Archive for December, 2011

CHTP CTIC ASTX Adcom meetings confirmed + GENT MAA update

Dec 29, 2011 No Comments by

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) –  The Cardiovascular and Renal Drugs Advisory Committee will discuss new drug application (NDA)  proposed trade name NORTHERA (droxidopa capsules) on February 23, 2012, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and […]

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AVEO and ACAD shelf filings. APPY offering.

Dec 27, 2011 No Comments by

AVEO Pharmaceuticals, Inc.(NASDAQ: AVEO) today filed a shelf allowing it to issue shares and warrants to a value of $250m from time to time. ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)  filed a shelf after hours on Friday of $20 million. AspenBio Pharma, Inc. (NASDAQ: APPY) announced a direct offering of 1,605,000 shares and warrants to purchase up to 1,605,000 […]

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Merry Xmas – Summary of pharma events week ending 12/23/12

Dec 23, 2011 No Comments by

A Merry Xmas to all readers of BioPharmCatalyst. Thank you all for your support over the past year and wish you all a relaxing break with friends and family! See individual posts made in the last week for more detail.   PDUFA/FDA RELATED EVENTS Santarus, Inc. (NASDAQ: SNTS) submitted its NDA for UCERIS for mild to […]

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Companies facing NASDAQ delist or reverse splits in 2012

Dec 23, 2011 No Comments

If companies are unable to push their bid price above $1 they either face delisting from NASDAQ to OTCBB or will require a reverse split to remain on NASDAQ. Most of the companies below face no meaningful upcoming catalysts to propel their bid price above $1. Which companies are in this category? I have 10 […]

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Clinical updates for AVEO CYTR GERN CHTP + ABIO PARD CRIS news

Dec 22, 2011 No Comments

Poniard Pharmaceuticals, Inc. (NASDAQ: PARDD) today announced that its planned merger with Allozyne has been terminated. A condition of the merger was that it would qualify for listing on The Nasdaq Capital Market, which requires a share price of at least $4. It is currently trading at $2.95 despite effecting a 1:40 reverse split last month. […]

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A look back at reverse split and NASDAQ-delist projections made in August 2011

Dec 22, 2011 No Comments

On August 1, 2011, I listed seven companies facing NASDAQ delist or a reverse split to remain listed on NASDAQ. I now follow up the list by firstly noting my prediction, then what actually happened. You can read the original post HERE and results of other projections HERE. (First bracket indicates price as of August […]

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VVUS releases FORTRESS data as part of Qnexa NDA for obesity

Dec 22, 2011 No Comments

VIVUS, Inc. (NASDAQ: VVUS) today announced topline preliminary results from its FORTRESS study. The study was a retrospective  study of existing electronic healthcare databases to assess fetal outcomes, in the offspring of women who were exposed to topiramate during the first trimester of pregnancy. The study was conducted as part of the Qnexa NDA for obesity. The study showed that […]

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Dec 21, 2011 No Comments

Repligen Corporation (NASDAQ: RGEN) said that it has submitted its NDA for SecreFlo (RG1068) for pancreatic imaging in patients with pancreatitis. A 6-month priority review was requested. Impax Pharmaceuticals (NASDAQ: IPXL) also announced the submission of its NDA for IPX066  for the treatment of idiopathic Parkinson’s disease (PD). Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) maintained previous guidance that it expects to […]

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SNTS files NDA. ZGNX NDA due 2Q 2012 + PGNX Phase 3 data.

Dec 20, 2011 No Comments

Santarus, Inc. (NASDAQ: SNTS) announced that it submitted a New Drug Application (NDA) for UCERIS (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis. UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. The company had been aiming for some time to file the […]

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Upcoming Adcom meetings for CHTP & VVUS + ALKS FOLD RPTP TSRX news

Dec 19, 2011 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) mentioned last month that the FDA indicated its intent to discuss the Northera NDA at a February 2012 meeting of its Cardiovascular and Renal Drugs Advisory Committee.  A tentative schedule of all 2012 meetings was released today with the above mentioned committee to meet on February 23. VIVUS, Inc. (NASDAQ: VVUS) […]

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Weekly Summary of key pharma events – week ended 12/16/11

Dec 17, 2011 No Comments

See individual posts made in the last week for more detail. PDUFA/FDA RELATED EVENTS NeurogesX, Inc. (Nasdaq:NGSX) will meet with the FDA Anesthetic and Analgesic Drug Products Advisory Committee on February 9, 2012 to discuss the available efficacy and safety data for sNDA of QUTENZA for the management of neuropathic pain related to HIV-associated peripheral neuropathy. Isis Pharmaceuticals, […]

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