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Stock Market & Financial Investment News

News Breaks
January 9, 2014
08:38 EDTBMY, VRTXVertex announces first data from initial cohorts of VX-135 Phase 2a study
Vertex Pharmaceuticals (VRTX) announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135 in combination with daclatasvir, Bristol-Myers Squibb's (BMY) NS5A replication complex inhibitor. In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment was 83% in treatment-naÔve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. In this arm, one patient discontinued treatment after the first dose due to a serious adverse event of vomiting/nausea. The 11 other patients in this arm completed 12 weeks of treatment, and 91 percent (10 of 11) achieved SVR4. In the study, the majority of adverse events were mild. Vertex expects to submit data to present at a medical meeting in 2014.
News For VRTX;BMY From The Last 14 Days
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March 26, 2015
10:10 EDTVRTXAnalyst calls sharp pullback in biotech stocks 'misguided'
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07:30 EDTBMYDeutsche Bank to hold a conference
Pharma One-on-One Day is being held in Denver, Colorado on March 26.
06:45 EDTVRTXBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 25, 2015
15:15 EDTVRTXVertex April weekly volatility elevated
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10:36 EDTVRTXOptions with decreasing implied volatility
Options with decreasing implied volatility: FOLD WLL WBAI ASPS GES PSEC CTRP LNCO VRTX ARP
March 24, 2015
08:02 EDTBMYBristol-Myers acquires exclusive license from Novo Nordisk for research program
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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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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 Vertexís 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.
March 20, 2015
07:55 EDTBMYAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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March 13, 2015
11:19 EDTVRTXBioMarin rallies amid positive call on DMD drug timeline, takeover rumor
The shares of drug maker BioMarin (BMRN) are climbing after research firm Jefferies quoted a regulatory expert as saying that the company's drisapersen drug has a good chance of being approved on an accelerated basis by the FDA. Drisapersen is a treatment for Duchenne Muscular Dystrophy, or DMD. WHAT'S NEW: "There is a strong possibility" that the FDA will grant accelerated approval to drisapersen because there is currently no approved drug for the treatment of DMD, Jefferies analyst Eun Yang quoted the expert as saying. The expert is also optimistic about the outlook for accelerated approval because she had a good experience working with BioMarin while she was with the FDA and because BioMarin has a favorable track record with the FDA, according to Yang. There is a 60% chance that drisapersen will be approved by the end of this year and the stock can rise to $155, versus its current level of about $121.50, if that does occur, the analyst stated. Yang's price target on the stock increased to $135 from $125 and the analyst kept a Buy rating on the shares. WHAT'S NOTABLE: Pharmaceutical giant AstraZeneca (AZN) has been rumored to be interested in buying BioMarin for $175 per share in cash, British newspaper Daily Mail reported. , Piper Jaffray analyst Joshua Schimmer wrote in a note to investors this morning that BioMarin, along with Vertex (VRTX) and Incyte (INCY), have a "clear path" to joining the group of companies with market caps of over $10B projected to deliver greater than 20% EPS CAGR, which the analyst identified as a set of criteria that has previously pointed to companies that make good potential takeover targets. PRICE ACTION: In mid-morning trading, BioMarin climbed nearly 4% to $120.
March 12, 2015
15:02 EDTBMYBristol-Myers announces FDA acceptance of NDA for daclatasvir
Bristol-Myers Squibb Company announced that the resubmitted new drug application, or NDA, for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the FDA for use in combination with sofosbuvir for the treatment of chronic hepatitis C, or HCV, genotype 3. The original NDA has been amended to include data from the Phase III ALLY-3 trial, which showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment in 90% of treatment-naÔve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will now review the submission within a six-month timeframe.
12:49 EDTBMYWHO recommends tenofovir or entecavir for hepatitis B treatment
The World Health Organization issued its first-ever guidance for the treatment of chronic hepatitis B. Its recommended medicines consist of Gilead's (GILD) tenofovir or Bristol-Myers' (BMY) entecavir. Teva (TEVA) has FDA approval for generic entecavir.

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