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Sep. 25, 2015, 3:07 PM
- A sharply lower healthcare sector (XLV -3%) has dragged the S&P 500 (SPY -0.2%) into the red and the Nasdaq (NASDAQ:QQQ) down a full 1%. The Dow (DIA +0.4%) remains higher, courtesy of a post-earnings 9% moonshot in Nike.
- Biotechs (IBB -5.7%) and Pharmaceuticals (XPH -5.9%) are hardest hit, continuing to feel the pressure from Hillary Clinton's assault on drug-pricing. Gilead (GILD -2.5%), Biogen (BIIB -3.5%), Celgene (CELG -5.4%), Amgen (AMGN -3.6%), Allergan (AGN -4%), Mylan (MYL -5.6%).
- ETFs: IBB, IYH, XLV, XBI, VHT, PJP, BBH, FBT, HQH, CURE, XPH, HQL, PBE, FXH, RXL, IHE, FHLC, SBIO, PPH, RYH, BBC, THQ, BBP, RXD, LABU, LABD, UBIO, ZBIO
Sep. 25, 2015, 7:22 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of an expanded indication of Celgene's (NASDAQ:CELG) VIDAZA (azacitidine for injection) for the treatment of adult patients at least 65 years old with acute myeloid leukemia (AML) who are not eligible for hematopoietic stem cell transplantation. The expanded label now covers those patients who have >30% myeloblasts according to the WHO classification. Previously, VIDAZA's label covered AML patients with <30% myeloblasts.
- Myeloblasts are unipotent stem cells in the bone marrow. In AML, their functioning is disrupted which potentially interferes with the body's ability to fight infections and can lead to anemia and hemorrhages.
- The data supporting CHMP's positive opinion was generated from the clinical trial called AML-001 which showed an increase in median overall survival of 60% (10.4 months versus 6.5 months) in patients receiving VIDAZA plus best supportive care compared to conventional care regimens.
- A final decision from the European Commission usually takes ~60 days.
Sep. 23, 2015, 7:59 AM
- OncoGenex Pharmaceuticals' (NASDAQ:OGXI) experimental apatorsen (OGX-427), in combination with Celgene's (NASDAQ:CELG) Abraxane (paclitaxel) and gemcitabine, failed to show a treatment benefit compared to Abraxane and gemcitabine alone in a Phase 2 clinical trial in treatment-naive metastatic pancreatic cancer patients. The results of the study, called Rainier, will be presented by sponsor Sarah Cannon Research Institute at a future medical conference.
- CEO Scott Cormack says, "While we are disappointed with the Rainier results, we also recognize the challenges associated with developing effective treatments for such a lethal and complex disease. We remain confident in our broader apatorsen program, which includes ongoing Phase 2 clinical trials in lung, prostate and bladder cancers."
- Apatorsen is a once-weekly intravenous drug designed to inhibit heat shock protein 27 (Hsp27), an intracellular protein that helps cancer cells survive.
- There are ~340K new cases of pancreatic cancer each year worldwide. Most patients die within the first year of diagnosis. The five-year survival rate is less than 10%.
- Shares are off 18% premarket on increased volume.
Aug. 31, 2015, 12:22 PM
- OncoMed Pharmaceuticals (OMED -0.8%) completes the enrollment of 177 subjects eight months ahead of schedule in its Phase 2 clinical trial, called ALPINE, evaluating tarextumab in treatment-naive advanced pancreatic cancer patients. Specifically, the study will investigate the efficacy of tarextumab in combination with Celgene's (CELG -3.1%) Abraxane (paclitaxel protein-bound particles for injectable suspension) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer.
- The primary endpoint is overall survival (OS). Top-line data are expected in H2 2016.
- Tarextumab (OMP-59R5) is a fully human monoclonal antibody that binds to the Notch2 and Notch3 receptors. It is believed to have two mechanisms of action: down-regulating the Notch signaling pathway which appears to have anti-cancer stem cell effects and affecting pericytes, contractile cells that wrap around endothelial cells of small blood vessels, impacting the stromal (connective tissue) and tumor microenvironments.
Aug. 20, 2015, 2:35 AM
- Yesterday was the 11th anniversary since Google's (GOOG, GOOGL) initial public offering, and there's no doubt the company has had a remarkable run (Class A shares +1,277%).
- Although the online advertising giant has given a massive return to investors, there are still 13 stocks that outperformed Google since 8/19/2004:
- Alexion Pharmaceuticals (NASDAQ:ALXN); Amazon (NASDAQ:AMZN); Apple (NASDAQ:AAPL); Celgene (NASDAQ:CELG); Gilead Sciences (NASDAQ:GILD); Intuitive Surgical (NASDAQ:ISRG); Keurig Green Mountain (NASDAQ:GMCR); Monster Beverage (NASDAQ:MNST); Netflix (NASDAQ:NFLX); Priceline (NASDAQ:PCLN); Regeneron Pharmaceuticals (NASDAQ:REGN); salesforce.com (NYSE:CRM); Vertex Pharmaceuticals (NASDAQ:VRTX).
Aug. 11, 2015, 8:47 AM
- The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) pertaining to Celgene's (NASDAQ:CELG) bid for Receptos (NASDAQ:RCPT) expired yesterday. This satisfies one of the conditions for the closing of the transaction, expected this quarter.
- Celgene's offer will expire at midnight ET on Monday, August 24, unless extended.
Aug. 5, 2015, 8:45 AM
- The Federal Trade Commission grants early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with Celgene's (NASDAQ:CELG) 10-year collaboration agreement with Juno Therapeutics (NASDAQ:JUNO), making it effective on July 31.
- Celgene will make an initial investment of $1B, consisting of an upfront payment of $150M and the purchase of 9,137,672 common shares of Juno at $93 per share.
- JUNO is up 2% premarket on light volume. CELG is up a fraction.
- Previously: Juno up 53% after hours on 10-year Celgene deal (June 29)
Aug. 4, 2015, 4:52 PM
- Celgene (NASDAQ:CELG) prices five series of senior unsecured notes representing an aggregate of $8B. $1.0B will mature in 2018 and bear annual interest of 2.125%, $1.5B will mature in 2020 and bear 2.875%, $1.0B will mature in 2022 and bear 3.550%, $2.5B will mature in 2025 and bear 3.875% and $2.0B will mature in 2045 and bear 5.000%. Each series' actual price produced yields slightly higher that the stated rates.
- Proceeds will help fund the Receptos acquisition.
Aug. 4, 2015, 8:12 AM
- As permitted under its 2009 Collaboration and Option Agreement with GlobeImmune (NASDAQ:GBIM), Celgene (NASDAQ:CELG) exercises its option to exclusively license GI-6207, a product candidate developed with GlobeImmune's proprietary Tarmogen platform. GI-6207, the second Tarmogen-derived product candidate licensed to Celgene, targets cancers that express carcinoembryonic antigen (CEA). It is currently in Phase 2 development for medullary thyroid cancer (MTC) at the National Cancer Institute. Top-line results are expected in H2 2016.
- CEA is over-expressed in various human epithelial cancers, including MTC. Preclinical studies showed that GI-6207 could induce an immune response to CEA as well as therapeutic anti-tumor responses. In an earlier Phase 1 trial of monotherapy GI-6207, 20% (n=5/25) of subjects receiving the drug experienced stable or decreased levels of CEA and stable disease.
- Under the terms of the agreement, GlobeImmune will receive an option exercise payment of $1.9M, regulatory- and sales-based milestones and royalties on commercial sales.
- There are ~500K new cancer cases each year in the U.S. characterized by the over-expression of CEA.
- Update: GBIM is up 46% premarket on light volume. CELG is up a fraction.
Aug. 3, 2015, 8:42 AM
- Celgene Corporation (CELG) announces plans to offer senior unsecured notes under a shelf registration statement with the Securities and Exchange Commission. The offering is subject to market and other conditions.The interest rate, the maturity dates and other key terms of the offering will be determined at the time of pricing.
- The company anticipates that the net proceeds will finance a portion of the acquisition of Receptos (RCPT) and the remainder for general corporate purposes. This may include further development of Celgene's clinical and pre-clinical programs, capital expenditures, general corporate development activities, meeting working capital needs, share repurchases and repayment of some or all of Celgene's outstanding commercial paper.
- J.P. Morgan, Citigroup, Deutsche Bank, and Merrill Lynch, Pierce, Fenner & Smith Incorporated are acting as joint book-running managers and representatives of the several underwriters. Previously: Celgene to buy Receptos for $7.2B (July 14 2015)
Jul. 23, 2015, 8:24 AM
- Celgene (NASDAQ:CELG) Q2 results ($M): Total Revenues: 2,277.8 (+21.6%); Net Product Sales: 2,254.1 (+22.2%); U.S. Product Sales: 1,350.3 (+25.8%); International Product Sales: 903.8 (+17.2%).
- Net Income: 356.2 (-40.4%); EPS: 0.43 (-40.3%); CF Ops: 284.0 (-45.0%).
- Key Product Sales: Revlimid: 1,444.0 (+19.0%); Abraxane: 244.2 (+13.4%); Pomalyst/Imnovid: 234.5 (+45.7%); Vidaza: 152.1 (+0.1%).
- 2015 Guidance: Net Product Sales: $9.0B - 9.5B (unch); Revlimid Sales: $5.6B - 5.7B (unch); Abraxane Sales: $1.0B - 1.25B (unch); EPS: $2.17 - 2.46 from $2.97 - 3.19; Non-GAAP EPS: $4.75 - 4. 85 from $4.60 - 4.75.
Jul. 23, 2015, 7:32 AM
- Celgene (NASDAQ:CELG): Q2 EPS of $1.23 beats by $0.04.
- Revenue of $2.28B (+21.9% Y/Y) beats by $20M.
- Shares +0.9% PM.
Jul. 22, 2015, 5:30 PM
- ABB, ABC, ADS, AEP, ALK, AMAG, AOS, ASPS, BCC, BHE, BKU, BMS, BMY, BSX, CAB, CAM, CAT, CELG, CFX, CLFD, CMCSA, CMS, COR, CS, CSL, CY, DAN, DFRG, DGX, DHR, DLX, DNKN, DOW, DPS, DST, EQM, EQT, FAF, FCX, FIS, FNB, GM, GMT, GNTX, GPI, GPK, HBAN, HERO, HUB.B, IMAX, IQNT, IVC, JNS, KKR, KMB, LAZ, LLY, LUV, MAC, MCD, MHO, MINI, MJN, MMM, MNRO, MRGE, NDAQ, NEO, NUE, NWE, ORI, PDS, PENN, PHM, PRLB, PTEN, QSII, R, RCI, RS, RTN, SCHL, SFE, SHPG, SNA, SQNS, STC, STM, SYNT, TCB, TROW, UA, UAL, UNP, USG, UTEK, VAC, VRX, WAB, WCC, WIT, WM, WRLD, XRS
Jul. 22, 2015, 12:43 PM
- Celgene (CELG +1.5%) reports Q2 results tomorrow before the open. Consensus view is EPS of $1.19 (+65%) on revenues of $2.3B (+23%).
Jul. 16, 2015, 12:31 PM
- UniQure (QURE -0.1%) initiated with Outperform rating by Cowen & Co.
- Axovant Sciences (AXON +2.7%) initiated with Market Outperform rating and price target of $36 (103% upside) by JMP Securities.
- Walgreens Boots Alliance (WBA +1.6%) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $110 (15% upside) from $90.
- Celgene (CELG +3.1%) maintained with Buy rating by Nomura. Price target raised to $165 (22% upside) from $146. Receptos (RCPT -0.3%) downgraded to Neutral from Buy with a $232 (predictable) price target.
Jul. 15, 2015, 10:36 AM
- Celgene's (CELG +9.5%) $7.2B deal for Receptos (RCPT +10.3%) is “a great acquisition at a great price," Nomura analysts say, as ozanimod could enable CELG's inflammation and immunology franchise to double peak sales to $10B and reduce reliance on Revlimid to drive future growth, and the acquisition price of less than 2x peak sales is a steep discount relative to recent comparisons.
- Wedbush analyst Liana Moussatos sees plenty of potential upside to justify a rival bidder stepping in for RCPT, noting that she had estimated the company could be valued at $348/share, or ~$10.9B, in a buyout, substantially more than CELG's $232 offer.
- The deal is boosting some biotech names (IBB +1.9%), including PTC Therapeutics (PTCT +11.7%), Celsion (CLSN +7.1%) and Arena Pharmaceuticals (ARNA +6.7%).
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