New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 12, 2014
16:20 EDTAZN, NKTRNektar: U.S. AADPAC recommends no cardiovascular trial for pamora class
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the majority of US FDA Anesthetic and Analgesic Drug Products Advisory Committee members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist class of drugs, which includes MOVANTIKTM, an investigational treatment for opioid-induced constipation for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act date set by the FDA for MOVANTIK is September 16.
News For NKTR;AZN From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
March 2, 2015
09:02 EDTAZNAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
Subscribe for More Information
February 27, 2015
06:24 EDTAZNAstraZeneca turning antibiotic R&D into separate subsidiary, Reuters reports
Subscribe for More Information
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)
Subscribe for More Information
February 23, 2015
12:53 EDTAZNAnalysts debate potential for competing Salix takeover bid
Subscribe for More Information
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
Subscribe for More Information
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use