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AKER Withdraws 510(K), TTOO Turns Head, CPRX, LOXO To Face FDA In Nov.


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(RTTNews.com) - Today's Daily Dose brings you news about Akers' withdrawal of its 510(k) application for PIFA Chlamydia; upcoming regulatory catalyst for Astellas, Catalyst Pharma, Exelixis, Loxo Oncology; T2 Biosystems touching a 52-week high and Wellcare Health's blockbuster acquisition.

Read on…

Shares of Akers Biosciences Inc. ( AKER ) plunged more than 33% on Tuesday, following the Company's decision to withdraw its initial 510(k) application for PIFA Chlamydia, a rapid diagnostic test device for chlamydia infection, in order to re-evaluate its options with regards to this product development opportunity.

The decision to withdraw the application was based on the recommendation of the FDA.

AKER closed Tuesday's trading at $0.39, down 33.58%.

Astellas Pharma Inc.'s (ALPMY.OB) New Drug Application for Gilteritinib has been accepted for Priority Review - with a decision expected on November 29, 2018.

The Company is seeking approval of Gilteritinib for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

ALPMY.OB closed Tuesday's trading at $15.34, up 0.92%.

Catalyst Pharmaceuticals Inc.'s (CPRX) New Drug Application for Firdapse for the treatment of Lambert-Eaton myasthenic syndrome has been accepted for a Priority Review by the FDA - with a decision expected by November 28, 2018.

Lambert-Eaton Myasthenic Syndrome, or LEMS in short, is an autoimmune disorder, in which the part of the neuromuscular junction is damaged due to attack from antibodies. This condition is characterized by muscle weakness, a tingling sensation in the affected areas, fatigue, and dry mouth. (Source: NIH).

The Company in-licensed the North American Rights to Firdapse from BioMarin Pharmaceutical Inc. (BMRN) in October 2012.

Firdapse received marketing approval in the E.U. for the treatment of Lambert-Eaton myasthenic syndrome in December 2009, and is the first and only approved drug in Europe for this condition.

The drug fetched annual revenue of $18.8 million in 2017 and quarterly revenue of $4.9 million in the first quarter of 2018 for BioMarin.

CPRX closed Tuesday's trading at $3.54, up 8.59%.

The European Commission has authorized Clovis Oncology Inc.'s (CLVS) Rubraca as monotherapy treatment for women with recurrent ovarian cancer.

Rubraca, which is the first PARP inhibitor licensed for ovarian treatment indication in the EU, is a new option for women with recurrent BRCA mutant ovarian cancer with platinum-sensitive, relapsed or progressive disease, who are unable to tolerate further platinum-based chemotherapy.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The drug is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA- approved companion diagnostic for Rubraca.

The net product revenue for Rubraca was $55.5 million for the year ended December 31, 2017.

CLVS closed Tuesday's trading at $48.71, up 0.16%.

Exelixis Inc.'s (EXEL) supplemental New Drug Application for CABOMETYX tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma has been accepted for FDA review - with a decision date set for January 14, 2019.

CABOMETYX tablets are already approved in the United States for the treatment of patients with advanced renal cell carcinoma. It is also approved in the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy, and in the European Union for previously untreated intermediate- or poor-risk advanced RCC.

The drug generated $324.0 million in net product revenue in full year 2017, and $128.9 million in net product revenues in the first quarter of 2018.

EXEL closed Tuesday's trading at $20.31, down 2.54%. In after-hours, the stock was up 1.33% to $20.58.

Loxo Oncology Inc.'s (LOXO) New Drug Application for Larotrectinib has been accepted for priority review by the FDA, with a decision date set for November 26, 2018.

The Company is seeking approval of Larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

Loxo has a global collaboration with Bayer to co-promote Larotrectinib and another investigational drug LOXO-195 in the U.S. with a 50/50 profit share. However, in rest of the world, Bayer will lead the regulatory and commercial activities.

Bayer plans to submit a Marketing Authorization Application for Larotrectinib in the European Union in 2018.

LOXO closed Tuesday's trading at $168.39, up 1.62%.

Shares of T2 Biosystems Inc. (TTOO) touched a new 52-week high, following FDA clearance for the Company's T2Bacteria Panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections. This is the first FDA-cleared test to identify sepsis-causing bacteria direct from whole blood.

The T2Bacteria Panel cuts time to diagnosis from days to hours, allowing greater certainty and new protocols for deadly infections in hospital setting, according to the Company. All other FDA-cleared diagnostic tests that detect bacteria in blood require a positive blood culture sample prior to bacterial species specific identification, which typically delays results by one to five days.

The Company also announced that it is commencing an underwritten registered public offering of 5.65 million shares of its common stock.

TTOO was trading around $2.96 when we alerted our premium subscribers to this stock on August 8, 2017.

TTOO touched a new 52-week high of $9.05 in intraday trading on Tuesday before closing the day's trading at $8.06, down 9.13%. In after-hours, the stock was down another 5.83% to $7.59.

WellCare Health Plans Inc. (WCG) is all set to acquire Meridian Health Plan of Michigan Inc., Meridian Health Plan of Illinois, Inc., and MeridianRx, a pharmacy benefit manager, for $2.5 billion in cash.

Meridian expects to generate more than $4.3 billion in total revenue in 2018.

The acquisition is expected to produce $0.40 to $0.50 of accretion to WellCare's adjusted earnings per share in 2019, $0.70 to $0.80 of accretion in 2020, and over $1.00 of accretion in 2021.

The transaction is slated to close by the end of 2018, subject to customary closing conditions, including regulatory approvals.

WCG closed Tuesday's trading at $221.15, up 0.49%.


Read the original article on RTTNews (http://www.rttnews.com/2899660/aker-withdraws-510-k-ttoo-turns-head-cprx-loxo-to-face-fda-in-nov.aspx)


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This article appears in: Stocks , Politics
Referenced Symbols: AKER ,


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