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Thu, Jan. 28, 8:59 AM
- Incyte (NASDAQ:INCY) is down 12% premarket on light volume in response to its announcement that it terminated a Phase 2 sub-study, INCB 18424-267, assessing Jakafi (ruxolitinib) or placebo in combination with Bayer's (OTCPK:BAYRY) Stivarga (regorafenib) in patients with relapsed/refractory metastatic colorectal cancer with high C-reactive protein (CRP), a potential new indication for the drug. An interim analysis of the high CRP group revealed that ruxolitinib plus regorafenib failed to demonstrate a sufficient level of efficacy to justify continuing the study.
- Ruxolitinib, a JAK1/JAK2 inhibitor, is cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
- Regorafenib, a kinase inhibitor, is approved for the treatment of colorectal cancer and gastrointestinal stromal tumor.
- Incyte markets Jakafi in the U.S. and Novartis (NYSE:NVS) sells it elsewhere under the brand name Jakavi.
Wed, Jan. 27, 7:15 AM
- Novartis (NYSE:NVS) Q4 results ($M): Total Revenues: 12,520 (-4.2%); Pharmaceuticals: 7,865 (+0.1%); Alcon: 2,349 (-13.1%); Sandoz: 2,306 (-8.2%).
- Net Income: 1,056 (-29.0%); EPS: 0.44 (-29.0%); CF Ops: 4,157 (-20.1%).
- Key product sales: Gleevec/Glivec: 1,219 (-1.5%); Gilenya: 742 (+11.4%); Lucentis: 499 (-15.1%); Afinitor/Votubia: 382 (-10.3%); Sandostatin: 413 (-0.7%); Tasigna: 432 (+0.9%); Galvus: 294 (+999%); Diovan/Co-Diovan: 292 (-23.0%); Exforge: 249 (-16.4%); Exjade/Jadenu: 248 (+2.1%); Cosentyx: 121.
- 2016 Guidance: Group Net Sales and core operating income in line with 2015.
Tue, Jan. 12, 8:33 AM
- Cellectis S.A. (NASDAQ:CLLS) is up 9% premarket on light volume in response to the news that it has developed a new chimeric antigen receptor (CAR) architecture that permits control over CAR-T cell functions, potentially enabling the ability to control unwanted risks such a cytokine-release syndrome and "on-target, off-tumor" effect. Currently, the only remedies for these effects rely on suicide mechanisms that completely eradicate the engineered T-cells which results in a premature end of the treatment.
- Cellectis scientists engineered a system directly integrated with the CAR architecture by adding a small molecule that turns a CAR-T cell from an "off" state to an "on" state, thereby controlling activation and mitigating the risk of CAR-induced toxicities. It also creates opportunities for spatial activation of the engineered CAR-T cells using local targeted drug delivery.
- The study was just published in the journal Scientific Reports.
- Related tickers: (NASDAQ:JUNO)(NASDAQ:KITE)(NASDAQ:BLUE)(NASDAQ:BLCM)(NYSE:NVS)(NASDAQ:SRNE)
Mon, Jan. 11, 12:05 PM
- Thinly traded nano cap GenVec (GNVC -63.6%) plummets on a 7x surge in volume, albeit on turnover of only 550K shares, in response to a regulatory filing disclosing that Novartis (NVS -0.6%) has paused patient enrollment in its Phase 1/2 clinical trial assessing GenVec's lead product candidate, CGF166, for the treatment of severe-to-profound bilateral hearing loss. Novartis took action on the basis of a recommendation from the independent data safety monitoring board. No other details are provided.
- CGF166 is an advanced adenoviral vector engineered to deliver the human atonal gene under the control of a tissue-specific promoter. Novartis licensed it in January 2010.
Oct. 1, 2015, 8:30 AM
- Nano cap (NASDAQ:XOMA) zooms up 62% premarket on robust volume in response to its announcement that it has exclusively licensed global development and commercialization rights to its anti-transforming growth factor-beta (TGFb) antibody program to Novartis (NYSE:NVS).
- Under the terms of the agreement, XOMA will receive an upfront payment of $37M, up to $480M in various milestones and mid-single-digit to low double-digit royalties on net sales. Novartis also agrees to extend the maturity date of the XOMA's ~$13.5M in outstanding debt to September 20, 2020. In exchange for the extension, XOMA agrees to reduce the royalties it will earn from Novartis' clinical stage anti-CD40 antibodies.
- XOMA says the funds from this deal, along with its planned cost saving measures, will be sufficient to fund operations into 2017.
- TGFb is an immune suppressive cytokine that plays a role in the progression of advanced cancer and fibrosis if elevated.
Sep. 25, 2015, 5:40 PM
Sep. 11, 2015, 5:37 PM
Aug. 24, 2015, 2:13 PM
- The FDA has approved a label expansion for Novartis' (NYSE:NVS) Promacta (eltrombopag), a treatment for chronic immune thrombocytopenia (ITP) -- a rare blood disorder -- to include children 1 year or older who aren't responding sufficiently to other treatment.
- The product, which uses Captisol platform technology from Ligand Pharmaceuticals (NASDAQ:LGND), was approved in June for children 6 years and older, and in 2008 for adults.
- The new label includes an oral suspension formulation, better for younger children who might not be able to swallow tablets.
- Ligand is up 0.5%; Novartis is trading down 1.5%.
Aug. 17, 2015, 6:58 AM
- Nano cap AVEO Oncology (NASDAQ:AVEO) enters into an exclusive worldwide license agreement with Novartis (NYSE:NVS) for the development and commercialization of AV-380, AVEO's humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), and related antibodies.
- GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been associated with cachexia (weakness and wasting of the body) in cachectic cancer patients. Preclinical data show that inhibiting GDF15 may reverse the effects of cachexia by switching from catabolism (destructive metabolism) to anabolism (constructive metabolism).
- Under the terms of the agreement, AVEO will receive an upfront payment of $15M, potential milestones totaling $311M and tiered royalties from high single-digit to low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs.
- Cachexia, a serious complication in advanced cancers and other chronic diseases, affects ~5M Americans.
- Shares are up 126% premarket on robust volume.
Aug. 14, 2015, 12:00 PM
- Nano cap Prima BioMed (PBMD +42.5%) jumps on a 9x surge in volume in response to its announcement that it will receive an disclosed clinical milestone payment from Novartis (NVS) related to the Phase 1 study of its IMP701 LAG-3 antibody for the treatment of cancer.
- The license and collaboration agreement was signed in September 2012 between Immutep (acquired by Prima in December 2014) and CoStim Pharmaceuticals (acquired by Novartis in February 2014).
- Prima is eligible to receive additional development-related milestones and royalties on commercial sales.
- IMP701 binds to LAG-3 (Lymphocyte Activation Gene 3), an antibody that plays a key role in controlling the signaling pathways in both effector T cells and regulatory T cells. Binding to LAG-3 removes two brakes that prevent the immune system from responding to and killing cancer cells.
Jul. 20, 2015, 7:42 AM
- Top-line results from a Phase 3 clinical trial, called METEOR, show Exelixis' (NASDAQ:EXEL) Cometriq (cabozantinib) reduced the risk of disease progression or death by 42% compared to Novartis' (NYSE:NVS) Afinitor (everolimus). The late-stage study compared the two drugs in 658 patients with renal cell carcinoma (RCC) who had experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.
- The trial met its primary endpoint of a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients (p<0.0001) as determined by an independent radiology committee.
- Data on Overall Survival (OS) in the population of 658 patients were immature at the data cutoff, although an interim analysis showed a trend in OS favoring cabozantinib. Final analysis of OS is expected around August 2016.
- Exelixis plans to complete regulatory filings in the U.S. and Europe early next year. The FDA designated cabozantinib for Fast Track review for RCC in April. It originally approved it in November 2012 for the treatment of progressive metastatic medullary thyroid cancer.
- The company will host a conference call this morning at 8:30 am ET to discuss the data.
- Shares are up 33% premarket on robust volume.
Jul. 16, 2015, 8:34 AM
- Small cap Radius Health (NASDAQ:RDUS) is up a modest 2% premarket on light volume in response to its announcement that its investigational drug RAD1901, in combination with CDK4/6 inhibitors [Pfizer's (NYSE:PFE) Ibrance (palbociclib)] and mTOR inhibitors [Novartis' (NYSE:NVS) Afinitor (everolimus)] showed anti-tumor activity in preclinical breast cancer models with either wild type or mutant ESR1 (estrogen receptor 1). Tumor shrinkage was much greater when exposed to the combination including RAD1901 compared to the other agents alone.
- RAD1901 is a selective estrogen receptor degrader (SERD) that crosses the blood-brain barrier. If approved, it will be the first ER-targeted therapy to have this capability thereby enabling the treatment of intracranial metastatic breast cancer tumors.
- The company is currently enrolling patients in a Phase 1 dose escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor-positive and HER2-negative breast cancer. The study will determine the recommended dose for a Phase 2 trial.
Apr. 23, 2015, 5:26 AM
- Novartis (NYSE:NVS): Q1 EPS of $1.33 beats by $0.14.
- Revenue of $11.94B misses by $960M.
- Shares +1.3% PM.
Feb. 25, 2015, 1:43 PM
Feb. 12, 2015, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Jan. 27, 2015, 6:09 AM
- Novartis (NYSE:NVS): Q4 EPS of $1.21 in-line.
- Revenue of $14.63B (-2.0% Y/Y) beats by $50M.
- Shares +1.7% PM.
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