23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
15:36 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

FDA extends review of Progenics' Azedra

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said FDA will extend its review of an NDA for Azedra iobenguane I 131, postponing its PDUFA date to July 30 from April 30. The therapy is under Priority Review to...
16:21 , Mar 23, 2018 |  BC Extra  |  Company News

FDA extends review of Progenics' Azedra

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) slipped $0.82 (10%) to $7.54 on Friday after it said FDA will extend its review of an NDA for Azedra iobenguane I 131, postponing its PDUFA date to July 30 from...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
23:12 , Jan 3, 2018 |  BC Week In Review  |  Clinical News

Progenics gets Priority Review for Azedra in rare NETs

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said FDA accepted and granted Priority Review to an NDA for Azedra iobenguane I 131 (Ultratrace I-131-MIBG, Ultratrace iobenguane I 131) to treat malignant recurrent and/or unresectable pheochromocytoma and paraganglioma. Its...
19:19 , Dec 29, 2017 |  BC Extra  |  Company News

Progenics' Azedra gets Priority Review for rare NETs

On Friday, Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said FDA accepted and granted Priority Review to an NDA for Azedra iobenguane I 131 (Ultratrace I-131-MIBG, Ultratrace iobenguane I 131) to treat malignant recurrent and/or unresectable pheochromocytoma and...
20:41 , Nov 10, 2017 |  BC Week In Review  |  Clinical News

Progenics completes rolling Azedra NDA

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) completed rolling submission of an NDA to FDA for Azedra iobenguane I 131 (Ultratrace I-131-MIBG, Ultratrace iobenguane I 131) to treat malignant recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
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...
18:34 , Mar 31, 2017 |  BC Week In Review  |  Clinical News

Azedra: Ph IIb data

Top-line data from 68 evaluable patients with malignant relapsed or refractory pheochromocytoma or paraganglioma in an open-label, U.S. Phase IIb trial showed that Azedra met the primary endpoint of ≥12 patients achieving a ≥50% reduction...