Clinical updates for SPHS MEIP SLXP CLSN CNAT ADHD TTPH

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 […]

Daily News Read more

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

Feb 25, 2014 No Comments by

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 […]

Daily News Read more

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

Jan 15, 2014 No Comments by

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 […]

Daily News Read more

FDA says no to early NDA filing for SRPT + CHTP offering+ updates for APPA GTXI OREX SNSS SNTA SPPI ARIA PBYI CLSN KBIO ARIA PBYI OXGN BDSI SGYP ONTX MGNX

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

ZGNX Advisory Committee date set + pipeline updates for CLSN TZYM OGXI OGXN SNSS CPRX GTXI IGXT SCMP POZN ZCLS NPSP ZIOP CEMP CYTR CUR + ARRY MYRX SPEX news

Nov 10, 2012 No Comments

Celsion Corporation (NASDAQ: CLSN) announced that it projects that it has reached its target of 380 events in its Phase 3 HEAT Study, of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. Top line results are expected to be released in January 2013. Zogenix, […]

Read more

ISIS PDUFA date set. LGND/GSK file Promacta sNDA. EXEL files NDA + initiates second Phase 3 mCRPC + CLSN ALNY INSM ACRX news

May 30, 2012 No Comments

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (ISIS), announced yesterday that the FDA has set a PDUFA date of of January 29, 2013 for  KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme. […]

Read more