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Stock Market & Financial Investment News

News Breaks
March 5, 2013
08:13 EDTVRTX, RHHBYVertex flu treatment may become large franchise, says William Blair
After Vertex (VRTX) reported data for its flu treatment, William Blair believes that the data appears promising and superior in some ways to Roche's (RHHBY) Tamiflu, a multibillion dollar franchise. The firm doesn't think the Street has assigned any value to Vertex's flu treatment, and it maintains an Outperform rating on the stock.
News For VRTX;RHHBY From The Last 14 Days
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March 25, 2015
10:35 EDTRHHBYFDA approves expanded indication for Eylea
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March 24, 2015
07:45 EDTRHHBYFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 23, 2015
16:20 EDTVRTXOn The Fly: Closing Wrap
Stocks on Wall Street opened in relatively quiet fashion and remained that way throughout the session until a sharp selloff in the closing minutes. For most of the day the averages moved in a narrow range, as the Dow broke its streak of consecutive days with triple digit moves. Like stocks, the oil markets had a quiet session that stood out amid the recent volatility in crude prices. A late day drop prevented the major stock indexes from adding to the big gains they'd notched on Friday. ECONOMIC EVENTS: In the U.S., the Chicago Fed's national activity index fell to -0.11 in February, below expectations for a reading of 0.10. Existing home sales rose 1.2% to a 4.88M rate in February, which was below the consensus forecast for them to grow 2% to a 4.92M unit rate. COMPANY NEWS: Shares of Kansas City Southern (KSU) declined $9.21, or 7.96%, to $106.48 after the railroad operator lowered its fiscal year revenue guidance to reflect slower year-to-date carload growth primarily from the energy sector, along with a continued deterioration in the value of the Mexican peso against the U.S. dollar and lower fuel surcharge revenues driven by lower WTI prices. The revenue warning appeared to weigh on others in the rail industry as well, with Union Pacific (UNP) falling $4.67, or 3.98%, to $112.78, Norfolk Southern (NSC) dropping $3.87, or 3.5%, to $106.56 and Canadian National (CNI) sliding $1.13, or 1.65%, to $67.24. MAJOR MOVERS: Among the notable gainers was ImmunoGen (IMGN), which gained $1.25, or 16.8%, to $8.69 after Takeda (TKPYY) licensed rights to use the company's antibody drug conjugate technology. Also higher was Tenet Healthcare (THC), which rose $2.45, or 4.94%, to $52.07 after agreeing to combine its short-stay surgery and imaging center assets into a new joint venture with United Surgical Partners International. Tenet will initially own 50.1% of the joint venture and will consolidate its financial results and will have a path to full ownership of USPI over the next five years through a put/call structure, the company noted. Among the noteworthy losers was MEI Pharma (MEIP), which plunged $4.37, or 69.37%, to $1.93 and was downgraded by at least four Wall Street research firms after the combination of Pracinostat and azacitidine showed no difference in the rate of complete remission, the primary endpoint of a Phase II study, compared to azacitidine alone. Also lower were shares of Vertex (VRTX), which fell $5.21, or 3.98%, to $125.79 after reporting data from a study evaluating VX-661 in combination with ivacaftor in cystic fibrosis that JPMorgan said was generally below expectations. INDEXES: The Dow fell 11.61, or 0.06%, to 18,116.04, the Nasdaq lost 15.44, or 0.31%, to 5,010.97, and the S&P 500 dropped 3.68, or 0.17%, to 2,104.42.
12:17 EDTVRTXOn The Fly: Midday Wrap
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10:18 EDTVRTXVertex data not a surprise given recent commentary, says JPMorgan
JPMorgan said Vertex's VX-661 top-line Phase 2 data was generally below expectations but should not be too surprising given recent management commentary. The firm said its thesis remains unchanged and believes few biotechs offer a comparable level of competitive dominance and substantial earnings leverage as Vertex and reiterated its Overweight rating.
10:14 EDTVRTXVertex weakness a buying opportunity, says Piper Jaffray
Piper Jaffray said it views the Phase II study evaluating VX-661 in combination with ivacaftor in CF as too small and too short to derive meaningful conclusions and would use today's weakness following the data as a buying opportunity ahead of approval for KALYDECO + lumacaftor homozygous F508del-CFTR mutation patients, noting that the PDUFA date for the indication is July 5. The firm keeps an Overweight rating and $146 price target on Vertex shares, which are down 4.3% to $125.35 in morning trading.
09:38 EDTVRTXVertex shares defended at CRT Capital
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09:37 EDTVRTXActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AUY SLB PFE MCP CELG VRTX SHPG GILD LOGI TSLA TASR NFLX SCTY WFM
09:28 EDTVRTXOn The Fly: Pre-market Movers
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09:03 EDTVRTXLeerink analysts hold a meeting with a conference call hookup
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08:46 EDTRHHBYEli Lilly price target raised to $85 from $78 at Cowen
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07:47 EDTVRTXVertex says VX-661, ivacaftor generally well tolerated in 12-week Phase 2 study
Vertex Pharmaceuticals announced data from a 12-week Phase 2 study evaluating VX-661 in combination with ivacaftor in 39 people with CF ages 18 and older who have two copies of the F508del mutation. The study evaluated two doses of VX-661 in combination with ivacaftor. The primary endpoint of the study was safety. The study showed that the combination regimen was generally well tolerated, and all patients completed 12 weeks of treatment. The most common adverse events were pulmonary exacerbation, which occurred in 38% of all patients who received VX-661 and 44% of those who received placebo, and cough, which occurred in 33% of all patients who received VX-661 and 39% of those who received placebo. Secondary endpoints evaluated the effect of the combination on lung function, and the mean within-group absolute improvement from baseline in ppFEV1 for those who received 100 mg of VX-661 in combination with ivacafto was 4.4 and 3.0 percentage points at week 4 and through 12 weeks of treatment, respectively. Consistent with prior Phase 2 studies that evaluated 4 weeks of treatment with VX-661 in combination with ivacaftor, this study showed a rapid improvement in lung function within four weeks of treatment, and after patients completed treatment, lung function returned to baseline. These safety and efficacy data, together with other data from multiple previously completed Phase 2 studies of VX-661, support Vertex’s ongoing Phase 3 program of VX-661 in combination with ivacaftor. The Phase 3 program is evaluating VX-661 in combination with ivacaftor and consists of four Phase 3 studies, including a study in people with two copies of the F508del mutation that began enrollment in February. The other three studies will enroll people with CF who have one copy of the F508del mutation and a second mutation that is either a gating mutation, residual function mutation or a mutation that results in minimal CFTR function.
06:32 EDTRHHBYFoundation Medicine announces board changes in connection to Roche transaction
Foundation Medicine (FMI) announced proposed changes to its board in connection with its pending strategic collaboration with Roche (RHHBY). Under the terms of the agreement with Roche, Foundation Medicine’s board will increase to nine directors upon the closing of the transaction, including three board designees selected by Roche. The pending transaction with Roche remains subject to the satisfaction of certain closing conditions, including the successful completion of the tender offer commenced by Roche on February 2, 2015 and the approval of certain matters at the special meeting of Foundation Medicine stockholders to be held on April 2, 2015. The closing is expected to occur in the second quarter of 2015.
March 20, 2015
11:33 EDTRHHBYFly Review: Analysts correctly predict jump in Biogen shares
The shares of Biogen (BIIB) are rallying after the company reported results for a Phase 1b study of its Alzheimer's drug, BIIB-037. On March 18, as reported on that day by The Fly, RBC Capital predicted that the stock would rise after the results were published. A number of other firms were also upbeat on the stock ahead of the data release. WHAT'S NEW: Earlier this morning Biogen announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. Beta amyloid is a protein that produces plaque in the brain. Scientists suspect that plaques in the brain are a cause of Alzheimer's. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. PRE-EVENT CALLS: RBC Capital analyst Michael Yee predicted earlier this week in a note to investors that Biogen would report strong data for BIIB-037 and the stock should "work higher" after the data is unveiled. Alzheimer's patients taking the high dose of Biogen's BIIB-037 drug should exhibit a stabilization of cognition levels, Yee stated. Conversely, the cognition levels of patients taking the placebo should drop slightly, the analyst predicted. On March 13, in a note summarized by The Fly on that day, JPMorgan recommended buying Biogen shares ahead of the data release. Investors still incorporated a low probability of success for the drug, and the stock could rise further, the firm wrote. On March 19, in a note also published by The Fly, Credit Suisse wrote that Biogen's multiple could rise if the data on BIIB-037 was positive. It raised its price target on the name to $500 from $400. ANALYST REACTION: This morning, Barclays raised Biogen's price target to $500 from $435 following the company's report of "impressive" full results from the Alzheimer's study. Piper Jaffray analyst Joshua Schimmer also raised his price target for Biogen shares to $500 this morning, calling today’s BIIB-037 results "robust and impressive." Schimmer believes the trial showed a "consistent and dramatic" dose effect on both radiographic and clinical disease features and thinks the side effects "pale in comparison" to the drug’s efficacy. OTHERS TO WATCH: Eli Lilly (LLY) and Roche (RHHBY) are also currently developing similar Alzheimer's treatments. PRICE ACTION: In late morning trading, Biogen rose 7% to $464. The stock is up about 9% since Wednesday. Eli Lilly shares are up 1.6% to $75.40 this morning, while Roche rose 2.2% to $35. Reference Link
09:01 EDTRHHBYEli Lilly up 2% to $75.75 in pre-market trading
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March 19, 2015
16:14 EDTRHHBYProthena report positive results from Phase 1 study of PRX002
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07:02 EDTRHHBYSigma-Aldrich signs exclusive distribution agreement with Roche
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March 18, 2015
12:48 EDTRHHBYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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07:46 EDTRHHBYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
March 17, 2015
08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
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