FDA Snubs MYL, Roche Wins FDA Panel Vote Hands Down, TNXP Falls After-hours

(RTTNews) - Amgen's (AMGN) supplemental Biologics License Application for BLINCYTO seeking to expand its use for the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia has been accepted for review by the FDA - with a decision date set for August 14, 2017.

The application also seeks to convert accelerated approval of BLINCYTO to full approval in the indication of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL, that was granted in December 2014.

Last September, the FDA approved the expanded indication of BLINCYTO to treat pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia.

The drug brought home sales of $115 million in 2016, up 49% from the prior year.

AMGN closed Wednesday's trading at $163.06, down 1.00%.

Anthera Pharmaceuticals Inc. (ANTH) has reported positive results from its extension period of phase III study of Sollpura, dubbed SOLUTION, in cystic fibrosis patients with exocrine pancreatic insufficiency.

In the extension phase of the SOLITION study, Sollpura demonstrated comparable maintenance in key measurements of height, weight, and BMI. The drug candidate was well tolerated throughout the 20-Week Extension Period, says the company.

The SOLUTION trial results were initially reported last December. The study had narrowly missed the primary endpoint for change in the Coefficient of Fat Absorption (CFA) non-inferiority margin.

The company plans to initiate a new study, named RESULT, to demonstrate the efficacy of Sollpura by addressing the scientific findings from the SOLUTION study in the first half of 2017 - with top line data anticipated at the end of 2017 or early 2018.

ANTH closed Wednesday's trading at $0.43, down 0.90%.

Mylan N.V.'s (MYL) abbreviated new drug application seeking approval of generic version of GlaxoSmithKline's respiratory drug Advair Diskus has been turned down by the FDA.

Advair Diskus is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The last patent on Advair Diskus expired in August 2016. Advair Diskus generated about $4.7 billion in sales last year.

MYL closed Wednesday's trading at $40.35, down 3.28%.

Roche's (RHHBY.OB) subcutaneous Rituximab co-formulated with Halozyme Therapeutics Inc.'s (HALO) Enhanze Technology has been unanimously recommended for approval by an FDA panel in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.

The FDA's decision date is set for June 26, 2017.

Rituximab co-formulated with Halozyme's Enhanze Technology was approved in Europe in 2014 and is currently marketed as the subcutaneous (SC) formulation of MabThera in approximately 50 countries worldwide.

MabThera/Rituxan (rituximab) is one of Roche's top-selling drug, and it generated revenues of 7.30 billion Swiss francs in 2016, up 3% from 2015.

HALO closed Wednesday's trading at $14.29, up 0.56%.

Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) were down over 15% in extended trading on Wednesday, following the proposed public offering of common stock.

Last September, the company announced that its phase III trial of TNX-102 SL in patients with fibromyalgia failed to meet the primary endpoint. A phase III study of TNX-102 SL for the treatment of posttraumatic stress disorder, dubbed HONOR, has just begun.

The net proceeds from the offering will be used to support the continued development of TNX-102 SL for the treatment of posttraumatic stress disorder, to further develop other pipeline programs, for working capital and other general corporate purposes.

TNXP closed Wednesday's trading at $5.57, up 34.54%. In after-hours, the stock was down 15.62% to $4.70.