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News Breaks
June 12, 2014
13:29 EDTAZN, NKTRNektar Naloxegol can still be approved around end of year, says Piper Jaffray
After most members of an FDA panel voted against requiring a cardiovascular outcomes trial for Nektar's (NKTR) and AstraZeneca's (AZN) naloxegol and other similar drugs drugs, Piper Jaffray thinks the vote seems to be positive for Nektar. However, the firm thinks the drug's precise path to market remains uncertain, given what it sees as "FDA dysfunction." Piper continues to believe that the most likely outcome is that the drug will be approved around the end of 2014 and be launched in the first quarter of 2015. It reiterates an Overweight rating on Nektar.
News For NKTR;AZN From The Last 14 Days
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February 27, 2015
06:24 EDTAZNAstraZeneca turning antibiotic R&D into separate subsidiary, Reuters reports
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February 25, 2015
13:08 EDTNKTRNektar volatility increases on start of Phase 3 study of NKTR-181
Nektar March call option implied volatility is at 87, April is at 78, May is at 74; compared to its 26-week average of 70 according to Track Data, suggesting large near term price movement on the announcement of the start of Phase 3 study of NKTR-181.
09:28 EDTNKTRNektar announces start of Phase 3 study of NKTR-181
Nektar announced the enrollment of the first patient in SUMMIT-07, its initial Phase 3 study of NKTR-181, a first-in-class, opioid analgesic molecule with a slow rate of entry into the brain. The company said this slow rate of entry is designed to reduce the euphoria that can lead to the abuse of current opioid analgesics. SUMMIT-07 will evaluate the efficacy, safety and tolerability of NKTR-181 in patients with chronic low back pain who are also opioid-na´ve. NKTR-181 is a new chemical entity that was created using Nektar's proprietary small molecule polymer conjugate technology. NKTR-181 has several potential differentiating properties that are inherent to the structure of the molecule, including a slow rate of entry into the CNS as measured by pupillometry and a plasma pharmacokinetic profile that supports twice-daily oral dosing. NKTR-181 is not a reformulation of a marketed opioid, which is a commonly-used method to attempt to prevent the manipulation of existing long-acting opioid drugs into more abusable forms. NKTR-181 has been granted has been granted Fast Track designation for the treatment of moderate to severe chronic pain by the U.S. Food and Drug Administration.
February 24, 2015
17:00 EDTNKTRNektar reports Q4 EPS (35c), consensus (36c)
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February 23, 2015
12:53 EDTAZNAnalysts debate potential for competing Salix takeover bid
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07:55 EDTAZNJefferies says other bidders may emerge for Salix
Jefferies says it could envision other bidders emerging for Salix (SLXP) and points out recent media reports have suggested Shire (SHPG) and Endo (ENDP) have considered making a bid for the company. It lists AstraZeneca (AZN) and Takeda as others who could have possible interest in Salix. The firm believes Valeant (VRX) could afford to pay more for Salix should other bidders emerge.
February 20, 2015
07:23 EDTAZNAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTAZNAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 17, 2015
17:16 EDTAZNActavis confirms temporary injunction related to generic Pulmicort RESPULES
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