Fly News Breaks for May 19, 2017
May 19, 2017 | 08:50 EDT
BMO Capital analyst Alex Arfaei says that "the ASCO abstracts solidify Merck's (MRK) significant leadership in the important 1L-NSCLC market." The analyst says that Incyte's (INCY) Epacadostat appears to be "adding meaningful clinical benefit to Keytruda." He believes that the data "clearly indicates" that Keytruda monotherapy should be the standard of care in about 25% of 1L-NSCLC patients.
News For MRK;INCY From the Last 2 Days
Jul 25, 2017 | 11:29 EDT
Shares of Eli Lilly (LLY) are sliding after the company announced that a resubmission to the Food and Drug Administration for the New Drug Application, or NDA, for baricitinib will be delayed beyond 2017. Eli Lilly also reported second quarter results this morning, which came in above consensus estimates. NDA RESUBMISSION DELAYED: Eli Lilly and Incyte (INCY) announced that a resubmission to the FDA for the NDA, for baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis, will be delayed beyond 2017. The companies will be further discussing the path forward with the agency and evaluating options for resubmission, including the potential for an additional clinical study, as requested by the FDA. The length of time to a resubmission for the NDA will depend on which option the companies pursue and further FDA discussions, but is anticipated to be a minimum of 18 months. The FDA has indicated that a new clinical study is necessary for a resubmission in order to further characterize the benefit/risk across doses, in light of the observed imbalance in thromboembolic events that occurred during the placebo-controlled period of the RA clinical program. This request for an additional clinical study does not impact the ongoing clinical trials for baricitinib. The NDA for rheumatoid arthritis contained the results of four positive Phase 3 clinical trials that met their primary endpoints. Thromboembolic events - diagnosed as deep venous thrombosis and pulmonary embolism - were reported in five patients receiving baricitinib during the controlled period of two of seven completed Phase 2 or Phase 3 trials in rheumatoid arthritis. Although an imbalance was observed during the placebo controlled period of the clinical trials, the rate of these events in the overall baricitinib clinical program was consistent with that seen among the general population of treated RA patients. In the European Union, where baricitinib 2-mg and 4-mg tablets have been approved since February 2017, the European Medicines Agency's Committee for Medicinal Products for Human Use recently agreed to update the label with a precaution for patients who have risk factors for DVT and PE. RESULTS: Eli Lilly reported second quarter earnings per share of $1.11 and revenue of $5.82B, both above consensus of $1.05 and $5.6B, respectively. The company also raised its 2017 earnings per share view to $4.10-$4.20 from $4.05-$4.15, and 2017 revenue guidance to $22B-$22.5B from $21.8B-$22.3B. Eli Lilly also said that in addition to building upon new oncology products such as Cyramza, Lartruvo, and abemaciclib, it will pursue new standard-of-care changing therapies that target tumor dependencies in molecularly enriched populations, build rational combinations that overcome resistance, and develop next-generation immunotherapies. Using this framework, Lilly will focus on seven pipeline assets for priority internal development and three additional assets which are pending data from ongoing trials. PRICE ACTION: In late morning trading, shares of Eli Lilly have dropped almost 4% to $81.41, while Incyte's stock has dropped about 3% to $133.69.
Jul 25, 2017 | 08:36 EDT
Merck announced the presentation of results from the DRIVE-AHEAD study, the second of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of doravirine, the company's investigational, non-nucleoside reverse transcriptase inhibitor, for the treatment of HIV-1 infection. At 48 weeks, the study showed that a once-daily single tablet, fixed-dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate met its primary efficacy endpoint of non-inferiority based on the proportion of participants achieving levels of HIV-1 RNA less than 50 copies/mL at 48 weeks of treatment, compared to a fixed-dose combination of efavirenz, emtricitabine, and TDF, in treatment-naive adults infected with HIV-1. In addition, through 48 weeks, statistically significantly fewer patients taking DOR/3TC/TDF reported pre-specified categories of neuropsychiatric events than patients receiving the EFV/FTC/TDF regimen. Treatment with DOR/3TC/TDF also showed a statistically significant lower change from baseline in fasting low density lipoprotein cholesterol and non-high density lipoprotein cholesterolcompared to EFV/FTC/TDF at Week 48. Findings from the ongoing DRIVE-AHEAD Phase 3 trial were featured as part of a late-breaking oral presentation session at the 9th International Conference on HIV Science taking place in Paris, France, from July 23-26, 2017.
Jul 24, 2017 | 17:25 EDT
UP AFTER EARNINGS: Celanese (CE), up 4.9%... Rambus (RMBS), up 3.6%... Cadence Design Systems (CDNS), up 1.5%... Swift Transportation (SWFT), up 1.3%... American Campus Communities (ACC), up 1.1%. DOWN AFTER EARNINGS: Heidrick & Struggles (HSII), down 9.9%... Sanmina (SANM), down 9.3%... Anadarko Petroleum (APC), down 3.7%... Alphabet (GOOG), down 3.1%. ALSO LOWER: Team (TISI), down 20.2% after it reported lower than expected preliminary Q2 revenue and after it filed to sell $175M of convertible senior notes due 2023... QEP Resources (QEP), down 5.4% after it agreed to sell natural gas assets in Wyoming for $777.5M... Merck (MRK), down 0.9% after its Phase 3 Study of Keytruda did not meet its primary endpoint.
Jul 24, 2017 | 07:09 EDT
Merck announced the presentation of Week 96 results from the pivotal Phase 3 ONCEMRK study evaluating the efficacy and safety of ISENTRESS HD1, a 1200 mg once-daily dose of the company's integrase inhibitor, ISENTRESS, administered orally as two 600 mg film-coated tablets, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg, who are treatment-naive or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily. Previously, the findings at Week 48 demonstrated that once-daily ISENTRESS HD met its primary efficacy endpoint of non-inferiority to twice-daily ISENTRESS, with a similar safety and tolerability profile. The Week 96 results reaffirm the comparable efficacy and safety of ISENTRESS HD. These study results were presented today during a late-breaking abstract session at the 9th International Conference on HIV Science being held in Paris, France, from July 23-26, 2017. ISENTRESS and ISENTRESS HD do not cure HIV-1 infection or AIDS. Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS or ISENTRESS HD and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develop and monitor clinical status, including liver aminotransferases closely Week 96 data from the ONCEMRK study showed that 81.5% of the 531 patients taking once-daily ISENTRESS HD 1200 mg achieved viral suppression of less than 40 copies/mL of HIV-1 RNA, compared to 80.1% of the 266 patients taking twice-daily ISENTRESS 400 mg, both in combination therapy with emtricitabine plus tenofovir disoproxil fumarate, with a treatment difference of 1.4% Increases in CD4+T-cell counts from baseline were comparable for the two treatment regimens, with an average increase of 261.6 cells/mm3 for once-daily ISENTRESS HD and 262.2 cells/mm3 for twice-daily ISENTRESS. Efficacy was consistent across a variety of patient populations, including those with high viral load at baseline. Treatment-emergent viral mutations leading to any drug resistance were detected in less than 1% of patients in both treatment arms, with 4/531 in the once-daily ISENTRESS HD treatment arm, and 2/266 in the twice-daily ISENTRESS treatment arm through 96 weeks. The rate of discontinuation of therapy due to adverse events through 96 weeks was low