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FDA Approves DVAX's Hep B Vaccine, OMER Catches Eyes, It's 4 For SGEN's Adcetris

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Today's Daily Dose brings you news about the strong Q3 results of Omeros, FDA approvals of hepatitis B vaccine, CINV drug and a lymphoma drug.

Read on...

Shares of Dynavax Technologies Corp. (DVAX) were up more than 15% in extended trading on Thursday, following FDA approval of HEPLISAV-B, the Company's vaccine for prevention of Hepatitis B in adults.

HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults. GlaxoSmithKline plc's (GSK) Engerix-B and Merck & Co Inc's (MRK) RECOMBIVAX HB are the other FDA-approved hepatitis B vaccines.

In phase III trials, HEPLISAV-B was evaluated against Engerix-B. According to the trial results, two doses of HEPLISAV-B given one month apart provided significantly higher rates of protection with an equivalent safety profile compared to three doses of Engerix-B that is administered over six months.

Dynavax expects to commercially launch HEPLISAV-B in the United States in the first quarter of 2018.

DVAX closed Thursday's trading at $20.05, down 3.84%. In after-hours, the stock was up 15.46% to $23.10.

Omeros Corp. (OMER) has reported strong results for the third quarter ended September 30, 2017, lifting investors' spirits.

Net loss for the recent third quarter narrowed to $7.5 million or $0.16 per share from $14.0 million or $0.34 per share in the year-ago quarter. Total revenue, which comprised sales of OMIDRIA, rose to $21.7 million from revenue of $11.3 million for the same period in 2016.

OMIDRIA, approved in May 2014, is indicated for use in cataract and other intraocular lens replacement procedures.

Analysts polled by Thomson Reuters expected the Company to report a loss of $0.33 per share on revenue of $17.77 million.

OMER closed Thursday's trading at $14.09, down 1.09%. In after-hours, the stock was up 13.48% to $15.99.

The FDA has approved Heron Therapeutics Inc.'s (HRTX) Cinvanti for the prevention of chemotherapy-induced nausea and vomiting.

Cinvanti is a polysorbate 80-free, IV formulation of neurokinin-1 (NK1) receptor antagonist Aprepitant, the same active ingredient as in Merck's approved antiemetic drug Emend. Since Cinvanti does not contain polysorbate 80, it may have a lower incidence of certain types of adverse reactions than reported with Emend IV.

Emend had sales of $549 million in full year 2016, and $276 million in the first half of 2017.

Last month, the FDA approved Tesaro Inc.'s (TSRO) intravenous version of Varubi for chemotherapy-induced nausea and vomiting. Varubi is also a NK1 receptor antagonist.

CINVANTI is expected to be launched commercially in the U.S. in January of next year.

HRTX closed Thursday's trading at $17.35, up 2.66%.

The FDA has approved an expanded indication for Seattle Genetics Inc.'s (SGEN) ADCETRIS for use in the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. This marks the fourth FDA-approved indication for ADCETRIS.

The drug also has (1) regular approval for treatment of classical Hodgkin lymphoma (cHL) patients who fail autologous hematopoietic stem cell transplantation (auto-HSCT) or who fail at least two prior multi-agent chemotherapy regimens and are not auto-HSCT candidates, (2) regular approval for the treatment of patients with cHL at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for treatment of systemic anaplastic large cell lymphoma (sALCL) patients who fail at least one prior multi-agent chemotherapy regimen.

For the first nine months of 2017, ADCETRIS sales were $223.8 million compared to $195.0 million in the year-ago period.

SGEN closed Thursday's trading at $57.91, up 0.07%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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