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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RCPT hits endpoints. PFE returns Remoxy rights. SRPT NDA filing delay. RGLS VNDA offerings + HTBX ADMS updates.

Oct 28, 2014 No Comments by

Receptos, Inc. (Nasdaq:RCPT) announced that TOUCHSTONE, the Phase 2 trial of RPC1063 in ulcerative colitis (UC), met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1 mg dose of RPC1063 in the 8-week induction period. A Phase 3 trial is planned for 2015. The company also plan to initiate a […]

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25 Recent IPOs added to the BioPharmCatalyst database

Oct 25, 2014 No Comments by

As a result of recent Initial Public offerings since July 2014, BioPharmCatalyst is pleased to let readers know that 25 companies have been added to the Company Pipeline Database. These companies all have candidates in at least Phase 2 development (or pending). Companies with upcoming data releases have also been added to the FDA Calendar. […]

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NPSP PDUFA delay. Pipeline updates for BMRN and IMGN

Oct 24, 2014 No Comments

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) announced that their PDUFA date for its Natpara Biologics License Application (BLA) has been extended by three months from October 24, 2014 to January 24, 2015. The company cited the need for the the FDA to review a major amendment, and also requested the company to submit a Risk Evaluation and […]

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ALKS PDUFA date set. RLYP files NDA for hyperkalemia

Oct 22, 2014 No Comments

Alkermes plc (NASDAQ: ALKS) announced that the FDA has set a PDUFA date of August. 22, 2015 for aripiprazole lauroxil, for the treatment of schizophrenia. Relypsa, Inc. (Nasdaq:RLYP) announced that they have submitted a New Drug Application (NDA) to the FDA seeking approval for Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia.   Tweet

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GEVA starts rolling NDA. OMER trial halt. VRTX gets Adcom thumbs up + AGIO news

Oct 22, 2014 No Comments

Synageva BioPharma Corp. (Synageva) (NASDAQ: GEVA) announced the start of a rolling submission of a Biologics License Application (BLA) to the FDA for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency). The company anticipates completing the rolling submission of the BLA to the FDA and submitting the Marketing Authorization Application (MAA) […]

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NBIX initiates Phase 3 tardive dyskinesia trial. NLNK license deal with Genentech. CVM offering.

Oct 21, 2014 No Comments

NewLink Genetics Corporation (NASDAQ: NLNK), announced that they have entered into a license agreement with Genentech for the development of NLG919, an IDO pathway inhibitor. NewLink will receive an upfront payment of $150m and will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well […]

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GWPH pipeline update. ESPR offering. BLUE sickle cell disease data due 2015 + OHRP update

Oct 15, 2014 No Comments

bluebird bio, Inc. (Nasdaq: BLUE) announced that the first patient has undergone infusion in a Phase 1/2 trial of LentiGlobin gene therapy in patients with severe sickle cell disease. Initial clinical data on LentiGlobin in sickle cell disease patients are due in 2015. GW Pharmaceuticals plc (Nasdaq: GWPH) provided an update that a Phase 2/3 trial […]

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SGEN Phase 3 AETHERA data due Monday. ALIM PSDV FDA Approval. ACRX NDA update + GLYC delay

Sep 27, 2014 No Comments

Seattle Genetics, Inc. (Nasdaq:SGEN) will host a conference call and webcast on Monday, September 29, 2014, at 8:30 a.m. Eastern Time (ET) regarding top-line results from its ADCETRIS Phase 3 AETHERA clinical trial for Hodgkin lymphoma patients at risk of relapse following autologous stem cell transplant. Alimera Sciences, Inc. (NASDAQ: ALIM) and pSivida Corp. (NASDAQ: […]

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