Archive for December, 2011

ISTA rejects takeover offer. MELA and STEM price offerings.

Dec 16, 2011 No Comments

ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) informed investors today that its Board had unanimously rejected a takeover offer from Valeant Pharmaceuticals International, Inc. (NYSE: VRX) to acquire all shares for $6.50 per share. ISTA noted that the offer was grossly inadequate and significantly undervalues ISTA as it is poised for significant revenue growth next year. The company has […]

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NGSX Adcom meeting date set. ISIS NDA delay + OREX ARIA CORT STEM news

Dec 15, 2011 No Comments

NeurogesX, Inc. (Nasdaq:NGSX) – The FDA Anesthetic and Analgesic Drug Products Advisory Committee will meet on February 9, 2012 to discuss the available efficacy and safety data for the supplemental new drug application (sNDA) of QUTENZA (capsaicin 8%) Patch, for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery […]

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Chart – Corcept Therapeutics Incorporated – (CORT)

Dec 14, 2011 No Comments

Chart by @VexTrades - Upcoming Events PDUFA date February 17, 2012 for Korlym (CORLUX) for the treatment of the manifestations of Cushing’s Syndrome. Click on chart to enlarge, then click on “expand” icon at top right for a clearer image.

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BPAX trial failure. ARIA & OREX to raise cash. CERS shelf + ANTH news

Dec 14, 2011 No Comments

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) said today that it failed its two pivotal Phase 3 LibiGel efficacy trials and did not meet the co-primary or secondary endpoints. In the first trial, called BLOOM-1, patients who received LibiGel showed an increase of 1.47 days with a satisfying sexual event compared with 1.26 days for those who received the […]

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THLD Phase 2 pancreatic data due Feb. ECYT disappoints + CTIC PCYC news

Dec 13, 2011 No Comments

Threshold Pharmaceuticals, Inc.(NASDAQ: THLD) today announced that it now expects to report the primary analysis of the TH-302 Phase 2 pancreatic trial in mid- to late February of 2012. It completed enrollment of this trial as scheduled in June 2011 with the enrollment of 214 patients. Pharmacyclics, Inc (Nasdaq: PCYC), announced today updated results of a Phase 1b/2 trial of […]

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ALXA panel vote.YMI CYT387 data + PCYC CYTR IMMU GERN NKTR OPTR news

Dec 12, 2011 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) appeared before the Psychopharmacologic Drugs Advisory Committee (PDAC) today where the committee was divided on whether Adasuve should be approved as a single dose when used with FDA proposed REMS, with 9 votes FOR, 8 votes AGAINST and one abstention. It had earlier voted that Adasuve had been shown to be effective […]

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BioSante Pharmaceuticals, Inc -BPAX – chart updated

Dec 12, 2011 No Comments

Chart by @VexTrades - EDIT 12/15/11 – This chart is of little significance since following the posting BPAX released data showing it had failed its Phase 3 efficacy trials.   Upcoming Events Phase 3 efficacy data of Libigel for Female sexual dysfunction due 4Q 2011. Stock does tend to sell off following the release of data so trade wisely! […]

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ARIA presents positive ponatinib data at ASH + ARRY

Dec 11, 2011 No Comments

 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced preliminary clinical data showing that 47% of chronic-phase CML patients achieved a major response from the pivotal PACE trial, an ongoing Phase 2 study of ponatinib in patients with chronic myeloid leukemia (CML) or Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL), who are resistant or intolerant to dasatinib or nilotinib […]

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Upcoming Catalysts as of December 9 2011

Dec 11, 2011 No Comments

Some short and long term potential catalysts as of December 9 2011 (share prices as at the close of trading Friday, December 9, 2011). See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take […]

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Chart: VIVUS, Inc – VVUS

Dec 11, 2011 No Comments

By @VexTrades - Upcoming Events December 2011 -  Top-line results due from its retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy or FORTRESS, in the offspring of women who were exposed to topiramate during the first trimester of pregnancy. Data will be used as part of the QNEXA NDA resubmission […]

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Weekly Summary of key pharma events – week ended 12/9/11

Dec 10, 2011 No Comments

Affymax, Inc. (Nasdaq:AFFY) received positive recommendation from the FDA Oncologic Drugs Advisory Committee (ODAC) for its  New Drug Application (NDA) of peginesatide for the proposed treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis was reviewed. The panel was asked to consider the following question, “Considering the safety issues associated with […]

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