Today - Monday, January 26, 2015
- Gilead Sciences (GILD +1.4%) and pharmacy benefits manager EnvisionRx enter into an agreement whereby Sovaldi and Harvoni will be offered on an exclusive basis to EnvisionRx patients for the treatment of HCV infection.
- Consistent with PBM industry practice, exceptions will be allowed for other HCV medications in certain circumstances.
- Financial terms are undisclosed.
- Related ticker: (ABBV +0.3%)
1:10 PM| Comment!
- Centene (CNC +1.3%) acquires Eugene-based Agate Resources, a diversified holding company that offers a variety of healthcare products and services to Oregon residents.
- Chairman and CEO Michael F. Neidorff says, "We view the Oregon CCO (coordinated care organization) model as consistent with our philosophy that healthcare is best delivered locally. Agate has demonstrated success working closely with providers and key community stakeholders and we are committed to maintaining that approach in the future."
- The transaction, expected to close in Q3, will be accretive to earnings in the first year following the close. Financial terms are undisclosed.
12:30 PM| Comment!
- Brookdale Senior Living (BKD -10%) slumps on a 3x spike in volume after the company announced that it expects to report Q4 cash from facility operations (CFFO) of $0.53 per share, which is $0.10 lower that Q3's $0.63.
- Management lowered its 2015 CFFO guidance to $2.60 - 2.75 from $2.95 - 3.10.
- The company plans to report Q4 and full-year results on February 4 after the close. The conference call be held the next day, February 5, at 10:00 am ET.
- Consensus view for Q4 and 2014 are EPS of $0.64 and $2.60 on revenues of $1.23B and $3.81B, respectively.
- Thinly-traded nano cap Heat Biologics (HTBX +13.7%) is up in early trading on a 50% spike in volume albeit on turnover of only 33K shares. This morning it announced the presentation of positive data from a Phase 1 trial that demonstrated substantially increased tumor infiltrating lymphocytes following treatment with HS-410 (Vesigenurtacel-L) in patients with non-muscle invasive bladder cancer. The increase in these lymphocytes appeared to correlate with the clinical response observed with HS-410.
- An interim analysis of the 10-patient study is expected in H1.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Merck's (MRK +0.2%) Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Merck acquired the rights to Sivextro via its acquisition of Cubist Pharmaceuticals.
- A final decision from the European Commission usually takes ~60 days.
- The FDA approved Sivextro in June.
- Previously: FDA give thumbs up to Cubist antibiotic (June 21, 2014)
10:20 AM| Comment!
- The FDA approves Impax Laboratories' (IPXL -0.9%) generic version of Lamictal (lamotrigine) Orally Disintegrating Tablets in 25 mg, 50 mg, 100 mg and 200 mg doses. The product will launched promptly by its generic division, Global Pharmaceuticals. Per IMS Health, the U.S. market for Lamictal is ~$56M. It is used treat epilepsy and bipolar disorder.
- Impax acquired the Abbreviated New Drug Application (ANDA) for the product from Actavis in July 2014.
9:57 AM| Comment!
- On a preliminary basis, Lannett Company (LCI +8.1%) expects to post EPS of $1.18 - 1.21 on revenues of ~$115M for fiscal Q2. Its outlook for fiscal Q3 and Q4 is results similar to fiscal Q1.
- The company will report final fiscal Q2 results on February 4 after the close. The conference call will begin at 4:30 pm ET.
- The FDA approves DexCom's (NASDAQ:DXCM) Dexcom G4 Continuous Glucose Monitoring System with Share. The Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient's receiver and an app on the patient's iPhone to transmit glucose information to apps on the Apple mobile devices of up to five designated recipients.
- The company will start shipping Share receivers to new patients in March.
- Previously: Dexcom OK to market glucose monitoring app (Jan. 23)
- Giddy traders propel nano cap Brainstorm Cell Therapeutics (NASDAQ:BCLI) up 11% premarket on robust volume in response to its announcement of positive preclinical results for NurOwn cells in the BTBR mouse model of autism. Treatment with NurOwn demonstrated marked behavioral benefits in BTBR mice after a single treatment. The results are encouraging but a colossal amount of development work lies ahead to validate the efficacy of NurOwn in humans for this indication.
- NurOwn cells are mesenchymal stem cells that have been induced, via the company's proprietary methods, to secrete a variety of neurotrophic factors.
- Citing its lack of abuse and dependence potential, the U.S. Drug Enforcement Agency (DEA) removes naloxegol from its list of Schedule II drugs.
- Naloxegol was developed by Nektar Therapeutics (NASDAQ:NKTR) for the treatment of opioid-induced constipation. It is marketed under the brand name Movantik by AstraZeneca (NYSE:AZN).
- Antares Pharma (NASDAQ:ATRS) receives a Complete Response Letter (CRL) from the FDA regarding its Abbreviated New Drug Application (ANDA) for sumatriptan injection USP for the treatment of acute migraine. The CRL cited labeling revisions and minor deficiencies. The company intends to work closely with the agency to address the issues.
- If approved, sumatriptan injection USP will be the company's first ANDA approval and the second device approved from the Vibex auto injector platform.
- Teva Pharmaceutical Industries (NYSE:TEVA) will distribute the product.
- The FDA approves Rockwell Medical's (NASDAQ:RMTI) Triferic (ferric pyrophosphate solution) for the maintenance of hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.
- Shares are up 15% premarket on robust volume.
- Previously: PDUFA date approaches for Rockwell's Triferic (Jan. 22)
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