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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...
4:50 PM, Oct 09, 2018  |  BC Extra | Clinical News

Arbutus falls on HBV program updates

Arbutus Biopharma Corp. (NASDAQ:ABUS) lost $3.09 (34%) to $6 on Tuesday after announcing updates for two of its HBV programs. The move translated to a loss of over $170 million in the company's market cap. Arbutus...
1:30 PM, Oct 09, 2018  |  BC Extra | Clinical News

Affimed sinks after placing clinical hold on bispecific T cell engager

Affimed N.V. (NASDAQ:AFMD) fell $1.13 (24%) to $3.50 Tuesday after it placed a clinical hold on two studies of blood cancer candidate AFM11 following three treatment-related serious adverse events, including a patient death. The product...
2:55 PM, Oct 08, 2018  |  BC Extra | Clinical News

Cavion planning Phase III for essential tremor candidate despite Phase II miss

Cavion Inc. (Charlottesville, Va.) said CX-8998 missed the primary endpoint in the Phase II T-CALM trial to treat moderate to severe essential tremor. Despite the miss, the company plans to start a Phase III trial...
1:32 PM, Oct 08, 2018  |  BC Extra | Clinical News

Rival RET inhibitor data highlighted at thyroid meeting

Loxo Oncology Inc. (NASDAQ:LOXO) and Blueprint Medicines Corp. (NASDAQ:BPMC) each reported updated data on Saturday at the American Thyroid Association meeting in Washington from clinical trials evaluating their respective ret proto-oncogene (RET) inhibitors to treat...
11:39 AM, Oct 05, 2018  |  BC Extra | Clinical News

Cytokinetics' reldesemtiv misses COPD, frailty endpoints

Cytokinetics Inc. (NASDAQ:CYTK) and Astellas Pharma Inc. (Tokyo:4503) said reldesemtiv (CK-2127107) missed the primary and secondary endpoints in a Phase II trial to treat chronic obstructive pulmonary disease. The partners also said an interim analysis...

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