BPC May 16 updates – TRVN and ADRO miss endpoints in Phase 2b trails + updates from ADHD AIMT CERC CLSN CRBP DPRX MCRB PSTI SPHS SYN

May 16, 2016 2 Comments by

Updates to the Company Pipeline Database for May 16, 2016, are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADHD 4.17 MDX (Metadoxine Extended Release (MG01CI)) Adult ADHD Phase 3 Data from second Phase 3 trial due by end of 2016 ADHD 4.17 MDX (Metadoxine Extended Release (MG01CI)) Pediatric ADHD Phase 2b […]

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FDA approves Generic Copaxone – MNTA. MDCO thumbs up from Adcom. RPRX PDUFA date set + ALIOF CLSN EBIO PVCT STEM TRGT updates

Apr 16, 2015 No Comments by

Latest updates to the Company Pipeline Database for April 15 and 16. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALIOF 124.28 Ponesimod Relapsing multiple sclerosis Phase 3 Phase 3 initiated mid-April 2015 CLSN 2.94 ThermoDox Recurrent Chest Wall Breast Cancer (RCWBC) Phase 2 Phase 2 enrolment to be completed 3Q […]

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Sep 03, 2014 No Comments by

Sophiris Bio Inc. (NASDAQ: SPHS) announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH. An interim analysis is due around the end of 2014, with complete data in 2H 2015. MEI Pharma, Inc. (Nasdaq: MEIP) announced that it has completed […]

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ECYT – key data due March. AMPE offering. SLXP PDUFA delay. AUXL sNDA PDUFA set

Feb 25, 2014 No Comments

Salix Pharmaceuticals, Ltd.  (NASDAQ:SLXP) and Pharming Group NV (NYSE Euronext:PHARM) announced that the FDA has extended the PDUFA Date to July 16, 2014 for their Biologics License Application (BLA) for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). Celsion Corporation (NASDAQ: CLSN) maintained previous guidance that their Phase 3 trial […]

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Further delays for AMRN. CLSN RNN offerings. Updates for ZIOP and GERN

Jan 15, 2014 No Comments

Amarin Corporation plc (Nasdaq:AMRN $2.40) announced that the FDA notified the company that a determination on Amarin’s request for reconsideration of the October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement will be delayed.No definitive date has been given for the FDA response planned response. Celsion Corporation  (NASDAQ:CLSN $4.00)  announced they will issue approximately $15 million of […]

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Nov 13, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it plans to offer shares of its common stock in an underwritten public offering. A.P. Pharma, Inc. (OTCBB: APPA.OB) said that their resubmission of the NDA for Sustol (formerly known as APF530) is targeted for 1Q 2014 GTx, Inc. (Nasdaq: GTXI) said that they expect to complete enrollment of their Phase […]

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NASDAQ instructs AFFY to delist. DEPO CRL. ONTY trial failure. VNDA files NDA. MNKD data due this summer + CLSN OMER AEGR news

Jun 01, 2013 No Comments

Affymax (NASDAQ: AFFY) was notified by NASDAQ that it has determined the company is operating as a public shell and no longer has an operating business. As a result, NASDAQ have requested that the company delist from NASDAQ before trading on June 6, 2013. The  company intends to list on the OTC Bulletin Board. Vanda […]

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NKTR initiates Phase 2 NSCLC. CYTK update. BMTI responds to FDA + CLSN news

Feb 06, 2013 No Comments

Nektar Therapeutics (NASDAQ:NKTR) announced the start of a Phase 2 investigator-initiated trial of etirinotecan pegol in patients with metastatic and recurrent NSCLC. Cytokinetics, Incorporated (Nasdaq: CYTK) gave a pipeline update noting that it intends to release data in 2013 from both its Phase 2b trial (BENEFIT-ALS), evaluating tirasemtiv in patients with amyotrophic lateral sclerosis, and its Phase 2b trial […]

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CLSN fails Phase 3 ThermoDox trial. Updates for SPPI ARQL VNDA CYTR

Feb 01, 2013 No Comments

Celsion Corporation (NASDAQ: CLSN) announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase 3 trial in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer. Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. (Nasdaq: ARQL)  announced that the first patient has been enrolled in the pivotal Phase […]

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CLSN Phase 3 data due Thursday. STML pipeline profile. Offering details for NLNK NAVB VTUS + ANX MDGN updates

Jan 30, 2013 No Comments

Celsion Corporation (NASDAQ: CLSN) today announced that it will host a conference call and webcast at 8:00 a.m. Eastern Time on Thursday, January 31, 2013 to present the top-line results from its pivotal Phase 3 HEAT Study with ThermoDox in combination with radiofrequency ablation (RFA) in patients with intermediate hepatocellular carcinoma (HCC) versus those patients receiving RFA alone. Stemline Therapeutics, Inc […]

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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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