CEMP To Face FDA Panel, RIGL On A High, FDA Nod For Erelzi, KPTI Awaits STORM

(RTTNews) - ARIAD Pharmaceuticals Inc. (ARIA) has completed the rolling submission of its New Drug Application for Brigatinib to the FDA.

The company is seeking accelerated approval of Brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to Crizotinib, and has requested a priority review of the application.

ARIAD plans to submit a Marketing Authorization Application for Brigatinib to the European Medicines Agency in early 2017.

ARIA closed Tuesday's trading at $10.43, up 2.15%.

Cempra Inc.'s (CEMP) New Drug Applications for oral and IV Solithromycin for community-acquired bacterial pneumonia are set to be reviewed by an FDA panel on November 4, 2016.

Solithromycin was granted qualified infectious diseases product (QIDP) designation which entitled the new drug applications to eight month priority reviews, resulting in PDUFA dates of December 27, and December 28, 2016, respectively, for the oral and intravenous NDAs.

CEMP closed Tuesday's trading at $21.44, up 0.80%.

Shares of Kamada Ltd. (KMDA) rose more than 7% on Tuesday, following positive results from its phase II study of inhaled Alpha-1 Antitrypsin for the treatment of Alpha-1 Antitrypsin Deficiency.

The primary efficacy measures of the study included antigenic AAT levels and Anti-Neutrophil Elastase inhibitory (ANEC) levels in the lung as well as additional anti-proteolitic and anti-inflammatory biomarkers, all of which increased significantly.

KMDA closed Tuesday's trading at $4.89, up 7.95%.

Shares of Karyopharm Therapeutics Inc. (KPTI) soared over 36% on Tuesday after the company said it will provide an overview of top-line results from its Phase 2b study for oral Selinexor in multiple myeloma, dubbed STORM, on September 6, 2016.

The company intends to expand its STORM study to include approximately 120 additional patients with penta-refractory multiple myeloma.

KPTI closed Tuesday's trading at $9.73, up 36.66%.

The FDA has approved Erelzi, a biosimilar to Amgen Inc.'s (AMGN) Enbrel, for multiple inflammatory diseases.

Erelzi is manufactured by Sandoz, a Novartis (NVS) company. It is the second biosimilar from Sandoz to receive FDA approval in the U.S., and the first being Zarxio, a biosimilar to Amgen's Neupogen, which was approved last March.

Erelzi is approved for all indications as that of Amgen's Enbrel, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. Enbrel had worldwide sales of $5.36 billion in 2015 compared to $4.69 billion in 2014.

An application for Sandoz biosimilar Enbrel is under review by the European Medicines Agency.

NVS closed Tuesday's trading at $79.34, down 0.38%.

OncoMed Pharmaceuticals Inc. (OMED) has completed patient enrollment in its phase II clinical trial of Tarextumab for the treatment of small cell lung cancer, three months ahead of schedule. The trial, dubbed PINNACLE, has enrolled 145 patients.

Topline data from the PINNACLE study are expected to be reported at the end of 2016 or in early 2017.

OMED closed Tuesday's trading at $10.84, up 3.34%.

Portola Pharmaceuticals Inc. (PTLA) has announced encouraging interim results from ANNEXA-4, the ongoing phase 3b/4 study of AndexXa, a Factor Xa inhibitor antidote.

According to the study results, AndexXa rapidly and substantially reversed anti-Factor Xa activity, and sustained this reversal when followed by a 120-minute infusion. Additionally, 79% of the patients achieved excellent or good hemostasis (stoppage of bleeding) over a 12-hour period following infusion.

Based on the interim results, the company is optimistic that ANNEXA-4 is on track to achieve its co-primary efficacy endpoints upon study completion.

The Biologics License Application for AndexXa was turned down by the FDA earlier this month - with the regulatory agency seeking additional information primarily related to manufacturing.

PTLA closed Tuesday's trading at $20.59, up 1.03%.

Shares of Rigel Pharmaceuticals Inc. (RIGL) jumped as much as 53% on Tuesday to touch a new 52-week high, on positive phase III results of Fostamatinib in chronic/persistent immune thrombocytopenia.

In the first of two phase III studies of Fostamatinib, 18% of patients receiving the compound achieved a stable platelet response compared to none receiving a placebo control.

A stable platelet response was defined as achieving greater than 50,000 platelets per uL of blood on at least four of the last six scheduled visits between weeks 14 and 24 of treatment.

Immune thrombocytopenia, or ITP, is a condition where the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts.

The results from the second phase III study of Fostamatinib are expected in October/November 2016.

RIGL closed Tuesday's trading at $3.93, up 48.86%. In after hours, the stock was down 2.29% to $3.84.