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Eagle Pharmaceuticals Inc (EGRX.OQ)

EGRX.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Eagle Pharmaceuticals Gets Final FDA Approval For Bendamustine Hydrochloride Ready-To-Dilute Solution In 500Ml Admixture
Wednesday, 16 May 2018 

May 16 (Reuters) - Eagle Pharmaceuticals Inc ::EAGLE PHARMACEUTICALS INC GRANTED FINAL FDA APPROVAL FOR BENDAMUSTINE HYDROCHLORIDE READY-TO-DILUTE SOLUTION IN A 500ML ADMIXTURE.SAYS EAGLE TO SHIP 500ML ADMIXTURE PRODUCT IMMEDIATELY.  Full Article

Eagle Pharmaceuticals’ Vasopressin ANDA Accepted For Filing By The FDA
Monday, 16 Apr 2018 

April 16 (Reuters) - Eagle Pharmaceuticals Inc ::EAGLE PHARMACEUTICALS’ VASOPRESSIN ANDA ACCEPTED FOR FILING BY THE FDA.EAGLE PHARMACEUTICALS INC - PRODUCT IS GENERIC VERSION OF ENDO INTERNATIONAL PLC'S ORIGINAL VASOSTRICT FORMULATION.  Full Article

Iridian Asset Management Reports 10.1 Pct Passive Stake In Eagle Pharmaceuticals
Tuesday, 9 Jan 2018 

Jan 8 (Reuters) - Iridian Asset Management::IRIDIAN ASSET MANAGEMENT REPORTS 10.1 PERCENT PASSIVE STAKE IN EAGLE PHARMACEUTICALS AS OF DEC 31, 2017 - SEC FILING‍​.  Full Article

Eagle Pharmaceuticals Commences Pivotal Study For Fulvestrant
Thursday, 7 Dec 2017 

Dec 7 (Reuters) - Eagle Pharmaceuticals Inc ::EAGLE PHARMACEUTICALS COMMENCES PIVOTAL STUDY FOR FULVESTRANT.EAGLE PHARMACEUTICALS- ANTICIPATES COMPLETION OF FULVESTRANT STUDY WITHIN TWELVE MONTHS, AND AN EXPECTED NDA FILING IN Q4 OF 2018.  Full Article

Eagle Pharmaceuticals Q3 earnings per share $0.98
Wednesday, 8 Nov 2017 

Nov 8 (Reuters) - Eagle Pharmaceuticals Inc :Eagle Pharmaceuticals Inc reports third quarter 2017 results.Q3 adjusted non-GAAP earnings per share $1.22.Q3 earnings per share $0.98.Q3 revenue $63 million versus I/B/E/S view $51.9 million.Q3 earnings per share view $0.80 -- Thomson Reuters I/B/E/S.Expect full year 2017 research and development expense will be consistent with upper end of $31-$35 million range​.Plan to begin dosing patients in Fulvestrant study in a few weeks and expect to file an NDA in Q4 of 2018​.Expect full year 2017 SG&A expense to be in range of $67 million - $70 million, slightly higher than previous guidance​.Will continue purchasing up to an additional $100 million shares under current share repurchase plan​.On PEMFEXY, says "hope to find a way to market" as soon as possible, once co's litigation with Eli Lilly is resolved​.  Full Article

EAGLE PHARMACEUTICALS RECEIVES TENTATIVE FDA APPROVAL FOR PEMFEXY
Saturday, 28 Oct 2017 

Oct 27 (Reuters) - Eagle Pharmaceuticals Inc ::EAGLE PHARMACEUTICALS RECEIVES TENTATIVE FDA APPROVAL FOR PEMFEXY (PEMETREXED INJECTION) READY-TO-DILUTE.EAGLE PHARMACEUTICALS INC - ‍FDA HAS GRANTED TENTATIVE APPROVAL FOR COMPANY'S PEMFEXY​.  Full Article

Eagle Pharmaceuticals reports positive results from animal study supporting efficacy of RYANODEX for exertional heat stroke
Tuesday, 13 Dec 2016 

Eagle Pharmaceuticals Inc : Eagle Pharmaceuticals inc - we anticipate completing NDA filing as soon as possible for RYANODEX . Eagle Pharmaceuticals reports positive results from pivotal animal study supporting the efficacy of RYANODEX for exertional heat stroke . Robust and clinically meaningful treatment difference in favor of RYANODEX was statistically significant . Eagle pharmaceuticals - eagle could be first to market with a potentially life-saving treatment for EHS, if approved by FDA, as early as mid-2017 .Eagle Pharmaceuticals - clinical and nonclinical components of development program provide adequate safety, efficacy data to complete our NDA submission.  Full Article

Eagle Pharma Q2 earnings $0.80/shr
Tuesday, 9 Aug 2016 

Eagle Pharmaceuticals Inc : Reports second quarter 2016 results . Announces $75 million share repurchase program . Changes in shareholders' stock holdings may trigger a "technical change of control" . Should co be required to amortize nol, there will be a cash impact of approximately $10 mln incurred over next few quarters . Changes in structure of co's shareholders' stock holdings may trigger how co "utilizes accumulated net operating losses" . Q2 shr view $0.71 -- thomson reuters i/b/e/s . Q2 revenue $40.9 mln vs i/b/e/s view $40.8 mln .Q2 shr $0.80.  Full Article

Eagle pharmaceuticals updates on FDA meeting for Ryanodex
Tuesday, 9 Aug 2016 

Eagle Pharmaceuticals Inc : Eagle Pharmaceuticals reports positive outcome from fda meeting for Ryanodex for exertional heat stroke NDA submission . Hajj study results sufficient for human data in filing . Eagle purchases royalty rights to Ryanodex portfolio . Purchases royalty rights to Ryanodex portfolio . Reduced future Ryanodex royalty obligations to licensing partner from 15% to 3% of net sales in exchange for $15 million in cash .Expect requesting priority review of nda for Ryanodex and, if granted by FDA, to market treatment for ehs as early as next year.  Full Article