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AEZS Gets Down To Serious Work, APVO Surges, FDA Tentative Nod For MRK

Pharma 071717

Today's Daily Dose brings you news about Aeterna's leadership change; Aptevo's agreement with Alligator Bioscience; Amgen's regulatory catalyst related to migraine med Aimovig; Diffusion Pharma's milestone achievement; Incyte's progress in GRAVITAS-301 study and FDA's tentative nod for Merck.

Read on...

Aeterna Zentaris Inc. (AEZS) (AEZS.TO) has formed a special committee of independent directors to consider and evaluate various strategic and financing alternatives to maximize shareholder value.

The Company's resubmitted New Drug Application seeking approval of Macrilen for the evaluation of growth hormone deficiency in adults is under FDA review - with a decision date set for December 30, 2017. Macrilen was issued a Complete Response Letter by the FDA in November 2014.

The Company also announced that Michael Ward has been appointed as the Chief Executive Officer, replacing David Dodd with immediate effect.

AEZS closed Thursday's trading at $2.80, up 19.66%. In after-hours, the stock was up another 17.14% to $3.28.

Aptevo Therapeutics Inc. (APVO) has entered into an agreement with Alligator Bioscience to co-develop a novel immunotherapy bispecific antibody candidate, ALG.APV-527.

Under the terms of the agreement, the two companies will jointly own and share equally in the development costs associated with advancing ALG.APV-527 through to the end of phase II clinical development.

Aptevo has two clinical drug candidates - MOR209/ES414 monotherapy in patients with metastatic castration-resistant prostate cancer, under phase I trial, and Otlertuzumab for chronic lymphocytic leukemia, under phase II study.

APVO closed Thursday's trading at $1.69, down 1.74%. In after-hours, the stock was up 17.75% to $1.99.

Amgen's (AMGN) Biologics License Application for Aimovig for the prevention of migraine in patients experiencing four or more migraine days per month has been accepted for review by the FDA.

The FDA is expected to announce its decision on Aimovig on May 17, 2018.

AMGN closed Thursday's trading at $179.32, up 0.08%.

Diffusion Pharmaceuticals Inc. (DFFN) has completed a major production run of its lead drug candidate trans sodium crocetinate, which will be used in its planned Phase 3 trial for the treatment of newly diagnosed inoperable glioblastoma (GBM) brain cancer.

Diffusion plans to initiate the phase III clinical trial of trans sodium crocetinate by the end of 2017.

DFFN closed Thursday's trading at $2.14, up 10.31%.

HealthSouth Corp. (HLS) has declared a quarterly cash dividend on its common stock of $0.25 per share, payable on Oct. 16, 2017, to holders of record on Oct. 2, 2017.

HLS closed Thursday's trading at $46.00, up 0.46%.

Incyte Corp. (INCY) announced that the first patient has been treated in pivotal phase III trial of Itacitinib as first-line treatment of patients with acute graft-versus-host disease.

The trial, dubbed GRAVITAS-301 will evaluate the efficacy and safety of Itacitinib in combination with corticosteroids compared to placebo plus corticosteroids in patients with acute GVHD.

The study is designed to enroll approximately 430 patients 18 years or older who have undergone one allogeneic transplant from any donor and any donor source for a hematologic malignancy or disorders.

INCY closed Thursday's trading at $133.79, up 2.56%. In after-hours, the stock was up 0.08% to $133.90.

The FDA has granted tentative approval to Merck's (MRK) LUSDUNA Nexvue for the treatment of people with type 1 and type 2 diabetes.

LUSDUNA Nexvue, formerly known as MK-129, is a follow-on biologic insulin glargine, and is being developed by Merck with funding from Samsung Bioepis. LUSDUNA Nexvue is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement.

Sanofi initiated a lawsuit in September 2016, which automatically invoked a stay on final FDA approval of LUSDUNA Nexvue for a period of up to 30 months, or in the event a court finds in favor of Merck, whichever comes sooner.

MRK closed Thursday's trading at $62.94, up 0.51%.

Pernix Therapeutics Holdings Inc. (PTX) has announced certain preliminary unaudited financial results for the second quarter ended June 30, 2017.

The Company expects Q2, 2017 net revenue to be between $33.0 and $35.0 million compared to net revenue of $36.7 million in the second quarter of 2016. Net loss for the second quarter of 2017 is expected to be between $20.5 million and $24.5 million, an improvement over second quarter net loss of $31.1 million.

The full second quarter 2017 financial and operating results are scheduled to be announced on July 27, 2017.

PTX closed Thursday's trading at $4.49, down 1.75%.

T2 Biosystems Inc. (TTOO) is scheduled to release its 2017 second quarter financial and operational results after the market closes on Thursday, August 3, 2017.

Very recently, the Company received a CE Mark for its T2Bacteria Panel, enabling commercialization in Europe. The T2Bacteria Panel provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture.

In the U.S., the T2Bacteria Panel is currently available for Research Use Only (RUO) and the Company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA.

TTOO closed Thursday's trading at $2.86, unchanged from the previous day's close. In after-hours, the stock was up 5.59% to $3.02.

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