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News Breaks
May 15, 2014
07:14 EDTABBV, PCYC, RHHBYAbbVie, Roche drug a real threat to Pharmacyclics, says Bernstein
After analyzing abstracts from the ASCO conference, Bernstein believes that ABT199, a treatment for CLL from Roche (RHHBY) and AbbVie (ABBV), is a "real threat" to Pharmacyclics' (PCYC) Imbruvica. However, the firm continues to believe that Imbruvica is impressive due to its duration of effect. It keeps an Outperform rating on Roche and a Market Perform rating on Pharmacyclics.
News For ABBV;RHHBY;PCYC From The Last 14 Days
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December 19, 2014
05:33 EDTRHHBYGenentech provides update on Phase III MARIANNE
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December 18, 2014
12:46 EDTRHHBYRoche acquires privately held Dutalys for $133.75M up front
Roche announced that it has agreed to acquire Dutalys GmbH, a privately held biotechnology company based in Vienna, Austria. Dutalys specializes in the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMab technology, Roche said. Under the terms of the agreement, Roche will make an upfront cash payment of $133.75M to shareholders and make additional contingent payments of up to $355M based on the achievement of certain predetermined milestones.
December 16, 2014
08:47 EDTRHHBYHemispherx Ampligen provides anti-tumor activity
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05:46 EDTRHHBYRoche launches PCR molecular diagnostic system for point of care environment
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December 15, 2014
05:24 EDTRHHBYExelixis announces Genentech files NDA for cobimetinib, vemurafenib combination
Exelixis (EXEL) announced its collaborator Genentech, a member of the Roche Group (RHHBY), has completed the filing of its New Drug Application, or NDA, with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
December 12, 2014
08:01 EDTPCYCPiper predicts two large-cap biotechs could be acquired in 2015
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05:52 EDTRHHBYRoche announces retirement of Genentech research head
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December 11, 2014
10:13 EDTABBVOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: ARIAD (ARIA) downgraded at Credit Suisse... AbbVie (ABBV) downgraded to Equal Weight from Overweight at Morgan Stanley... Aimco (AIV) downgraded to Hold from Buy at KeyBanc... Anglo American (AAUKY) downgraded to Underperform from Neutral at Exane BNP Paribas... Approach Resources (AREX) downgraded at Sterne Agee... CommVault (CVLT) downgraded to Neutral from Outperform at Macquarie... Fifth Street Senior (FSFR) downgraded to Perform from Outperform at Oppenheimer... Harmonic (HLIT) downgraded to Neutral from Buy at Sidoti... Macerich (MAC) downgraded to Hold from Buy at Deutsche Bank... Newell Rubbermaid (NWL) downgraded to Outperform from Strong Buy at Raymond James... Olin Corp. (OLN) downgraded at Longbow... Penn West (PWE) downgraded to Underperform from Neutral at BofA/Merrill... Prudential plc (PUK) downgraded to Neutral from Buy at Nomura... Semiconductor Manufacturing (SMI) downgraded to Hold from Buy at Jefferies... Suncor (SU) downgraded to Neutral from Buy at BofA/Merrill... Talisman Energy (TLM) downgraded to Underperform from Neutral at BofA/Merrill... Thompson Creek (TC) downgraded to Hold from Buy at Deutsche Bank... Toll Brothers (TOL) downgraded to Underperform from Sector Perform at RBC Capital... Travelers (TRV) downgraded to Neutral from Buy at UBS... United Therapeutics (UTHR) downgraded at Credit Suisse... Vera Bradley (VRA) downgraded to Underperform from Neutral at Sterne Agee.
08:34 EDTABBVAbbVie downgraded at Morgan Stanley
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07:54 EDTABBVGilead shares poised to continue to advance, says RBC Capital
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06:29 EDTABBVShire CEO sees no immediate need to spend break-up fee, Reuters reports
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06:20 EDTABBVAbbVie downgraded to Equal Weight from Overweight at Morgan Stanley
December 10, 2014
09:18 EDTPCYCPharmacyclics data 'impressive,' says Roth Capital
Roth Capital believes that Pharmacyclics presented important updates at the ASH conference on Imbruvica. The firm thinks the data "all point to Imbruvica's potency in hematological malignancies." It reiterates a $188 price target and Buy rating on the shares.
December 9, 2014
12:22 EDTRHHBYPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
07:44 EDTRHHBY, ABBVAmerican Association for Cancer Research to hold a symposium
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05:50 EDTPCYCPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:43 EDTPCYCPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:27 EDTPCYCPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
13:45 EDTPCYCTG Therapeutics says TG-1101 well tolerated in Phase 2 study
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08:32 EDTPCYCTrout Group to hold events at ASH 2014
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