Biotech Stock Roundup: ASH Data In Focus, Amgen Gets FDA Nod To Remicade Biosimilar
Zacks Investment Research | Dec 10, 2019 09:41PM ET
This week, the focus was on data presented at the annual conference of the American Society of Hematology ("ASH") from Dec 7-10. Apart from this, the regular pipeline updates were also significant to the biotech sector.
Recap of the Week’s Most Important Stories:
ASH Roundup: Several companies were at ASH with data on approved and pipeline drugs.
Kite, a Gilead Sciences, Inc. (NASDAQ:GILD) company, announced long-term data from the ZUMA-1 study on CAR T cell therapy, Yescarta (axicabtagene ciloleucel), in adult patients with refractory large B-cell lymphoma at the 61st ASH Annual Meeting & Exposition in Orlando.
This included updated overall survival (OS) data from the phase II study after three years, following a single infusion of Yescarta as well as an analysis from a separate safety management cohort of patients receiving early steroid intervention for cytokine release syndrome (CRS) and neurologic events. With a minimum follow-up of three years after a single infusion of Yescarta (median follow-up of 39.1 months), approximately 47% of patients with refractory large B-cell lymphoma in ZUMA-1 phase II cohorts were alive, while the median OS was 25.8 months.
The company also announced primary results from ZUMA-2, a global, multicenter, single-arm, open-label phase 2 study of KTE-X19, which is an investigational CD19 CAR T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma (MCL). In the study, 93% of patients treated with investigational KTE-X19 achieved response.
bluebird bio, Inc. (NASDAQ:BLUE) and partner Bristol-Myers Squibb Company (NYSE:BMY) the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
Sage Plunges on Study Failure: Shares of Sage Therapeutics (NASDAQ:SAGE) plummeted after it announced that a phase III study on SAGE-217 for the treatment of major depressive disorder (MDD) failed to meet the primary endpoint. The MOUNTAIN study evaluated the efficacy, safety and pharmacokinetics of SAGE-217 in adult patients diagnosed with MDD. The phase III study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. SAGE-217 30 mg, given once-daily as an oral treatment, was associated with a mean reduction of 12.6 in HAM-D total score compared to 11.2 for placebo.
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