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Fabry Disease Drug OK'd In Japan, FDA Delays Decision On Azedra, HTGM On Watch


Today's Daily Dose brings you news about approval of Amicus Fabry disease drug in Japan; commercial launch of La Jolla's GIAPREZA in the U.S.; Emergent Bio's stock repurchase program; better-than expected quarterly financial results of HTG Molecular Diagnostics; FDA postponing the decision date on Progenics' AZEDRA, and reverse stock split of Ritter.

Read on…

Amicus Therapeutics' (FOLD) Galafold has been approved in Japan for the treatment of patients aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.

Galafold is the first and only oral precision medicine for Fabry disease in Japan. The Company will now proceed with pricing and reimbursement processes, and anticipates launching Galafold in Japan in the coming months once those processes have concluded.

The drug was approved in the European Union in May 2016. It is under FDA review in the U.S., with a decision anticipated by August 13, 2018.

Full-year 2017 Galafold revenue totaled approximately $36 million. The Company expects global revenue for Galafold to range between $75 million and $85 million in 2018.

FOLD closed Thursday's trading at $14.13, down 4.98%.

Emergent BioSolutions Inc. (EBS) is all set to implement a stock repurchase program for up to $50 million of the company's common stock from time to time on the open market or in privately negotiated transactions. The term of the board authorization of the repurchase program is until December 31, 2019.

The Company ended the year 2017 with cash of approximately $178 million. There were approximately 49.8 million shares of common stock outstanding as of March 19, 2018.

EBS closed Thursday's trading at $53.30, down 2.00%.

HTG Molecular Diagnostics Inc. (HTGM) has reported better-than-expected financial results for the fourth quarter and year ended December 31, 2017.

Net loss for the fourth quarter of 2017 narrowed to $1.9 million or $0.15 per share on revenue of $7.9 million. Analysts polled by Thomson Reuters expected a loss of $0.31 per share and revenue of $6.98 million.

In the fourth quarter of 2016, the Company had reported a net loss of $5.7 million or $0.76 per share and revenue of $1.5 million.

HTGM closed Thursday's trading at $5.39, down 1.28%.

La Jolla Pharmaceutical Co. (LJPC) has launched GIAPREZA (angiotensin II), injection for intravenous infusion, in the U.S.

GIAPREZA was approved by the FDA in December 2017 to increase blood pressure in adults with septic or other distributive shock. The Wholesale Acquisition Cost of GIAPREZA is $1,500 per vial.

LJPC closed Thursday's trading at $28.65, up 0.46%.

It is advantage Pacific Biosciences of California Inc. (PACB) now.

Judge Leonard P. Stark of the U.S. District Court for the District of Delaware has turned down Oxford Nanopore Technologies Inc.'s request to dismiss Pacific Biosciences' complaint for infringement related to patent No. 9,738,929, which relates to nucleic acid sequence analysis.

Alleging that Oxford Nanopore's 2D and 1D2 sequencing technique infringed on the '929 patent, Pacific Biosciences sued Oxford Nanopore last September. A hearing on the matter was held on February 27, 2018 and the ruling by Judge Stark was issued on March 22, 2018.

Last November, Richard G. Andrews of the U.S. District Court for the District of Delaware had denied Oxford Nanopore's motion to dismiss Pacific Biosciences' another complaint alleging infringement of Patent No. 9,546,400, relating to a method for sequencing a nucleic acid template.

A trial for these matters, along with Pacific Biosciences' complaint for infringement of U.S. Patent No. 9,678,056 (which Oxford Nanopore did not seek to dismiss), is scheduled to occur in early 2020.

PACB closed Thursday's trading at $2.43, down 1.22%.

Progenics Pharmaceuticals Inc. (PGNX) will have to wait a little longer to know the FDA decision on its drug candidate AZEDRA, proposed for the treatment of patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors.

The FDA decision, which was originally scheduled for April 30, 2018, has been extended by three months to July 30, 2018. The extension is the result of the submission of additional Chemistry, Manufacturing, and Controls (CMC) information by Progenics, which required additional time for FDA review.

PGNX closed Thursday's trading at $8.36, unchanged from the previous day's close.

Ritter Pharmaceuticals Inc. (RTTR) is all set to implement a 1-for-10 reverse split of its Common Stock, par value $0.001 per share, which will come into effect on March 23, 2018.

As a result of the reverse stock split, the number of issued and outstanding shares of Common Stock will be reduced from approximately 49.4 million to approximately 4.94 million.

RTTR closed Thursday's trading at $0.29, up 0.69%.

vTv Therapeutics Inc. (VTVT) has completed phase 1b part of its phase 1b/2 study evaluating TTP399 in adult patients with type 1 diabetes, or T1D.

The phase 1b/2 study, dubbed Simplici-T1, being conducted with support from JDRF, is designed to evaluate TTP399 as an add-on to insulin therapy for people living with T1D.

The phase 2 portion of the Simplici-T1 study will be initiated in April of this year.

VTVT closed Thursday's trading at $4.81, up 1.26%.

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