Kite Pharma announced successful data from ZUMA-1 pivotal trial in relapsed/refractory B cell non-Hodgkin's lymphoma (ORR=82%). FDA approval application has been initiated. The stock jumped about 25%. Our update note to subscribers of the premium service can be accessed here.
Another significant news was FDA acceptance of Dynavax Technologies' (NASDAQ:DVAX) response to CRL for HEPLISAV-B vaccine. FDA has set PDUFA on August 10, 2017. The stock jumped about 27% after-hours today. Our update note to subscribers of the premium service can be accessed here.
Cempra (NASDAQ:CEMP) announced its quarterly report today. A phase 3 trial of Solithromycin in treatment of gonorrhea did not reach the primary end-point despite encouraging data in females. Our update note to subscribers of the premium service can be accessed here.
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Ac Immune (NASDAQ:ACIU) and partner Genentech (OTCQX:RHHBY) will start a second phase 3 study of crenezumab (humanized IgG4 monoclonal antibody) in mild Alzheimer's disease. The first phase 3 CREAD trial is also enrolling patients.
Valeant (VRX) stock was down 14% after announcing disappointing quarterly earnings and 2017 guidance. Several brokerages downgraded the stock including Wells Fargo, Mizuho and RBC Capital.
Adamas Pharmaceuticals (NASDAQ:ADMS) announced additional data from an open-label phase 3 study of ADS-5102 to treat levodopa-induced dyskinesia (LID) in Parkinson's disease. The data showed reduction in LID for up to 64 weeks. FDA already accepted NDA for the drug with PDUFA date on August 24, 2017.
FDA accepted NDA for Eagle Pharma's (NASDAQ:EGRX) pemterexed for treatment of locally advanced/metastatic non small cell lung cancer. FDA also accepted Teva Pharmaceuticals' (NYSE:TEVA) NDA for SD-809 for tardive dyskinesia (PDUFA-August 30).
aTyr Pharma (NASDAQ:LIFE) stock jumped 16% after receiving FDA Orphan drug designation for Resolaris for treatment of limb-girdle muscular dystrophy. FDA accepted Lexicon Pharma's (NASDAQ:LXRX) Xermelo to treat carcinoid syndrome. Corbus Pharma (NASDAQ:CRBP) stock was down after announcing $27 million secondary equity offering priced at $7. FDA accepted Merck's (NYSE:MRK) BLA for avelumab for metastatic urothelial cancer (PDUFA=August 27).
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Selected analyst ratings from today:
Cellectis (NASDAQ:CLLS): Wells Fargo, Outperform with PT=$31-33.
Horizon Pharma (NASDAQ:HZNP): Guggenheim, Buy with PT=$30.
Durect (NASDAQ:DRRX): HC Wainwright, Buy with PT=$3
Bioverativ (NASDAQ:BIVV): Piper Jeffrey, Buy with PT=$65.
Fate Therapeutics (NASDAQ:FATE): Wedbush, Buy with PT=$7.
Kite Pharma (NASDAQ:KITE): HC Wainwright, Buy with PT=$85; Canaccord Genuity, Buy with PT=$75.
Newlink Genetics (NASDAQ:NLNK): Cantor Fitzgerald, Buy with PT=$20.
Amgen (NASDAQ:AMGN): Oppenheimer, Buy with PT=$189.
Exelixis (NASDAQ:EXEL): William Blair, Buy with no PT given.
Esperion (NASDAQ:ESPR): Citi, Buy with no PT given.
Theravance Biopharma (NASDAQ:TBPH): Needham, Buy with PT=$40.
Celgene (NASDAQ:CELG): Jefferies, Buy with PT=$155.
Novavax (NASDAQ:NVAX): Cantor Fitzgerald, Hold with PT=$2.
Intercept Pharma (NASDAQ:ICPT): Citi, Buy with PT=$240.
Endo Pharma (NASDAQ:ENDP): Mizuho, Buy, PT=$16.
Shire (NASDAQ:SHPG): Cowen, outperform, PT=181.
Allergan (NYSE:AGN): Cowen, outperform, PT=$245.
Unusual up volume: Kite Pharma
Disclosure: I am/we are long KITE, CEMP, DVAX, NVAX, ICPT, CELG, ADMS, VSAR.