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DVAX Back In News, Spectral Shock For Investors, MACK Giving Pink Slips


Shares of Dynavax Technologies Corp. (DVAX) rose as much as 26% on Monday on news that the company has received anticipated requests for information from the FDA review team in connection with the pending Biologics License Application for HEPLISAV-B Hepatitis B Vaccine.

The company noted that the review team's questions are in line with its expectations.

Last month, the FDA notified the company of the cancellation of the Advisory Committee meeting to review HEPLISAV-B Biologics License Application, which was scheduled for November 16, 2016. The FDA had also informed then that the remaining questions will be addressed between Dynavax and the review team via the normal process.

The FDA's final decision on HEPLISAV-B is slated for December 15, 2016.

DVAX closed Monday's trading at $12.48, up 18.97%.

Dermira Inc.'s (DERM) phase III trial of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis has met the trial goals.

In the trial, dubbed CIMPASI-2, CIMZIA demonstrated statistically significant improvements in two co-primary endpoints say, the percentage of patients who achieved a 75% or greater disease improvement from baseline and the percentage of patients achieving at least a two-point improvement on a five-point Physician's Global Assessment (PGA) scale to a final score representing clear or almost clear skin, at week 16.

Two more phase III trials of CIMZIA are underway, and results from these trials are expected by the end of the first quarter of 2017.

CIMZIA is currently approved and marketed by Belgium-based biopharmaceutical firm UCB Pharma S.A. for the treatment of numerous inflammatory diseases in multiple countries, including the United States. The drug is not approved for psoriasis. In July 2014, UCB granted Dermira an exclusive license to develop Cimzia in psoriasis in the USA, Canada and the European Union.

DERM closed Monday's trading 3.58% higher at $35.03.

Jazz Pharmaceuticals plc (JAZZ) has initiated a rolling submission of the New Drug Application for Vyxeos, an investigational agent for the treatment of acute myeloid leukemia. The company expects to complete the submission of the NDA by early 2017, and will request a priority review.

Vyxeos came under Jazz' fold when it acquired Celator Pharmaceuticals in July 2016.

Vyxeos, if approved, would be the first new treatment demonstrating a significant advancement in treating AML in over 20 years, noted Jazz.

JAZZ closed Monday's trading at $121.91, up 0.35%.

Merrimack Pharmaceuticals Inc. (MACK) is laying off 20% of its workforce immediately, and eliminating more than $200 million in expected costs over the next two years as a major part of restructuring.

In line with this restructuring, the Board of Directors has accepted the resignation of President and CEO Robert Mulroy, effective immediately. Gary Crocker, Chairman of the Board, has taken over as interim President and CEO.

MACK closed Monday's trading at $6.04, down 4.88%.

Shares of Spectral Medical Inc. (EDTXF.OB) (EDT.TO) plunged nearly 85% on Monday as its phase III pivotal trial of Toraymyxin medical device for the treatment of patients with septic shock did not statistically achieve its primary end point of absolute reduction in mortality at 28 days.

However, the clinical data demonstrates a positive benefit for patients in septic shock and a significant improvement in cardiovascular function was observed, says the company.

The company plans to meet with FDA to discuss regulatory pathway towards potential approval for Toraymyxin.

Toraymyxin is designed for the extracorporeal treatment of whole blood, to selectively adsorb endotoxin present in the circulation.

EDTXF.OB closed Monday's trading at $0.19, down 84.64%.

VIVUS Inc. (VVUS) has granted Metuchen Pharmaceuticals LLC, a fully-paid, perpetual license for exclusive rights to commercialize STENDRA in the U.S., Canada, South America and India, and has received $70 million in return.

STENDRA was approved by the FDA in April 2012 for the treatment of erectile dysfunction in the United States and sold under the trade name SPEDRA in the European Union.

The rights to commercialize STENDRA in the U.S. and Canada and their territories were previously held by Auxilium Pharmaceuticals, a subsidiary of Endo International, plc, (ENDP).

In December 2015, Auxilium notified VIVUS of its intention to return the U.S. and Canadian commercial rights for STENDRA. The license agreement between Auxilium and VIVUS for STENDRA U.S. and Canadian commercial rights was terminated on September 30, 2016.

VVUS closed Monday's trading at $1.15, up 0.88%.

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