Today - Friday, May 22, 2015
- Major health insurers in some states are proposing rate increases of as much as 51% for plans sold under the federal health law, according to a WSJ analysis, setting the stage for an intense debate over the law’s impact.
- All the insurers cite high medical costs incurred by people newly enrolled under the Affordable Care Act, saying their proposed rates reflect the revenue they need to pay claims now that they have had time to analyze their experience with the law’s requirement that they offer the same rates to everyone regardless of medical history.
- Some insurers are trying to catch up with the impact of expensive drugs such as Sovaldi, foreseeing significant pent-up demand from the newly enrolled, says a fellow at the Society of Actuaries.
- Relevant tickers: IHF, HNT, UNH, MOH, CNC, UAM, AET, CI, HUM, HCA, WCG, GTS, EMCI, MGLN
10:46 AM| 2 Comments
- ConforMIS (CFMS) files for an IPO in a bid to raise up to $173M.
- The medical technology company reported revenue of $48.19M in 2014 and total operating expenses of $62.97M.
- ConforMIS uses 3D printing to manufacture some components of its knee replacement implants.
- SEC S-1
- Otonomy (NASDAQ:OTIC) -19.5% premarket after reporting that its OTO-104 experimental drug did not meet the main goal of reducing the incidence of vertigo in a mid-stage trial in patients suffering from Ménière's disease.
- OTIC says the results narrowly missed the primary endpoint during the third month following treatment compared to a one month baseline period.
- OTIC says the data provides a strong enough basis to move forward with two parallel late-stage trials, with the first expected to start by the end of the year.
- Amgen's (NASDAQ:AMGN) new cholesterol drug, Repatha (evolocumab), has been recommended for approval in Europe, putting the U.S. drugmaker ahead of a race with rival Sanofi's (NYSE:SNY) Praluent.
- Neither has won approval in the all-important U.S. market yet.
- Repatha belongs to a new class of cholesterol-lowering drugs known as PCSK9 inhibitors that have the potential to drastically reduce the risk of heart attacks when used in addition to standard treatment.
- AMGN +0.5% premarket
- The European Medicines Agency has recommended approval for Merck's (NYSE:MRK) immune system-boosting cancer drug Keytruda (pembrolizumab), following a similar green light last month for Bristol-Myers Squibb's (NYSE:BMY) rival product Opdivo.
- Both Keytruda and Opdivo are already approved in the U.S.
- Previously: Merck files for new indication for Keytruda (Apr. 20 2015)
- Previously: Merck presents new data showing effectiveness of Keytruda (Apr. 20 2015)
6:21 AM| Comment!
6:13 AM| Comment!
Thursday, May 21, 2015
- A Phase 3 clinical trial, called RADIANT-4, evaluating Novartis' (NVS +1.5%) Afinitor (everolimus) in 302 patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal or lung origin met its primary endpoint of a statistically significant extension of progression-free survival (PFS). Complete results will be presented at a future medical meeting. Worldwide regulatory filings are planned for this year.
- Patients with NET, a rare type of cancer that originates in neuroendocrine cells found throughout the body, have limited treatment options.
- Afinitor is approved in various countries for the treatment of neuroendocrine tumors of pancreatic origin, renal cell carcinoma and HR+ breast cancer.
- Biodel (BIOD -0.9%) commences a Phase 2b clinical trial evaluating BIOD-531, its proprietary recombinant human insulin-based ultra-rapid-acting prandial/basal combination insulin. The trial, called Study 3-250, is a randomized, open-label, parallel group study that will enroll ~130 patients with type 2 diabetes. Participants will be randomized to receive either BIOD-531 or Eli Lilly's (LLY +0.6%) Humalog Mix 75/25 dosed twice daily for 18 weeks. The primary endpoint is the change in HbA1c from baseline. Top-line results are expected in mid-2016.
- BIOD-531 is a formulation of recombinant human insulin that is designed to be more rapid-acting than currently available insulins for type 1 and type 2 diabetics.
- Kite Pharma (KITE -0.9%) announces that the first refractory non-Hodgkin's lymphoma (NHL) patient has been treated with its investigational anti-CD19 chimeric antigen receptor (CAR) T cell therapy, KTE-C19, in the safety stage of a Phase 1/2 trial. The trial has an enrollment target of 124, 112 of which will be recruited in the Phase 2 portion.
- KTE-C19 is a therapy in which the patient's T cells are genetically modified to express a CAR that targets the CD19 antigen, a protein expressed on the surface of B-cell lymphoma and leukemia cells. This enables the T cells to locate and kill the cancer cells.
- Under the decentralized procedure, Baxter International (BAX -0.7%) submits a marketing authorization application to 17 authorities in Europe seeking approval of its 20% concentration subcutaneous immune globulin treatment for patients with primary immunodeficiencies. The company is advancing the 20% product in an effort to expand its treatment portfolio in primary immunodeficiencies.
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
- On June 13, bluebird bio (BLUE +6%) will present clinical data on its ongoing Phase 1/2 trial, HGB-205, evaluating Lentiglobin BB305 in patients with beta-thalassemia and sickle cell disease (SCD), at the 20th Congress of the European Hematology Association in Vienna, Austria.
- Two patients with beta-thalassemia major remain transfusion independent at 14 months and 11 months post transplant, respectively.
- One SCD patient who was receiving chronic transfusions before transplantation was weaned off in 88 days and showed an anti-sickling hemoglobin level of 24% at 4.5 months follow up. According to the company, a level of at least 30 has the potential to reduce or eliminate the serious and life-threatening events associated with SCD.
- Lentiglobin BB305 is a gene therapy that inserts a functional human beta-globin gene into the patient's own hematopoietic stems cells in a process performed outside of the body. The modified cells are then infused into the patient.
- Astellas Pharma (OTCPK:ALPMY -0.1%) finalizes the enrollment of 150 kidney transplant patients a year ahead of schedule in a Phase 2 study evaluating its therapeutic cytomegalovirus (CMV) vaccine candidate ASP0113. The randomized, double-blind, placebo-controlled trial will assess ASP0113 in CMV-seronegative kidney transplant patients receiving a kidney from a CMV-seropositive donor.
- The primary endpoint will compare the efficacy of ASP0113 + 100 days of valganciclovir to placebo + 100 days of valganciclovir in reducing the incidence of CMV viremia (virus is in the blood) for one year following the first vaccination. Top-line results are expected in H2 2016.
- Under current standard of care, about half of D+/R- kidney transplant recipients experience CMV viremia and ~35% experience CMV disease with one year after transplantation.
- Astellas licensed the Orphan Drug-designated product candidate from Vical (VICL +1.1%).
- CMV is a type of herpes virus that most people come in contact with in their lifetimes. It is asymptomatic in healthy individuals but presents mononucleosis-type symptoms in those with weakened immune systems.
- Thinly traded nano cap Actinium Pharmaceuticals (NYSEMKT:ATNM) is up 15% premarket on increased volume in response to its announcement of a planned poster presentation at ASCO on the Phase 1/2 study of Actimab-A in elderly patients with newly diagnosed acute myeloid leukemia (AML).
- Two out of three Actimab-A-treated patients in Cohort 3 achieved complete remission with different degrees of hematological recovery.
- Actimab-A is a radiolabeled antibody being developed for the treatment of AML.
- Micro cap Calithera Biosciences (NASDAQ:CALA) is up 18% premarket on increased volume in response to its announcement of initial Phase 1 results for its lead product candidate, CB-839, in 15 patients with acute leukemia. Stable disease for 4 - 10 cycles of treatment (21 days/cycle) was observed in five patients. One of these achieved a complete response after six treatment cycles.
- The data will be presented on June 12 at the 20th Congress of the European Hematology Association in Vienna, Austria.
- CB-839 is an orally available inhibitor of human glutaminase, an enzyme that correlates with the cellular consumption of glutamine, a key nutrient for rapidly dividing cancer cells.
- The company intends to proceed to Phase 2 development later this year or early 2016.
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