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AMGN's LIBERTY Meets Goals, ANTH Yields RESULT, CCXI Up On Cancer Trial Data

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Today's Daily Dose brings you news about Amgen's LIBERTY migraine study; positive interim futility analysis of Anthera's phase III clinical study of Sollpura; FDA approval of Baxter's Bivalirudin; positive overall survival results from ChemoCentryx's pancreatic cancer trial; Nymox Pharma's encouraging 5-year results of its prostate cancer study and Resmed's better-than-expected results for the second quarter of fiscal year 2018.

Read on…

Amgen's (AMGN) phase 3b study of Aimovig (erenumab) 140 mg in patients with episodic migraine who have failed multiple prior preventive treatments has met its primary endpoint and all secondary endpoints.

In the study, dubbed LIBERTY, significantly more patients taking Aimovig experienced at least a 50 percent reduction from baseline in their monthly migraine days compared to placebo.

The Biologics License Application for Aimovig for the prevention of migraine in patients experiencing four or more migraine days per month is under FDA review - with a decision date set for May 17, 2018.

AMGN closed Monday's trading at $192.33, up 1.61%.

The second, and final, interim futility analysis of Anthera Pharmaceuticals Inc.'s (ANTH) phase III clinical study of Sollpura for the treatment of Exocrine Pancreatic Insufficiency, dubbed RESULT, has yielded positive outcome.

The Company completed patient recruitment of the RESULT study in November 2017 and is on track to report topline data later this quarter.

ANTH closed Monday's trading at $1.42, up 10.94%.

The FDA has approved Baxter International Inc.'s (BAX) Bivalirudin for use as an anticoagulant in patients undergoing percutaneous coronary intervention, a common non-surgical procedure to treat blocked or narrowed blood vessels in the heart.

Bivalirudin is expected to be launched in the United States in early 2018 in two commonly prescribed dosage forms and strengths: 250 mg of bivalirudin per 50 mL (5 mg/mL) and 500 mg of bivalirudin per 100 mL (5 mg/mL).

BAX closed Monday's trading at $70.20, up 0.27%.

Bio-Rad Laboratories Inc. (BIO) has received FDA clearance for IH-Incubator L and IH-Centrifuge L instruments to be used with the full range of its IH-System Gel Reagents for manual blood typing methods.

The unique design of the two instruments maximizes efficiency and space in the laboratory by accommodating both conventional tube and gel blood typing, the Company noted.

BIO closed Monday's trading at $254.65, up 0.04%.

Shares of ChemoCentryx Inc. (CCXI) were up over 6% in extended trading on Monday, following positive overall survival results from an ongoing phase Ib clinical trial of CCX872 in the treatment of locally advanced/metastatic pancreatic cancer.

According to the study results, CCX872 plus FOLFIRINOX resulted in overall survival of 29 percent at 18 months in all patients. The numbers compare favorably with previously published overall survival rates of 18.6% using FOLFIRINOX alone to treat pancreatic cancer patients with metastatic disease.

CCXI closed Monday's trading at $8.31, down 0.48%. In after-hours, the stock was up 6.50% to $8.85.

Harvard Bioscience Inc. (HBIO) has acquired privately-held Data Sciences International Inc. for approximately $70 million. Also, the Company has completed the sale of its wholly-owned subsidiary Denville Scientific Inc. to Thomas Scientific, LLC for approximately $20 million, which includes a $3 million earn-out provision.

As a result of the transactions, the Company's fiscal 2018 annual revenue is expected to be between $118 million and $123 million, and non-GAAP adjusted EPS is anticipated to be between $0.19 and $0.23. Analysts polled by Thomson Reuters are expecting earnings of $0.17 per share and revenue of $104.13 million for fiscal 2018.

HBIO closed Monday's trading at $3.90, down 1.27%. In after-hours, the stock was up 7.69% to $4.20.

Nymox Pharmaceutical Corp. (NYMX) jumped as much as 34% on Monday, following encouraging 5-year results from a prospective randomized controlled prostate cancer study of its investigational drug Fexapotide Triflutate in the U.S.

The study involved 146 men with the biopsy confirmed diagnosis of T1c prostate cancer, which is the most common type of low grade localized prostate cancer.

After 5 years, the study has now shown that high dose Fexapotide 15mg single dosage treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression, and that both doses of Fexapotide (15mg and 2.5mg) were consistently effective, noted the Company.

The Company's filing seeking approval for Fexapotide in Europe for BPH is under review in the European Union.

NYMX closed Monday's trading at $3.54, up 13.10%.

Shares of ResMed Inc. (RMD) were up over 9% in extended trading on Monday, following better-than-expected results for the second quarter of fiscal year 2018.

For the recent second quarter, non-GAAP net income was $143.8 million or $1.00 per share on revenue of $601.27 million. Wall Street analysts were expecting earnings of $0.78 per share and revenue of $580.2 million.

In the year-ago comparable quarter, non-GAAP net income was $103.2 million or $0.73 per share and revenue was $530.4 million.

RMD closed Monday's trading at $87.51, down 1.32%. In after-hours, the stock was up 9.91% to $96.18.

VistaGen Therapeutics Inc. (VTGN) is scheduled to provide an update on its phase II study of AV-101 as an oral new generation adjunctive treatment for Major Depressive Disorder and outline key 2018 initiatives on January 29, 2018.

Earlier this month, the Company announced that it is on track to dose the first patient in its phase II trial of AV-101 as an adjunctive treatment for Major Depressive Disorder in the first quarter of 2018.

VTGN closed Monday's trading at $1.32, up 9.10%.

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