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Thursday, February 28, 2013
ANAC phase 3 results
Anacor Pharmaceuticals (NASDAQ:ANAC) today announced positive
preliminary results from the second of two Phase 3 trials of tavaborole
(known as Study 302). Tavaborole is a topical anti-fungal for the
treatment of onychomycosis, a fungal infection of the nail and nail bed
that affects approximately 35 million people in the United States.
Results from the first Phase 3 trial (known as Study 301) were announced
on January 29, 2013. In both studies, tavaborole achieved statistically
significant and clinically meaningful results on all primary and
secondary endpoints.
THRX Advisory Commitee Meeting 03/07/2013
Agenda
The
committee will discuss the new drug application (NDA) 204275 for
fluticasone furoate and vilanterol dry powder inhaler (proposed
tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term
maintenance treatment of airflow obstruction and for reducing
exacerbations in patients with chronic obstructive pulmonary disease.
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Wednesday, February 27, 2013
DEPO Advisory Committee Meeting March 4, 2013
Depomed Announces Serada® NDA Acceptance and FDA Advisory Committee Meeting
MENLO PARK, Calif., Oct. 15, 2012 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO) today announced that its New Drug Application (NDA) for Serada® has been accepted for filing by the U.S. Food and Drug Administration (FDA). In addition, the FDA has informed the company that the FDA's Reproductive Health Drugs Advisory Committee will discuss the Serada NDA at an Advisory Committee meeting tentatively scheduled for March 4, 2013.
The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
Stocks to Watch - 2/28/13
Zogenix, Inc. (ZGNX)
Uni-Pixel, Inc. (UNXL)
Guidewire Software, Inc. (GWRE)
Optimer Pharmaceuticals, Inc. (OPTR)
GeoGlobal Resources Inc. (GGR)
Meru Networks, Inc. (MERU)
StarTek, Inc. (SRT)
MAKO Surgical Corp. (MAKO)
U.S. Silica Holdings, Inc. (SLCA)
Dollar Tree, Inc. (DLTR)
FreeSeas Inc. (FREE)
Endeavour International Corporation (END)
Adventrx Pharmaceuticals, Inc. (ANX)
Uni-Pixel, Inc. (UNXL)
Guidewire Software, Inc. (GWRE)
Optimer Pharmaceuticals, Inc. (OPTR)
GeoGlobal Resources Inc. (GGR)
Meru Networks, Inc. (MERU)
StarTek, Inc. (SRT)
MAKO Surgical Corp. (MAKO)
U.S. Silica Holdings, Inc. (SLCA)
Dollar Tree, Inc. (DLTR)
FreeSeas Inc. (FREE)
Endeavour International Corporation (END)
Adventrx Pharmaceuticals, Inc. (ANX)
ZGNX FDA update
Zogenix reported Tuesday that the Food and Drug Administration would
take longer than expected to review its drug Zohydro, a long-acting
version of the painkiller hydrocodone. The FDA did not provide an
explanation for the delay but indicated it "would likely be brief and
may last only several weeks." Zogenix said the company has not been
asked to submit any additional information.
Tuesday, February 26, 2013
ZGNX
Zogenix (ZGNX) You'll want to mark March 1st on your calendar.That is zogenix pdufa date.That's the day the U.S. Food and Drug Administration is going to be passing down a decision in the company's Zohydro ER drug.The drug is just another version of hydrocone but in a extended release format.Which is good for stopping the abuse of pain killers.But the bad news is, the advisory panel that makes a recommendation to the
FDA regarding new drug requests has recommended - by a margin of 11 to 2
- that the agency NOT approve Zohydro ER.This is why I have taken a short position in ZGNX.I will probably cover half of my shares before mar 1 just to be on the safe side.And hold my free shares through the decision on mar 1.
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