanded approval for the prevention of delayed nausea and vomiting in adults receiving moderately emetogenic chemotherapy.

EMEND for Injection was approved as part of a three-day antiemetic regimen for use in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic and highly emetogenic cancer chemotherapy in 2008.

MRK closed Thursday's trading at $48.59, down 2.92%.

OncoGenex Pharmaceuticals Inc. (OGXI) is planning to rein in expenses by reducing its workforce by approximately 27%, a move that is expected to extend cash runway into the third quarter of 2017.

The company had cash of roughly $55.2 million at December 31, 2015.

OncoGenex has a couple of catalysts up its sleeve that are worth watching.

The final analysis of a phase III trial evaluating a survival benefit for Custirsen in combination with cabazitaxel as second-line chemotherapy in patients with castrate-resistant prostate cancer, dubbed AFFINITY, is expected in the third quarter of 2016.

The final survival analysis of a phase III trial evaluating Custirsen in combination with Docetaxel as second-line chemotherapy in patients with non-small cell lung cancer, dubbed ENSPIRIT, is expected in the first half of 2017.

In the second half of 2016, the company expects to report results from a phase II trial of Apatorsen in combination with Docetaxel in patients with advanced or metastatic bladder cancer and results from a phase II trial of Apatorsen with carboplatin and pemetrexed chemotherapy in patients with previously untreated advanced non-squamous non-small cell lung cancer.

OGXI closed Thursday's trading at $0.78, down 0.61%.

SciClone Pharmaceuticals Inc. (SCLN) has reached a final settlement with the SEC and DOJ in the investigation into the company's possible violations of the Foreign Corrupt Practices Act, or FCPA.

Under the terms of the settlement agreement, SciClone has agreed to pay a total of $12.8 million, including disgorgement, pre-judgment interest and a penalty, as previously disclosed in its Form 10-Q filed with the SEC on August 10, 2015.

The company is also considering a range of strategic alternatives to enhance stockholder value.

SCLN closed Thursday's trading at $8.19, up 1.99%.

Shire plc's (SHPG) resubmitted New Drug Application for Lifitegrast for the treatment of signs and symptoms of dry eye disease in adults has been accepted for review by the FDA - with a decision slated for July 22, 2016.

Lifitegrast was issued a complete response letter by the FDA on October 16, 2015 requesting the company an additional clinical study and more information related to product quality.

SHPG closed Thursday's trading at $163.34, up 0.33%.