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March 2, 2013
16:19 EDTSNY, REGNSanofi, Regeneron report positive proof-of-concept data for dupilumab
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.
News For SNY;REGN From The Last 14 Days
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October 6, 2015
18:48 EDTREGN, SNYExpress Scripts to include Praluent and Repatha in its formulary
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13:32 EDTSNYBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
07:23 EDTREGN, SNYAmerican Society of Human Genetics to hold annual meeting
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October 5, 2015
16:12 EDTSNYRegulus to present new preclinical data on RG-012 for kidney disease
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10:19 EDTREGNSpark trial success a positive for gene therapy sector, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer said he views the news that Spark Therapeutics (ONCE) "highly anticipated" SPK-RPE65 Phase 3 gene therapy study for congenital blindness met its primary endpoint as a positive for the ophthalmology gene therapy field as well as the broader gene therapy sector. Schimmer added that Applied Genetic Technologies' (AGTC) early clinical data in the second half of this year will be a further test of the ophthalmology gene therapy platform. The analyst noted that other companies with gene therapy programs include Avalanche (AAVL), Biogen (BIIB), bluebird bio (BLUE), BioMarin (BMRN), Cellectis (CLLS), Medgenics (MDGN), uniQure (QURE), Pfizer (PFE), Regeneron (REGN) and Sangamo (SGMO).
10:02 EDTREGNBofa/Merrill healthcare analysts hold an analyst/industry conference call
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October 2, 2015
11:18 EDTREGNMorgan Stanley downgrades select pharma stocks amid drug price scrutiny
Morgan Stanley downgraded several stocks in the pharmaceutical sector, dropping drugmakers Valeant (VRX), Gilead (GILD) and Regeneron (REGN) to Equal Weight from Overweight. The firm also downgraded specialty pharmacy Diplomat Pharmacy (DPLO) to Equal Weight and cut its rating on drug distributor AmerisourceBergen (ABC) to Underweight, the firm's equivalent of a sell rating. WHAT'S NEW: Democrats' scrutiny of high drug prices may continue, warned Morgan Stanley analyst David Risinger. As a result, it is hard to predict when Valeant, which generated 14% of its Q2 sales rise from price increases, will see its P/E multiple rise, Risinger believes. The company's lower multiple will hinder its ability to conduct M&A and swap or issue equity, according to Risinger, who set a $200 price target on the stock. Morgan Stanley analyst Matthew Harrison downgraded Gilead, noting that U.S. hepatitis C volume growth has dropped in the last few months. Although Harrison thinks that the U.S. hepatitis C market is still strong, he believes that the data could cause the Street to become concerned about Gilead's fourth quarter and 2016 outlook. He set a $127 price target on the shares. Harrison also downgraded Regeneron, stating his belief that two other drug makers, Alexion (ALXN) and Vertex (VRTX), have stronger near-term appreciation potential. He added that Regeneron has a number of potential negative catalysts, including drug pricing concerns and his belief, based on physician feedback, that the launch of the company's cholesterol drug, Praluent, could miss expectations. He set a $593 price target on the shares. AmerisourceBergen, which provides pharmaceutical sourcing and distribution service to healthcare providers, is the most levered to branded price inflation and that attribute could weigh on the shares, said Risinger, who cut his price target to $93 from $120 on the stock. The uncertain outlook for drug prices could keep the stock range-bound, added the analyst. PRICE ACTION: In morning trading, Valeant dropped 2.3% to $175.50, Gilead declined 1% to $97.26, Regeneron was flat near to $472 per share and AmerisourceBergen slid 1.3% to $93.25.
10:50 EDTSNYAmicus plunges after saying unlikely to submit migalastat NDA by year end
Shares of Amicus Therapeutics (FOLD) fell dramatically in morning trading after the company said it is unlikely to submit a New Drug Application for its Fabry disease treatment to the U.S. Food and Drug Administration by the end of the year. WHAT'S NEW: Amicus said this morning that it does not expect to be in the position to submit a New Drug Application for migalastat monotherapy, a treatment of Fabry disease, in the United States by the end of 2015 as a result of additional regulatory guidance from the FDA. The company said it received final FDA minutes from its September pre-NDA meeting and has had more follow-up meetings with the agency this week. Amicus said it plans to further evaluate several U.S. pathways to support submission requesting full approval, including gathering additional data. The FDA requested further integration of extant clinical data across studies, which requires more time to complete, the company said. WHAT'S NOTABLE: On September 15, Amicus Therapeutics said that, following a pre-NDA meeting with the FDA, it was still on track to submit an NDA for migalastat in the fourth quarter of 2015 under Accelerated Approval, which is only available to therapies for severe and life-threatening conditions that address "significant" unmet medical needs. In addition to the NDA submission, Amicus said it would submit for review the protocol for the Phase 4 study confirming "positive" effects of migalastat on gastrointestinal symptoms in patients. ANALYST OPINION: On September 16, Chardan analyst Gbola Amusa downgraded Amicus to Neutral from Buy, citing valuation and the stock's outperformance relative to the NASDAQ Biotechnology Index. At the time, Amusa said that Amicus' shares were near all-time highs and that he saw less scope for outperformance in the near-term. Amusa noted that, ahead of the Committee for Medicinal Products for Human Use's opinion on Amicus' Galafold, he thinks Amicus would be an "interesting" M&A target for Sanofi (SNY) and Shire (SHPG). Amusa said he sees a positive CHMP on Galafold by November or December, at which time the chances of Amicus getting acquired could increase. PRICE ACTION: Amicus Therapeutics dropped 32.07% to $9.28 in morning trading.
10:00 EDTREGNOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: AGCO (AGCO) downgraded to Underperform from Neutral at BofA/Merrill... AIG (AIG) downgraded to Market Perform with $63 target at FBR Capital... AmerisourceBergen (ABC) downgraded to Underweight from Equal Weight at Morgan Stanley... Astoria Financial (AF) downgraded to Hold from Buy at Sandler O'Neill... Capstone Turbine (CPST) downgraded to Hold from Buy at Craig-Hallum... Diplomat Pharmacy (DPLO) downgraded to Equal Weight from Overweight at Morgan Stanley... Fifth Third (FITB) downgraded to Neutral from Buy at Goldman... Gilead (GILD) downgraded to Equal Weight from Overweight at Morgan Stanley... Henkel (HENKY) downgraded to Neutral from Outperform at Exane BNP Paribas... Horsehead Holding (ZINC) downgraded to Perform from Outperform at Oppenheimer... LPL Financial (LPLA) downgraded to Sell from Neutral at UBS... MYR Group (MYRG) downgraded on electricity outlook at BB&T... Orion Marine (ORN) downgraded on reduced dredging awards at BB&T... QTS Realty Trust (QTS) downgraded to Hold from Buy at Stifel... Quanta Services (PWR) downgraded to Hold from Buy at BB&T... Regeneron (REGN) downgraded to Equal Weight from Overweight at Morgan Stanley... Ryanair (RYAAY) downgraded to Hold from Buy at HSBC... T. Rowe Price (TROW) downgraded to Neutral from Buy at UBS... Telekom Austria (TKAGY) downgraded to Hold from Buy at HSBC... Valeant (VRX) downgraded to Equal Weight from Overweight at Morgan Stanley.
07:06 EDTREGNRegeneron downgraded to Equal Weight from Overweight at Morgan Stanley
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October 1, 2015
16:09 EDTREGNRegeneron announces collaboration with Mitsubishi Tanabe Pharma
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13:58 EDTSNY, REGNExpress Scripts hints at slow start for new cholesterol drugs
An interview with Express Scripts' (ESRX) Everett Neville hinted at slow adoption rates for a pair of new cholesterol treatments known as PCSK9 inhibitors, spurring Piper Jaffray analysts to weigh in on the matter this morning. REJECTION RATES: In a Reuters interview published Wednesday, Express Scripts VP of Pharma Strategies and Chief Trade Relations Officer Everett Neville commented that two new PCSK9 drugs would not be "budget busters" because most prescriptions for the treatments are actually being denied. Praluent from Regeneron (REGN) and Sanofi (SNY) as well as Amgen's (AMGN) Repatha were approved in recent months to treat high cholesterol, but their $14,000-plus yearly costs have come under fire, including from the Institute for Clinical and Economic Review. "We're seeing a lot of patients who either don't qualify or their physicians are not providing [necessary] information," Neville explained, indicating that use of the cholesterol treatments is coming in at the low end of expectations. ANALYST BREAKDOWN: Piper Jaffray analyst Edward Tenthoff said Neville's statements "validate" his view that PCSK9 adoption rates would be vulnerable to pushback from reimbursers like Express Scripts. Tenthoff added that he continues to see a slow launch for Regeneron's Praluent in particular, especially given the lack of cardiovascular outcomes data. Fellow Piper Jaffray analyst Joshua Schimmer took a more optimistic view, acknowledging the apparently high prescription rejection rate but arguing that the patient pool for the drugs is expected to "grow substantially" once cardiovascular data is released. PRICE ACTION: Express Scripts shares have slipped roughly 0.9% amid broader market losses, while shares of Regeneron, Sanofi, and Amgen are all showing minor declines of less than 1%.
13:00 EDTSNYAlnylam recent weakness a buying opportunity, says Piper Jaffray
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08:56 EDTSNYSanofi launches authorized generic version of Arava for arhritis
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07:01 EDTSNYGenzyme opts into ALN-AT3 Hemophilia Program
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05:54 EDTREGNExpress Scripts hinted at slow anti-PCSK9 launches, says Piper Jaffray
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September 30, 2015
17:34 EDTSNY, REGNExpress Scripts says many PCSK9 prescriptions denied, Reuters reports
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September 29, 2015
12:35 EDTSNYPerrigo shareholders pressure company to explore sale, Reuters says
Certain Perrigo (PRGO) shareholders have requested that company explore a sale, hoping for an alternative to Mylan's (MYL) approximately $25B hostile bid, Reuters reports, citing people familiar with the matter. The pressure represents a challenge to Perrigo's defense strategy, the report says. Some of the company's shareholders view Novartis (NVS), Sanofi (SNY), Procter & Gamble (PG), and Colgate-Palmolive (CL) as potential suitors, the report says. Reference Link
08:07 EDTSNYSanofi announces FDA accepted filing of NDA for lixisenatide
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05:16 EDTSNYSanofi announces NDA for Lixisenatide accepted for review by FDA
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