Celsion Warms Up, AMGN Gets FDA Nod, SKBI Put On Notice, VVUS Sues Teva

(RTTNews) - Amgen (AMGN) has received FDA approval for Corlanor, an oral medication, indicated to reduce the risk of hospitalization for worsening heart failure in patients with chronic heart failure. This is the first new chronic heart failure medicine approved in the U.S. in nearly a decade.

AMGN closed Wednesday's trading at $165.47, up 1.78%. In after-hours, the stock was up 1.77% at $168.40.

Cellectar Biosciences Inc. (CLRB) has initiated patient dosing in a phase I proof-of-concept study of I-131-CLR1404 in patients with relapsed or refractory multiple myeloma. I-131-CLR1404 has already received orphan drug designation from the FDA for this indication.

CLRB closed Wednesday's trading 4.13% higher at $3.28.

Shares of Celsion Corp. (CLSN) rose more than 18% on Wednesday following positive interim data from the company's ongoing open-label phase 2 trial of ThermoDox in recurrent chest wall breast cancer.

The trial, dubbed DIGNITY, is designed to enroll up to 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 16 patients enrolled and treated, 12 were eligible for evaluation of efficacy. Based on data available to date, 67% of patients experienced a clinical benefit of their highly refractory disease with a local response rate of 58% observed in the 12 evaluable patients, notably 5 complete responses, 2 partial responses and 1 patient with stable disease.

The company remains on track to complete enrollment in the study in the third quarter of 2015.

CLSN closed Wednesday's trading at $3.15, up 18.55%.

The FDA's Cardiovascular and Renal Drugs Advisory Committee has voted 9 to 2 with one abstention to recommend approval of Medicines Co.'s (MDCO) investigational intravenous antiplatelet agent Cangrelor as an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural thrombotic events such as myocardial infarction, stent thrombosis and ischemia-driven revascularization.

The panel's recommendation is not binding on the FDA, and the final decision by the regulatory agency is scheduled for June 23, 2015.

MDCO was up 5.80% to $30.65 in after-hours on Wednesday.

Provectus Biopharmaceuticals Inc. (PVCT) has commenced enrollment in its phase 3 international FDA comparative clinical trial of PV-10 for melanoma.

The study, designed to enroll 225 patients, will compare PV-10 versus systemic chemotherapy with Dacarbazine or Temozolomide to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for Ipilimumab or another immune checkpoint inhibitor. The Primary Outcome Measure is progression-free survival to be assessed every 12 weeks up to 18 months.

PVCT closed Wednesday's trading at $0.84, up 1.19%.

Skystar Bio-Pharmaceutical Co. (SKBI) has been informed by the Nasdaq Stock Market that the company is not in compliance with Nasdaq Listing Rule 5250(c)(1) as it had not filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2014.

The company has time until June 15, 2015 to submit a plan of compliance with the foregoing listing deficiency. Skystar expects to file the 2014 Annual Report by the end of May 2015, well ahead of the plan of compliance deadline.

SKBI closed Wednesday's trading at $4, up 1.96%.

VIVUS Inc. (VVUS) has filed a patent suit against Teva, which is seeking to market and sell generic versions of the currently approved doses of diet drug Qsymia prior to expiration of its patents.

VIVUS' Qsymia was approved by the FDA as an addition to a reduced-calorie diet and exercise for chronic weight management in July 2012. The net product revenue from sales of Qsymia was $45.3 million in 2014 compared to $23.7 million in 2013.

The patent exclusivity for Qsymia in the U.S. is expected to extend to June 2029, according to VIVUS.

VVUS closed Wednesday's trading at $2.45, up 0.41%.