Upcoming data for CUR KBIO NKTR. AVNR approval delay likely. DVAX reverse split + AEZS RMTI GNCA HRTX IMMU TLOG OPK DSCO ANAC IMMU HPTX SPPI RPTP CMRX VSAR

Nov 08, 2014 No Comments by

Neuralstem, Inc. (NYSE MKT: CUR) announced that the Phase 2 data lock of NSI-566 spinal cord-derived stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS) is scheduled to conclude in late January 2015 at which time the company anticipates providing its Phase 2 ALS results. The company also noted that a Phase 2 trial of NSI-189 for […]

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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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Updates for ALNY ZGNX INSV DNDN OGXI ANAC RPTP NPSP NKTR KERX APPA SRPT THLD OPXA BCRX IMUC INFI

Aug 09, 2013 No Comments by

Zogenix, Inc. (Nasdaq:ZGNX $1.52) said it continues to expect that the FDA will reach a decision regarding the Zohyrdo ER New Drug Application(NDA), during the summer of 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP $18.10) said that it expects to submit its Biologic License Application in 4Q 2013 for Natpara for patients with hypoparathyroidism. It also plans to initiate […]

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INSM Phase 3 data to be released Monday. CHMP approvals for HALO DNDN RPTP + CRL for JNJ

Jun 30, 2013 No Comments

Insmed Incorporated (NASDAQ: INSM) announced that it will report top-line results from its European and Canadian Phase 3 study of ARIKACE to treat cystic fibrosis patients with Pseudomonas aeruginosa lung infections on Monday, July 1, 2013 at 7:00 a.m. Eastern time. Cell Therapeutics, Inc. (NASDAQ: CTIC and MTA: CTIC) announced the resignation of Steven E. Benner, M.D., M.H.S., Senior Vice President, Chief Medical […]

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RPTP FDA Appovel + Pipeline updates for GTXI SNTA OGXI MNTA IDIX DVAX QCOR

May 01, 2013 No Comments

Raptor Pharmaceutical Corp. (Nasdaq: RPTP) announced that the FDA has approved PROCYSBI (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will meet in the first half of June with the FDA regarding the its Biologic License Application (BLA) for HEPLISAV, […]

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RPTP PDUFA date extension. NPSP receives early approval. TSPT fails Phase 2 trial. ALXA approval + SPPI news

Dec 23, 2012 No Comments

Raptor Pharmaceutical Corp. (Nasdaq:RPTP) announced that FDA will require additional time to complete its review of the New Drug Application for RP103 (PROCYSBI), for the potential treatment of nephropathic cystinosis. The new PDUFA date has been extended from January 30, 2013 to April 30, 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), announced that FDA approved Gattex for subcutaneous use for the treatment of […]

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30 Upcoming Catalysts – PDUFA dates, FDA Advisory meetings and Clinical data releases

Dec 01, 2012 10 Comments

30 short and long term potential catalysts as of December 1, 2012. See the links in the FDA Calendar for more details about each catalyst. Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA):  PDUFA date December 21 2012 for the Class 2 resubmssion of Staccato loxapine (ADASUVE). CHMP (EMA) decision due December 14, 2012. A.P. Pharma, Inc. (OTCBB: APPA): PDUFA Mar 27, 2013 […]

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DCTH PDUFA date set. CRTX CRL. Pipeline updates for IDIX CLDX THLD KERX INCY ECYT RPTP SGEN ISIS PCRX PLX

Nov 04, 2012 No Comments

Delcath Systems, Inc. (NASDAQ: DCTH) announced a PDUFA date of June 15, 2013, for the resubmission of its New Drug Application (NDA) of its chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver. Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced that it received a Complete Response Letter (CRL) for […]

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VTUS fails Phase 3 trial. MAPP due to refile NDA by early 4Q. CYTR Phase 2b data due 2013 + LXRX CUR RPTP news

Jun 26, 2012 No Comments

Ventrus Biosciences, Inc. (Nasdaq:VTUS) today reported that its Phase 3, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints. CytRx Corporation (NASDAQ: CYTR) announced the recommendation by the Data Safety Monitoring Board (DSMB) to continue with its Phase 2b trial of tamibarotene in combination with chemotherapeutical agents […]

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INFI stops Phase 2 trials. RPTP Phase 2/3 Cysteamine data due 1H 2014 + CTIC news

Jun 19, 2012 No Comments

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced that following disappointing initial data it will be stopping its Phase 2 trials of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma and in patients with myelofibrosis. Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) announced that the University of Washington has begun enrolment in a Phase 2 trial of […]

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CLDX Phase 2b data due May 23. RIGL pipeline update. RPTP ATM sales agreement + GTXI SVNT news

May 01, 2012 No Comments

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012. The company had planned to present these data at the American Society of Clinical Oncology(ASCO) 2012 Annual Meeting. However, due to a clerical error […]

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