Archive for May, 2012

CHTP and ALKS halt further trials following disappointing trial data + OMER news

May 31, 2012 No Comments by

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it failed to meet its primary endpoint in its Phase 2 trial of CH-4051 in patients with rheumatoid arthritis (RA). As a result it plans to discontinue development of CH-4051. Alkermes plc (NASDAQ: ALKS) said that it did not meet its “pre-specified criteria for advancing into Phase 3 clinical trials” […]

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ISIS PDUFA date set. LGND/GSK file Promacta sNDA. EXEL files NDA + initiates second Phase 3 mCRPC + CLSN ALNY INSM ACRX news

May 30, 2012 No Comments by

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (ISIS), announced yesterday that the FDA has set a PDUFA date of of January 29, 2013 for  KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme. […]

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25 Upcoming Catalysts as of May 29, 2012

May 29, 2012 No Comments by

25 short and long term potential catalysts as of May 29, 2012. 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 SHORT or LONG positions in certain stock. Alkermes plc (Nasdaq: ALKS) – Phase 2b data of ALKS […]

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Financial Database has been updated with 1Q 2012 cash positions

May 24, 2012 No Comments

The Financial Database has been updated with two key additions. 1) Cash, cash equivalents, and short term investments have been added as of the end of 1Q (March 31) 2012. Note that long term investments are not included in the figures. 2) Notes have been added where a company has raised cash through a direct […]

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NBIX releases Phase 2 data. NBY and SPPI initiate Phase 2 trials

May 18, 2012 No Comments

Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced the initiation of a Phase 2 trial of ZEVALIN for intravenous use + rituximab in combination with motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL). Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced efficacy and safety results from its Phase 2 trial of urocortin 2 in 53 patients […]

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Abstracts have been added to the ASCO Calendar!

May 17, 2012 No Comments

Earlier today abstracts to next month’s ASCO meeting were released. Approximately 75 of those abstracts can now be found in the BioPharmCatalyst ASCO Calendar, which can be found HERE. Session times and other information can also be found to give you a one-stop resource provided to save you much time in searching for abstracts.

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ARNA offering. RIGL Phase 2 asthma trial to be initiated this summer

May 17, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced the pricing of an underwritten public offering of 11m shares at a price to the public of $5.50 per share. The gross proceeds to Arena from this offering are expected to be $60.5 million with a 30-day option to offer up to an aggregate of 1,650,000 additional shares. Rigel Pharmaceuticals, Inc., (Nasdaq: RIGL) said […]

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OSUR positive Adcom vote. SNSS interim data due 3Q. CYTR reverse split.

May 15, 2012 No Comments

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) said today that it is on track to release interim data from its Phase 3 VALOR trial in acute myeloid leukemia, during 3Q 2012. CytRx Corporation (Nasdaq: CYTR) today announced a reverse split of its common stock at a ratio of 1-for-7. CytRx’s common stock will begin trading on NASDAQ on a split-adjusted […]

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VTUS releases Phase 3 data. Pipeline updates for ATHX and MDGN

May 14, 2012 No Comments

Ventrus Biosciences, Inc. (Nasdaq:VTUS) today reported positive results from its Phase 3 trial of diltiazem hydrochloride cream (VEN 307) in patients with anal fissures.  Both 4% and 2% diltiazem treatment arms demonstrated significant improvements compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation (pain score improvement 0.44, […]

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Pipeline updates for YMI OREX IMMU BDSI FOLD

May 11, 2012 No Comments

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM) provided an update today on CYT387 for the treatment of myelofibrosis. It intends to initiate its Phase 3 trial during 2H 2012. By the end of 2012 both final data from its Phase 1/2 Core trial and interim data from the Phase 1/2 Extension trial are expected to be reported. Interim […]

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ARNA positive Adcom vote. APPA NDA due mid-2012. PATH to resubmit NDA 3Q + TZYM OMER BIOD CTIC MNOV ANAC PBTH updates

May 10, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, to recommend approval of lorcaserin in patients with obesity. The current PDUFA date is June 27, 2012. However, this may be extended by three months if further data is provided by the company. A.P. Pharma, Inc.(OTCBB:APPA.OB) […]

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