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Jul. 24, 2015, 7:29 AM
- The European Medicine's Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) for the treatment of certain adults with hypercholesterolemia. A final decision by the European Commission usually takes ~60 days.
- The PDUFA date for the FDA's decision is today.
Jul. 23, 2015, 1:47 PM
- Tomorrow is the FDA's action (PDUFA) date for its review of regulatory filings submitted by Amgen and Sanofi.
- Sanofi's (SNY +1.2%) NDA for cholesterol-lowering Praluent (alirocumab), co-developed with Regeneron Pharmaceuticals (REGN -0.2%). On June 9, the Ad Comm voted 13 - 3 supporting approval.
- Amgen's (AMGN -0.4%) sNDA for Kyprolis (carfilzomib) for the second-line treatment of relapsed multiple myeloma. Filing accepted for review on March 30.
Jul. 21, 2015, 8:03 AM
- As expected, the European Commission approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximum tolerated dose of a statin or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated. It is also approved to the treatment of adults and adolescents at least 12 years old with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies.
- Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved in the world. Regulatory clearance for Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) should happen shortly, however. PCSK9 inhibitors are poised to dominate the post-statin cholesterol-lowering market.
- Previously: Amgen gets EU backing for Repatha (May 22)
- Previously: Regeneron up 1.1% as trading reopens after Ad Comm approval (June 9)
Jul. 16, 2015, 11:42 AM
- Screen criteria: Market cap at least $500M; number of mutual fund investors at least equal to prior period; 50-day average turnover at least 400,000; annual sales at least $300M and EPS growth has accelerated the past three quarters.
- (ALKS +1%)(ALR +0.4%)(CERN +0.1%)(DVA +0.1%)(IMS +0.2%)(LLY +1%)(OMI +0.4%)(REGN +1.2%)(UNH -1.6%)(WAT +0.1%)
- This is not a list of buy/sell recommendations but rather a targeted list of stock that may be suitable for more in-depth research.
Jul. 10, 2015, 7:05 AM
- Ultragenyx (NASDAQ:RARE) initiated with Market Outperform rating with a $119 (6% upside) price target by JMP Securities.
- Regeneron Pharmaceuticals (NASDAQ:REGN) downgraded to Sell from Neutral by UBS. Price target maintained at $500 (2% downside risk).
- Amgen (NASDAQ:AMGN) downgraded to Neutral from Buy by UBS. Price target lowered to $165 (9% upside) from $185.
Jul. 9, 2015, 7:32 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) report that a Phase 3 trial in 216 Japanese patients, called ODYSSEY JAPAN, evaluating bad cholesterol-lowering Praluent (alirocumab) successfully met its primary endpoint. At week 24, the Praluent arm experienced a mean 64% greater reduction in low-density lipoprotein cholesterol (LDL-C) when added to current standard-of-care including statins compared to standard-of-care alone (p<0.0001). Also at week 24, 97% of patients reached their LDL-C treatment goal, with 99% remaining on the lower dose of 75 mg.
- The results were presented at the Annual Scientific Meeting of the Japan Atherosclerosis Society in Sendai, Japan. A regulatory submission is expected in the near future.
- Praluent, a PCSK9 inhibitor, is currently under regulatory review in the U.S. and Europe.
Jun. 26, 2015, 7:29 AM
- The Japanese Ministry of Health, Labour and Welfare approves the use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) injection for the treatment of patients with macular edema secondary to retinal vein occlusion (RVO). This new indication includes macular edema secondary to branch retinal vein occlusion (BRVO) in addition to the previously approved macular edema secondary to central retinal vein occlusion (CRVO).
- RVO, which includes BRVO and CRVO, is a chronic eye condition that can lead to a sudden loss of vision. It is second only to diabetic retinopathy as the most frequent cause of vision loss from diseases affecting the retina's blood vessels. RVO, BRVO and CRVO affect 16.4M, 13.9M and 2.5M people worldwide, respectively.
- Regeneron is partnering with Bayer HealthCare (OTCPK:BAYRY) on the global development of Eylea. Regeneron maintains exclusive rights in the U.S. while Bayer has exclusive rights ex-U.S. with the companies sharing equally in the profits. Regeneron receives a percentage of net sales of Eylea in Japan.
- In September 2012 Eylea was cleared in Japan for the treatment of wet AMD.
Jun. 15, 2015, 6:52 PM
- Relatively recent IPO Avalanche Biotechnologies (NASDAQ:AAVL) craters 40% after hours on robust volume in response to its announcement of top-line results from a Phase 2a study assessing its lead product candidate, AVA-101, in patients with wet age-related macular degeneration (wet AMD). The primary endpoint of the trial was safety, but secondary efficacy measures have apparently disappointed investors despite the study not being powered to show statistical significance.
- The trial enrolled 32 wet AMD patients at least 55 years old. They were randomized to receive AVA-101 (n=21) or control (n=11). Both arms received two ranibizumab injections [Roche's (OTCQX:RHHBY) Lucentis] at day 0 and week 4. Almost all (n=29/32) had received prior anti-VEGF therapy with a median of 10 prior injections.
- The mean change in best corrected visual acuity (BCVA) from baseline in the AVA-101 cohort was +2.2 letters compared to -9.3 letters for control. In addition, 42.9% of patients (n=9/21) receiving AVA-101 improved or maintained stable vision with two or fewer rescue injections compared to 9.1% (n=1/11) for control. BCVA improvement of at least 10 letters with no more than two rescue injections occurred in 23.8% of the AVA-101 arm versus 0% in control.
- The modest average letter gain for the AVA-101 arm is substantially less than published studies of Eylea and Lucentis, which have demonstrated mean improvements in BCVA scores of 18.9 letters and 14.2 letters, respectively. If the difference persists in subsequent studies, then Regeneron will be less likely to take advantage of its right of first negotiation for the rights to AVA-101.
- The value proposition of AVA-101, a gene therapy that contains a gene that encodes a naturally occurring anti-VEGF protein, is a single subretinal injection compared intravitreal (inside the eye) injections as frequent as once per month for Regeneron's (NASDAQ:REGN) Eylea and Roche's Lucentis.
Jun. 10, 2015, 3:58 PM| Jun. 10, 2015, 3:58 PM | 7 Comments
Jun. 10, 2015, 10:25 AM
- Esperion Therapeutics (ESPR -24%) drops on a 3x surge in volume as investors apparently perceive more modest prospects for the company's cholesterol-lowering drug candidate, ETC-1002, after yesterday's positive Ad Comm vote for Regeneron (REGN -4.9%) and Sanofi's (SNY +0.7%) Praluent (alirocumab), which is now poised for approval sometime this summer.
- UBS analyst Andrew Peters remains undeterred. He maintains his Buy rating and $140 price target.
- Previously: Esperion cholesterol-lowering drug candidate successful in Phase 2 study (March 17)
Jun. 10, 2015, 8:41 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) slumps 4% premarket on light volume in response to yesterday's Ad Comm vote on its cholesterol-lowering med Praluent (alirocumab), co-developed with Sanofi (NYSE:SNY).
- The committee voted 13-3 in favor of approval, but only in combination with a statin or as monotherapy in patients who cannot tolerate statins. Ideally, the vote would have supported the use of alirocumab as unconditional monotherapy.
- SNY is up a fraction premarket on modest volume.
Jun. 9, 2015, 6:51 PM
- Regeneron (NASDAQ:REGN) has reopened for trading, up 1.1% to $532, after an FDA Ad Comm ruling in favor of its and Sanofi's Praluent (alirocumab) cholesterol-lowering drug.
- Shares had been halted since just before 7 a.m.
- The vote was 13-3. On Wednesday, the committee turns its attention to Amgen's (NASDAQ:AMGN) drug evolocumab.
- Sanofi estimates that 11M Americans might qualify for the drugs, which could run up to $10K/year in cost. Amgen estimates that 8M Americans might qualify.
Jun. 9, 2015, 5:10 PM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee votes 13-3 recommending approval of Praluent (NYSE:SNY) (NASDAQ:REGN) (alirocumab).
- Previously: Ad Comm approaches for Sanofi/Regeneron cholesterol-lowering med (June 5)
- Previously: Regeneron's alirocumab shows durable effect in lowering "bad" cholesterol in high risk patients (March 16)
Jun. 9, 2015, 7:20 AM
Jun. 5, 2015, 11:02 AM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets Tuesday, June 9 to discuss the Biologics License Application (BLA) submitted by Sanofi (SNY -2.7%) seeing approval for Praluent (alirocumab) for the treatment of adult patients with high cholesterol (hypercholesterolemia) or mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C) as monotherapy or in combination with a statin. Sanofi and Regeneron Pharmaceuticals (REGN +1.9%) co-developed Praluent.
- FDA Briefing doc
- Sanofi/Regeneron briefing doc
- Addendum to Sanofi/Regeneron briefing doc
- The committee will review Amgen's (AMGN +0.1%) BLA for Repatha on Wednesday, June 10 (briefing docs not yet posted).
Jun. 5, 2015, 9:23 AM
- Amgen (NASDAQ:AMGN) announces the completion of enrollment of ~27,500 patients in the Phase 3 study, called FOURIER, assessing whether treatment with Repatha (evolocumab) reduces the risk of cardiovascular (CV) events in patients with high cholesterol and clinically relevant CV disease. The trial will compare Repatha in combination with statin therapy to placebo plus statin therapy. Results are expected no later than 2017.
- Evolocumab is an investigational fully human monoclonal antibody that inhibits convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.
- PCSK9 inhibitors are posed to dominate the post-statin cholesterol-lowering market. Amgen is neck-and-neck with Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab). Europe's CHMP recommended Repatha for approval several weeks ago. A final decision by the European Commission usually takes ~60 days. The EMA accepted the MAA for Praluent in January 2015. An FDA advisory committee will meet on June 9 to discuss Praluent's BLA and June 10 to discuss Rapatha's. The PDUFA date for Repatha is August 27 while Praluent's is July 24.
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