Thu, Jul. 28, 10:02 AM| Thu, Jul. 28, 10:02 AM | 2 Comments
Tue, Jul. 19, 5:04 AM
- Novartis (NYSE:NVS) -1% premarket after lowering its full year earnings guidance on plans to increase spending on its drug Entresto.
- Ericsson (NASDAQ:ERIC) reversed earlier losses as investors digested the firm's plans to cut costs by twice as much as previously thought.
- Rio Tinto (NYSE:RIO) -5% premarket after reporting that Q2 iron-ore production rose a weaker-than-expected 8%.
Thu, Jun. 30, 4:18 PM
- Array BioPharma (NASDAQ:ARRY) files a New Drug Application (NDA) with the FDA seeking approval of lead product candidate binimetinib for the treatment NRAS mutation-positive melanoma. The principal data supporting the application was generated in the Phase 3 NEMO study which showed an improvement in progression-free survival versus the chemo agent dacarbazine.
- Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. Array licensed binimetinib to Novartis (NYSE:NVS) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (NYSE:GSK) oncology business in early 2015.
- Previously: Array Bio's lead product candidate successful in late-stage melanoma study; shares up 28% premarket (Dec. 16, 2015)
Tue, May 3, 6:34 PM
- Medivation (NASDAQ:MDVN) +3.9% AH following a Reuters report that Pfizer (NYSE:PFE) has approached the company to express interest in an acquisition, raising the possibility of a bid rivaling Sanofi's (NYSE:SNY) $9.3B offer by Sanofi.
- MDVN has not yet decided whether it should engage with PFE in negotiations and is in discussions with its financial and legal advisers, according to the report.
- MDVN last week rejected SNY's $52.50/share takeover proposal, and PFE, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have been speculated as potential suitors.
Fri, Apr. 29, 3:09 PM
- Also mentioned alongside AZN and PFE as weighing bids for Medivation (MDVN +2.3%) is Novartis (NYSE:NVS), according to the report.
- Earlier today, Medivation rejected Sanofi's (SNY -4.6%) $9.3B, or $52.50 per share offer, with one of Bloomberg's sources saying the company is looking for at least $65 per share. Sanofi has the capacity to go higher, say sources, but is naturally reluctant to overpay.
Tue, Apr. 26, 8:04 AM
- Exelixis (NASDAQ:EXEL) is up 9% premarket on increased volume in response to its announcement that the FDA has approved lead cancer drug cabozantinib, branded as CABOMETYX, for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Market launch will commence in the next few weeks.
- The data supporting approval was generated in the Phase 3 METEOR study which showed treatment with CABOMETYX reduced the rate of cancer progression or death by 42% compared to everolimus [Novartis' (NYSE:NVS) Afinitor].
Fri, Apr. 1, 10:00 AM
- Array BioPharma (ARRY -3.7%) slumps on increased volume in response to its announcement that it has terminated its Phase 3 study, MILO, assessing binimetinib in low-grade ovarian cancer due to lack of efficacy. Detailed results will be shared with the scientific community at a later date.
- Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a certain cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. It is being investigated in BRAF-positive (COLUMBUS study) and NRAS-positive (NEMO study) melanoma.
- Array licensed binimetinib to Novartis (NVS -2.3%) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (GSK -1.7%) oncology business in early 2015.
- Now read Earnings Peek: Array BioPharma Has A Lot Going On And A Lot of Money
Fri, Apr. 1, 3:50 AM
- UBS cuts Novartis (NYSE:NVS) to Neutral from Buy.
- Drops price target to CHF72 from CHF100. Implied upside 6%.
- Cuts core EPS estimates by 7-17% for 2016-20, citing reduced Entresto sales and higher marketing spend, and weaker expectations for oncology business and non-Pharma divisions.
- Notes that earnings momentum has been negative since 2Q15 results.
- Says significant acceleration of Entresto U.S. script trends may not materialize before mid-2017, and therefore cuts Entresto 2020 sales estimates to $4.6B vs $8.3B.
- NVS -2.5% this morning in Zurich.
- Now read Entresto Is A Growth Driver For Novartis »
Thu, Mar. 31, 1:33 PM
- Thinly traded micro cap Aclaris Therapeutics (ACRS +16.5%) breaks out today on modestly higher volume. Shares have climbed almost 22% since Monday when the company announced that it acquired global rights to certain Janus Kinase (JAK) inhibitors for the treatment of hair loss and other dermatological conditions via its acquisition of Vixen Pharmaceuticals who licensed the intellectual property from Columbia University.
- The deal included an upfront payment, future milestones and royalties on commercial sales. No specific financial details were disclosed.
- JAK inhibition is an approach used to treat cancer and inflammatory diseases. Examples of approved JAK inhibitors are Pfizer's (PFE -0.3%) XELJANZ (tofacitinib citrate) for rheumatoid arthritis and Novartis' (NVS +0.2%) Jakafi (ruxolitinib) for polycythemia vera and myelofibrosis. Researchers at Columbia discovered the link between JAK inhibition and hair loss.
- Now read Aclaris Therapeutics: A Sizable Market There For The Taking
Mon, Mar. 21, 12:32 PM
- Endo International (ENDP -3.1%) eases on increased volume in response to the news that the FDA has approved a generic version of Voltaren Gel (diclofenac sodium topical gel) 1%, a topical non-steroidal anti-inflammatory medication for the treatment of arthritis pain, a product that accounted for more than 6% of company's 2015 sales ($207.2M/3268.7M).
- The company says its 2016 guidance issued last month anticipated that the appearance of a generic competitor would not materially impact Voltaren Gel sales until the end of the year. Should the market launch commence soon, management will update its guidance no later than its Q1 earning presentation in early May. It has the option of launching its own generic under its December 2015 license agreement with Novartis (NVS +1.1%) and its Sandoz unit.
- Endo also says it has no plans to reduce its pain salesforce as it is in the midst of launching BELBUCA (buprenorphine HCl buccal film), cleared by the FDA in October 2015.
Thu, Jan. 28, 8:59 AM
- Incyte (NASDAQ:INCY) is down 12% premarket on light volume in response to its announcement that it terminated a Phase 2 sub-study, INCB 18424-267, assessing Jakafi (ruxolitinib) or placebo in combination with Bayer's (OTCPK:BAYRY) Stivarga (regorafenib) in patients with relapsed/refractory metastatic colorectal cancer with high C-reactive protein (CRP), a potential new indication for the drug. An interim analysis of the high CRP group revealed that ruxolitinib plus regorafenib failed to demonstrate a sufficient level of efficacy to justify continuing the study.
- Ruxolitinib, a JAK1/JAK2 inhibitor, is cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
- Regorafenib, a kinase inhibitor, is approved for the treatment of colorectal cancer and gastrointestinal stromal tumor.
- Incyte markets Jakafi in the U.S. and Novartis (NYSE:NVS) sells it elsewhere under the brand name Jakavi.
Wed, Jan. 27, 7:15 AM
- Novartis (NYSE:NVS) Q4 results ($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
Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers... More
Industry: Drug Manufacturers - Major