-=Amarin (AMRN) reported earnings on Tue 5 Nov 19 (b/o)

Amarin beats by $0.03, beats on revs
Reports Q3 (Sep) loss of $0.01 per share, $0.03 better than the S&P Capital IQ Consensus of ($0.04); revenues rose 104.4% year/year to $112.4 mln vs the $110.04 mln S&P Capital IQ Consensus.

Amarin reiterates FY19 revenue; FDA advisory committee meeting pertaining to the sNDA for axpanded Vascepa approval is scheduled to be held on November 14, 2019

Amarin reiterates its net revenue guidance for 2019 of $380 million to $420 million. Amarin does not plan to issue quantified 2020 guidance until after it knows the details of the label for Vascepa following the PDUFA date.

December 28, 2019 is the Prescription Drug User Fee Act (PDUFA) target date for action on Amarin's supplemental New Drug Application (sNDA) seeking approval of Vascepa as the first drug approved for cardiovascular risk reduction in the patient population studied in REDUCE-IT. An FDA advisory committee meeting pertaining to the sNDA for Vascepa is scheduled to be held on November 14, 2019 at the FDA's offices in White Oak, Maryland. As is the usual protocol, briefing books will be used for preparation of advisory committee panel members with information related to Vascepa, the related science and questions that the advisory committee panel members will be asked to vote on at the meeting. The briefing books typically are made public two days before the commencement of the advisory committee meeting.

Earnings this week : Nov 4 - 8, 19 (wk 45)

Monday (Nov 4)

• Morning: BHC CYOU COHU RACE FE GCI KOS MMYT SOHU S SUP SYY UAA
• Afternoon: AAN ACOR ADUS AOSL APLE APTS AWR BHF BKD BKH BWXT CBT CC CDE CDEV CHGG CPE DIOD DK DOOR ED ELVT ETH EVBG EVER FBM FICO FN FRPT FRTA FTSI GRPN HHC HIG HLIO HPR HR HTZ IFF ITRI JKHY KAMN KMPR KMT LASR LMNX MAR MDRX MOS MYGN NBIX NCMI NTR O OTTR OUT OXY PAHC PBPB PI PLMR PLOW PRU PXD QTS REAL RMBS RNG RYAM SHAK SHO SNCR STE STRL SWM SYKE TCMD THC TNDM TSE UBER VAC VECO WES WTR XEC 

Tuesday (Nov 5)

• Morning: AFI AGN AMRC AMRN ARNC ASC ATH ATHM ATRO AVNS AVTR BCPC BDX BMCH BPMC BSIG CEIX CHH CHK CNK CSWI CTLT EEX EMR ENDP EQM EXPD FI FIS FTDR GEO GLDD GSKY GSX HLNE HSIC ICPT IPHS IPI JLL LAMR LCII LGIH LPX MDGL MGP MNK MYE MYL NEM NOVT NPO NS NWN OCN OXFD PBI PINC PPL PTON RCM REGN RHP RPD SERV SGRY SRC SSTK SXC TA THR TLRA TPR TRVG UNT UNVR USAC USFD VCEL VIRT VPG VRTV VST WBT WLK ZBH
• Afternoon: ACHC AKCA ALRM Y ATUS AVD ANDE AINV AIZ AVLR BTG BEAT WIFI CZR CARG CDK CENX CNO COHR CMP CPSI SCOR CPS CSOD CCRN CWK DVA DVN FANG DEI EVRI ES EVH FATE FRGI FIVN FLDM FTR GTES GTE GPRE GHL GWPH HCKT HCR HST HUBS ICHR IOSP INGN INSP PODD IPAR IRTC JAZZ KAR KRG KTOS KPI LC LGND LTHM MTCH MBI MCHP MODN MWA NP NEWR NUS OAS OHI OPK PE PAYS PAA PAGP PLT PTLA PRMW PRA RDUS RRGB RRR RGNX SWIR SSRM SXI INN SUPN CGBD TSLX TRUP TWO RARE VGR VOYA WMC WLL WW

Wednesday (Nov 6)

• Morning: AES XLRN AYR ALE AMRX ANIP WAAS GOLD BKI BLMN BCOR BR CSTE CPRI CRCM CARS CBRE FUN GIB CRL IMOS CIR CWEN CNHI CNR COTY CVIA CVS CYBR DEA ELAN ENBL ESPR GLOG GCP GEL HZNP HUM NSIT IONS JELD KELYA KL LAUR LXP LL MFA MIDD NYT NXST DNOW ODP OMI PZZA PFGC PRGO DOC RDWR SMG SEE SQNS SBGI SND VNTR VER VG VMC WNC WD WEC WEN WLH
• Afternoon: AIMT, ATSG, ALB, LNT, UHAL, AEL, ANGI, ANSS, AAOI, ASRT, ATO, EQH, AXGN, BIDU, BAND, BNFT, BL, BRKS, CECO, CVNA, CTL, COLL, CNDT, CXW, DAR, DCP, DXCM, DXPE, DVAX, ELF, EGAN, ERI, EBS, ECPG, ET, ELF, ENS, EOG, EVRG, EXPE, STAY, FG, FISV, FIT, FLT, FLO, FLNT, FSCT, FOSL, FOXA, GKOS, GMED, GLUU, GDDY, LOPE, HOLX, TWNK, IAG, ICFI, IAC, IVC, NVTA, IQ, KGC, LCI, LHCG, RAMP, MFC, MRO, MTRX, NTRA, NKTR, NVRO, NEX, OSUR, ORA, OR, PAAS, PGRE, PK, PDCE, PLYA, PRI, PROS, PSEC, PRSC, PBYI, QTWO, QCOM, QUOT, RP, RDFN, RCII, REZI, ROKU, RGLD, RUBI, SAIL, SGMO, WTTR, SEDG, SJI, SWX, SPTN, SQ, SLF, SUN, TLND, TTGT, TXMD, TMST, TPIC, TRIP, TCX, TPC, UPWK, VVV, VNDA, VERI, VSLR, WK, WMGI, WYNN, ZAGG, ZAYO 

Thursday (Nov 7)

• Morning: ACIW, ADNT, WMS, APD, AMC, ABC, MT, AVA, AZUL, BCC, CAH, ECOM, CBB, CLVS, CCOI, CMCO, COMM, CORE, COT, DNR, DISCA, DISH, SATS, EPAM, EVOP, AG, FOCS, GOGO, GTN, HAIN, HL, HIMX, HII, INXN, JCI, KDP, KTB, KOP, LXRX, MBUU, MCFT, MDP, VIVO, MSGN, NHI, EYE, NLSN, NBL, NOMD, NCLH, NVMI, NRG, OGE, PCRX, PRTY, PRFT, PGTI, PNW, PLUG, RL, RLGY, SBH, SEAS, SNH, STRA, TGNA, TSG, TWI, THS, GTS, TGI, USPH, VSTO, WRK, WWW, ZTS 
• Afternoon: AAXN, AGO, AGS, AIRG, AL, ALTR, AMBC, AMH, AMPH, ANAB, AQN, ARLO, ARNA, ATVI, AVID, BE, BEDU, BGNE, BKNG, BOLD, CABO, CDAY, CHUY, COLD, CORT, CTRE, CUTR, CWH, CYRX, DBX, DIS, EB, ENLC, ENV, FARM, FSLY, G, GDOT, GH, GPRO, GSBD, IVR, JAG, JJSF, KIDS, KRO, KSHB, LADR, LPSN, MAIN, MATX, MED, MIME, MITK, MMI, MNST, MOD, MRAM, MTD, MTW, NCR, NDLS, NLOK, NNBR, NNI, NVEE, NWSA, ONTO, PEGA, PEN, PETQ, PLNT, PRAA, QHC, QNST, RBA, RLJ, RVLV, SCPL, SEMG, SGMS, SIEN, SPPI, SRPT, STMP, SVMK, SWAV, SWCH, TDC, TIVO, TRHC, TROX, TRUE, TTD, TTWO, TUSK, TXG, UEPS, UNIT, UPLD, VRTU, VSAT, WPRT, WSC, WTRH, XOG, YELP, ZG, ZGNX, ZIOP

Friday (Nov 8)

• Morning: AER, AEE, EPAY, CLNY, DRH DUK, ENB, ERF, ETM, ESNT, FLY, GTX, GNLN, HMC, MSG, MGA, ZEUS, REV, SSP, SVC, STWD, USCR, UNT

Notable earnings reports: 

• Under Armour (NYSE:UAA), Uber (UBER), Shake Shack (NYSE:SHAK), Marriott International (NASDAQ:MAR) and Bausch Health (NYSE:BHC) on November 4; 
• Booking Holdings (NASDAQ:BKNG), Match (NASDAQ:MTCH), Peloton Interactive (NASDAQ:PTON) and Tapestry (NYSE:TPR) on November 5; 
• Baidu (NASDAQ:BIDU), Square (NYSE:SQ), Roku (NASDAQ:ROKU), Qualcomm (NASDAQ:QCOM), Expedia (NASDAQ:EXPE), Barrick Gold (NYSE:GOLD) and CVS Health (NYSE:CVS) on November 6; 
• Disney (NYSE:DIS), Activision Blizzard (NASDAQ:ATVI), GoPro (NASDAQ:GPRO), Take-Two Interactive (NASDAQ:TTWO), Wynn Resorts (NASDAQ:WYNN), Dropbox (NASDAQ:DBX) and Zillow (NASDAQ:ZG) on November 7; 
• Scientific Games (NASDAQ:SGMS) and Duke Energy (NYSE:DUK) on November 8.

This week's biggest % winners & losers : March 25 - 29, 19 (wk 13)

The following are this week's top percentage gainers and losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: TCDA (38.62 +61.19%), CCXI (13.89 +27.31%), DNLI (23.22 +19.38%), AMRN (20.76 +18.56%), ADAP (4.30 +18.46%), GLPG (117.78 +18.41%), TGTX (8.04 +17.72%), GRTS (13.30 +16.16%), GTHX (16.6 +15.28%)
• Materials: EXP (84.30 +18.25%)
• Consumer Discretionary: BBBY (16.99 +24.01%), MOV (36.38 +14.91%), LULU (163.87 +14.43%), KMX (69.80  +13.26%)  
• Information Technology: AVYA (16.83 +27.4%), PRGS (44.37 +23.87%), QTNA (24.33 +21.59%), SYNA (39.75 +21.49%), SVMK (18.21 +21.24%), BB (10.09  +11.86%)

This week's top 20 % losers

• Healthcare: ARA (6.14 -35.37%), CDNA (31.52 -14.63%), TYME (1.76 -14.56%), CYH (3.73 -13.66%), IRTC (74.96 -11.75%), ABMD (285.59 -11.64%), SGRY (11.28 -10.9%)
• Materials: MUX (1.50 -10.71%), SA (12.39 -10.61%)
• Industrials: NLSN (23.67 -11.88%), MAXR (4.02 -11.26%)
• Consumer Discretionary: RH (102.95 -21.45%), HOME (17.86 -19.44%)
• Information Technology: SGH (19.2 -18.02%)
• Energy: PVAC (44.1 -14.39%), CVIA (5.59 -14%)

=Amarin (AMRN) : Diabetes Association Adds Drug to Its 'Must Have' List

• Amarin Corporation plc (AMRN) confirmed that the American Diabetes Association (ADA) issued important updates to the Standards of Medical Care in Diabetes for 2019 (Standards of Care), including updates related to the results of the REDUCE-IT cardiovascular outcomes study.

The company's Vascepa drug was added to the American Diabetes Association's Standards of Medical Care in Diabetes list for 2019. 

The drug, along with a specialized diet, has been shown to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Amarin has agreed to give the Food and Drug Administration data to support the ADA's finding in order expand Vascepa's FDA label to include its recommendation. 

"As we have commenced transmission of data to the FDA for the submission of our sNDA seeking an expansion of the Vascepa label based on the landmark REDUCE-IT results, we are pleased by ADA's acknowledgement of the importance of the REDUCE-IT results in its 2019 update of the Standards of Care," said Dr. Craig B. Granowitz, senior vice president and chief medical officer of Amarin.

Amarin said that Vascepa works without raising bad cholesterol when a four-gram dose is taken daily. 

=Amarin (AMRN) : positive trial results in cholesterol treatment Vascepa

• Company said its cholesterol treatment met its primary endpoint of risk reduction. The company said Vascepa LDL-C treatment was also well tolerated.

Amarin announces topline results from Vascepa cardiovascular outcomes trial -- REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction

The co announced topline results from the Vascepa cardiovascular (CV) outcomes trial, REDUCE-IT, a global study of 8,179 statin-treated adults with elevated CV risk. REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance, in major adverse CV events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo. Key topline results include:

• Efficacy: Approximately 25% relative risk reduction, demonstrated to a high degree of statistical significance, in the primary endpoint composite of the first occurrence of MACE, including cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. This result was supported by robust demonstrations of efficacy across multiple secondary endpoints.
• Safety: Vascepa was well tolerated with a safety profile consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling. The proportions of patients experiencing adverse events and serious adverse events in REDUCE-IT were similar between the active and placebo treatment groups. Median follow-up time in REDUCE-IT was 4.9 years.

As previously described, given the successful topline results of REDUCE-IT, Amarin is in the process of increasing the number of company sales representatives promoting Vascepa to over 400 people in the United States. This will provide a greater concentration of coverage in current sales territories and provide new coverage where Amarin currently does not have sales representatives. In addition to sales force expansion in the United States, Amarin plans to work with its international partners to support regulatory efforts outside the United States based on REDUCE-IT results. As previously described in the months leading up to REDUCE-IT results, Amarin increased its Vascepa inventory levels in preparation for positive results.