PRAN fails Phase 2 trial. DRTX postive Adcom vote. HRTX NDA filing due mid year + ANAC CRIS SYN updates

Apr 01, 2014 1 Comment by

Prana Biotechnology (ASX:PBT/NASDAQ:PRAN) announced that they did not meet the primary endpoint in their Phase 2 trial of PBT2,  in Alzheimer’s Disease (IMAGINE Trial). Durata Therapeutics, Inc. (Nasdaq:DRTX) announced that the FDA Anti-Infective Drugs Advisory Committee voted 12 to 0 in favour of Dalvance (dalbavancin) for injection, for the treatment of adult patients with acute […]

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Updates for GALE SCMP BLRX APPA RPTP ACOR RLYP INFI HALO ARNA CLVS SGEN ICPT GILD CUR MRK CYCC CRIS ACHN

Jan 13, 2014 No Comments by

Curis, Inc.(NASDAQ:CRIS) provided an update noting that Phase 2 data of everolimus for Operable Nodular BCC (basal cell carcinoma) are due 1Q 2014. Their submission to the FDA regarding the partial clinical hold of CUDC-427 is due shortly. A Phase 2 trial of Debio 0932 is due to be to initiated in 2H 2014. Galena Biopharma (Nasdaq:GALE) announced it has […]

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NBY Phase 2b fail. CRIS CUDC-427 placed on partial hold. Upcoming data releases for IMUC FURX + updates for XLRN OCRX INCY ABIO ALXA ESPR DCTH ACAD ALNY

Nov 06, 2013 No Comments by

NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY $0.90) announced that the auriclosene Phase 2b clinical study of impetigo did not meet its primary clinical endpoint. Curis, Inc. (Nasdaq:CRIS $2.86) announced that the FDA has placed their Phase 1 study of CUDC-427 on partial clinical hold following the report of death of a patient who progressed to […]

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20 Upcoming Non-PDUFA Catalysts as of April 29 2013

Apr 29, 2013 No Comments

20 short and long term potential catalysts as of April 29, 2013. See the links in the FDA Calendar for more details about some of the catalysts. AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX): Phase 3 topline data for Sufentanil NanoTab PCA System in patients after major orthopedic surgery (second pivotal) due 2Q 2013. Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE): Phase 3 data […]

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SUPN prices offering. EXEL FDA Approval + updates for AMRN CYTK XOMA CRIS THRX INSV

Nov 30, 2012 No Comments

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced the pricing of its public offering of 6m shares of its common stock at a price to the public of $8.00 per share with an option to issue 900,000 additional shares to cover over-allotments. Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced that it will offer 11m shares of its common stock at a price of $2.00 per […]

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DCTH NDA expected August. Pipeline updates and news for GTXI SVNT AIS CRIS DCTH MDVN DEPO ACAD ACRX CLVS SGEN

May 09, 2012 No Comments

Delcath Systems (NASDAQ: DCTH) said that it intends to submit its NDA for its Hepatic CHEMOSAT delivery system in mid-August, 2012. GTx, Inc. (Nasdaq: GTXI) said that the clinical hold placed on Capesaris (GTx-758),for secondary hormonal therapy of advanced prostate cancer, has been lifted by the FDA. The Phase 2 trial will test three lower doses of Capesaris (125 mg, […]

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NBIX VICL EXEL IMMU CRIS pipeline updates + numerous companies raising cash

Feb 09, 2012 No Comments

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) gave a pipeline update today noting that it expects to initiate its Phase 3 trial of elagolix for endometriosis during 1H 2012. It also expects data from its second Phase 2 trial of NBI-98854 in tardive dyskinesia patients during March 2012. A larger Phase 2b program is planned to be initiated during 2012. Topline data […]

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Upcoming PDUFA dates, Adcom meetings and clinical catalysts as of January 12 2012

Jan 12, 2012 No Comments

Some short and long term potential catalysts as of January 12, 2012 (share prices as at the close of trading Wednesday, January 11, 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 […]

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

Dec 23, 2011 No Comments

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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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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GSK CRIS file NDA for BCC. BPAX to file 4Q 2012. ONTY FOLD initiate trials

Sep 12, 2011 No Comments

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) said today that it expects to file its NDA of Libigel for female sexual dysfunction (FSD) during 4Q 2012. Oncothyreon Inc. (Nasdaq: ONTY) today announced enrollment of the first patient in a Phase 2 trial of PX-866 in patients with recurrent or metastatic castration-resistant prostate cancer. Curis, Inc. (NASDAQ: CRIS) […]

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