Tue, Oct. 25, 7:18 AM
- Novartis (NYSE:NVS) Q3 results ($M): Total Revenues: 12,126 (-1.1%); Innovative Medicines: 8,173 (-1.0%); Alcon: 1,436 (-2.2%); Sandoz: 2,517 (-1.0%).
- Oncology: 3,235 (-6.2%); Ophthalmology: 1,370 (-0.2%); Est. Medicines: 1,121 (-17.5%); Neuroscience: 924 (+3.9%); Immunology & Dermatology: 770(+37.7%); Respiratory: 390 (+18.9%); Cardio-Metabolic: 363 (+22.2%).
- Net Income: 1,945 (+2.6%); EPS: 0.81 (+5.2%); CF Ops: 3,231 (+3.4%).
- Key Product Sales: Gleevec/Glivec: 834 (-29.6%); Gilenya: 790 (+13.5%); Lucentis: 456 (-6.0%); Tasigna: 441 (+6.0%); Sandostatin: 413 (-1.4%); Afinitor/Votubia: 393 (-5.1%); Galvus: 306 (+8.9%); Cosentyx: 301 (+242.0%).
Tue, Oct. 25, 5:25 AM
- Syngenta's Q3 revenue came in at $2.5B dollars, down 3%, dragged lower by weak Latin American sales.
- Orange's (NYSE:ORAN) core operating profit beat expectations as strong growth in Spain offset waning revenue in its home market of France.
- Novartis (NYSE:NVS) posted a 4% slump in third quarter profit as sales in its Alcon eye care division and cancer drug Gleevec continued to see declines.
Tue, Oct. 25, 1:48 AM
Mon, Oct. 24, 5:30 PM
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Wed, Oct. 19, 8:45 AM
- Nano cap Cerulean (NASDAQ:CERU) rockets 78% premarket on the heels of two positive developments.
- First, it has entered into a $20M stock purchase agreement with Aspire Capital Fund, LLC under which Aspire bought 800K shares of common stock at $1.25, up almost 84% from yesterday's close of $0.6808. Cerulean has the right to sell up to the remaining $19M to Aspire over a 24-month period based on a formula linked to then-current market prices. It has also issued 700K commitment shares to Aspire. No warrants are involved.
- Second, Cerulean has entered into a strategic collaboration with Novartis (NYSE:NVS) to develop nanoparticle-drug conjugate (NDC) product candidates for up to five targets. Cerulean will leverage its proprietary Dynamic Tumor Targeting technology with Novartis' proprietary compounds. It will be responsible for creating the NDC candidates while Novartis will be responsible for further development and commercialization.
- Under the terms of the agreement, Cerulean will receive an upfront payment of $5M plus funding for five full-time equivalents (e.g., five full-time employees or 10 employees working half time). It will also be eligible for milestones and single-digit-to-low-double-digit royalties on net sales.
Sat, Oct. 8, 3:47 PM
- Interim results from a Phase 3 clinical trial, MONALEESA-2, evaluating Novartis' (NYSE:NVS) LEE011 (ribociclib) for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced/metastatic breast cancer demonstrated superiority over standard-of-care treatment. The data were presented today at the European Society for Medical Oncology 2016 Congress in Copenhagen and published simultaneously online in The New England Journal of Medicine.
- MONALEESA-2 is a randomized, double-blind, placebo-controlled multicenter study involving 668 HR+/HER2- breast cancer patients. Participants are receiving either LEE011 + letrozole (Novartis' Femara) or letrozole alone. The primary endpoint is progression-free survival (PFS) over 20 months. Secondary endpoints include overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR) and other metrics. According to ClinicalTrials.gov, the estimated study completion date is August 2019.
- Patients treated with LEE011 + letrozole experienced median PFS of 19.3 months compared to 14.7 months for letrozole alone (p=0.00000329) and a 44% reduction in the risk of death or cancer progression (hazard ratio: 0.56). 53% of patients with measurable disease showed at least a 30% reduction in their tumor size compared to 37% for letrozole (p=0.00028).
- The most common adverse events (AEs) in the LEE011 cohort and the comparison with the letrozole cohort were: neutropenia (74% vs. 5%), nausea (52% vs. 29%), infections (50% vs. 42%), fatigue (37% vs. 30%) and diarrhea (35% vs. 22%). The most common severe AEs (grade 3 or 4) and the comparisons with letrozole were: neutropenia (60% vs. 1%), leukopenia (21% vs. 1%), elevated alanine aminotransferase (a liver enzyme that is a biomarker for liver stress or damage) (9% vs. 1%), lymphopenia (7% vs. 1%) and elevated aspartate aminotransferase (another biomarker for heart or liver stress/damage) (6% vs. 1%).
- Breakthrough Therapy-tagged LEE011 inhibits a class of enzymes called cyclin dependent kinases (CDKs). It slows the progression of cancer by binding to two specific kinases: CDK4 and CDK6. When over-activated, they enable cancer cells to grow and proliferate too quickly. Novartis is developing the candidate under a research collaboration with Astex Pharmaceuticals.
Wed, Sep. 28, 6:56 PM
- A Phase 3 clinical trial, ARISE, assessing Amgen's (NASDAQ:AMGN) erenumab (formerly AMG 334) for the prevention of migraine met its primary endpoint of a statistically valid reduction from baseline in monthly migraine days in patients with episodic migraine compared to placebo. Specifically, patients receiving erenumab experienced an average 2.9-day reduction from baseline in monthly migraine days versus an average 1.8-day reduction for placebo.
- The results will be submitted for presentation at a future medical conference and for publication.
- Results from a second Phase 3, STRIVE, are expected later this year.
- Erenumab, a fully human monoclonal antibody, inhibits the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that cause incapacitating pain. It is being co-developed with Novartis (NYSE:NVS). Amgen retains commercial rights in the U.S., Canada and Japan and Novartis has commercial rights elsewhere.
Mon, Sep. 26, 9:25 AM
- Micro cap Array BioPharma (NASDAQ:ARRY) perks up 29% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial, COLUMBUS, assessing the combination of LGX818 (encorafenib) and MEK162 (binimetinib) for the treatment of patients with BRAF-positive, advanced, unresectable or metastatic melanoma.
- The study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) compared to vemurafenib [Roche's (OTCQX:RHHBY) Zelboraf] alone. Specifically, median PFS for the combination was 14.9 months versus 7.3 months for vemurafenib (p<0.001).
- Encorafenib is a BRAF inhibitor acquired from Novartis (NYSE:NVS) in early 2015. Binimetinib is a small molecule MEK inhibitor.
- The company intends to file marketing applications as soon as feasible.
Fri, Sep. 23, 4:14 PM
- The FDA grants three simultaneous approvals for the expanded use of Novartis' (NYSE:NVS) Ilaris (canakinumab), currently available for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a Periodic Fever Syndrome condition, and Systemic Juvenile Idiopathic Arthritis (SJIA), an autoinflammatory disorder.
- The new indications are for the treatment of three rare types of Periodic Fever Syndromes: Tumor Necrosis Factor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).
- Periodic Fever Syndromes are a group of rare autoinflammatory diseases characterized by persistent and disabling fevers accompanied by joint and muscle pain, swelling and skin rashes. The complication can be life-threatening.
- Canakinumab is a high-affinity human monoclonal antibody that inhibits (binds to) interleukin-1 beta, a proinflammatory protein that plays a key role in certain inflammatory disorders.
Fri, Sep. 23, 8:23 AM
- Proteon Therapeutics (NASDAQ:PRTO) initiated with Buy rating and $18 (91% upside) price target by H.C. Wainwright.
- Oncomed Pharmaceuticals (NASDAQ:OMED) initiated with Buy rating and $20 (62% upside) price target by H.C. Wainwright.
- Gilead Sciences (NASDAQ:GILD) initiated with Buy rating by Berenberg Bank.
- CASI Pharmaceuticals (NASDAQ:CASI) initiated with Buy rating and $4 (254% upside) price target by Maxim Group.
- Novartis (NYSE:NVS) initiated with Buy rating and $95 (16% upside) price target by Chardan Capital.
- Invuity (NASDAQ:IVTY) initiated with Buy rating and $18 (31% upside) price target by Lake Street Capital.
- Cerner (NASDAQ:CERN) initiated with Buy rating and $67 (6% upside) price target by Bank of America.
- Healthcare Services Group (NASDAQ:HCSG) initiated with Outperform rating and $46 (18% upside) price target by Baird.
Sat, Sep. 17, 5:53 PM
- Top-line results from a Phase 3 clinical trial, EXPAND, assessing Novartis' (NYSE:NVS) BAF312 (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS) showed a 21% reduction versus placebo in the risk of confirmed disability progression (p=0.013), the primary endpoint. The data were presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis in London.
- The risk reduction was assessed at Month 3. The company adds that the risk reduction at Month 6 was greater. BAF312 also significantly beat placebo over 12 and 24 months as measured by annualized relapse rate, the percent change in brain volume and the change from baseline in the volume to T2 lesions. BAF312 failed to beat placebo in the timed 25-foot walk test, however.
- According to ClinicalTrials.gov, the estimated study completion date is August 2017.
- Siponimod contributes to reducing the loss of physical and cognitive function in SPMS sufferers by modulating (binding to) specific types of the sphingosine-1-phosphate (S1P) receptor, which is found on the surface of certain cells in the central nervous system that cause the damage leading to the loss of function.
- The company intends to discuss the data with regulatory authorities.
- Previously: Novartis' BAF312 successful in late-stage multiple sclerosis study (Aug. 25)
Sat, Sep. 17, 5:13 PM
- A Phase 3 clinical trial, REFLECTIONS B537-02, assessing Pfizer's (NYSE:PFE) Remicade (infliximab) biosimilar candidate, PF-06438179 (infliximab-Pfizer) in patients with rheumatoid arthritis (RA) met its primary endpoint demonstrating equivalent efficacy with Remicade as measured by the number of participants achieving ACR20 (20% improvement in RA symptoms) at Week 14 of treatment. According to ClinicalTrials.gov, the estimated study completion date is May 2017.
- PF-06438179 is in development for all approved indications of Remicade, Janssen's (NYSE:JNJ) top seller at almost $6.9B (most recent four quarters).
- Novartis' (NYSE:NVS) Sandoz unit has commercialization rights to PF-06438179 in the European Economic Area (28 countries) while Pfizer retains the rights elsewhere.
Thu, Sep. 1, 8:39 AM
- Micro cap Array BioPharma (NASDAQ:ARRY) is up 5% premarket on increased volume in response to its announcement that the FDA has accepted for review its New Drug Application (NDA) seeking approval of lead product candidate binimetinib for the treatment of advanced NRAS mutation-positive melanoma, a subgroup of melanoma associated with a poor prognosis. The agency's action date (PDUFA) is June 30, 2017.
- 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 purchased GlaxoSmithKline's (NYSE:GSK) oncology business in early 2015.
Thu, Sep. 1, 8:12 AM
- In a regulatory filing, GenVec (NASDAQ:GNVC) reports that licensee Novartis (NYSE:NVS) remains fully committed to developing gene therapy candidate CGF166, GenVec's lead product candidate, for the treatment of severe-to-profound hearing loss. Novartis licensed it in January 2010.
- Yesterday, Novartis announced that it was disbanding its internal cell and gene therapy unit as a result of the evolution of its internal organizational design. Management believed a dedicated unit was no longer necessary in its development efforts, particularly CAR-T therapies.
- CGF166 is an advanced adenoviral vector engineered to deliver the human atonal gene to sensory cells in the inner ear. Top-line data from a Phase 1/2 study are expected in 2017.
Wed, Aug. 31, 9:14 AM
- Novartis (NYSE:NVS) is off a fraction premarket on the heels of the news that it has disbanded its internal cell and gene therapy unit. The company will redeploy ~280 of the 400 employees in the group to other positions in the company while 120 will be let go. The company believes that a dedicated unit no longer makes sense.
- In a statement, it says, "We have made the decision to re-integrate activities conducted by the Cell & Gene Therapies Unit into the larger Novartis organization, as part of a natural evolution of our internal organizational design. An isolated unit worked well under our prior Pharma Division structure, but with a new integrated development model, we can efficiently advance our work on CAR-T as part of our focus in immuno-oncology by reintegrating the functions."
- The move has surprised the CAR-T "industry" since Novartis had established itself as one of the leaders in the much-hyped field, along with Juno Therapeutics (NASDAQ:JUNO) and Kite Pharma (NASDAQ:KITE). In a recent letter to shareholders, CEO Joe Jimenez cited CAR-Ts as a key part of its oncology strategy.
- The action will not affect the company's support of the Novartis-Penn Center for Advanced Cellular Therapeutics, unveiled in February on Penn Medicine's campus. Novartis' seed investment of $20M helped build the center which will employ 100 cell therapy specialists. It entered into a global research and licensing agreement with UPenn in August 2012 to study CAR therapies. It will also not affect Novartis' plan to file a marketing application with the FDA in early 2017 seeking approval of CTL019 for the treatment of pediatric relapsed/refractory acute lymphoblastic leukemia.
- Previously: Novartis hits a home run with CAR-T therapy in ALL (Dec. 8, 2014)
Wed, Aug. 31, 6:57 AM
- The FDA approves Novartis' (NYSE:NVS) ARZERRA (ofatumumab), in combination with the chemo agents fludarabine and cyclophosphamide, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).
- ARZERRA was previously approved for the treatment of CLL patients who have not responded to fludarabine and Sanofi's (NYSE:SNY) LEMTRADA (alemtuzumab), in treatment-naive CLL patients not treated with fludarabine and maintenance treatment of CLL in partial/complete responders treated with at least two prior lines of therapy.
- Ofatumumab is a monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes.
- ARZERRA is being commercialized under a collaboration with Danish biotech Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY).