Sep. 15, 2014, 1:30 PM
- Concert Pharmaceuticals (CNCE +13.9%) jumps on a 50% surge in volume albeit only 250K shares. Its up move coincides with Avanir Pharmaceuticals' (AVNR +66.3%) pop after it reported positive Phase 2 results for AVP-923.
- Concert's license agreement with Avanir pertains to deuterium-modified dextromethorphan (d-DM) which is what AVP-786 is based on. AVP-923 is a combination of dextromethorphan and quinidine sulfate.
Sep. 15, 2014, 12:48 PM
Sep. 15, 2014, 9:16 AM
- Avanir Pharmaceuticals (NASDAQ:AVNR) explodes 46% premarket on massive volume in response to its announcement of positive results from its Phase 2 trial evaluating AVP-923 for the treatment of agitation in patients with Alzheimer's disease. AVP-923 achieved the primary endpoint of a statistically significant reduction in agitation versus placebo (p=0.00008).
- There are no FDA-approved drugs for this indication.
- Avanir will present the study results at the American Neurological Association's Annual Meeting in Baltimore, MD, October 12-14, 2014.
Sep. 15, 2014, 9:15 AM
Sep. 10, 2014, 12:47 PM
Sep. 10, 2014, 12:42 PM| Sep. 10, 2014, 12:42 PM | Comment!
Aug. 26, 2014, 2:02 PM
Aug. 26, 2014, 1:38 PM
- Avanir Pharmaceuticals (AVNR +1%) initiates a Phase 2 study to evaluate the safety, tolerability and efficacy of AVP-786 for the adjunctive treatment of major depressive disorder (MDD). AVP-786 is a combination of deuterium-modified dextromethorphan and ultra-low dose quinidine.
- The 10-week 30-site trial will enroll ~200 patients who have had an inadequate response to commonly prescribed antidepressants. In an effort to reduce placebo response rates, the trial will utilize a sequential parallel comparison design.
- The primary efficacy endpoint is MADRS total score.
Aug. 5, 2014, 5:45 PM| Aug. 5, 2014, 5:45 PM | Comment!
Aug. 5, 2014, 4:06 PM
Aug. 4, 2014, 5:35 PM
- AMTG, APEI, ARC, ATSG, ATVI, AVNR, AWR, AXLL, BIO, BKH, BMR, CHUY, CLR, CRTO, CSU, DAVE, DIS, DPM, DRYS, ENPH, EOG, FANG, FEYE, FRGI, FSLR, FTR, FUEL, GMED, GRPN, HCI, HGR, HT, ITRI, JAZZ, JCOM, KAR, LBTYA, MCHX, MITT, MODN, MPO, MRCY, NSTG, NYMT, OAS, OKE, OKS, ORA, ORIG, PBPB, PEGA, PNNT, PRAA, PZZA, QUAD, REXX, RLD, RST, RSYS, SGMS, SGY, SKT, SMCI, TDW, TMHC, TPC, TRMB, TTWO, UNTD, WBMD, WES, WGP, WMGI, WTR, XEC, Z, ZAGG, ZGNX
Jul. 21, 2014, 9:46 AM
- The FDA accepts Avanir Pharmaceuticals' (AVNR) IND for a Phase 2 trial evaluating the safety and efficacy of AVP-786, its product candidate for the adjunctive treatment of major depressive disorder (MDD). The firm expects to start the trial in Q3 2014.
- The 200-patient, randomized, double-blind, placebo-controlled proof-of-concept study will assess AVP-786 in patients suffering from MDD who have had inadequate responses to commonly prescribed antidepressants. The primary endpoint is the Montgomery-Asberg Depression Rating Scale (MADRS) total score versus placebo.
- AVP-786 the next generation AVP-923 compound. It is a combination of deuterium-modifed dextromethorphan and ultra-low dose quinidine.
Jul. 16, 2014, 9:25 AM
- Interim results from Avanir Pharmaceuticals' (NASDAQ:AVNR) 450-patient 12-week Phase 4 clinical trial of Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) demonstrate a substantial reduction in symptoms of pseudobulbar effect (PBA) in patients with Alzheimer's disease. PBA is a neurologic condition characterized by sudden and uncontrolled outbursts of laughing and/or crying in patients with neurolgic disease/injury.
- At baseline, patients had a mean CNS-LS score of 20.2 and suffered a median of 29 PBA episodes per week. At the end of the study, mean CNS-LS improved to 12.8 and median PBA episodes dropped to 5 per week.
- 77.8% of patients or caregivers rated themselves/patients as being much/very improved.
- 79.3% of clinicians rated the patient much/very much improved.
- Nuedexta is the only FDA-approved treatment for PBA.
Jun. 10, 2014, 5:55 PM
Jun. 10, 2014, 1:35 PM
- In a 275-patient Phase 3b clinical trial, Avanir Pharmaceuticals' (AVNR +1.7%) investigational migraine drug-device combination AVP-825 met its primary efficacy endpoint of achieving greater pain relief 30 minutes post dose compared to a 100 mg sumatriptan tablet. Several additional secondary endpoints were also met.
- AVP-825 is a combination of low-dose sumatriptan powder (22 mg) delivered intranasally via a plastic handheld apparatus (corporate presentation, Slide 13). The user exhales into the device which propels the medication into one side of the nose where it is absorbed deep in the nasal cavity. The potential to swallow or inhale sumatriptan powder is minimized by the automatic closing of the soft palate when exhaling into the device.
Jun. 10, 2014, 9:13 AM
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