BMRN Pulls The Plug On DMD Drug, LXRX To Face FDA In Nov, TEVA Snubbed

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) has withdrawn its Marketing Authorization Application for Kyndrisa from the European Medicines Agency as the CHMP intended to issue a negative opinion on the Duchenne Muscular Dystrophy drug candidate.

Kyndrisa was snubbed by the FDA too early this year, and in its Complete Response Letter, issued on January 14, 2016, the regulatory agency had concluded that the standard of substantial evidence of effectiveness was not met by Kyndrisa.

BioMarin intends to discontinue clinical and regulatory development of Kyndrisa as well as the three other first-generation follow-on products, BMN 044, BMN 045 and BMN 053, currently in phase II studies for distinct forms of Duchenne muscular dystrophy.

BMRN closed Tuesday's trading at $89.65, up 0.63%. In after hours, the stock was down 2.93% to $87.02.

Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. (LLY) announced that the FDA has approved Jentadueto XR, the extended release formulation of combo drug Jentadueto, for the treatment of type 2 diabetes in adults. JENTADUETO XR combines 2.5 mg or 5 mg of linagliptin with 1000 mg of metformin.

Jentadueto XR is the seventh new treatment from the Boehringer Ingelheim-Lilly Diabetes alliance to be approved by the FDA in the last five years.

The original formulation of Jentadueto was approved by the FDA in January 2012.

LLY closed Tuesday's trading at $75.03, up 0.05%.

Innocoll Holdings plc (INNL) has a couple of catalysts to watch out for in the coming months.

The company, which reported positive results last week from two U.S. phase III trials of XARACOLL in patients who had undergone abdominal hernia repair surgery, plans to submit NDA this year.

Another product candidate of the company is COGENZIA, and it is undergoing two identical phase III trials, one in the U.S. (COACT-1) and the second in the U.S. and Europe (COACT-2) for diabetic foot infections. Top line data from these studies are anticipated to be available in the third quarter or early fourth quarter of 2016, followed closely by an NDA submission.

INNL closed Tuesday's trading at $9.60, down 10.95%. In after hours, the stock was up 2.60% to $9.85.

Lexicon Pharmaceuticals Inc.'s (LXRX) New Drug Application for Telotristat etiprate, an oral drug for the treatment of carcinoid syndrome has been granted priority review by the FDA - with a decision scheduled for November 30, 2016.

LXRX closed Tuesday's trading at $14.21, up 3.87%.

Radius Health Inc.'s (RDUS) New Drug Application for Abaloparatide-SC, an investigational treatment for postmenopausal women with osteoporosis, has been accepted for filing by the FDA. The FDA decision can be expected in March of 2017.

A Centralised Marketing Authorisation Application for Abaloparatide-SC is currently undergoing active regulatory assessment by the Committee for Medicinal Products for Human Use of the EMA. The CHMP's Opinion regarding the MAA is expected in late 2016 or in 2017.

RDUS closed Tuesday's trading at $36.26, up 3.45%.

Teva Pharmaceutical Industries Ltd. (TEVA) has been issued a Complete Response Letter for SD-809 tablets for the treatment of chorea associated Huntington disease.

The New Drug Application for SD-809 was accepted for review by the FDA last August. SD-809 came under the aegis of Teva with the acquisition of Auspex Pharmaceuticals in May 2015.

In its Complete response Letter, the FDA has asked Teva to examine blood levels of certain metabolites. No new clinical trials have been requested.

Teva intends to submit its response to the CRL in Q3 2016.

TEVA closed Tuesday's trading at $51.87, up 0.41%.

Vertex Pharmaceuticals Inc.'s (VRTX) supplemental New Drug Application for the use of ORKAMBI in people with cystic fibrosis ages 6 to 11 who have two copies of the F508del mutation has been accepted for priority review by the FDA.

Accordingly, the regulatory agency's decision date is set for September 30, 2016.

ORKAMBI was approved by the FDA last July for the treatment of cystic fibrosis in patients age 12 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR (cystic fibrosis transmembrane conductance regulator) gene. The drug generated revenue of $223 million in the first quarter of 2016.

Looking ahead, the company anticipates total 2016 product revenues for ORKAMBI of $1.0 to $1.1 billion.

VRTX closed Tuesday's trading at $93.15, up 3.06%.