19:06 , Apr 13, 2018 |  BC Week In Review  |  Clinical News

China advisory committee to review CASI's multiple myeloma therapy

CASI Pharmaceuticals Inc. (NASDAQ:CASI) said China's Expert Advisory Anti-Tumor (Oncology) Drugs Committee will meet to review an application for CASI's Evomela melphalan to treat multiple myeloma. China FDA's Center for Drug Evaluation told CASI the...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
22:06 , Feb 23, 2018 |  BC Extra  |  Company News

Darzalex guidance buoys Genmab shares

Genmab A/S (CSE:GEN; Pink:GMXAY) gained DKK13.6 billion ($2.3 billion) in market cap across two days of trading after issuing an earnings report that included new 2018 guidance for multiple myeloma (MM) drug Darzalex daratumumab. Based...
16:20 , Jan 26, 2018 |  BC Week In Review  |  Clinical News

FDA grants Darzalex Priority Review for first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) said FDA accepted and granted Priority Review to an sBLA from partner Johnson & Johnson (NYSE:JNJ) for Darzalex daratumumab to treat multiple myeloma in the first-line setting. The PDUFA date is...
23:53 , Jan 19, 2018 |  BC Extra  |  Company News

FDA grants Darzalex Priority Review for first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) said FDA accepted and granted Priority Review to an sBLA from partner Johnson & Johnson (NYSE:JNJ) for Darzalex daratumumab to treat multiple myeloma in the first-line setting. The PDUFA date is...
00:01 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

J&J seeking first-line MM indication for Darzalex

Johnson & Johnson (NYSE:JNJ) submitted applications in both the U.S. and EU seeking to push Darzalex daratumumab (HuMax-CD38) into the first-line setting to treat multiple myeloma. On Nov. 21, the pharma said it submitted an sBLA...
22:25 , Nov 21, 2017 |  BC Extra  |  Company News

J&J seeking first-line MM indication for Darzalex

Johnson & Johnson (NYSE:JNJ) submitted applications in both the U.S. and EU seeking to push Darzalex daratumumab into the first-line setting to treat multiple myeloma. On Tuesday, the pharma said it submitted an sBLA to FDA...
19:01 , Oct 27, 2017 |  BC Week In Review  |  Financial News

CASI raises $23.9M in registered direct offering

On Oct. 13, CASI Pharmaceuticals Inc. (NASDAQ:CASI) raised $23.9 million through the sale of 8 million units at $3 in a registered direct offering led by existing stakeholders. Each unit comprises a share and two-and-a-half...
23:10 , Aug 28, 2017 |  BC Week In Review  |  Clinical News

Genmab's Darzalex meets in Phase III for first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) reported top-line data from a pre-planned interim analysis of the Phase III ALCYONE (MMY3007) trial showing that Darzalex daratumumab (HuMax-CD38) plus Velcade bortezomib, melphalan and prednisone (VMP) as first-line treatment of...
22:04 , Aug 24, 2017 |  BC Extra  |  Clinical News

Genmab up after Darzalex meets in Phase III for first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) gained DKK147 (11%) to DKK1,448 in Copenhagen on Thursday after it said Darzalex daratumumab met the primary endpoint in the Phase III ALCYONE trial as first-line treatment of multiple myeloma. The...