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Fly News Breaks for March 10, 2015
Mar 10, 2015 | 08:08 EDT
Jefferies says AbbVie (ABBV) remains its Top Global Pick in Pharmaceuticals on its belief the Pharmacyclics (PCYC) deal will be an inflection point for the stock. Pfizer (PFE) remains the firm's second pick and AstraZeneca (AZN) third, with the latter being promoted to Top European Pick. Roche (RHHBY) is in the fourth spot and Eli Lilly (LLY) has been moved to fifth in place of Bayer (BAYRY) which dropped to eighth. Bristol-Myers (BMY) and GlaxoSmithKline (GSK) are Jefferies' least preferred stocks in the space.
Oct 22, 2018 | 08:37 EDT
H.C. Wainwright analyst Debjit Chattopadhyay believes Roche's (RHHBY) preliminary data of RO6875281, a fibroblast activation protein targeted interleukin-2 variant, should concern the bulls of Nektar Therapeutics (NKTR). The 11% and 20% overall response rate for single agent RO6875281 in squamous cell head and neck cancer and melanoma is compelling, Chattopadhyay tells investors in a research note. Nektar's NKTR-214 had no monotherapy activity, and the early promise in combination with Opdivo "has faded potentially due to its limited PK profile," the analyst adds. In addition, Chattopadhyay believes the monotherapy activity with pegilodecakin, a pegylated IL-10 being developed by Eli Lily (LLY), further complicates the competitive landscape for NKTR-214. He believes the second generation of "not alpha" IL-2, which is poised to enter the clinic during 2019, could further "upend" NKTR-214 and might compel Nektar's partner Bristol-Myers Squibb (BMY) to "re-evaluate the aggressive development strategy that was outlined earlier this year." The analyst keeps a Neutral rating on Nektar with a $54 price target.
Oct 22, 2018 | 08:19 EDT
8th Annual IRT 2018 will be held in Philadelphia on October 22-23.
Oct 22, 2018 | 07:39 EDT
Citi analyst Andrew Baum downgraded Bristol-Myers Squibb (BMY) to Neutral from Buy and lowered his price target for the shares to $57 from $62. The drugmaker closed Friday down 3%, or $1.72, to $54.30. The downgrade largely reflects further likely "lowering of floor" Opdivo, Yervoy and earnings estimates from a base that is already materially below the consensus, Baum tells investors in a research note partially titled "The Final Straws." The analyst anticipates an "extraordinary" treatment effect from Keytruda in Merck's (MRK) Keynote-426 trial in renal cell carcinoma given the statistical significance for both progression-free survival and overall survival at the first interim analysis.
Oct 22, 2018 | 07:30 EDT
Notable put activity was cited Friday in Caterpillar (CAT), Bristol Myers Squibb (BMY), Halliburton (HAL), GameStop (GME), Trupanion (TRUP), and Philips (PHG).
Oct 22, 2018 | 05:33 EDT
Bristol-Myers announced new data from a cohort of the CheckMate -142 study in which Opdivo plus low-dose Yervoy demonstrated durable clinical benefit as a first-line treatment in patients with microsatellite instability-high, or MSI-H, or DNA mismatch repair deficient, or dMMR, metastatic colorectal cancer, or mCRC. With a median follow-up of 13.8 months, the primary endpoint of investigator-assessed objective response rate, or ORR, was 60%, with a 7% complete response, or CR, rate. Patient responses to the combination treatment were durable; at the time of data cutoff, the median duration of response, or DOR, had not yet been reached and 82% of responding patients had ongoing responses. Among the patients who responded, 74% have had responses lasting more than six months. Patients received Opdivo 3 mg/kg every two weeks plus Yervoy 1 mg/kg every six weeks until disease progression, death or unacceptable toxicity. Grade 3-4 treatment-related adverse events, or TRAEs, occurred in seven patients, and any grade TRAEs leading to treatment discontinuation occurred in three patients. These data from CheckMate -142 will be featured today from 9:15-9:27 CEST in a proffered paper session at the European Society for Medical Oncology 2018 Annual Congress in Munich, Germany and highlighted as part of the ESMO Press Programme.
Oct 21, 2018 | 16:40 EDT
AstraZeneca (AZN) and Merck (MRK) announced detailed results from the Phase 3 SOLO-1 trial testing LYNPARZA 300 mg tablets twice daily as a maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival for LYNPARZA as compared to placebo, reducing the risk of disease progression or death by 70%. At 41 months of follow-up, the median PFS for patients treated with LYNPARZA was not reached compared to 13.8 months for patients treated with placebo. Of those receiving LYNPARZA, 60.4% remained progression-free at 36 months, compared to 26.9% of women in the placebo arm. The SOLO-1 safety profile was in line with that observed in prior clinical trials. 71% of patients on LYNPARZA remained on the recommended starting dose. Additionally, 88% of patients on LYNPARZA continued treatment without an AE-related discontinuation. Further, 48% of patients on LYNPARZA did not have a dose interruption as a result of an AE. Per SOLO-1 protocol guidelines, patients who demonstrated a complete response at two years stopped treatment with LYNPARZA; patients who demonstrated a partial response and, who in the opinion of the treating physician can derive further benefit from continuous treatment, were treated beyond two years. AstraZeneca and Merck are exploring additional trials in ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase 3 trial, PAOLA-1. This trial is testing the effect of LYNPARZA in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer regardless of their BRCA status. Results are expected during the second half of 2019. LYNPARZA is not currently FDA-approved for advanced BRCAm ovarian cancer treatment in the first-line maintenance setting. LYNPARZA is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic.
Oct 21, 2018 | 12:56 EDT
Pfizer announced detailed overall survival data from the PALOMA-3 trial, which evaluated Ibrance in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer whose disease progressed on or after prior endocrine therapy. In the study, there was a numerical improvement in OS of nearly seven months with Ibranceplus fulvestrant compared to placebo plus fulvestrant, although this difference did not reach the prespecified threshold for statistical significance versus 28.0 months. The difference in median OS demonstrated in this analysis is consistent with the improvement previously demonstrated for the primary endpoint of median progression-free survival. In the updated PFS analysis for this study, the combination of Ibrance plus fulvestrant showed a statistically significant and clinically meaningful 6.6-month mPFS improvement compared to placebo plus fulvestrant. Overall survival is a secondary endpoint of PALOMA-3, and the trial design was not optimized to detect a statistically significant difference in OS. At the time of this analysis, follow-up was 44.8 months and approximately 60% of events had occurred in the 521 patients enrolled. Patients on both arms received up to 10 lines of post-progression treatment. The trend toward OS favoring the Ibrance plus fulvestrant arm was observed across most subgroups, with hazard ratios consistent with the overall population. In addition, for the overall population, the difference in OS was associated with prolonged time from randomization to first use of chemotherapy post-progression, an exploratory endpoint. Median time to chemotherapy was 17.6 months for patients who received Ibrance plus fulvestrant, twice that observed in patients who received placebo plus fulvestrant. The most common adverse reactions in PALOMA-3 included neutropenia, leukopenia, infections, fatigue and nausea. No new safety signals observed with longer follow-up were identified as part of this final OS analysis.
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