Top alert for 2014: MYGN (50%), LIVE (45%), CTIC (115%), KOOL (88%), PZG (32%), GOLD (6%), IOC (6%), RSOL(18%), PLUG (70%), IMMU (26%)

Saturday, January 25, 2014

Upcoming FDA approval for 2014 under $20: AEZS, ANAC, OMER, OREX, DRTX, POZN, MNKD, DRRX, RDHL, VNDA, ALIM, PSDV, RPRX, SRPT, SPPI, ACRX

Below are the selected Bio stocks to watch under $20:

11/5/2014 Aeterna Zentaris AEZS NDA for Macimorelin Acetate

07/29/2014 Anacor ANAC Pharmaceuticals Announces FDA Acceptance of Tavaborole NDA for Filing

07/1/2014 OMER NDA With the submission by Omeros of a New Drug Application (NDA) for OMS302 to the U.S. Food and Drug Administration (FDA) in July 2013, the MAA represents Omeros' second major submission seeking regulatory authorization to market OMS302


06/10/2014 Orexigen Therapeutics, Inc. : OREX  PDUFA Action Date for Contrave.

06/7/2014 Keryx Biopharmaceuticals :  KERX   PDUFA Action Date for Zerenex(TM).

05/26/2014 Durata Therapeutics DRTX NDA for Dalvance(TM) (dalbavancin hydrochloride)

04/24/2014 POZEN Inc. POZN PA32540/PA8140 (NDA) FDA decision on PA32540/PA8140 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

04/15/2014 MannKind Corp. MNKD AFREZZA Inhalation Powder (NDA) FDA decision on AFREZZA Inhalation Powder to improve glycemic control in adult patients suffering from type I or type II diabetes.

02/12/2014 DURECT Corp. DRRX POSIDUR (NDA) FDA decision on POSIDUR as a post-operative pain relief depot.

02/03/2014 INTELGENX TECHNOLOGS IGXT.OB Anti-Migraine VersaFilm oral film (NDA) FDA decision on Anti-Migraine VersaFilm oral film.

02/3/2014 RedHill Biopharma RDHL NDA for Acute Migraine

01/31/2014 VANDA PHARMACEUTICALS VNDA HETLIOZ (NDA) FDA decision on HETLIOZ for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.

ALIM, PSDV will file NDA in Q1

RPRX to file NDA in 2nd half of 2014

ACRX NDA submission in 3 qtr of 2014.

SRPT NDA submission in 1st qtr of 2014.

SPPI pivot trial result in 2nd qtr of 2014.



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