22:50 , Aug 19, 2019 |  BC Extra  |  Company News

Nabriva gets first approval in novel antibiotic class

Nabriva plans to launch its first approved antibiotic, Xenleta lefamulin, in mid-September to treat community-acquired bacterial pneumonia, and the company has taken steps to facilitate Xenleta's adoption through negotiations with healthcare providers, payers and pharmacies....
22:14 , Aug 16, 2019 |  BC Extra  |  Company News

Ahead of FDA decisions on one antibiotic, Nabriva plans resubmission of another

As it awaits FDA's decisions on twin NDAs for lefamulin, Nabriva said it plans to resubmit an NDA early next quarter for another one of its antibiotics following a complete response letter this year. Nabriva...
01:58 , Jun 29, 2019 |  BioCentury  |  Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
21:52 , May 1, 2019 |  BC Extra  |  Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

Complete response letter for Heron’s non-opioid pain therapy  Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
20:04 , Jan 18, 2019 |  BC Week In Review  |  Clinical News

FDA moves up PDUFA for Nabriva's Contepo by two months

Nabriva Therapeutics plc (NASDAQ:NBRV) said FDA accelerated its review timeline for Nabriva's broad-spectrum antibiotic Contepo fosfomycin, moving the NDA's PDUFA date to April 30 from June 30. Nabriva said the accelerated timeline is "due to...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
18:12 , Jul 27, 2018 |  BC Week In Review  |  Company News

Nabriva acquires Zavante

Nabriva Therapeutics plc (NASDAQ:NBRV) acquired Zavante Therapeutics Inc. (San Diego, Calif.) for 8.2 million Nabriva shares, or $27.1 million based on the company’s close of $3.30 on July 24, before the acquisition was announced after...
04:44 , Apr 7, 2017 |  BC Week In Review  |  Clinical News

Zolyd: Ph II/III ZEUS data

The double-blind, international Phase II/III ZEUS trial in 465 patients showed that thrice-daily 6 g IV Zolyd met the primary endpoint of non-inferiority to thrice-daily 4.5 g piperacillin/tazobactam in the proportion of patients who achieved...
04:02 , Apr 6, 2017 |  BC Extra  |  Clinical News

Zavante's Zolyd meets in pivotal cUTI study

Zavante Therapeutics Inc. (San Diego, Calif.) said Zolyd fosfomycin (ZTI-01) met the primary endpoint in the Phase II/III ZEUS trial to treat complicated urinary tract infections (cUTIs). The company plans to submit an NDA to...