Today, 1:54 PM
- Micro cap Amarin (AMRN +7%) is up on double normal volume in response to its announcement that the FDA has determined that Vascepa (icosapent ethyl) capsules are eligible for five-year new chemical entity (NCE) marketing exclusivity under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act. The NCE exclusivity will be in effect from the date of FDA approval, July 26, 2012 until July 26, 2017.
- In addition, there is a statutory 30-month stay triggered by patent litigation (the company is automatically notified when a would-be generic competitor files its Abbreviated New Drug Application with the FDA which, in turn, automatically results in patent infringement litigation which triggers the automatic 30-month stay while the patent challenge runs its course) that potentially extends Vascepa's marketing exclusivity to January 26, 2020.
- Vascepa accounted for almost all (99%) of the company's Q1 revenue of $25.5M.
Fri, May 13, 11:35 AM
- Prothena (PRTA +7.6%) initiated with Overweight rating and $60 (44% upside) price target by Barclays.
- Pfizer (PFE +0.5%) initiated with Hold rating and $38 (12% upside) price target by Berenberg.
- Amarin (AMRN +1.9%) initiated with Buy rating and $3.50 (111% upside) price target by Jefferies.
- Align Technology (ALGN +0.9%) initiated with Outperform rating and $84 (10% upside) price target by Credit Suisse.
- Presbia (LENS +2.9%) initiated with Buy rating and $14 (254% upside) price target by Rodman & Renshaw.
- LabStyle Innovations (OTCQB:DRIO +5.4%) initiated with Buy rating and $12 (121% upside) price target by Rodman & Renshaw.
- Juno Therapeutics (JUNO +1.5%) initiated with an Outperform rating and $55 (48% upside) price target by Cowen & Co.
- WebMD Health (WBMD +0.4%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey. Price target increased to $75 (18% upside) from $57.
- Sanofi (SNY +0.3%) upgraded to Overweight from Equal Weight by Barclays. Price target maintained at €84 (20% upside).
- Depomed (DEPO +4.1%) upgraded to Buy from Neutral by Mizuho Securities. Price target raised to $19 (4% upside) from $18.
Thu, May 5, 10:26 AM
- Amarin (AMRN -7.2%) Q1 results: Revenues: $25.5M (+60.4%); R&D Expense: $13.7M (+8.7%); SG&A: $28M (+13.4%); Operating Loss: ($23.1M) (+14.4%); Net Loss: ($29.8M) (+6.9%); Loss Per Share: ($0.16) (+11.1%); Non-GAAP Loss Per Share: ($0.14) (+12.5%); Quick Assets: $81.4M (-23.9%); CF Ops: ($24.8M) (-96.8%).
- 2016 Guidance: Net Product Revenue: $105M - 120M (unch).
Thu, May 5, 7:09 AM
Wed, May 4, 5:30 PM
- AAC, AAON, AAWW, ABC, ACIW, ACRE, ACTA, AGIO, AMCX, AMRC, AMRN, ANIP, ANSS, APA, APO, AVP, AXLL, BABA, BCRX, BDX, BR, CBB, CCC, CCOI, CDK, CHD, CHK, CLDT, CNAT, CNNX, CNSL, COT, CVC, CWEI, DDD, DIN, DISCA, DNR, EAC, ENOC, EPAM, ESNT, EVA, FIG, FLDM, G, GCAP, GWPH, HII, HL, HWCC, ICON, IT, ITG, ITT, JEC, JMBA, K, LAMR, LFUS, LINC, LIOX, LMOS, LQDT, LXP, MBLY, MDC, MFC, MGA, MGLN, MGM, MITL, MLM, MMS, MRK, MWW, NICE, NILE, NRG, NTCT, NYLD, OGE, ONE, OXY, PGNX, PGTI, PRFT, PRIM, PWR, RDEN, RDUS, REGN, RFP, RGEN, RLGY, RSTI, RWLK, SBH, SEAS, SFM, SHLX, SNH, SNI, SNR, SNSS, SPH, SQBG, STOR, TDC, TDY, TE, THS, TIME, TLP, TWI, UNT, USAC, USAK, USCR, VER, VG, VLP, WIN, WPC, WRLD
Thu, Mar. 31, 7:34 AM
- Target enrollment of ~8,000 subjects has been reached in Amarin's (NASDAQ:AMRN) Phase 3 REDUCE-IT study assessing the ability of Vascepa (icosapent ethyl), in combination with statin therapy, to reduce the risk of cardiovascular (CV) events in high-risk patients with mixed dyslipidemia. The company is now winding down patient recruitment on a country-by-country basis.
- In another development, the onset of ~60% of the target aggregate number (1,612) of primary CV events has triggered preparation for a pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee. The analysis should be done in about six months.
- According to clinicaltrials.gov, the primary endpoint of REDUCE-IT is a composite endpoint of CV death, heart attack, stroke, coronary revascularization and hospitalization for unstable angina over four to six years. The estimated study completion date is December 2017.
Wed, Mar. 9, 9:15 AM
- Gainers: LINE +27%. ATSG +24%. REXX +21%. DNR +19%. CRC +17%. BUFF +14%. LNCO +14%. BIOC +14%. SXE +14%. CJES +14%. SGY +14%. BETR +11%. AMRN +10%. BTE +9%. DANG +9%. BCEI +8%. GGB +7%. WLL +7%. SDLP +7%. EXPR +7%. CLF 6%. PBR 6%. CHK 6%. PBR.A 5%.
- Losers: SDRL -13%. DSX -9%. BPT -9%. GRPN -5%. PLNT -5%. YELP -5%.
Tue, Mar. 8, 4:39 PM
- Amarin (NASDAQ:AMRN) wins its First Amendment litigation against the FDA [Amarin Pharma, Inc. et al. v. FDA et al., No. 15-3588 (S.D.N.Y. May 7, 2015] concerning off-label promotion of Vascepa (icosapent ethyl) Capsules.
- Under the terms of the settlement, both parties agree to abide by the August 7, 2015 judicial declaration that Amarin may promote the off-label use of Vascepa to healthcare professionals with the proviso that it is done so in a truthful and non-misleading manner. In addition, the FDA agreed to provide the company with an optional preclearance provision through 2020 for new off-label claims. Both parties also agreed to a dispute resolution provision designed to avoid future litigation.
- The dispute arose over Amarin's desire to inform physicians of the data from the ANCHOR clinical trial which showed a statistically significant treatment benefit in patients with high triglycerides (between 200 mg/dL and 500 mg/dL) who received Vascepa. The FDA cried foul citing Vascepa's narrower clearance for patients with triglyceride levels above 500 mg/dL, a much smaller patient population.
- Shares are up 9% after hours on light volume.
- Previously: Court says Amarin can promote Vascepa for off-label uses; shares up 5% (Aug. 7, 2015)
- Previously: Amarin sues FDA to allow it to communicate ANCHOR results to docs (May 7, 2015)
- Update: Judge Paul Engelmayer approved the settlement terms on March 9.
Thu, Feb. 25, 10:19 AM
- Amarin (AMRN +5.6%) Q4 results: Revenues: $26.6M (+61.2%); R&D Expense: $13.3M (+7.3%); SG&A: $23.5M (+27.7%); Operating Loss: ($18.6M) (+7.9%); Net Loss: ($21.9M) (-11.2%); Loss Per Share: ($0.12) (-9.1%); Non-GAAP Loss Per Share: ($0.10) (+9.1%).
- FY2015 results: Revenues: $81.8M (+50.9%); R&D Expense: $51.1M (+1.6%); SG&A: $101M (+27.4%); Operating Loss: ($98.2M) (-2.3%); Net Loss: ($149.1M) (-164.4%); Loss Per Share: ($0.83) (-130.6%); Non-GAAP Loss Per Share: ($0.56) (+1.8%); Quick Assets: $107M (-10.5%).
- 2016 Guidance: Net Product Revenue: $105M - 120M.
Thu, Feb. 25, 9:12 AM| Thu, Feb. 25, 9:12 AM | 9 Comments
Thu, Feb. 25, 7:12 AM
Wed, Feb. 24, 5:30 PM
- AAON, ACIW, AG, ALKS, AMCX, AMRN, AMWD, ANSS, APA, APLP, AROC, BBY, BUD, CCOI, CHS, CLDX, CM, CNSL, CORE, CPB, CPK, CRI, CVC, DPZ, EGRX, EME, EMES, ENOC, FCH, FCN, FIG, GLOG, GOGO, GTLS, GVA, HBM, HEES, HMHC, HTWR, INCR, IONS, IRDM, IRM, ITC, KERX, KOP, KSS, LKQ, MITL, NEWM, NPO, [[NTi]], NXST, PCRX, PDCO, PF, PGTI, PRIM, PWR, RDUS, RGEN, RRD, RWLK, SAFM, SDRL, SEAS, SERV, SFM, SFUN, SHLD, SPAR, STWD, TD, TFX, TREE, TWI, UNT, UTHR, VAC, VC, VWR, W, WIN, WNR, WNRL, WPC, XCRA, ZBRA, ZEUS
Mon, Jan. 11, 12:49 PM
Nov. 20, 2015, 7:12 AM
- Amarin (NASDAQ:AMRN), through its wholly owned subsidiary Corsicanto Limited, inks a deal with one of its existing investors for the sale of $31.3M aggregate principal amount 3.50% November 2015 Exchangeable Senior Notes due 2032 for ~$27.5M (~12% discount). The new notes will have substantially the same terms as the company's 3.50% May 2014 Exchangeable Senior Notes except that the new notes will be issued by Amarin and are not guaranteed by an entity. They are exchangeable into Amarin's American Depositary Shares at an initial rate of 384.6154 ADSs per $1,000 principal amount (~$2.60 per ADS).
- Holders of the new notes have the option of requiring the company to purchase any outstanding new notes on each of January 19, 2019, January 19, 2024 and January 19, 2029 at 100% of principal plus accrued and unpaid interest. Amarin has the option of exchanging the new notes into ADSs with the proviso that the then-current ADS price is at least $2.86. If the company exercises its exchange option on or before January 15, 2018, in certain circumstances, then the exchange rate will be increased per a make-whole table that governs the new notes.
- About $15.9M of the proceeds will fund the purchase of some of the company's outstanding 3.50% Exchangeable Senior Notes due 2032 that were issued on January 9, 2012. After the transaction, about $15.1M will remain outstanding.
- Closing date is November 24.
Nov. 9, 2015, 10:05 AM
- A study of ~200 adult Japanese coronary heart disease (CHD) patients , called CHERRY, evaluating the efficacy of statin therapy [Livalo (pitavastatin)] alone and statin therapy in combination with highly-purified EPA showed that the addition of EPA significantly improved coronary plaque volume compared to treatment with statin alone. The data were presented yesterday at the American Heart Association Scientific Sessions in Orlando, Florida.
- After six to eight months, the EPA/statin cohort (n=97) showed statistically significant improvements in coronary plaque volume (p<0.001), lipid volume (p<0.05) and fibrous volume (p<0.05) while the statin-only cohort (n=96) failed to achieve statistical significance on any measure. The prevalence of clinically significant plaque regression, defined as more than a 15% reduction in plaque volume, was significantly greater in the EPA group versus the statin-only group (48% versus 25%; p<0.001).
- CHERRY is the first study to use IB-IVUS (integrated backscatter intravascular ultrasound) to measure the effects of statin plus EPA on plaque regression. It is considered a feasible means to predict future cardiovascular events while the analysis of specific tissue components is considered useful for assessing the risk of a coronary event in patients with atherosclerosis. The study was performed independently by researchers in Japan.
- EPA is the active ingredient in Amarin's (AMRN +6.9%) Vascepa (icosapent ethyl), which is currently being investigated for its potential to reduce the incidence of first major cardiovascular events in high-risk patients in an ~8,000-subject study called REDUCE-IT. The company expects to complete the trial in 2017 and publish results in 2018. Over 7,700 patients have been enrolled to date.
Nov. 9, 2015, 9:14 AM
Amarin Corp. Plc is a biopharmaceutical company, which engages in the commercialization and development of therapeutics to improve cardiovascular health. Its product, Vascepa capsules, is use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.... More
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