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Celgene Corporation (CELG)

  • Yesterday, 11:28 AM
    • Under its Priority Review process, the FDA approves elotuzumab, in combination with Celgene's (CELG -1.7%) REVLIMID (lenalidomide) and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received one to three prior lines of therapy.
    • In clinical studies, patients receiving elotuzumab plus REVLIMID and dexamethasone showed a longer period of progression-free survival (19.4 months) compared to those receiving REVLIMID and dexamethasone alone (14.9 months). In addition, 78.5% of patients treated with elotuzumab plus the other two experienced complete or partial shrinkage of their tumors compared to 60.1% of patients who did not receive elotuzumab.
    • Orphan Drug- and Breakthrough Therapy-tagged elotuzumab was co-developed by Bristol-Myers Squibb (BMY -0.7%) and AbbVie (ABBV -2.2%). BMY has sole commercialization rights to the product, which will be marketed under the brand name Empliciti.
    • Multiple myeloma, a type of blood cancer that occurs in plasma cells, strikes ~27K Americans each year resulting in over 11K deaths.
    • Elotuzumab is the second monoclonal antibody cleared by the FDA for MM. It approved Janssen's (JNJ -0.7%) Darzalex (daratumumab) several weeks ago.
    • Previously: FDA accepts elotuzumab BLA under Priority Review (Sept. 1)
    • Previously: FDA clears J&J's Darzalex for treatment-resistant multiple myeloma (Nov. 16)
    | Yesterday, 11:28 AM | 9 Comments
  • Fri, Nov. 20, 11:18 AM
    • The FDA approves Takeda Pharmaceuticals' (OTCPK:TKPHF)(OTCPK:TKPYY) Ninlaro (ixazomib), in combination with Celgene's (CELG +0.7%) REVLIMID (lenalidomide) and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least one prior line of therapy.
    • Priority Review- and Orphan Drug-tagged Ninlaro is a proteosome inhibitor. It works by blocking certain enzymes from multiple myeloma cells which interferes with their ability to grow and survive.
    • In clinical studies, MM patients receiving the Ninlaro combination experienced an average period of progression-free survival of 20.6 months compared to 14.7 months for those receiving lenalidomide and dexamethasone alone.
    | Fri, Nov. 20, 11:18 AM | Comment!
  • Thu, Nov. 5, 8:10 AM
    • Celgene (NASDAQ:CELG) Q3 results ($M): Total Revenues: 2,334.1 (+17.8%); Net Product Sales: 2,312.6 (+18.2%).
    • Net Income: (34.1) (-106.7%); EPS: (0.04) (-106.6%); Non-GAAP EPS: 1.23 (+26.8%); CF Ops: 285 (-68.4%). Earnings down due to upfront collaboration expenses led by Juno Therapeutics.
    • Key Product Sales: Revlimid: 1,453.5 (+11.8%); Abraxane: 229.9 (+8.3%); Pomalyst/Imnovid: 256.5 (+41.6%); Vidaza: 147.6 (-6.5%); Otezla: 138.7 (+688.1%).
    • 2015 Guidance: Net Product Sales: $9.0B - 9.5B (unch); Revlimid sales: ~$5.8B from $5.6B - 5.7B; Abraxane sales: $950M - 1.0B from $1.0B - 1.25B; EPS: $2.02 - 2.24 from $2.17 - 2.46; Non-GAAP EPS: 4.75 - 4.85 (unch).
    • Shares are down 4% premarket on increased volume.
    | Thu, Nov. 5, 8:10 AM | 10 Comments
  • Thu, Nov. 5, 7:41 AM
    • Celgene (NASDAQ:CELG): Q3 EPS of $1.23 beats by $0.01.
    • Revenue of $2.33B (+17.7% Y/Y) misses by $70M.
    • Shares -2.45% PM.
    • Press Release
    | Thu, Nov. 5, 7:41 AM | Comment!
  • Wed, Nov. 4, 5:30 PM
  • Fri, Oct. 30, 7:19 AM
    • The European Commission approves an expanded label for Celgene's (NASDAQ:CELG) VIDAZA (azacitidine for injection) to now include adult patients aged 65 years and older with acute myeloid leukemia (AML) who are not eligible for hematopoietic stem cell transplantation (HSCT). Elderly AML patients typically have poor prognoses.
    • The labeling has also been updated to include AML patients with greater than 30% myeloblasts according to the WHO classification. Previously, VIDAZA was approved for AML patients with less than 30% myeloblasts (white blood cells in the bone marrow). In AML, the function of myeloblasts is disrupted. The non-functioning cells can potentially interfere with the body's ability to fight infections and can lead to anemia and hemorrhages.
    • VIDAZA is cleared in the EU for the treatment of certain myelodysplastic syndromes, chronic myelomonocytic leukemia and AML.
    • VIDAZA is not approved in the U.S. for AML.
    | Fri, Oct. 30, 7:19 AM | Comment!
  • Wed, Oct. 21, 1:22 PM
    • As if anyone following biotechs needs reminding, sellers are overwhelming the space. The iShares Nasdaq Biotechnology ETF (IBB -2.8%) is down 6% since Monday.
    • Key tickers: (BIB -6.5%)(BIS +6.3%)(VRX -38.5%)(AGN -5.9%)(BIIB -0.1%)(AMGN -1.7%)(GILD -1%)(CELG -2%)
    | Wed, Oct. 21, 1:22 PM | 66 Comments
  • Mon, Oct. 19, 11:58 AM
    • Results from the 32-week maintenance phase of Celgene's (CELG +1.8%) TOUCHSTONE Phase 2 clinical trial assessing Ozanimod (RPC1063) in patients with moderate-to-severe ulcerative colitis (UC) showed statistically significantly higher proportion of subjects on Ozanimod achieved or maintained clinical remission compared to placebo. The data were presented at the American College of Gastroenterology Annual Scientific Meeting in Honolulu.
    • TOUCHSTONE evaluated two doses (0.5 mg and 1.0 mg) of Ozanimod in 197 UC patients. The primary endpoint was the proportion of patients in remission at week 8 versus placebo. In the maintenance phase, 103 patients who achieved clinical response at week 8 continued treatment for an additional 24 weeks. Of these, 91 completed 32 weeks of therapy.
    • 21% (n=14/67) of patients on Ozanimod 1.0 mg achieved or maintained clinical remission at week 32 compared to 6% (n=4/65) for placebo (p=0.0108). 51% (n=34/67) achieved clinical response versus 20% (n=13/65) for placebo (p=0.0002). The difference in mucosal improvement also significantly favored Ozanimod (32.8% vs. 12.3%; p=0.0046).
    • Adverse events were observed in 26.2% (n=11/42) of the Ozanimod 1.0 mg cohort. The most common were worsening of UC and urinary tract infection.
    • A Phase 3 study is currently underway. According to clinicaltrials, gov, the estimated date for final data collection for the primary endpoint is September 2018.
    • Celgene obtained the rights to Ozanimod via its acquisition of Receptos announced in July.
    | Mon, Oct. 19, 11:58 AM | 4 Comments
  • Tue, Oct. 13, 3:49 PM
    • Getting out in front of what should be more bashing of their business models at the Democratic debate tonight, the healthcare names (XLV -1.3%) have about doubled the decline in the S&P 500. Within healthcare, it's the biotechs (IBB -3.1%) and pharmaceuticals (XPH -3.2%) leading the way south.
    • Celgene (CELG -3.3%), Biogen (BIIB -3.6%), Amgen (AMGN -3.5%), Allergan (AGN -4.1%), Mylan (MYL -3.6%)
    • The biotech heavy Russell 2000 (IWM -1.4%) is feeling the pain as well.
    | Tue, Oct. 13, 3:49 PM | 27 Comments
  • Thu, Oct. 8, 9:36 AM
    • Concert Pharmaceuticals (NASDAQ:CNCE) earns an $8M milestone payment from collaboration partner Celgene (NASDAQ:CELG) triggered by the completion of Phase 1 assessment of CTP-730, a deuterium-modified analog of apremilast (Otezla). Results showed similar steady-state exposure for once-daily CTP-730 50 mg to twice-daily apremilast 30 mg.
    • The Phase 1 program included both single and multiple ascending dose studies in 85 healthy volunteers. CTP-730 was well tolerated with no serious adverse events observed.
    • The early-stage trials were conducted under the companies' 2013 development and license agreement to evaluate deuterium-modified compounds for inflammatory diseases and cancer.
    • Deuterium, or heavy hydrogen, forms a more stable bond with carbon compared to regular hydrogen. This potentially increases the stability of drugs since their metabolism often involves the breaking of hydrogen-carbon bonds.
    | Thu, Oct. 8, 9:36 AM | Comment!
  • Fri, Oct. 2, 8:09 AM
    • Concordia Healthcare (NASDAQ:CXRX) initiated with Outperform rating and $86 (90% upside) price target by RBC.
    • Mednax (NYSE:MD) initiated with Buy rating and $88 (15% upside) price target by Mizuho Securities.
    • Valeant Pharmaceuticals (NYSE:VRX) initiated with Buy rating and $290 (61% upside) price target by B of A Merrill Lynch. Downgraded to Equal Weight from Overweight by Morgan Stanley with price target of $200 (11% upside) down from $284.
    • Endo International (NASDAQ:ENDP) initiated with Buy rating and price target of $88 (26% upside) by Deutsche Bank.
    • Celgene (NASDAQ:CELG) upgraded to Overweight from Neutral with $152 (35% upside) price target by JP Morgan.
    • Cerner (NASDAQ:CERN) upgraded to Outperform from Sector Perform by RBC. Price target raised to $70 (17% upside) from $68.
    • Bristol-Myers Squibb (NYSE:BMY) upgraded to Buy from Neutral by UBS. Price target raised to $75 (25% upside) from $65.
    • Johnson & Johnson (NYSE:JNJ) upgraded to Buy from Hold by Deutsche Bank. Price target maintained at $110 (18% upside).
    • Vertex Pharmaceuticals (NASDAQ:VRTX) upgraded to Buy from Hold by Argus Research. Price target maintained at $126 (18% upside).
    • Ilumina (NASDAQ:ILMN) downgraded to Market Perform from Outperform by Leerink. Price target lowered to $185 (18% upside) from $225.
    • Fibrocell Science (NASDAQ:FCSC) downgraded to Neutral from Outperform by Wedbush. Price target lowered to $6 (61% upside) from $7.
    | Fri, Oct. 2, 8:09 AM | 16 Comments
  • Wed, Sep. 30, 12:49 PM
    • Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
    • Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
    | Wed, Sep. 30, 12:49 PM | 26 Comments
  • Fri, Sep. 25, 3:07 PM
    | Fri, Sep. 25, 3:07 PM | 134 Comments
  • Fri, Sep. 25, 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.
    | Fri, Sep. 25, 7:22 AM | 2 Comments
  • Wed, Sep. 23, 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.
    | Wed, Sep. 23, 7:59 AM | 1 Comment
  • Mon, Aug. 31, 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.
    | Mon, Aug. 31, 12:22 PM | Comment!
Company Description
Celgene Corp is a biopharmaceutical company. It is engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases.
Sector: Healthcare
Industry: Biotechnology
Country: United States