02.04.2014 05:17:12

MNKD Breathes Easy, Arrowhead Well On Target, CPRX Awaits Next Catalyst

(RTTNews) - Actavis plc (ACT) has acquired Silom Medical Company, a privately held generic pharmaceutical company focused on developing and marketing therapies in Thailand, for about $100 million in cash.

The deal catapults Actavis into a top-five position in the Thai generic pharmaceutical market, with leading positions in the ophthalmic and respiratory therapeutic categories and a strong cardiovascular franchise. The transaction is expected to be immediately accretive to non-GAAP earnings in 2014.

ACT closed Tuesday's trading 1.64% higher at $209.22. In after-hours, the stock gained another 1.11% to $211.55.

Arrowhead Research Corp. (ARWR) has fully enrolled and dosed the first cohort of 8 patients in a phase IIa clinical trial of ARC-520 for the treatment of chronic hepatitis B virus (HBV) infection. The trial remains on schedule to meet the previously stated goal of completing dosing in the second quarter and releasing top line results in the third quarter.

ARWR closed Tuesday's trading 11.33% higher at $18.28.

Catalyst Pharmaceutical Partners Inc. (CPRX) has completed patient enrollment in its pivotal phase III trial evaluating the safety and efficacy of its investigational therapy Firdapse for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome.

The company expects to report top-line data from the double-blind portion of the trial in the third quarter. If the trial is successful, the NDA will be filed with the FDA on a rolling basis in early 2015.

CPRX closed Tuesday's trading 2.65% higher at $2.32.

MannKind Corp.'s (MNKD) inhalable insulin Afrezza has been recommended for approval by an FDA panel. The panel members voted 13 to 1 to recommend that Afrezza be granted approval to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend its approval to improve glycemic control in adults with type 2 diabetes.

The FDA's final decision is slated for April 15, 2014.

If approved, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the United States. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

MNKD surged 110.45% to $8.46 in extended trading on Tuesday.

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