17:02 , May 25, 2018 |  BC Week In Review  |  Clinical News

Genmab's Arzerra misses in Phase III for indolent NHL

Genmab A/S (CSE:GEN) said Arzerra ofatumumab plus Treanda bendamustine missed the primary endpoint of improving progression-free survival (PFS) in the Phase III COMPLEMENT A+B trial to treat indolent B cell non-Hodgkin's lymphoma (NHL). The company...
18:32 , May 24, 2018 |  BC Extra  |  Clinical News

Genmab's Arzerra misses in Phase III for indolent NHL

Genmab A/S (CSE:GEN) said Arzerra ofatumumab plus Treanda bendamustine missed the primary endpoint of improving progression-free survival (PFS) in the Phase III COMPLEMENT A+B trial to treat indolent B cell non-Hodgkin's lymphoma. The company said...
13:50 , Apr 13, 2018 |  BC Week In Review  |  Clinical News

FDA Priority Review for Verastem's duvelisib

Verastem Inc. (NASDAQ:VSTM) said FDA accepted and granted Priority Review to an NDA seeking full approval of duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The NDA...
20:33 , Apr 9, 2018 |  BC Extra  |  Company News

Verastem gains on duvelisib Priority Review

Verastem Inc. (NASDAQ:VSTM) added $0.32 (11%) to $3.22 on Monday after it said FDA accepted and granted Priority Review to an NDA seeking full approval of duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic...
16:14 , Feb 9, 2018 |  BC Week In Review  |  Clinical News

Verastem submits NDA to FDA for duvelisib

Verastem Inc. (NASDAQ:VSTM) submitted an NDA to FDA for duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The NDA is also seeking accelerated approval of duvelisib to...
17:07 , Jan 26, 2018 |  BC Week In Review  |  Company News

Novartis to begin ex-U.S. compassionate use program for Arzerra

Genmab A/S (CSE:GEN; Pink:GMXAY) said partner Novartis AG (NYSE:NVS; SIX:NOVN) will begin offering Arzerra ofatumumab to patients outside the U.S. through compassionate use programs. Genmab said that over the past five years, additional CLL drugs...
02:15 , Dec 16, 2017 |  BioCentury  |  Product Development

Assessing the BCMA scene

Differences in patient populations and a dearth of clinical outcome data mean it’s too soon to declare bluebird bio Inc.’s anti-BCMA chimeric antigen receptor therapy the leader of the pack of CARs that presented clinical...
16:50 , Dec 15, 2017 |  BC Week In Review  |  Clinical News

Verastem reports additional Phase III data for duvelisib in CLL

Verastem Inc. (NASDAQ:VSTM) reported additional data from the Phase III DUO trial evaluating duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The data were presented at the...
21:33 , Dec 11, 2017 |  BC Extra  |  Clinical News

Verastem down on duvelisib update at ASH

Verastem Inc. (NASDAQ:VSTM) fell $0.73 (17%) to $3.60 on Monday after reporting additional data from the Phase III DUO trial evaluating duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic...
00:29 , Dec 9, 2017 |  BioCentury  |  Strategy

Genmab’s second act

For the second time, Genmab A/S finds itself at the threshold of transitioning into a commercial biotech and is planning to change its partnering approach to retain a more significant portion of the value of...