FDA Nod For AZN's Asthma Drug, Genmab Revises Outlook, NBY Disappoints

Pharma 111517

Today's Daily Dose brings you news about Apollo Medical's fiscal 2018 second quarter financial results; FDA approval of AstraZeneca's asthma drug; EyeGate's upcoming clinical trial catalysts; Genmab's revised revenue outlook and Pacira's update on its EXPAREL sNDA.

Read on...

Apollo Medical Holdings Inc.'s (AMEH.OB) net revenue for fiscal 2018 second quarter was $40.5 million, an increase of 177% compared to $14.6 million in the year-ago quarter.

Loss from operations widened to $4.1 million in the recent second quarter from $2.2 million in the comparable period of 2016, mainly due to the ongoing transactional expenses related to the pending merger with Network Medical Management Inc.

On September 30, 2017, the Company had total assets of $41.2 million, including cash and cash equivalents of $30.2 million.

AMEH.OB closed Tuesday's trading at $6.25, down 16.67%.

The FDA has approved AstraZeneca plc's (AZN) Biologics License Application for FASENRA (benralizumab) for severe eosinophilic asthma in patients aged 12 years and older.

In phase III trials, 8-week FASENRA dosing regimen resulted in up to 51% reduction in the annual asthma exacerbation rate (AAER) versus placebo.

FASENRA will be available as a subcutaneous injection via a prefilled syringe administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter, noted the Company. It is expected to be available in the US within the coming weeks.

In the European Union, the drug is one step closer to approval because it was only as recently as last week did the Committee for Medicinal Products for Human Use of the European Medicines Agency recommend its approval.

Analysts at Jefferies expect peak sales of the drug to hit $1.5 billion.

AZN closed Tuesday's trading at $33.25, up 1.03%.

aTyr Pharma Inc. (LIFE) is all set to initiate a phase I study of iMod.Fc for the treatment of interstitial lung diseases this quarter.

As of September 30, 2017, the Company had cash of $90.4 million.

LIFE closed Tuesday's trading at $3.70, up 1.37%.

EyeGate Pharmaceuticals Inc. (EYEG) has a couple of catalysts to watch out for in 2018.

-- The Company expects top-line results from phase 2b study of the EGP-437 combination product in cataract surgery patients in the first quarter of 2018 .
-- Enrollment in the Company's phase 3 study of EGP-437 in anterior uveitis is ongoing, with top-line results expected in the second quarter of 2018.

EYEG closed Tuesday's trading at $1.06, down 2.31%.

Evoke Pharma Inc. (EVOK) is preparing to submit its 505(b)(2) New Drug Application for Gimoti, its lead drug candidate for the treatment of symptoms associated with acute and recurrent diabetic gastroparesis, in the first quarter of 2018.

As of September 30, 2017, the Company had cash of roughly $10.4 million.

EVOK closed Tuesday's trading at $2.84, up 1.07%. In after-hours, the stock was down 3.17% to $2.75.

Genmab A/S (GMXAY.OB) is all set to receive $25 million in milestone payments from Janssen Biotech Inc., following the first commercial sale of DARZALEX in Japan.

DARZALEX received approval in Japan in September 2017 for the treatment of adults with relapsed or refractory multiple myeloma. The drug was approved in the U.S. in November 2015.

Accordingly, the Company has revised up its revenue guidance for 2017 to a range of DKK 2,110 - 2,310 million, an increase of DKK 160 million over its prior forecast.

GMXAY.OB closed Tuesday's trading at $92.00, up 3.56%.

Shares of NovaBay Pharmaceuticals Inc. (NBY) were down more than 4% in extended trading on Tuesday, following worse-than-expected quarterly results and disappointing revenue outlook for the year.

The net loss for the third quarter of 2017 was $2.4 million or $0.16 per share on net sales of $4.1 million. Analysts polled by Thomson Reuters were expecting a loss of $0.09 per share and sales of $4.77 million.

In the third quarter of 2016, the Company had incurred a net loss of $3.7 million or $0.34 per share, on net sales of $3.4 million.

For 2017, the Company now expects net sales to be between $17.5 million and $18.5 million, down from its prior outlook of $19 million.

NBY closed Tuesday's trading at $4.45, up 6.08%. In after-hours, the stock was down 4.49% to $4.25.

Oramed Pharmaceuticals Inc. (ORMP) has received the go-ahead from Israel's Ministry of Health to initiate an exploratory clinical study of its oral insulin capsule ORMD-0801 in patients with nonalcoholic steatohepatitis in the coming month.

The proposed three-month treatment study will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH.

ORMP closed Tuesday's trading at $9.36, up 1.74%.

Pacira Pharmaceuticals Inc.'s (PCRX) supplemental New Drug Application for EXPAREL as a nerve block for regional analgesia is expected to be reviewed by a panel of outside experts convened by the FDA on February 14 or 15, 2018.

The regulatory agency's final decision will be known by April 6, 2018.

EXPAREL was approved by the FDA in 2011 for the management of postsurgical pain.

In the recent third quarter, EXPAREL net product sales were $66.8 million, up 3% over prior year third quarter. For full year 2017, the Company expects EXPAREL net product sales to range between $280 million and $285 million.

PCRX closed Tuesday's trading at $39.92, down 6.61%.

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