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Eli Lilly and Company (LLY)

  • Yesterday, 10:48 AM
    • Eli Lilly (LLY +1.9%) says the FDA's approved Synjardy (empagliflozin and metformin hydrochloride) for treating adults with type 2 diabetes -- the fifth approval to come from a diabetes drug alliance with Boehringer Ingelheim Pharmaceuticals.
    • It's the third product with empagliflozin, which removes excess glucose through the urine by blocking re-absorption in the kidney. Metformin works in a complementary way, lowering glucose production by the liver.
    • The treatment also got approval from the European Medicines Agency in May.
    • Previously: Large scale CVOT shows superiority of Jardiance in reducing CV risk in type 2 diabetics (Aug. 20 2015)
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  • Wed, Aug. 5, 7:35 AM
    • Nano cap Biocept (NASDAQ:BIOC) launches its proprietary quantitative Target Selector assay targeting KRAS mutations, a predictive biomarker in cancer. The assay is performed on a blood sample (liquid biopsy) instead of a tissue biopsy which allows physicians to more easily monitor cancer patients for response to treatment and progression of disease.
    • ~40% of colorectal cancer patients are KRAS mutation positive. KRAS is also present in high frequency in other solid tumor cancers including lung and pancreatic cancers. Patients with the mutation are much more resistant to anti-EGFR monoclonal antibodies such as Amgen's (NASDAQ:AMGNVectibix (panitumumab) and Lilly's (NYSE:LLYErbitux (cetuximab).
    • Investors should keep an eye on the uptake of this test. If robust, then it validates its value proposition of a more convenient, cheaper and much less invasive method of monitoring cancer patients. To date, investors appear to lack confidence in the company's prospects. Shares are down 76% since its IPO at $10 in February 2014.
    • Shares are up 10% premarket on light volume.
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  • Wed, Jul. 15, 11:21 AM
    • "We are not making a negative call on the Alzheimer’s data readout on July 22," says analyst David Risinger, downgrading Lilly (LLY -1.5%) to Equalweight from Overweight, noting the stock is up 28% YTD versus the Pharmaceutical Index's 11% gain.
    • At current prices, says Risinger, investors appear to have factored in blockbuster enthusiasm for both solanezumab for Alzheimer’s and evacetrapib for cholesterol. "We see a balance risk-reward."
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  • Tue, Mar. 3, 11:46 AM
    • As Ben Levisohn reports, Goldman Sachs analyst Jay Olson downgraded MannKind (MNKD -9.6%) after he revised his valuation model to include net discounts to Afrezza of 40% instead of 20% in light of the downward price pressure from payers to other diabetes product makers.
    • He cites the recent launches of Boehringer Ingelheim's Jardiance (empagliflozin) tablets and Eli Lilly's (LLY -1%) Trulicity (dulaglutide injection) that came in 75% below his Q4 estimates. Afrezza's launch trajectory based on script data, albeit early stage, is also falling short of expectations.
    • Mr. Olson has lowered his 2025 sales projection 50% for Afrezza to $1B from $2B and reduced EPS estimates from 2017 onward. He believes that MannKind will achieve the sales targets required to capture $925M in milestones from commercial partner Sanofi (SNY -0.1%), however.
    • His $3 price target leaves a 50% downside from the current price.
    • Previously: MannKind off 10% premarket on Goldman downgrade (March 3)
  • Dec. 22, 2014, 8:23 AM
    • A Phase 3 clinical trial evaluating Radius Health's (NASDAQ:RDUS) investigational drug abaloparatide-SC for the treatment of women with postmenopausal osteoporosis met its primary endpoint of a statistically significant (83%) reduction in incident vertebral fractures compared to placebo (p<0.0001) (fracture rate: 0.72% versus 4.36%).
    • The open-label portion assessing Eli Lilly's (NYSE:LLY) Forteo (teriparatide injection), also achieved its primary endpoint of a statistically significant (78%) reduction in incident vertebral fractures compared to placebo (p<0.0001) (fracture rate: 0.98% versus 4.36%).
    • All secondary endpoints were met as well.
    • Abaloparatide is a synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP), a naturally occurring bone building hormone.
    • The company expects to submit is New Drug Application (NDA) in H2 2015.
    • Shares are up 6% premarket on light volume.
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  • Sep. 24, 2014, 10:52 AM
    • Lipocine's (LPCN +40.8%) oral testosterone replacement therapy candidate, LPCN 1021, achieves its primary efficacy endpoint in a Phase 3 clinical trial.
    • The FDA guidelines for primary efficacy success stipulate a minimum of 75% of trial subjects on active treatment achieve a serum testosterone concentration within the normal range of 300-1140 ng/dL and the lower bound of the 95% CI (confidence interval) must be greater than 65%.
    • In the Phase 3 study, 88% of LPCN 1021-treated patients achieved testosterone levels in the normal range with a lower bound CI of 82%.
    • LPCN 1021's safety profile was acceptable as well. Three percent of the subjects reported a serious adverse event, though none were drug-related. All drug-related adverse events were mild or moderate. The safety extension phase of the trial is ongoing.
    • One aspect of the value proposition of oral TRT therapy is the elimination of the risk of inadvertent testosterone transfer associated with transdermal gels (before the gel dries).
    • Related tickers: (LLY +0.6%)(ABBV +1.1%)(RPRX +8.1%)(AUXL -0.2%)(TEVA +0.4%)
  • Feb. 4, 2014, 2:33 PM
    • Novartis (NVS -0.7%) reportedly is drawing interest for its human vaccines unit as talks to swap its animal health business for assets from Merck (MRK +2.6%) slow down.
    • While the vaccines unit was initially on the table with animal health as part of the possible trade for MRK’s over-the-counter drugs business, NVS may now sell the vaccines unit separately in a deal that could be valued at ~$1B.
    • NVS and MRK are still talking but agreeing on valuation is proving difficult, so NVS has informally talked to Eli Lilly (LLY -0.1%) and Bayer (BAYRY, BAYZF) about the animal health business, according to the report.
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  • Jan. 31, 2014, 7:40 AM
    • Sanofi (SNY) has sued Eli Lilly (LLY) over the alleged infringement of patents related to the French company's top-selling Lantus diabetes treatment.
    • Sanofi's action comes a month after Lilly filed for FDA approval to sell a biosimilar version of Lantus and questioned the validity of several of its patents.
    • Sanofi's suit has triggered an automatic 30-month stay of approval by the FDA, which means Lilly won't be able to market its biosimilar drug until mid-2016, over a year later than previously expected.
    • Lantus generates worldwide revenue of $7B but is due to lose patent protection in the U.S. in February 2015.
    • Sanofi's shares were -1.7% premarket, while those of Novo Nordisk (NVO), another major provider of insulin products, were +3.3%.
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  • Jan. 10, 2014, 10:43 AM
    • Ironwood Pharmaceuticals (IRWD +4.9%) upgraded to Outperform from Market Perform at BMO. Price target is $16.
    • Bristol-Myers Squibb (BMY +0.7%upgraded to Overweight from Equalweight at Barclays. Price target hiked to $65 from $52.
    • Sequenom (SQNM -3.4%) cut to Neutral from Overweight at Piper. Price target is $2.50.
    • BioMarin (BMRN -2.2%cut to Equalweight from Overweight at Barclays. Price target is $73.
    • Johnson & Johnson (JNJ -0.5%cut to Equalweight from Overweight at Barclays. Price target is $99.
    • Pfizer (PFE -0.6%cut to Market Perform at Cowen. Price target is $34.
    • Eli Lilly (LLY -0.4%) downgraded to Underweight from Equalweight at Barclays. Price target cut to $51 from $58.
    • H.C. Wainwright starts Celsion (CLSN +7.7%) at Buy. Price target is $8.
    • Orexigen (OREX +1.1%initiated at Buy with a $9 target at Wallachbeth.
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  • Dec. 18, 2013, 5:35 PM
    • Top gainers, as of 5:15 p.m.: ALIM +38.0%. PSDV +36.4%. AKS +7.6%. GST +7.3%. USU +7.1%.
    • Top losers, as of 5:15 p.m.: RMGN -13.0%. APOG -2.5%. LLY -2.3%. BXE -2.2%. AEPI -2.1%.
    | 1 Comment
  • Nov. 11, 2013, 9:01 AM
    • Goldman cuts Eli Lilly (LLY) to Sell from Neutral.
    • Same story here, patent expirations and a thin pipeline equate to an uncertain outlook. Here's analyst Jami Rubin: "As LLY's primary care business declines due to patent expirations, the new product portfolio is increasingly important [but] we see a lack of differentiation for key pipeline products."
    • Rubin also points to the stock's premium valuation relative to ABBV.
    • Price target cut to $48 from $52.
    • LLY -1.5% premarket
  • Sep. 26, 2013, 2:11 PM
    • As expected, the Street is out negative on Eli Lilly's (LLY -3.3%) ramucirumab, as positive results in gastric cancer aren't enough to make up for the breast cancer miss.
    • "Breast cancer would have been a significant commercial opportunity," Goldman's Jami Rubin says, adding that although "gastric cancer is an area with significant unmet medical need," the ROSE miss may ultimately cost the company dearly on top line.
    • Goldman now sees 2018 ramucirumab sales of $420M versus $1.7B previously.
    • Price target lowered to $54 from $56.
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  • Sep. 26, 2013, 7:55 AM
    • Eli Lilly's (LLY) ramucirumab — which the company gained access to in 2008 with the $6.5B ImClone deal — meets its primary endpoint of extending both overall survival and progression-free survival in a Phase 3 trial enrolling patients with advanced gastric cancer.
    • The RAINBOW trial (which combined ramucirumab and paclitaxel) results follow similarly encouraging results from the single-agent trial REGARD.
    • However, LLY says ramucirumab did not meet its primary endpoint in ROSE, a Phase 3 study in women with locally recurrent or metastatic breast cancer and that appears to be what investors are focusing on. (PR)
    • LLY -5% premarket.
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  • Sep. 17, 2013, 1:47 PM
    • One of today's big movers is Repros Therapeutics (RPRX +11.3%), as fresh data on Androxal has the stock on a tear.
    • If you follow healthcare stocks closely, you know you can often look for the bear thesis from theStreet's Adam Feuerstein — today's RPRX rally is no exception.
    • Among the things Feuerstein wants to know: 1) "What was the rate of testosterone normalization for men treated with placebo?" 2) "What were the baseline and end-of-treatment levels of testosterone for patients in both arms of the study?", and 3) "Was the testosterone normalization endpoint reached with statistical significance?"
    • Other concerns include an apparently non-committal stance on whether the sperm-count endpoint was met and the prospect of a "messy challenge" to Androxal's patents (more on this here).
    • Companies who market "low T" treatments include ABBV, AUXL, and LLY
  • Aug. 28, 2013, 1:39 PM
    • ImmunoGen (IMGN +2.6%) spikes after an 8-K filed today shows the company has entered into a licensing agreement with Eli Lilly (LLY +0.6%).
    • Under the terms of the deal, LLY is granted exclusive use of IMGN's maytansinoid-based TAP technology to create and market "products directed to a specific antigen target."
    • IMGN is entitled to receive as much as $200.5M in milestone-related payments plus royalties on any future commercial sales. (8-K)
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  • Aug. 13, 2013, 9:47 AM
    • Analysts have been quick to downplay what appear to be positive Phase III results for Eli Lilly's (LLY +4.2%) lung cancer drug Necitumumab.
    • BMO doubts that the benefit to overall survivability of Necitumumab is meaningful (probably ~1 month) and worth the additional toxicity.
    • Citi is making a call to sell Lilly, as the stock is up too much vs what might be just a $300M opportunity.
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Company Description
Eli Lilly and Co is a drug manufacturing company. It discovers, develops, manufactures, and sells human pharmaceutical products and animal health products.