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Stock Market & Financial Investment News

News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA From The Last 14 Days
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March 27, 2015
10:03 EDTALKSOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: AEGON (AEG) downgraded to Neutral from Buy at Goldman... Alkermes (ALKS) downgraded to Neutral from Buy at Citigroup... American Eagle (AEO) downgraded to Sell from Neutral at Goldman... ArcelorMittal (MT) downgraded to Sell from Neutral at Citigroup... Black Diamond (BDE) downgraded to Sell from Hold at Feltl... Diodes (DIOD) downgraded to Outperform from Strong Buy at Raymond James... EMC (EMC) downgraded at Pacific Crest... Epizyme (EPZM) downgraded to Neutral from Buy at Citigroup... FutureFuel (FF) downgraded Neutral at Roth Capital... GameStop (GME) downgraded to Neutral from Buy at B. Riley... MSC Industrial (MSM) downgraded to Neutral from Outperform at RW Baird... Pioneer Energy (PES) downgraded to Hold from Buy at Deutsche Bank... Power Integrations (POWI) downgraded to Market Perform at Raymond James... Precision Drilling (PDS) downgraded to Hold from Buy at Deutsche Bank... SanDisk (SNDK) downgraded to Hold from Buy at Evercore ISI... Semtech (SMTC) downgraded to Outperform from Strong Buy at Raymond James... Swiss Re (SSREY) downgraded to Hold from Buy at Jefferies... Vantiv (VNTV) downgraded at SunTrust... Vivendi (VIVHY) downgraded to Underperform from Outperform at Exane BNP Paribas... WESCO (WCC) downgraded to Neutral from Outperform at RW Baird... World Acceptance (WRLD) downgraded to Underperform from Neutral at Macquarie... Zurich Insurance (ZURVY) downgraded to Neutral from Buy at Goldman.
07:45 EDTTEVAFDA to hold a public meeting
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07:25 EDTTEVA, PFETeva appears to be weighing transformative deal, says Bernstein
After attending Teva's (TEVA) meeting with investors, Bernstein thinks that the company is considering making a 'transformative' acquisition, although it believes that such a deal may not be imminent. The firm sees Mylan ((MYL) and the generic units of Actavis (ACT), Pfizer (PFE), and possibly Valeant (VRX) as the four logical candidates. It says that Teva can pay $81 per share for Mylan, and that a takeover of Mylan would raise Teva's EPS to about $6.50 in 2017 and $7 in 2018. Bernstein raised its price target on Teva to $69 from $60 and keeps an Outperform rating on the shares.
06:15 EDTALKSAlkermes downgraded to Neutral from Buy at Citigroup
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March 26, 2015
12:13 EDTCELGCelgene, MorphoSys mutually agree to end MOR202 collaboration
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11:13 EDTAZNBofA/Merrill European pharma analyst holds an analyst/industry conference call
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09:36 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TWTR FB KRFT BIDU TSLA CELG NFLX FCAU
09:01 EDTPRXLPAREXEL agrees to acquire business assets of Quantum Solutions India
PAREXEL announced that the company has signed a definitive agreement to acquire all of the business assets of privately-owned Quantum Solutions India, a provider of specialized pharmacovigilance services, based in Chandigarh, India. Pharmacovigilance refers to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The acquisition is expected to close in early April of 2015, subject to the satisfaction of closing conditions.
07:30 EDTTEVA, PFEDeutsche Bank to hold a conference
Pharma One-on-One Day is being held in Denver, Colorado on March 26.
06:45 EDTCELGBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 24, 2015
07:45 EDTTEVA, PFEFDA 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
07:26 EDTCELGCelgene drug competitor will need additional studies, says UBS
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06:22 EDTTEVATeva appointment shows transformative M&A not off table, says Citigroup
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March 23, 2015
16:01 EDTTEVA, CELGOptions Update; March 23, 2015
iPath S&P 500 VIX Short-Term Futures down 48c to 25.24 Option volume leaders: AAPL TSLA TWTR GILD CELG FB TSLA AMZN TEVA PBR according to Track Data.
12:10 EDTTEVATeva migraine drug data positive for Amgen, says Piper Jaffray
Piper Jaffray said the "positive" trial data Teva (TEVA) reported for its anti-CGRP antibody in migraines is another important validation for the class of drugs that is also being worked on by Amgen (AMGN), Eli Lilly (LLY) and Alder Biopharmaceuticals (ALDR). The firm said it thinks Amgen is one of the leaders in CGRP antibody space and reiterated its Overweight rating and $187 price target on Amgen shares.
11:32 EDTCELGStocks with call strike movement; GILD CELG
Gilead (GILD) August 115 call option implied volatility increased 5% to 27, Celgene (CELG) July 140 call option implied volatility increased 3% to 28 according to IVolatility.
11:09 EDTPFEPfizer hits best level in over decade after Jefferies adds to list of best ideas
The shares of Pfizer (PFE) are rising after an analyst wrote that the company's shares are poised to rise significantly over the next one to two years. Additionally, the company announced that it would resume developing its painkiller, tanezumab, in partnership with Eli Lilly (LLY). ANALYST OUTLOOK: Pfizer's breast cancer drug for postmenopausal women, Ibrance, has had one of the best launches of any oncology drug ever, Jefferies analyst Jeffrey Holdford wrote in a note to investors today. A survey of U.S. oncologists conducted by the firm shows that the doctors expect the drug to be used on about 50% of patients needing first line hormonal therapy within one year, while the drug will be used as an off-label treatment in all lines of therapy, the analyst wrote. The drug will generate revenue of $5.5B in 2020, versus the consensus outlook of $3.3B, Holford estimated. Meanwhile, the drug maker's Global Established Pharmaceutical, or GEP, business' revenue and profits should top consensus estimates by14% by 2018, according to the analyst. Pfizer could generate value through accretive M&A activity and by separating the GEP unit by 2017, Holdford stated. He raised his price target on the name to $45 from $42, kept a buy rating on the shares, and added the stock to the firm's Franchise Picks list, which encompasses its best ideas. WHAT'S NOTABLE: Pfizer announced that, in partnership with Eli Lilly, it would resume its Phase 3 clinical program for tanezumab. The announcement was made after the FDA removed a partial clinical hold on the drug, Pfizer noted. As a result of its decision, Pfizer expects to receive a $200M payment, in accordance with the companies' agreement, Pfizer stated. PRICE ACTION: In mid-morning trading, Pfizer climbed 2.4% to $35.08. The stock has not traded at a price per share this high since 2004.
11:01 EDTPFEPfizer rallies to fresh 52-week high, levels to watch
Shares are up over 2.8% at time of writing to $35.14, just below the new 52-week high at $35.26 which is now initial resistance. Next resistance above is at $35.89 and then at $36.63. Support is at $34.89.
09:45 EDTAZNUBS to hold a field trip
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09:37 EDTPFE, CELGActive 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
09:06 EDTAZNInsmed appoints Eugene Sullivan as Chief Medical and Scientific Officer
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09:03 EDTAZNLeerink analysts hold a meeting with a conference call hookup
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08:50 EDTTEVATeva reports TEV-48125 met endpoints in phase 2b study
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08:06 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
Pfizer (PFE) and Eli Lilly and Company (LLY) announced that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200M upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. FDA to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February. In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
08:05 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
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07:36 EDTPFE, AZNPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
05:55 EDTCELGStocks with implied volatility movement; AMZN CELG
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March 20, 2015
13:04 EDTCELGCelgene reports results from long-term efficacy,safety analyses of Otezla trials
Celgene announced that results from long-term efficacy and safety analyses of the ESTEEM phase III clinical trial program of Otezla were presented at the 73rd Annual Meeting of the American Academy of Dermatology. OTEZLA is the company’s oral, selective inhibitor of phosphodiesterase 4 approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis. In ESTEEM 1 and 2, patients were randomized to treatment with OTEZLA 30 mg twice daily or placebo for the first 16 weeks. At week 16, patients either continued on OTEZLA or were switched from placebo to OTEZLA 30 mg twice daily through week 32. Patients initially randomized to OTEZLA who achieved a Psoriasis Area and Severity Index-75 response or PASI-50 response at week 32 were then re-randomized to either OTEZLA 30 mg twice daily or placebo. Celgene said improvements in the severity of preexisting nail, scalp and palmoplantar psoriasis achieved at week 16 were maintained in OTEZLA responders through week 52 in ESTEEM 2; OTEZLA improved the severity of palmoplantar psoriasis at week 16 in a subset of patients across three trials; Long-term safety profile for up to 104 weeks in ESTEEM 1 was consistent with previously reported data from OTEZLA clinical trial programs, with no new safety signals and no clinically meaningful changes in laboratory values.
13:03 EDTPFEPfizer says oral tofacitinib meets primary endpoint in Phase 3 trials
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13:01 EDTCELGCelgene announces positive Phase III study results evaluating Otezla
Celgene announced that results from its ongoing phase III LIBERATE trial evaluating Otezla, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with moderate to severe plaque psoriasis. The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16. At week 16, patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index-75 response. At week 16, statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg when compared with placebo. A post-hoc analysis revealed no significant difference between OTEZLA and etanercept in PASI-75 at week 16. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
10:51 EDTCELGStocks with call strike movement; DAL CELG
Delta Air Lines (DAL) September 57.5 call option implied volatility decreased 1% to 34, Celgene (CELG) July 145 call option implied volatility increased 3% to 28 according to IVolatility.
09:45 EDTCELGActive equity options trading on open
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07:55 EDTAZN, PFEAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTPFE, CELGAmerican Academy of Dermatology to hold annual meeting
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06:26 EDTCELGCelgene price target raised to $144 from $135 at Piper Jaffray
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March 19, 2015
11:00 EDTPFEPfizer participates in a conference call with Bernstein
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09:37 EDTCELGActive equity options trading on open
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08:37 EDTAZNNektar and Daiichi Sankyo to commercialize Movantik in the U.S.
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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17:07 EDTCELGCelgene GED-0301 Phase II data published in New England Journal of Medicine
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16:13 EDTTEVAFibrocell Science appoints Keith Goldan as CFO
Fibrocell Science announced the appointment of Keith Goldan as senior VP and Chief Financial Officer, effective immediately. Prior to joining Fibrocell, Goldan served as CFO of two publicly traded companies. Most recently he served as SVP and CFO of NuPathe, which was acquired by Teva Pharmaceutical (TEVA) in 2014.
11:36 EDTTEVAIgnyta price target raised to $17 from $14 at Leerink
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10:08 EDTTEVAEagle Pharmaceuticals price target increased to $67 from $43 at William Blair
William Blair raised its price target on Eagle Pharmaceuticals to $67 from $43 citing its belief that the company can become profitable and have significant cash flow pending the approval of EP-3102. The company added that it view last week's FDA label change for Teva's (TEVA) Treanda as a positive for EP-3102 and that its new price target assumes 2016 launch and "reasonable" penetration for EP-3102.
07:13 EDTTEVATeva volatility elevated, shares near four year high
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March 17, 2015
19:42 EDTTEVAOn The Fly: After Hours Movers
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16:03 EDTTEVAIgnyta acquires 4 oncology R&D assets from Teva for 1.5M shares of common stock
Teva (TEVA) and Ignyta (RXDX) announced the acquisition by Ignyta of the worldwide rights and assets relating to four targeted oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7M shares at $10 per share, valuing the total offering at approximately $41.6M. Under the terms of the asset purchase agreement with Teva, Ignyta is acquiring all of Teva’s assets and worldwide rights relating to four oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Teva has agreed not to sell or otherwise transfer any of these shares until March 17, 2016, and Ignyta is required to register the resale of these shares with the SEC prior to such date. Ignyta also assumed all of Teva’s ongoing obligations under certain contracts relating to the purchased programs, including the agreements under which Teva in-licensed rights to the assets.
14:10 EDTAZNIGI Laboratories recent sell-off a buying opportunity, says Craig-Hallum
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10:26 EDTTEVAOptions with increasing implied volatility
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March 16, 2015
11:40 EDTTEVAEnzo Biochem to request rehearing of court of appeals decision
Enzo Biochem (ENZ) said, acting upon advice of counsel, that it disagrees with the March 16 split 2-to-1 decision of the Court of Appeals sitting in panel for the Federal Circuit that reverses-in-part and vacates-in-part the judgment in Enzo’s favor that Applera Corp., now Life Technologies (LIFE), infringed Enzo’s patents covering pioneering technologies relating to compounds used in DNA sequencing systems to read the genetic code, and remands the case to the District Court as to whether the accused product infringes. Counter to the District Court’s construction of the ‘767 patent as allowing for directly-detectable labels on nucleotides and polynucleotides, and counter to the jury’s verdict that the patent describes such labelling, the Court of Appeals, held such labelling excluded by claim 1 of that patent. Enzo notes also that the Court’s partial vacatur and reversal of the judgment does not end the case, but remands the case back to the District Court to find whether the accused product infringes. Enzo will request rehearing of that decision, both by the original panel and by the full en banc Court. Enzo believes rehearing is warranted by the panel’s failure to give appropriate weight to fact findings, including facts found by the jury, consistent with a broader construction of the patent, as required by the Supreme Court’s recent decision in Teva Pharmaceuticals (TEVA).
10:28 EDTTEVAOptions with increasing implied volatility
Options with increasing implied volatility: PVA NFLX BMRN DNOW MYL TEVA PEP GE
09:01 EDTACORFlex Pharma names Thomas Wessel as Chief Medical Officer
Flex Pharma (FLKS) announced the appointment of Thomas Wessel, M.D., Ph.D., as its Chief Medical Officer, reporting to Christoph Westphal M.D., Ph.D., Flex Pharma’s President, CEO and Chair. Flex Pharma also announced that Elizabeth Woo, M.B.A., has been promoted to Senior VP, Investor Relations and Corporate Communications. Previously, Dr. Wessel has been the Chief Medical Officer of Acorda Therapeutics (ACOR).
08:44 EDTTEVAFDA warning on liquid bendamustine may help Eagle's EP-3102, says Piper Jaffray
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07:30 EDTAZNAmerican College of Cardiology to hold an expo
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06:40 EDTPFEPCSK9 studies show potential improvement in heart health, WSJ says
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March 13, 2015
17:33 EDTCELGS&P announces changes to S&P 100 Index
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11:19 EDTAZNBioMarin 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.
10:51 EDTTEVAOptions with increasing implied volatility
Options with increasing implied volatility: PVA BBEP SLXP ENDP MYL BBBY TEVA ZTS
08:07 EDTAZNAstraZeneca rumored to have BioMarin 'on shopping list,' Daily Mail says
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05:47 EDTTEVAStocks with implied volatility movement; SLXP MNKD
Stocks with implied volatility movement; Salix (SLXP) 20, Teva (TEVA) 27 according to iVolatility.
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