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

Feb 04, 2015 No Comments by

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 by

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 by

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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ADMP files NDA. INO reverse split update. CTIC name change. AKBA update.

May 30, 2014 No Comments

Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced the submission of a 505(b)(2) New Drug Application (NDA) to the FDA for its epinephrine pre-filled single dose syringe (PFS) product, for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Akebia Therapeutics, Inc. (NASDAQ:AKBA) maintained guidance that Phase 2b data of AKB-6548, for the treatment of anemia related to chronic kidney disease (CKD) […]

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NYMX trial updates. TSRO ALIM IDIX raising cash + CTIC news

Jan 29, 2014 No Comments

Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update noting that patient participation in the NX02-0017 pivotal Phase 3 benign prostatic hyperplasia (BPH) study is completed. Patient participation in the second pivotal trial, NX02-0018, will be completed in 2Q 2014. Unblinding and data analyses of the two pivotal studies will commence in 2Q 2014 with top line results […]

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CHTP wins at Adcom + updates for MEIP MNOV BMRN CYTR NKTR CTIC NYMX

Jan 15, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $2.30) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic […]

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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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CTIC Tosedostat placed on partial clinical hold. CYTK reverse split. CYTR aldoxorubicin data due 2H 2013 + PBMD ANTH updates

Jun 25, 2013 No Comments

Cell Therapeutics, Inc. (NASDAQ:CTIC) was informed by the FDA that a partial clinical hold has been placed on Tosedostat, for the treatment of blood-related cancers. This follows the death of a patient from myocarditis. The FDA has requested additional data on patients treated with Tosedostat, including additional information about the patient that died. These data will […]

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IDIX expects clinical hold response this quarter + CTIC INO THRX VPHM updates

Jan 09, 2013 No Comments

Idenix Pharmaceuticals Inc (NASDAQ: IDIX) noted today that it expects a  response from the FDA regarding the clinical hold of IDX184, during 1Q 2013. Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) today announced that it has initiated a Phase 3 trial, known as PERSIST-1 or PAC325, for pacritinib, for the treatment of patients with myelofibrosis. GlaxoSmithKline plc (LSE: GSK) […]

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ONXX receives positive recommendation from ODAC. POZN bio-equivalence of PA32540 not shown. CYTK offering. CTIC President resigns

Jun 21, 2012 No Comments

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11-0 [with 1 abstention] in favour of  Kyprolis (carfilzomib) for the treatment of relapsed and refractory multiple myeloma. The PDUFA date  for accelerated approval is July 27, 2012. Cytokinetics, Incorporated (Nasdaq: CYTK) priced two underwritten offerings for total gross proceeds of $60m. […]

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