16:30 , Sep 21, 2018 |  BC Week In Review  |  Financial News

G1 prices $180M follow-on

G1 Therapeutics Inc. (NASDAQ:GTHX) raised $180 million in a follow-on that priced after hours on Sept. 18. G1 sold 3 million shares at $60 in an offering underwritten by J. P. Morgan, Cowen, Needham, Wedbush, BTIG...
17:34 , Sep 19, 2018 |  BC Extra  |  Financial News

argenx, G1 price follow-ons, CRISPR proposes

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) and G1 Therapeutics Inc. (NASDAQ:GTHX) raised $300.6 million and $180 million, respectively, in follow-ons that priced after hours Tuesday. argenx sold 3.5 million ADSs at $86.50, an 8% discount to its NASDAQ...
18:56 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Novartis' PI3Kα inhibitor meets in Phase III for breast cancer

Novartis AG (NYSE:NVS; SIX:NOVN) said alpelisib (BYL719) met the primary endpoint in the Phase III SOLAR-1 trial to treat advanced breast cancer in previously treated patients that harbor the phosphoinositide 3-kinase (PI3K) catalytic subunit α...
21:36 , Aug 23, 2018 |  BC Extra  |  Clinical News

Novartis' PI3Kα inhibitor meets in Phase III for breast cancer

Novartis AG (NYSE:NVS; SIX:NOVN) said alpelisib (BYL719) met the primary endpoint in the Phase III SOLAR-1 trial to treat advanced breast cancer in previously treated patients that harbor the phosphoinositide 3-kinase (PI3K) catalytic subunit α...
17:06 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval...
22:08 , Jul 27, 2018 |  BC Extra  |  Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals Friday, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval of...
20:49 , Jul 18, 2018 |  BC Extra  |  Company News

FDA real-time pilot speeds Kisqali label expansion

FDA announced on Wednesday that it approved Kisqali ribociclib from Novartis AG (NYSE:NVS; SIX:NOVN) in combination with an aromatase inhibitor for breast cancer in premenopausal and perimenopausal women in the first-line setting, five months ahead...
16:44 , Jul 6, 2018 |  BC Week In Review  |  Clinical News

Novartis' Kisqali combo meets PFS endpoint in Phase III for breast cancer in postmenopausal women

Novartis AG (NYSE:NVS; SIX:NOVN) reported data from the Phase III MONALEESA-3 trial to treat breast cancer showing that Kisqali ribociclib in combination with Faslodex fulvestrant met the primary endpoint of improving median progression-free survival (PFS)...
18:04 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

Pfizer's Ibrance fails to improve OS in Phase III for breast cancer

Pfizer Inc. (NYSE:PFE) said Ibrance palbociclib plus Faslodex fulvestrant failed to significantly improve overall survival (OS), a secondary endpoint, vs. placebo plus Faslodex in the Phase III PALOMA-3 trial to treat hormone receptor-positive, HER2-negative metastatic...
17:45 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

G1 reports Phase Ib data for G1T38 in breast cancer

G1 Therapeutics Inc. (NASDAQ:GTHX) reported preliminary data from 24 estrogen receptor-positive, HER2-negative breast cancer patients in the Phase Ib portion of a Phase Ib/IIa trial showing that G1T38 plus Faslodex fulvestrant led to a partial...