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FDA Says No To INCY, ZTS Snaps Up NVET, MDXG On The Move

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Denmark-based global pharmaceutical company ALK has received European approval for the expanded use of ACARIZAX in adolescent patients with house dust mite-induced allergic rhinitis. This house dust mite sublingual allergy immunotherapy tablet is already approved for use in adults.

Austria, Czech Republic, Denmark, Finland, Italy, the Netherlands, Norway, Poland, Sweden, Slovakia, and the key European markets of France and Germany are the countries where ACARIZAX is now approved for use in adolescents too.

In the U.S., the drug is approved for use in adults 18 through 65 years of age.

AmpliPhi Biosciences Corp. (APHB) is all set to implement a one-for-ten reverse split of its outstanding common stock, which will become effective at approximately 5:00 PM Eastern Time on April 24, 2017.

The Company's common stock will begin trading on the NYSE MKT on a split-adjusted basis at the open of trading on April 25, 2017.

AmpliPhi Bio believes that the implementation of the reverse stock split may improve the marketability and liquidity of its common stock and encourage interest and trading in its common stock.

APHB closed Thursday's trading at $0.35, down 1.96%.

CASI Pharmaceuticals Inc.'s (CASI) phase II trial of ENMD-2076 in previously treated locally advanced or metastatic triple-negative breast cancer has enrolled a total of 41 patients, which has been determined to be sufficient to assess the potential efficacy of the compound.

Another phase IIa study in China in patients with triple-negative breast cancer continues to accrue patients in the dose escalation phase, the primary objective of which is to determine the recommended phase II dose in Chinese study subjects. This dose escalation phase is expected to reach the full accrual target in Q3 2017.

CASI closed Thursday's trading at $1.22, up 5.17%.

Eli Lilly and Co. (LLY) and Incyte Corp. (INCY) have been left disappointed, following FDA's refusal to approve Baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis.

In its Complete Response Letter handed down to the companies, the FDA indicated that additional clinical data are needed to determine the most appropriate doses and to further characterize safety concerns across treatment arms.

The companies disagree with the agency's conclusions. The timing of resubmission of the New Drug Application for Baricitinib will be based on further discussions with the FDA.

Baricitinib was approved in the European Union, under trade name Olumiant, as recently as February of this year for the treatment of moderate-to-severe active rheumatoid arthritis.

INCY closed Thursday's trading at $140.84, up 1.86%.

MiMedx Group Inc. (MDXG) has reported revenue of $72.6 million for the first quarter of 2017, up 36% over the year-ago quarter. The consensus forecast among analysts polled by Thomson Reuters is $70.22 million.

The Company will be releasing its full financial results for the first quarter ended March 31, 2017, before the opening of the market on Friday, April 28, 2017.

MDXG closed Thursday's trading at $10.74, up 8.48%.

Shares of Nexvet Biopharma plc (NVET) soared more than 63% on Thursday as the Company is all set to be acquired by Zoetis Inc. (ZTS) for a purchase price of US$6.72 per share in cash.

The purchase price represents an aggregate equity valuation of approximately US$85 million and a 66% premium over Nexvet's closing price on April 12, 2017.

Zoetis, which will purchase Nexvet, through its wholly owned subsidiary Zoetis Bidco, believes that the acquisition will strengthen its pipeline in companion animal therapeutics for chronic pain.

The acquisition is currently expected to be completed during the second half of 2017.

NVET closed Thursday's trading at $6.62, up 63.46%. ZTS closed the day's trading at $53.10, down 0.23%.

Rexahn Pharmaceuticals Inc. (RNN) will implement a 1-for-10 reverse stock split of outstanding shares of the Company's common stock that will become effective at the opening of trading on May 5, 2017.

Peter Suzdak, Chief Executive Officer commented, "I want to thank our shareholders for their continued support of Rexahn. Our board has determined that this is an appropriate time to implement a reverse split and we believe that it will enhance the appeal of our common stock to the financial community, including institutional investors and the general investing public".

RNN closed Thursday's trading at $0.46, down 26.14%.

by RTT Staff Writer

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