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Mon, Jan. 26, 8:47 AM
- Citing its lack of abuse and dependence potential, the U.S. Drug Enforcement Agency (DEA) removes naloxegol from its list of Schedule II drugs.
- Naloxegol was developed by Nektar Therapeutics (NASDAQ:NKTR) for the treatment of opioid-induced constipation. It is marketed under the brand name Movantik by AstraZeneca (NYSE:AZN).
Dec. 9, 2014, 7:14 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Moventig (naloxegol) for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives. It is the first once-daily oral peripherally -acting mu-opioid receptor agonist (PAMORA) approved in the EU.
- Moventig is part of an exclusive worldwide license agreement initiated in 2009 with Nektar Therapeutics (NASDAQ:NKTR). The product utilizes Nektar's oral small molecule polymer conjugate technology.
- Previously: Ad Comm supports approval of Moventig for OIC (Sept. 26, 2014)
- Previously: FDA clears OIC drug (Sept. 16, 2014)
- OIC-related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
Dec. 3, 2014, 12:45 PM
Nov. 6, 2014, 5:36 PM
Nov. 6, 2014, 4:45 PM| Comment!
Nov. 1, 2014, 6:19 PM
Oct. 16, 2014, 9:52 AM
- In conjunction with development partner Actavis (ACT -0.5%), Ironwood Pharmaceuticals (IRWD -0.7%) initiates a Phase 2 clinical trial (~240 patients) to assess the safety and efficacy of linaclotide for the treatment of adults with opioid-induced constipation (OIC). Data is expected in 2H 2015.
- Linaclotide is currently FDA-approved for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation.
- OIC-related tickers: (SLXP -0.6%)(PGNX +1.9%)(NKTR -0.5%)(AZN -2%)(CBST +0.1%)(SGYP +0.7%)(SCMP -0.3%)
Sep. 29, 2014, 6:07 PM
- Following a successful Phase 3 trial, the FDA has approved Relistor for "the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain."
- Salix (NASDAQ:SLXP) will sell Relistor under a license from developer Progenics (NASDAQ:PGNX). Many expected FDA approval to arrive following a favorable July ruling.
- PGNX +3.4% AH.
- Related tickers: (AZN)(CBST +0.9%)(SGYP -3.4%)(NKTR -0.9%)
Sep. 26, 2014, 8:35 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Nektar Therapeutics' (NASDAQ:NKTR) Moventig (naloxegol) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives.
- Moventig is a peripherally-acting mu-opioid receptor antagonist (PAMORA). The once-daily tablet blocks the binding of opioids to opioid receptors in tissues such as the gastrointestinal tract.
- The drug candidate is based on Nektar Therapeutics' (NKTR) oral small molecule polymer conjugate technology which AstraZeneca (NYSE:AZN) licensed in 2009. It was cleared for sale in the U.S. on September 16 under the name Movantik. AstraZeneca is responsible for commercialization worldwide.
- Under the terms of the license agreement, Nektar is eligible to receive up to $235M in aggregate regulatory and launch milestones, tiered sales-related milestones up to $375M and double-digit royalties on net global sales.
- Related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
Sep. 23, 2014, 12:31 PM| Comment!
Sep. 16, 2014, 10:51 AM
- The FDA approves Nektar Therapeutics' (NKTR -0.1%) Movantik (naloxegol) for the treatment of patients with opioid-induced constipation who take opioids for the management of chronic non-cancer pain.
- Movantik is distributed by AstraZeneca (AZN -0.9%).
- Related tickers: (PGNX -0.2%) (SLXP +3.7%) (CBST +0.1%)
Aug. 11, 2014, 7:47 AM
- The FDA assigns a PDUFA date of September 29, 2014 for Salix Pharmaceuticals' (NASDAQ:SLXP) sNDA for Relistor (methylnaltrexone bromide) for treatment of opioid-induced constipation.
- Salix successfully appealed a CRL that the agency issued on July 27, 2012.
- Related tickers: (NASDAQ:PGNX) (NASDAQ:NKTR) (NYSE:AZN) (NASDAQ:CBST)
Jul. 31, 2014, 4:34 PM
NKTR vs. ETF Alternatives
Nektar Therapeutics Inc is a clinical-stage biopharmaceutical company. The Company develops a pipeline of drug candidates that utilizes its PEGylation and polymer conjugate technology platforms that are designed to developmolecular entities.
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