New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 12, 2014
04:55 EDTBLUE, BLUE, BLUE, BLUE, ACE, ACE, ACE, ACE, XLRN, XLRN, XLRN, XLRN, TGTX, TGTX, TGTX, TGTX, NVS, NVS, NVS, NVS, AGIO, AGIO, AGIO, AGIO, AG, AG, AG, AGEuropean Hematology Association to hold a conference
19th Congress of the European Hematology Association will be held in Milan, Italy on June 12-15.
News For BLUE;ACE;XLRN;TGTX;NVS;AGIO;AG From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | all recent news | >>
May 20, 2015
07:10 EDTBLUEPiper Jaffray to hold a symposium
Subscribe for More Information
May 19, 2015
15:13 EDTBLUEbluebird bio June volatility elevated as shares near record high
Subscribe for More Information
12:54 EDTBLUEbluebird bio price target raised to $214 from $154 at BofA/Merrill
BofA/Merrill raised its price target for bluebird bio to $214 after the company this morning announced its regulatory strategy for LentiGlobin BB305 in beta-thalassemia major. It keeps a Buy rating on the name. Wedbush just raised its price target for bluebird shares to $222.
12:51 EDTBLUEbluebird bio price target raised to $222 from $146 at Wedbush
Subscribe for More Information
10:51 EDTBLUEbluebird bio advances as LentiGlobin seen moving faster than expected
The shares of drug developer bluebird bio (BLUE) are surging after the company announced that its LentiGlobin BB305 drug could be granted accelerated approvals in both the U.S. and Europe as a treatment for beta-thalassemia major. In notes to investors earlier today, JPMorgan and Piper were upbeat on the outlook for the drug's development to progress faster than was previously expected. WHAT'S NEW: After meeting with European and U.S. drug regulators, bluebird bio announced that it would participate in the EU's Adaptive Pathways pilot program. The program was launched by the EU in an effort to provide medicine to patients more quickly, the company stated. bluebird bio said that it now believes that it will be able to seek conditional EU approval of LentoGlobin as a treatment for beta-thalassemia major. Following its meeting with the FDA, bluebird said that data for upcoming clinical trials could enable the company to file an application for FDA approval of LentiGlobin. The company added that it had made agreements with the FDA on the general design of two of its upcoming trials. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer wrote that Blubird seems poised to file for EU approval of LentiGlobin much sooner than anticipated, since EU regulators have indicated that they will enable the company to apply for approval on the basis of only two clinical studies, The FDA is also moving more quickly than Schimmer previously anticipated, the analyst stated. Schimmer said he had previously believed that LentiGlobin would be launched in 2020, but he now thinks the drug could be approved as early as 2017 in the EU and 2018-2019 in the U.S. The analyst kept an Overweight rating on the stock. Similarly, JPMorgan analyst Cory Kasimov wrote that LentiGlobin could be approved before his 2019 estimate, particularly in the EU, where the regulator is not requiring any new trials. LentiGlobin's outlook as a beta-thalassemia major treatment has become more certain as a result of the news, according to the analyst, who continued to recommend buying the shares of bluebird bio. PRICE ACTION: In mid-morning trading, bluebird rose 5.4% to $164.85.
08:57 EDTBLUEPiper sees upside to LentiGlobin launch expectations
Piper Jaffray sees upside potential to its expectation that LentiGlobin will launch in 2020 after the bluebird bio this morning provided a regulatory update. Piper believes approval in Europe for treatment of beta-thal major could come as much as three years earlier than expected while approval in the U.S. is likely to be ahead of expectations as well. The firm reiterates an Overweight rating on bluebird with a $186 price target.
08:57 EDTAGIO, NVSLeerink biotech analyst holds an analyst/industry conference call
Subscribe for More Information
08:21 EDTBLUEbluebird bio approval may come sooner than expected, says JPMorgan
JPMorgan analyst Cory Kasimov reiterates an Overweight rating on bluebird bio after the company announced this morning regulatory plans for LentiGlobin in B-thalassemia in the U.S. and Europe. Kasimov says approval could come earlier than the firm's current 2019 estimate with bluebird seeking accelerated approval in both geographies. The analyst recommends remaining a buyer of the stock ahead of the B-thalassemia data in June. Shares of the clinical-stage biotechnology company are up $5.60 to $162 in pre-market trading.
06:55 EDTNVSGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
06:05 EDTBLUEbluebird bio discusses potential approval pathways for LentiGlobin BB305
Subscribe for More Information
May 18, 2015
12:29 EDTNVSCorium announces publication of data for needle-free transdermal flu vaccine
Corium International announced the publication of "promising" data on the use of its needle-free transdermal system to deliver influenza vaccine in the June 9 issue of Vaccine. The manuscript, entitled "Fabrication of cell culture-derived influenza vaccine dissolvable microstructures and evaluation of immunogenicity in guinea pigs," details results of a preclinical study conducted by Novartis Vaccines (NVS) and Corium. The results demonstrate the compatibility of Corium's MicroCor needle-free transdermal system with cell culture-derived influenza vaccines, and establish its potential as a next-generation vaccine delivery system, the company said.
09:06 EDTACEFireEye announces strategic alliance with ACE Group
Subscribe for More Information
07:38 EDTNVSNovartis outlook has improved, says Bernstein
Subscribe for More Information
07:37 EDTAGIOAgios Pharmaceuticals AG-120 granted FDA Fast Track designation
Subscribe for More Information
07:31 EDTXLRNCelgene, Acceleron granted fast track designations for luspatercept
Subscribe for More Information
May 15, 2015
09:31 EDTNVSAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
08:51 EDTXLRNAcceleron management to meet with Leerink
Subscribe for More Information
May 13, 2015
17:40 EDTXLRNAcceleron to present DART study data at ASCO
Acceleron Pharma, a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair, announced that data from the DART study, an ongoing phase 2 clinical trial of dalantercept in patients with advanced renal cell carcinoma will be presented at the 2015 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago, Illinois.
17:33 EDTTGTXTG Therapeutics to present updated data for TG-1101 at ASCO
Subscribe for More Information
13:40 EDTBLUEbluebird bio June volatility elevated on wide price movement
Subscribe for More Information
1 | 2 | 3 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use