16:21 , Dec 15, 2017 |  BC Week In Review  |  Clinical News

CHMP requests more information on betrixaban VTE MAA

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EMA’s CHMP requested additional information related to its MAA for betrixaban (PRT054021) for extended-duration prophylaxis of venous thromboembolism (VTE) in adults with acute medical illness and risk factors for VTE....
19:46 , Jul 5, 2017 |  BC Week In Review  |  Clinical News

FDA approves Portola's Bevyxxa betrixaban to prevent VTE

FDA approved an NDA from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) for Bevyxxa betrixaban (PRT054021) to prevent venous thromboembolism (VTE) in hospitalized and post-discharge adults with acute illnesses who are at high risk for complications. The oral...
19:14 , Jun 23, 2017 |  BC Extra  |  Company News

Portola soars after FDA approves anticoagulant Bevyxxa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) jumped $17.81 (47%) to $56.06 on Friday after FDA approved Bevyxxa betrixaban to prevent venous thromboembolism (VTE) in hospitalized and post-discharge adults with acute illnesses who are at high risk for...
22:45 , Apr 7, 2017 |  BioCentury  |  Finance

To market, to market

Investors are hoping that a slew of approvals and data readouts can maintain biotech’s momentum on the heels of several high-profile successes that came just before or after 1Q’s end. Chief among those was Vertex...
21:53 , Feb 9, 2017 |  BC Week In Review  |  Clinical News

Betrixaban regulatory update

Portola said FDA does not plan to hold an advisory committee meeting to discuss an NDA for the company's betrixaban. The agency did not identify any issues during its mid-cycle review that require a meeting,...
16:24 , Feb 8, 2017 |  BC Extra  |  Company News

Portola: FDA won't require betrixaban meeting

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said FDA does not plan to hold an advisory committee meeting to discuss an NDA for the company's betrixaban ( PRT054021 ). The agency did not identify any issues during its...
22:19 , Jan 4, 2017 |  BC Week In Review  |  Clinical News

Betrixaban regulatory update

FDA accepted and granted Priority Review to an NDA for betrixaban as extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. The PDUFA date is June 24. Portola...
22:29 , Dec 23, 2016 |  BC Extra  |  Company News

Portola jumps on Priority Review for betrixaban

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) gained $6.33 (34%) to $25.06 after it said FDA accepted and granted Priority Review to the biotech’s NDA for betrixaban ( PRT054021 ) for extended-duration prophylaxis of venous thromboembolism (VTE) in...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Betrixaban regulatory update

Portola said it submitted to FDA an NDA for betrixaban as extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. The oral Factor Xa inhibitor has Fast Track...
07:00 , Oct 25, 2016 |  BC Extra  |  Company News

Portola submits NDA for betrixaban

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said it submitted an NDA to FDA for oral Factor Xa inhibitor betrixaban ( PRT054021 ) as extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors...