INSM data due today. CYCC topline Sapacitabine data due 2015. EXEL data due later this year + BIND EVOK ECYT news

Mar 26, 2014 No Comments

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) said it expects to complete enrolment in their Phase 3 SEAMLESS trial of Sapacitabine in patients with acute myeloid leukemia (AML). Topline data are due in 2015. Insmed Incorporated (NASDAQ: INSM) will announce results from its U.S. phase 2 clinical trial of ARIKAYCE, to treat nontuberculous mycobacteria (NTM) lung infections on Wednesday, March 26, 2014 at approximately 7:00 a.m. […]

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QRXPY Adcom date set. RMTI submits NDA. ARIA and CYTR initiate pivotal trials.

Mar 25, 2014 No Comments

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced that the FDA has set 22 April 2014 as the date of the Advisory Committee meeting to consider the resubmitted Moxduo New Drug Application (NDA). The PDUFA date is 25 May, 2014. Rockwell Medical, Inc. (Nasdaq:RMTI)  announced the submission of a New Drug Application (NDA) to the FDA for Triferic (soluble […]

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CPRX Phase 3 data due 3Q. Offerings for SGMO NBY + update for PTLA

Mar 20, 2014 No Comments

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that it has commenced a $100 million underwritten public offering of shares of its common stock. NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY) announced that it intends to offer shares of its common stock and warrants in an underwritten public offering. Portola Pharmaceuticals (Nasdaq:PTLA) announced that it has initiated a Phase 3 […]

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AERI Phase 2b data due early 3Q + updates for ADHD and IRWD.

Mar 19, 2014 No Comments

Alcobra Ltd. (Nasdaq:ADHD) announced that the first patient has been enrolled in a Phase 3 clinical trial of MDX in the treatment of Adults with ADHD. The trial is expected to be completed in 2H 2014. Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that dosing has begun in its Phase 2a trial of IW-3718 in patients suffering from […]

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NKTR Adcom date set. ICPT meets Phase 3 POISE endpoint + GWPH INO updates

Mar 18, 2014 No Comments

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) announced that it met the primary endpoint in its international Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg. Nektar Therapeutic (NASDAQ: NKTR) and AstraZeneca have been […]

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APPY pivotal data due Thursday. ITMN offering.

Mar 13, 2014 No Comments

Venaxis, Inc. (Nasdaq: APPY) announced it will host a conference call to discuss top-line results from its pivotal study of the APPY1 Test on Thursday, March 13, 2014, at 8:30 a.m. ET.  InterMune, Inc. (NASDAQ: ITMN) announced that it plans to offer 7,500,000 shares of its common stock in an underwritten public offering. Tweet

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OXGN hits primary endpoint. SNTA data release extension +updates for SSH and OGXI

Mar 12, 2014 No Comments

OXiGENE, Inc. (Nasdaq:OXGN) announced that it met its primary endpoint of a statistically significant increase in progression-free survival in its Phase 2 clinical trial evaluating Avastin(bevacizumab) with or without ZYBRESTAT to treat patients with recurrent ovarian cancer. One of their secondary endpoints, objective response rate, was higher but not statistically significant. All patients will continue to be followed for […]

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ETRM Adcom rescheduled.

Mar 11, 2014 No Comments

EnteroMedics Inc. (NASDAQ: ETRM) announced that the FDA has rescheduled the Advisory Committee meeting of the Center for Devices and Radiologic Health’s (CDRH) for Tuesday, June 17, 2014 to review the Maestro System delivering VBLOC vagal blocking therapy as a treatment for morbid obesity. The company noted that the delay is due to a scheduling conflict on behalf of the CDRH. […]

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Pipeline updates for NBY NWBO CMRX ACHN NLNK

Mar 08, 2014 No Comments

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) provided an update noting that data from their Viral Conjunctivitis Phase 2 trial are due in mid-2014. Northwest Biotherapeutics (NASDAQ: NWBO) announced the Data Safety Monitoring Board (DSMB) review of the efficacy data of their Phase 3 GBM Trial is still pending. Regarding the safety review, the DSMB have reviewed the […]

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