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News For PFE;BMY;NVS;LLY From The Last 14 Days
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October 6, 2015
16:12 EDTPFETRACON Pharmaceuticals appoints Ronald Shazer as Chief Medical Officer
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13:32 EDTNVS, BMY, LLY, PFEBiotechs 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 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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07:01 EDTBMYBristol-Myers says granted FDA priority review for Daklinza sNDAs
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05:23 EDTLLYEli Lilly, Adocia initiate Phase 1b study of BioChaperone Lispro
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October 5, 2015
11:09 EDTBMYBristol-Myers to pay $14M to settle SEC charge of FCPA violations
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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).
05:25 EDTNVSAlcon receives FDA approval for AcrySof IQ Aspheric IOL
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October 2, 2015
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.
08:16 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.
October 1, 2015
11:06 EDTNVSXOMA price target raised to $1.50 from $1 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for XOMA (XOMA) to $1.50 after the company partnered a preclinical TGF-beta antibody with Novartis (NVS) for $37M upfront and up to $480M in milestones. The payment brings XOMA's pro forma cash to $88M, enabling the company to advance its endocrine antibody pipeline, including lead candidate XOMA 358 for hyperinsulinism disorders, Tenthoff tells investors in a research note. The analyst keeps a Neutral rating on the name. The stock is up 20c to 95c in early trading.
11:04 EDTBMYBristol-Myers says Opdivo-Yervoy combo to cost about $265,000/year on average
Bloomberg reported on pricing for Bristol-Myers' Opdivo in combination with Yervoy, citing a company spokesperson.
10:37 EDTLLYBofA/Merrill's Top 10 US Ideas for Q4 2015
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08:04 EDTPFEPfizer completes acquisition of Nimerix, Mencevax from GSK
Pfizer (PFE) announced that it has completed the acquisition of GlaxoSmithKline's (GSK) quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.
07:39 EDTPFE, BMYJPMorgan sees opportunities in pharma after pullback
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07:37 EDTNVSXOMA announces agreement for anti-TGFb program with Novartis
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07:31 EDTPFE, BMYLeerink to hold a roundtable
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07:04 EDTBMYBristol-Myers' Opdivo + Yervoy regimen for melanoma approved by FDA
Bristol-Myers announced that the FDA approved Opdivo - nivolumab - in combination with Yervoy - ipilimumab -, for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This is the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The approval is based on data from the pivotal study, CheckMate -069. Results from the trial demonstrated a statistically significant increase in confirmed objective response rate - the study's primary endpoint - in patients with BRAF wild-type melanoma treated with the Opdivo + Yervoy Regimen vs. those treated with Yervoy monotherapy. Complete responses were seen in 17% of patients. Partial responses were seen in 43% of the Regimen group and 11% of the Yervoy monotherapy group. Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, other adverse reactions; infusion reactions; and embryofetal toxicity.
September 30, 2015
17:04 EDTNVSNovartis says results of Phase 3 study of secukinumab met endpoints
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09:59 EDTPFEActive equity options trading on open
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