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Stockreport

Regeneron's (REGN) Lymphoma Candidate Rejected by the FDA [Yahoo! Finance]

Regeneron Pharmaceuticals, Inc. (REGN)  More Company Research Source: Yahoo! Finance
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: investor.regeneron.com
Odronextamab is an investigational bispecific monoclonal antibody designed to bind to a component of the T-cell receptor complex while binding and bridging T-cells to a protein expressed on B-cells. The BLA is seeking the approval of the candidate in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. Regeneron stated that the sole issue with approvability is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the clinical efficacy or safety, trial design, labeling or manufacturing of the candidate. We remind investors that REGN has been actively enrolling patients in multiple phase III trials for odronextamab as part of the OLYMPIA program. The program is expected to change the treatment paradigm of several B-cell non-Hodgkin lymphoma subtypes, including in earlier lines [Read more]
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Stockreport

Regeneron's (REGN) Lymphoma Candidate Rejected by the FDA [Yahoo! Finance]

Regeneron Pharmaceuticals, Inc.  (REGN) 
More Company Research Source: Yahoo! Finance
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: investor.regeneron.com
Odronextamab is an investigational bispecific monoclonal antibody designed to bind to a component of the T-cell receptor complex while binding and bridging T-cells to a protein expressed on B-cells. The BLA is seeking the approval of the candidate in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. Regeneron stated that the sole issue with approvability is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the clinical efficacy or safety, trial design, labeling or manufacturing of the candidate. We remind investors that REGN has been actively enrolling patients in multiple phase III trials for odronextamab as part of the OLYMPIA program. The program is expected to change the treatment paradigm of several B-cell non-Hodgkin lymphoma subtypes, including in earlier lines [Read more]
IMPACT SNAPSHOT
EVENT TIME:
REGN
Last Price
Price Change
Price Change %
Volume Shares
Max Up
Max Down
Volume Ratio
%
Don't Miss Out On The Next BIG Stock Move
Performance comparison Updated
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
LAST PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
LAST PRICE
VWAP
High:
MAX UP
High:
Low:
MAX DOWN
Low:
%
 POST NEWS RANGE
%
PRICE CHANGE
PRICE CHANGE PERCENTAGE
S&P 500 (SPX)
%
 VOLUME RATIO
%
VOLUME (SHARES)
TICKS
AVG SHARES PER TRADE
EVENT DAY
Event Day Chart will not be displayed beyond 90-day period of the event
PERFORMANCE SINCE EVENT
TIME AND VELOCITY ANALYSIS