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3:47 PM, Oct 19, 2018  |  BC Extra | Clinical News

Clovis' Rubraca leads to 44% ORR in Phase II for CRPC

Clovis Oncology Inc. (NASDAQ:CLVS) said twice-daily Rubraca rucaparib led to a confirmed objective response rate (ORR) by investigator assessment of 44% in 25 evaluable patients with a BRCA1/2 mutation in the Phase II TRITON2 trial...
3:14 PM, Oct 18, 2018  |  BC Extra | Clinical News

Big gain for Proteostasis on Phase I data for CF doublet

Proteostasis Therapeutics Inc. (NASDAQ:PTI) jumped $8.46 (448%) to $10.35 on Thursday after reporting that its doublet cystic fibrosis therapy improved percent predicted forced expiratory volume in 1 second (ppFEV1) and sweat chloride levels in a...
11:48 AM, Oct 18, 2018  |  BC Extra | Clinical News

Apellis pauses Phase III trials after single lot of APL-2 causes inflammation

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) lost $2.85 (17%) to $13.86 on Thursday after it voluntarily paused dosing in Phase III trials of intravitreal APL-2 to treat geographic atrophy due to eight reported cases of non-infectious inflammation...
11:00 AM, Oct 18, 2018  |  BC Extra | Clinical News

Keytruda, Inlyta combo headed for first-line RCC submissions

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab in combination with Inlyta axitinib met the primary endpoints vs. Sutent sunitinib in the Phase III KEYNOTE-426 trial as first-line treatment of renal cell carcinoma. Merck plans...
11:42 AM, Oct 17, 2018  |  BC Extra | Clinical News

Eisai, Purdue insomnia candidate meets in second Phase III

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) said lemborexant met the primary and secondary endpoints in the Phase III SUNRISE 2 trial to treat insomnia. The trial is the second Phase III...
10:31 PM, Oct 15, 2018  |  BC Extra | Clinical News

Pharnext planning U.S., EU submissions for Charcot-Marie-Tooth therapy on Phase III data

Pharnext S.A. (Euronext:ALPHA) plans to submit regulatory applications to FDA and EMA in 2H19 for PXT3003 to treat mild to moderate Charcot-Marie-Tooth 1A (CMT1A) disease after a high dose of the compound met the primary...
1:49 PM, Oct 15, 2018  |  BC Extra | Clinical News

Krystal gains on early data for topical gene therapy in skin blistering disease

Krystal Biotech Inc. (NASDAQ:KRYS) added $4.32 (28%) to $20 on Monday when it reported interim data from the Phase I/II GEM trial showing that topical gene therapy KB103 met all primary efficacy and safety endpoints...
3:04 PM, Oct 12, 2018  |  BC Extra | Clinical News

Opdivo misses survival endpoint in Phase III for SCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Opdivo nivolumab missed the primary endpoint of improving overall survival (OS) in the Phase III CheckMate -331 trial to treat small cell lung cancer in patients who relapsed following platinum-based...
5:15 AM, Oct 12, 2018  |  BC Extra | Clinical News

Phase II data for Merck's Btk inhibitor highlighted at ECTRIMS

Merck KGaA (Xetra:MRK) reported 24-week data from a Phase II trial to treat relapsing multiple sclerosis showing that evobrutinib (M2951) reduced the mean total number of gadolinium-enhancing T1 lesions by up to 2.7 over placebo....
11:15 AM, Oct 11, 2018  |  BC Extra | Clinical News

FDA lifts hold on IND for CRISPR's sickle cell trial

CRISPR Therapeutics AG (NASDAQ:CRSP) and partner Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said late Wednesday that FDA lifted a clinical hold on an IND for a Phase I/II trial of gene therapy CTX001 to treat sickle cell...

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