ALNY pipeline update. Offering details for OPXA MDGN

Feb 08, 2013 No Comments

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) gave a pipeline update noting that expects to report data from its Phase 2 trial of ALN-TTR02 for transthyretin-mediated amyloidosis (ATTR) in mid-2013. Assuming positive results from the Phase 2 trial, Alnylam expects to start a Phase 3 trial for ALN-TTR02 in familial amyloidotic polyneuropathy (FAP) patients by the end of 2013. It […]

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VICL Phase 3 Allovectin data due mid 2013. OXGN Phase 2 ovarian data due 2013

Feb 07, 2013 No Comments

Vical Incorporated (Nasdaq:VICL) gave a pipeline update noting that top-line data from its Phase 3 registration trial of Allovectin vs. chemotherapy in patients with metastatic melanoma, are expected to be released in mid-2013. It also said that its partner Astellas, is planning to initiate a Phase 3 trial of TransVax for hematopoietic stem cell transplant (HSCT) recipients and to […]

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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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HEB issued CRL for Ampligen. IDIX discontinues IDX184 trial + CLDX offering

Feb 04, 2013 No Comments

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX) announced that it will cease development of IDX184, in phase 2b testing for the treatment of hepatitis C virus (HCV) infection. IDX184 was placed on partial clinical hold in August 2014 due to cardiac adverse events seen in a competitor’s phase 2 clinical trial of BMS-986094. In February 2013, the FDA communicated that the IDX184 […]

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HPTX FDA Approval for RAVICITI. KBIO IPO pipeline profile. EDAP files PMA

Feb 01, 2013 No Comments

Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the FDA has approved RAVICTI for the treatment of Urea Cycle Disorders (UCD) in patients two years of age and older. The drug is expected to be commercially available by the end of April 2013. KaloBios Pharmaceuticals, Inc (NASDAQ: KBIO) – Recent IPO: Pipeline profile KB001-A  is in a Phase […]

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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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ISIS FDA Approval. ANAC meets endpoint but disappoints. Offering news for KERX VTUS NLNK

Jan 30, 2013 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) announced positive preliminary results from the first of two Phase 3 trials of tavaborole, for onychomycosis, a fungal infection of the nail and nail bed. 6.5% of patients treated with tavaborole met the primary endpoint of “complete cure” vs. 0.5% of patients treated with vehicle (p=0.001) at week 52. However, data disappointed traders […]

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ANAC data and new biotech IPO Tuesday. RPRX data delay.KERX postive data release. SPPI NDA due mid 2013 + BCRX news

Jan 28, 2013 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) will release preliminary results from the first of two Phase 3 studies of tavaborole for onychomycosis tomorrow, January 29, 2013 at approximately 7:00 a.m. ET. The announcement will be followed by a conference call at 8:00 a.m. ET to discuss the results. Stemline Therapeutics, Inc., (NASDAQ: STML) today announced the pricing of its initial public offering of […]

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