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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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14:29 EDTINFIInfinity Pharmaceuticals to host research and development day
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10:19 EDTPFESpark 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 EDTAMGN, AGNBofa/Merrill healthcare analysts hold an analyst/industry conference call
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06:54 EDTJNJJohnson & Johnson resumed with a Neutral at Piper Jaffray
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05:29 EDTMRKDako announces FDA approval of new companion diagnostic assay
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October 4, 2015
19:07 EDTJNJCardinal Health sees Cordis acquisition adding more than 20c to FY17 EPS
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14:28 EDTMRKMerck to license Dificid in Taiwan for $3M plus milestone payments
OBI Pharma announced an agreement with Merck to transfer exclusive rights to develop and commercialize Dificid, or fidaxomicin, in Taiwan to Merck. OBI Pharma will receive an initial up-front payment of $3M and is eligible to receive royalties and payments associated with the completion of certain undisclosed milestones. Merck will be responsible for all future costs associated with commercialization, development, and manufacturing of Dificid in Taiwan.
October 2, 2015
15:43 EDTMRKQuest Diagnostics introduces Dako's PD-L1 companion diagnostic for KEYTRUDA
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15:25 EDTMRKAgilent's Dako confirms FDA approval of NSCLC diagnostic
Dako, an Agilent Technologies (A) company and a worldwide provider of cancer diagnostics, announced the FDA approval of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer, or NSCLC, is likely to respond to a new form of treatment. The approval of PD-L1 IHC 22C3 pharmDx strengthens Dako's portfolio of companion diagnostics and the company's leadership position in developing and commercializing companion diagnostic products. Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck (MRK), maker of the anti-PD-1 therapy Keytruda. The FDA approved PD-L1 IHC 22C3 pharmDx for use in the United States. Dako hopes to gain regulatory approval for the new diagnostic in Canada, Europe and other jurisdictions next year.
14:50 EDTMRKMerck confirms FDA approval of Keytruda
Merck announced that the FDA has approved Keytruda monotherapy, the company's anti-PD-1 therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. Under FDA's accelerated approval regulations, this indication for Keytruda is approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
14:14 EDTAGNGabelli liquidates stake in KYTHERA
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13:51 EDTMRKFDA approves Merck's Keytruda for advanced non-small cell lung cancer
The U.S. Food and Drug Administration granted accelerated approval for Keytruda to treat patients with advanced non-small cell lung cancer whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors. In 2014, Keytruda was approved to treat patients with advanced melanoma following treatment with ipilimumab, a type of immunotherapy. Keytruda is marketed by Merck and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America.
13:43 EDTMRKFDA approves Merck lung cancer treatment Keytruda
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10:50 EDTSNY, SHPGAmicus 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 EDTPFEOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Alexion (ALXN) upgraded to Overweight from Equal Weight at Morgan Stanley... BlackRock (BLK) upgraded to Buy from Neutral at UBS... Dunkin' Brands (DNKN) upgraded to Outperform from Underperform at CLSA... EnPro (NPO) upgraded to Buy from Neutral at Sidoti... Finish Line (FINL) upgraded to Neutral from Sell at Goldman... FutureFuel (FF) upgraded to Buy from Neutral at Roth Capital... Google (GOOG) upgraded to Outperform from Perform at Oppenheimer... Johnson Controls (JCI) upgraded to Buy from Neutral at Nomura... Kennametal (KMT) upgraded to Neutral from Underperform at BofA/Merrill... Lufthansa (DLAKY) upgraded to Buy from Hold at HSBC... Martin Marietta (MLM) upgraded to Buy from Neutral at Longbow... Northern Trust (NTRS) upgraded to Neutral from Sell at UBS... PMC-Sierra (PMCS) upgraded to Positive from Neutral at Susquehanna... Pfizer (PFE) upgraded to Overweight from Equal Weight at Morgan Stanley... Realogy (RLGY) upgraded to Buy from Neutral at Citi... Sarepta (SRPT) upgraded to Outperform from Neutral at Wedbush... Summit Materials (SUM) upgraded to Buy from Neutral at Goldman... TreeHouse (THS) upgraded to Buy from Neutral at BofA/Merrill... Vertex (VRTX) upgraded to Overweight from Equal Weight at Morgan Stanley.
08:31 EDTAGNAllergan and Humana announce research partnership
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08:16 EDTPFEPfizer upgraded to Overweight from Equal Weight at Morgan Stanley
Morgan Stanley upgraded Pfizer to Overweight and raised its price target to $38 from $35. Analyst David Risinger expects revenue growth to turn positive in 2016 after years of declines and said Pfizer has a strong balance sheet to take advantage of weakness in the pharma and biotech sectors. Risinger sees share upside with limited downside risk as fundamentals improve and management takes advantage of its strong financial position.
07:53 EDTSHPGShire has conference call hosted by JPMorgan
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07:04 EDTAGNHorizon Pharma enters settlement pact with Actavis Labs over RAYOS
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