CTIC NDA withdrawn following full clinical hold + updates for BLPH EPRS INSY NYMX OHRP SGEN TBRA VTVT

Feb 10, 2016 No Comments by

Updates to the Company Pipeline Database for February 9, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary BLPH 2.84 INOpulse delivery device Pulmonary Arterial Hypertension (PAH) Phase 3 Phase 3 to commence in 2016 CTIC 0.50 Pacritinib -PERSIST-1 Myelofibrosis NDA filing withdrawn Announced February 9, 2016 that NDA submission […]

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SRPT PDUFA date extension. BCRX Phase 2 trial fail. CTIC Pacritinib placed on clinical hold + AVXL OMED BOTA CYTX RNN updates

Feb 09, 2016 No Comments by

Updates to the Company Pipeline Database for February 8, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary AVXL 4.32 ANAVEX 2-73 Mild to moderate Alzheimer’s disease Phase 2a Phase 2a interim data released January 2016. Trial is ongoing. Additional Phase 2/3 trial planned BCRX 1.78 BCX4161 – OPuS-2 Hereditary […]

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65 pipeline updates predominantly from companies attending the JP Morgan Healthcare Conference

Jan 12, 2016 No Comments by

Pipeline updates galore as companies give latest guidance at the JP Morgan Healthcare Conference. Click HERE to register for meeting information and webcasts. Latest updates to the Company Pipeline Database from January 11, 2016. Refer to the FDA Calendar for upcoming catalysts: ACOR 39.98 Dalfampridine Post stroke deficits Phase 2b/3 Phase 3 interim data due 2016 ACOR 39.98 CVT-301 […]

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Latest pipeline updates for ADXS CEMP CHMA CLBS CTIC CVM CYTK DERM KMDA OCRX ONTX ORMP RVNC SYN TKAI

Jan 09, 2016 No Comments

Please find below latest updates to the Company Pipeline Database added on January 8, 2016. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADXS 7.94 Axalimogene filolisbac – AIM2CERV Trial High-risk, locally advanced cervical cancer Phase 3 Phase 3 to commence in mid-2016 ADXS 7.94 Axalimogene filolisbac – GOG 0265 study Cervical cancer […]

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Pipeline updates for ADHD ALXA ANAC ARQL CCXI CERU CLVS CTIC GWPH INFI MGNX PGNX PTLA RDUS SCMP TRLPF TTPH VNDA VSAR XNPT

May 07, 2015 No Comments

Latest updates to the Company Pipeline Database for May 6 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADHD 5.53 MDX (Metadoxine Extended Release (MG01CI)) Fragile X Syndrome Phase 2b Phase 2b enrolment due to be completed 1Q 2015. Data due 2Q 2015 ADHD 5.53 MDX (Metadoxine Extended Release (MG01CI)) Adult […]

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Updates for ACAD ANAC BIND BSTC CCXI CNAT CTIC CYTK EBIO EGLT FATE HRTX MRNS OCRX PLX PPHM SNTA SPPI TBPH TKAI TKMR XENE ZSPH

Mar 14, 2015 No Comments

Latest updates to the Company Pipeline Database. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ACAD 34.45 Pimavanserin Parkinson’s disease psychosis (PDP) Phase 3 NDA filing of Pimavanserin for Parkinson’s disease psychosis (PDP) due 2H 2015 3/14/2015 ANAC 55.66 AN2728 Mild-to-moderate atopic dermatitis Phase 3 Phase 3 […]

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SPPI PDUFA date set. KYTH Adcom approval. Setback for ACRX + updates for CTIC EDAP GLMD IMUC LGND SSH

Mar 10, 2015 No Comments

Latest updates to the Company Pipeline Database. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ACRX 5.51 ARX-04 Moderate-to-severe acute pain Phase 3 Phase 3 planned 3/10/2015 ACRX 5.51 Zalviso Post-operative pain following open abdominal surgery and hip or knee replacement surgery CRL CRL Jul 26 2014. […]

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Updates for ASPX ISIS CTIC MRNS + CPXX added to the database.

Feb 04, 2015 No Comments

Latest updates to the Company Pipeline Database for February 3, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ASPX 58.22 SD-809 Tardive Dyskinesia (TD) Phase 2/3 Phase 2b enrolment completed early Feb 2015. Topline data due mid 2015. Data from Phase 3 trial due 2016 2/4/2015 […]

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Pipeline updates for BIND CTIC DERM + ALKS to initiate pivotal ALKS 3831 trial

Jan 08, 2015 No Comments

Latest updates to the Company Pipeline Database from January 7, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Text Updated ALKS 66.75 ALKS 3831 Schizophrenia Phase 2 Phase 2 data released Jan 2015.Met primary endpoint, equivalence to olanzapine. Pivotal trial planned for 2015 1/8/2015 BIND 5.15 BIND-014 Cancer – […]

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CTIC and CEMP Phase 3 data due 1Q 2015 + pipeline updates for SNTA + CMRX offering

Oct 29, 2014 No Comments

CTI BioPharma Corp. (CTI) (NASDAQ: CTIC) provided an update, maintaining previous guidance that they continue to expect data from their PERSIST-1 pivotal Phase 3 trial of pacritinib for patients with myelofibrosis in 1Q 2015. Cempra, Inc. (Nasdaq:CEMP) also provided an update noting that data from their Phase 3 trial of oral solithromycin in adult patients with moderate […]

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POZN resubmits NDA. Trial updates for CTIC OGXI THLD RARE

Jul 02, 2014 No Comments

POZEN Inc. (NASDAQ: POZN) announced that it has resubmitted the NDA for PA8140/PA32540 to the FDA. They expect to hear back from the FDA within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review […]

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