Tue, Feb. 24, 5:39 PM
Dec. 3, 2014, 12:45 PM
Nov. 6, 2014, 5:36 PM
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%)
Jun. 13, 2014, 12:46 PM
Jun. 13, 2014, 9:11 AM
Jun. 12, 2014, 6:48 PM
- Nektar Therapeutics (NKTR) +9.2% AH after a long trading halt, as an FDA advisory panel recommended against requiring cardiovascular outcome trials for a certain class of drugs - including NKTR's Movantik - in the treatment of constipation caused by opioid medicines (earlier).
- The drug treatment, being developed by NKTR partner AstraZeneca (AZN), also is being reviewed by health agencies in the European Union and Canada.
- The FDA is expected to make a decision on Movantik by Sept. 16.
Jun. 12, 2014, 5:36 PM
Jun. 11, 2014, 8:28 AM
- The NASDAQ halts trading of Progenix Pharmaceuticals (PGNX) while the FDA's Anesthetic and Analgesic Drug Products Ad Comm meets today and tomorrow to discuss the potential cardiovascular risks associated with peripherally-acting opioid receptor agonists and the design and size of cardiovascular outcomes trials needed to support the approval of drugs in the class for the indication of opioid-induced constipation (OIC).
- The Ad Comm meeting was originally announced in June 2013 in response to an appeal by Progenics' collaboration partner Salix Pharmaceuticals (SLXP) of a CRL it received in July 2012 regarding its NDA for Relistor (methylnaltrexone bromide) for the treatment of opioid-induced constipation in patients with chronic non-cancer pain.
- The FDA stated that it will take action under the appeal within 30 days after receiving input from the Advisory Committee.
- Trading in Nektar Therapeutics (NKTR) has been halted as well. Its product candidate for OIC is Movantik (naloxegol oxalate).
- Briefing docs
Feb. 26, 2014, 5:37 PM
Jan. 21, 2014, 5:46 PM
Nov. 8, 2013, 12:53 PM
Nov. 8, 2013, 11:33 AM
- Nektar Therapeutics (NKTR +19.3%) rallies after Q3 results come in well ahead of Street estimates.
- The company says it is "working with advisors and the FDA to design an optimal Phase 3 program" for NKTR-181. Initiation expected by "mid-2014."
- Q3 R&D spend: $43.9M.
- BAX 855 BLA still on track for 2014.
- Cash as of September 30: $208.6M. (PR)
Sep. 27, 2013, 2:55 PM
- William Blair and Brean are out positive on Nektar Therapeutics (NKTR -19.9%) amid a rather dramatic sell-off triggered by NKTR-181's Phase 2 miss. (previous coverage)
- Due to "significant progress with both its proprietary and partnered programs [and] the breadth of development with its technology platform," NKTR remains a viable asset," William Blair's John Sonnier says.
- "Perhaps more severe patients need to be enrolled in order to see a difference between drug and placebo," Brean's Jonathan Aschoff muses, reiterating a Buy rating but lowering his price target to $14 from $17.
Sep. 27, 2013, 12:45 PM
Sep. 27, 2013, 9:15 AM
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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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