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7896 items
2:24 PM, Aug 16, 2018  |  BC Extra | Clinical News

Regeneron, Teva’s anti-NGF mAb meets 16-week endpoints in Phase III for OA pain

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said fasinumab met the co-primary endpoints at week 16 in a substudy of the larger Phase III FACT LTS & OA trial to...
11:28 AM, Aug 07, 2018  |  BC Extra | Clinical News

Spark falls on Factor VIII activity data for hemophilia A therapy

Spark Therapeutics Inc. (NASDAQ:ONCE) fell $21.60 (28%) to $56.01 on Tuesday after reporting new Phase I/II data showing that the highest tested dose of hemophilia A gene therapy SPK-8011 led to lower than expected Factor...
2:07 PM, Aug 06, 2018  |  BC Extra | Clinical News

Ovid falls on Phase II data for Angelman syndrome candidate

Ovid Therapeutics Inc. (NASDAQ:OVID) fell $3.44 (36%) to $6.08 on Monday after reporting that gaboxadol (OV101) failed to significantly improve prespecified efficacy measures of behavior, sleep and gait in the Phase II STARS trial to...
2:12 PM, Aug 02, 2018  |  BC Extra | Clinical News

Epizyme falls on DLBCL discontinuations for tazemetostat

Epizyme Inc. (NASDAQ:EPZM) lost $3.10 (24%) to $9.90 on Thursday after discontinuing development of tazemetostat both as monotherapy and in combination with prednisolone to treat diffuse large B cell lymphoma. The news comes three months...
5:01 AM, Aug 02, 2018  |  BC Extra | Clinical News

Celtaxsys planning Phase III program for CF candidate

Celtaxsys Inc. (Atlanta, Ga.) said it hopes to start Phase III testing in 2H19 evaluating acebilustat (CTX-4430) to treat cystic fibrosis after reporting data from the Phase II EMPIRE-CF trial of the candidate in the...
10:41 AM, Jul 31, 2018  |  BC Extra | Clinical News

Otsuka's guadecitabine misses in Phase III for first-line AML

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and its Astex Pharmaceuticals Inc. subsidiary said first-line treatment with guadecitabine (formerly SGI-110) missed the co-primary endpoints in the Phase III ASTRAL-1 trial to treat previously untreated acute myelogenous...
3:24 PM, Jul 30, 2018  |  BC Extra | Clinical News

Additional study needed for RedHill's Crohn disease candidate

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) said another Phase III trial is "most likely to be required" to support an NDA submission to FDA for Crohn disease candidate RHB-104. On a conference call Monday to discuss...
5:04 PM, Jul 26, 2018  |  BC Extra | Clinical News

AZ reveals another Phase III selumetinib miss

AstraZeneca plc (LSE:AZN; NYSE:AZN) disclosed in its 2Q18 earnings that it discontinued development of selumetinib to treat differentiated thyroid cancer after the candidate missed the primary endpoint in the Phase III ASTRA trial in the...
4:50 PM, Jul 25, 2018  |  BC Extra | Clinical News

BAN2401 slows cognitive decline by 30% in Phase II Alzheimer's trial

Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB) presented highly anticipated detailed results for BAN2401 Wednesday at the Alzheimer's Association International Conference showing that the anti-β amyloid therapy slowed cognitive decline by as much as...
1:57 PM, Jul 25, 2018  |  BC Extra | Clinical News

resTORbio forging ahead with anti-infective after Phase IIb readout

Data from Part 2 of a Phase IIb trial evaluating RTB101 from resTORbio Inc. (NASDAQ:TORC) to prevent respiratory tract infections showed that all three dose regimens of the candidate missed the study's primary endpoint vs....