Avanir Pharmaceuticals (AVNR) is a biopharmaceutical company, focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders (CNS). The company just released top line results of their phase 2 trial for the treatment of agitation / aggression in Alzheimer's patients that were statistically significant. The stock increased almost 100% after the top line results were released.
Quick Facts:
206 million shares outstanding
2.3 billion market cap
$317 million in cash
Intellectual Property:
AVP-923 US 2026
AVP-923 EU 2023
AVP-786 US 2030
AVP-786 EU 2028
AVP-923 (Nuedexta)
Approved in the U.S. for (PBA), Pseudobulbar Affect, and approved in the EU also for PBA. Commercialization in the U.S. in 2011, and EU currently underway.
Phase 2 trial for Agitation / Aggression in Alzheimer's patients:
JAMA Phase 2 Agitation Alzheimer's
Primary endpoint .001 on the agitation/aggression domain score of the NPI
Stage 1 (baseline to week 5) .001
Stage 2 (week 5 to week 10 change) .02
Cornell Scale for Depression in Dementia, 10 week = .03
AVP-786 Adjunct Therapy Major Depressive Disorder
NCT02153502
Phase 2 - Results 2016
Bottom Line: Avanir Pharmaceuticals has many moving parts in various stages of progress. The most important date for this company is the PDUFA date of November 26, 2014, which will be the FDA's decision on whether to approve AVP-825 for acute treatment of migraine. This is an inhaled treatment that has proven much more effective than oral capsule. The recent top line results look very promising for AVP-923 in Alzheimer's patients who are experiencing agitation / aggression. AVP-786 holds promise for CNS indications and it has patent out to 2030 U.S. Thank you for reading.
Quick Facts:
206 million shares outstanding
2.3 billion market cap
$317 million in cash
Intellectual Property:
AVP-923 US 2026
AVP-923 EU 2023
AVP-786 US 2030
AVP-786 EU 2028
AVP-923 (Nuedexta)
Approved in the U.S. for (PBA), Pseudobulbar Affect, and approved in the EU also for PBA. Commercialization in the U.S. in 2011, and EU currently underway.
Phase 2 trial for Agitation / Aggression in Alzheimer's patients:
JAMA Phase 2 Agitation Alzheimer's
Primary endpoint .001 on the agitation/aggression domain score of the NPI
Stage 1 (baseline to week 5) .001
Stage 2 (week 5 to week 10 change) .02
Cornell Scale for Depression in Dementia, 10 week = .03
AVP-786 Adjunct Therapy Major Depressive Disorder
NCT02153502
Phase 2 - Results 2016
Bottom Line: Avanir Pharmaceuticals has many moving parts in various stages of progress. The most important date for this company is the PDUFA date of November 26, 2014, which will be the FDA's decision on whether to approve AVP-825 for acute treatment of migraine. This is an inhaled treatment that has proven much more effective than oral capsule. The recent top line results look very promising for AVP-923 in Alzheimer's patients who are experiencing agitation / aggression. AVP-786 holds promise for CNS indications and it has patent out to 2030 U.S. Thank you for reading.
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