FDA Nod For MRK's Keytruda, SGMO Soars On Gene Therapy Deal, OMER Catches Eyes

(RTTNews) - Today's Daily Dose brings you news about Merck's expanded approval of Keytruda; Sangamo's collaboration with Pfizer; AstraZeneca's results from asthma trial and first quarter results of Omeros and SciClone.

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AstraZeneca plc (AZN) announced that the first of two pivotal phase III trials evaluating Tralokinumab in adult and adolescent patients with severe asthma, dubbed STRATOS 1, failed to meet its primary endpoint of a significant reduction in the annual asthma exacerbation rate.

The second pivotal phase III trial of Tralokinumab, dubbed STRATOS 2, is underway, with results expected in second half of 2017.

AZN closed Wednesday's trading at $31.04, up 0.45%.

Shares of Conatus Pharmaceuticals Inc. (CNAT) were down over 15% in extended trading on Wednesday after the Company proposed a public offering of its common stock.

The Company had cash of $80.5 million at March 31, 2017.

You can find more about CNAT at our Company Spotlight column.

The FDA has approved Merck & Co Inc.'s (MRK) Keytruda in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer.

Keytruda was approved as a monotherapy for treatment naïve metastatic NSCLC patients last year.

Keytruda has already received FDA approval for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.

The drug brought home sales of $1.40 billion in 2016, up 148% compared to 2015.

MRK closed Monday's trading at $63.94, up 1.03%. In after-hours, the stock was up 3.07% to $65.90.

Omeros Corp.'s (OMER) net loss is $15.1 million or $0.34 per share on total revenue of $12.3 million in the first quarter of 2017. This compared with a net loss of $20.54 million or $0.54 per share and revenue of $7.42 million in the year-ago quarter.

The company's Q1 2017 revenue is comprised of only OMIDRIA sales and it represents 69% growth from the prior year's first quarter.

OMIDRIA is indicated for use during cataract surgery or intraocular replacement and for intraocular use.

OMER closed Wednesday's trading at $16.14, up 0.62%. In after-hours, the stock was up 4.71% to $16.90.

Shares of Sangamo Therapeutics Inc. (SGMO) were up 44.83% to $6.30 in extended trading on Wednesday, following a global collaboration with Pfizer Inc. (PFE) for Hemophilia A gene therapy.

The agreement also covers SB-525, one of Sangamo's four lead product candidates, which is expected to enter the clinic this quarter.

Under the terms of the collaboration agreement, Sangamo will receive a $70 million upfront payment and potential milestone payments of up to $475 million and tiered double-digit royalties from Pfizer.

SGMO closed Wednesday's trading at $4.35, down 1.14%. In after-hours, the stock was up 44.83% to $6.30.

SciClone Pharmaceuticals Inc.'s (SCLN) non-GAAP net income in the first quarter of 2017 rose to $16.6 million or $0.31 per share from $9.7 million or $0.19 per for the same period of the prior year.

Revenues in the first quarter of 2017, which is comprised mostly of ZADAXIN product sales, were $42.9 million, compared to $36.5 million for the same period in 2016.

ZADAXIN is SciClone's proprietary lead product, approved in over 30 countries and may be used for the treatment of hepatitis B, hepatitis C, and certain cancers, and as an immune system enhancer, according to the local regulatory approvals.

SCLN closed Wednesday's trading at $9.65, down 2.03%. In after-hours, the stock was up 4.66% to $10.10.