Today, 7:35 AM
- Janssen-Cilag International NV (NYSE:JNJ) submits a Type II variation application to the European Medicines Agency (EMA) seeking approval of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) REVLIMID] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE] and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior line of therapy.
- DARZALEX is currently approved in the EU as monotherapy in adult patients with relapsed/refractory MM whose prior therapy included a proteasome inhibitor (i.e., VELCADE) and an immunomodulatory agent (i.e., REVLIMID) and experienced disease progression on the last therapy.
- In two Phase 3 studies, CASTOR and POLLUX, supporting the application MM patients who had received one or more prior lines of therapy who were treated with one of the combinations experienced greater than a 60% reduction in the risk of disease progression or death (hazard ratio less than 0.40).
Yesterday, 4:27 PM
- Nano cap Tokai Pharmaceuticals (NASDAQ:TKAI) hits the skids again with lead product candidate galeterone. Today, the company disclosed that it has terminated enrollment in its Phase 2 expansion clinical trial, ARMOR2, assessing galeterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have become resistant to Medivation's (NASDAQ:MDVN) Xtandi (enzalutamide).
- It has also decided not to proceed with its planned study of galeterone in mCRPC patients who rapidly progress on either Xtandi or Janssen's (NYSE:JNJ) Zytiga (abiraterone acetate).
- A month ago, shares crumbled when the company announced that it terminated its Phase 3 ARMOR3-SV study of galeterone in treatment-naive mCRPC patients who tumors express the splice variant AR-V7 after the independent Data Monitoring Committee determined that the trial was unlikely to meet its efficacy endpoint.
- The company says it is continuing its analysis of the ARMOR3-SV data and is assessing its options with the galeterone program.
- Shares are down 23% after hours on robust volume.
Wed, Aug. 17, 4:08 PM
- Janssen Biotech (NYSE:JNJ) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval of the use of DARZALEX (daratumumab), in combination with lenalidomide [Celgene's (NASDAQ:CELG) Revlimid] and dexamethasone or bortezomib [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) VELCADE] and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- The FDA granted Breakthrough Therapy status for DARZALEX for this indication last month. Janssen has requested Priority Review of the filing.
- The FDA approved DARZALEX in November 2015 as monotherapy for MM patients who have received at least three prior lines of therapy.
Tue, Jul. 26, 8:43 AM
- Thinly traded micro cap Tokai Pharmaceuticals (NASDAQ:TKAI) craters 70% premarket on higher-than-normal volume in response to its announcement that it will stop its Phase 3 clinical trial, ARMOR3-SV, assessing lead product candidate galeterone compared to enzalutamide (XTANDI) in treatment-naive men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the androgen receptor splice variant AR-V7. The company made its decision based on the recommendation from the independent Data Monitoring Committee that the trial was unlikely to meet its primary efficacy endpoint.
- Tokai intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to enzalutamide and its planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate (ZYTIGA).
- Galeterone is an orally available small molecule that disrupts the androgen receptor (NYSE:AR) signaling pathway by degrading AR, blocking the binding of testosterone or dihydrotestosterone with AR and inhibiting CYP17, an enzyme that plays a key role in the synthesis of testosterone. Prostate cancer is stoked by androgens acting through the androgen receptor.
- Related tickers: (NASDAQ:MDVN)(OTCPK:ALPMF)(OTCPK:ALPMY)(NYSE:JNJ)
Tue, Jul. 26, 7:49 AM
- Bristol-Myers Squibb (NYSE:BMY) and Janssen Biotech (NYSE:JNJ) will collaborate in a Phase 2 clinical trial assessing the combination of BMY's Opdivo (nivolumab) and Janssen's immunotherapy JNJ-64041757 in patients with non-small cell lung cancer (NSCLC).
- JNJ-64041757 is an antigen-presentation therapeutic based on Live Attenuated Double-Deleted Listeria monocytogenes bacteria strains engineered to induce an immune response against NSCLC tumors. It is currently in Phase 1 development for lung cancer.
- Opdivo is indicated for the treatment of NSCLC with progression on or after platinum-based chemo.
Mon, Jul. 25, 11:04 PM
- The FDA designates Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab) a Breakthrough Therapy, in combination with Celgene's (NASDAQ:CELG) REVLIMID (lenalidomide) and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- DARZALEX is currently approved in the U.S. for the treatment of MM patients who have received at least three prior lines of therapy. Several months ago, the European Commission approved it as monotherapy in adults with relapsed/refractory MM whose prior therapy included a proteasome inhibitor [e.g. Takeda's Ninlaro (ixazomib)] and an immunomodulatory agent and have shown disease progression on the last therapy.
- Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA) (or supplemental NDA in this case).
Fri, Jul. 22, 8:40 AM
- Johnson & Johnson (NYSE:JNJ) upgraded to Buy from Hold by Argus Research. Price target raised to $145 (16% upside) from $130.
- Humana (NYSE:HUM) upgraded to Buy from Hold by Jefferies. Price target raised to $210 (22% upside) from $199.
- Teva Pharmaceutical Industries (NYSE:TEVA) upgraded to Buy from Hold by HSBC. Price target raised to $65 (19% upside) from $61.
- Relypsa (NASDAQ:RLYP) downgraded to Neutral from Buy by Citigroup. Price target raised to $32 (0% upside) from $25.
- Evoke Pharma (NASDAQ:EVOK) downgraded to Hold from Buy by Noble Financial. Downgraded to Hold from Buy by Brean Capital. Downgraded to Neutral from Buy by Rodman & Renshaw.
- Merck (NYSE:MRK) downgraded to Market Perform from Outperform with a $62 (5% upside) price target by BMO Capital.
- St. Jude Medial (NYSE:STJ) downgraded to Neutral from Outperform by Wedbush. Price target raised to $84 (3% upside) from $70.
- Teva Pharmaceutical Industries (TEVA) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $60 (10% upside) from $70.
Tue, Jul. 19, 8:05 AM
- Johnson & Johnson (NYSE:JNJ) Q2 results ($M): Total Revenues: 18,482 (+3.9%); Consumer: 3,419 (-1.8%); Pharmaceutical: 8,654 (+8.9%); Medical Devices & Diagnostics: 6,409 (+0.8%).
- Sales By Region: U.S.: 9,572 (+7.4%); Europe: 4,090 (-1.5%); W. Hemisphere ex-U.S.: 1,542 (+2.7%); Asia Pacific & Africa: 3,278 (+1.7%).
- Sales By Business: OTC: 1,008 (+3.5%); Immunology: 3,038 (+19.0%); Infectious Diseases: 829 (-19.7%); Neuroscience: 1,602 (+2.4%); Oncology: 1,474 (+28.8%); Cardiovascular/Metabolism/Other: 1,711 (+3.6%); Medical Devices & Diagnostics: 6,409 (+0.8%).
- Key Product Sales: Remicade: 1,780 (+6.7%); Stelara: 804 (+41.1%); Zytiga: 601 (+10.1%); Xarelto: 594 (+25.8%).
- 2016 Guidance: Total Revenues: $71.5B - 72.2B from $71.2B - 71.9B; Non-GAAP EPS: $6.63 - 6.73 from $6.53 - 6.68.
- Shares are up 3% premarket on increased volume.
Tue, Jul. 19, 6:42 AM
Mon, Jul. 18, 5:30 PM
Mon, Jul. 18, 3:18 PM
Mon, Jul. 18, 9:59 AM
- Janssen Therapeutics (JNJ) announces that the FDA has approved an expansion to the PREZISTA (darunavir) U.S. package insert to include data from a study investigating the use of PREZISTA during pregnancy and the postpartum period.
- PREZISTA is indicated for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents. The recent label update includes dosing recommendations for pregnant women with HIV. The results show that PREZISTA taken with ritonavir was well-tolerated during pregnancy and the postpartum period.
- An analysis of 34 women who received PREZISTA/ritonavir in combination with a background regimen demonstrated that exposures to PREZISTA and ritonavir were lower during pregnancy compared with the postpartum period. There were no reports of mother-to-child HIV transmission among the 29 women who continued therapy through delivery.
Fri, Jul. 15, 10:10 AM
- Wells Fargo ticks off 20 S&P 500 stocks with the most upside potential vs. consensus, and the 20 with the most downside risk vs. consensus.
- The list is compiled by comparing the midpoint of Wells Fargo Securities valuation ranges to consensus fair value estimates, volatility adjusting the percentage difference, and ranking the resulting score.
- Upside: AEE, BEN, CCL, DVA, EIX, ES, EXC, FTR, HUM, INTC, JNJ, LNT, PEG, PNW, SCG, T, WEC, WU, XEL, XOM.
- Downside: ANTM, C, CI, COF, EQT, FOXA, FSLR, GS, KIM, LH, MON, MSI, MYL, NVDA, NWSA, SLG, TIF, TSO, UA, WLTW.
Mon, Jul. 11, 7:23 AM
Fri, Jul. 8, 7:34 AM
- AstraZeneca (NYSE:AZN) pays FibroGen (NASDAQ:FGEN) $62M under its 2013 collaboration agreement to develop roxadustat (FG-4592) in the U.S. and certain other territories for the treatment of anemia in chronic kidney disease (CKD) patients on or not on dialysis.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa [Janssen's (NYSE:JNJ) Procrit].
Sun, Jul. 3, 2:50 PM
- via Barclays:
- "Although stocks in the U.S. and Europe have partially bounced back from the sharp selloff sparked by the U.K. referendum result, risks remain prevalent. [Analyst] Keith Parker foresees further equity downside alongside a prolonged market bottoming process, during which positioning is likely to turn much more defensive at active managers.
- "With this in mind, our stock screen this week highlights Overweight-rated stocks that screen defensively based on sector and equity beta but are also expected to generate superior ROE and free cash flows in FY1.
- "Our screen considers the following factors: i) Large-cap (US $5 billion+) stock in the consumer staples, utilities, telecom or healthcare sectors. ii) Adjusted beta less than 1.0. iii) Rated Overweight by Barclays equity research. iv) 15%+ ROE and 4.5%+ FCF yield expected in FY1, based on Barclays estimates."
- The stocks: Aetna (NYSE:AET), BT Group plc (NYSE:BT), Cardinal Health (NYSE:CAH), Coloplast (OTC:CLPBF, OTCPK:CLPBY), CVS (NYSE:CVS), Estee Lauder (NYSE:EL), Express Scripts (NASDAQ:ESRX), Glanbia (OTC:GLAPF, OTCPK:GLAPY), Grifols (NASDAQ:GRFS), Imperial Brands (OTCQX:IMBBY, OTCQX:ITYBF), Johnson & Johnson (NYSE:JNJ), Ahold (OTCQX:AHONY, OTCQX:AHODF, OTCQX:AHOND), LabCorp (NYSE:LH), Perrigo (NYSE:PRGO), Telus (NYSE:TU), Unilever (UL, UN), UnitedHealth Group (NYSE:UNH)
- See full table here.
Johnson & Johnson operates as an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company, through its subsidiaries operates in three... More
Industry: Drug Manufacturers - Major
Country: United States