02:33 , Jul 13, 2019 |  BioCentury  |  Finance

How crossover, insider support and big money correlated with performance across 1H19 IPOs

The performance of 1H19 IPOs point toward a continuation of a dual-class system where biotechs backed by deep-pocketed VCs and crossover investors can tap the public market at will and generate stronger after-market performance than...
23:56 , Jul 1, 2019 |  BC Extra  |  Company News

Management Tracks: BioCryst hires its first CBO; plus ObsEva, Veracyte and more

Rare disease company BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) hired Megan Sniecinski as its first CBO. She was SVP of business operations and program management at PTC Therapeutics Inc. (NASDAQ:PTCT). Reproductive health company ObsEva S.A. (NASDAQ:OBSV; SIX:OBSN)...
21:57 , Jun 27, 2019 |  BC Innovations  |  Product Development

Gene therapy’s next frontier lies beyond rare, monogenic diseases

As in vivo gene therapies continue notching approvals for rare monogenic diseases, the next frontier for the modality will be in treating complex indications without obvious genetic drivers. At least seven companies have clinical or...
23:16 , Jun 21, 2019 |  BC Extra  |  Company News

June 21 Company Quick Takes: FDA rejects Daiichi's AML candidate; plus Sanofi, Novartis and more

Complete response letter for Daiichi's quizartinib  Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory...
00:12 , Jun 7, 2019 |  BC Extra  |  Company News

June 6 Company Quick Takes: Take two for Celgene's ozanimod; plus Protalix, ABPI, Axovant and Mylan

Celgene resubmits NDA for ozanimod   FDA and EMA accepted submissions from Celgene Corp. (NASDAQ:CELG) for ozanimod to treat multiple sclerosis. The PDUFA date for the selective S1PR1 and S1PR5 modulator is March 25, 2020,...
20:49 , May 24, 2019 |  BioCentury  |  Finance

How Europe’s hotspots of innovation could fuel its rise as a global player in new modalities

It is clear that Europe has hotspots of innovation that are discovering and developing the next wave of new therapeutic modalities. Nearly every category of new modality has a European champion, with clusters forming around...
19:26 , Apr 30, 2019 |  BC Extra  |  Clinical News

April 30 Clinical Quick Takes: Xencor, Axovant, Cell Medica

Partial hold lifted on Xencor's blood cancer bispecific  FDA lifted a partial clinical hold on a Phase I trial of XmAb14045 from Xencor Inc. (NASDAQ:XNCR), which is evaluating the bispecific antibody against CD3 and CD123...
12:44 , Mar 21, 2019 |  BC Innovations  |  Emerging Company Profile

A Passage to optimal CNS vectors

Passage is arming itself with AAV vectors, gene therapies and non-human primate studies from gene therapy pioneer James Wilson at UPenn to develop disease-modifying treatments for rare monogenic diseases affecting the CNS. The company launched...
13:50 , Mar 14, 2019 |  BC Extra  |  Financial News

With new data in hand, Axovant raises $40M

Days after revealing the first clinical data from its gene therapy pipeline, Axovant raised $40 million through the sale of 26.7 million shares at $1.50 in a follow-on offering. Axovant Sciences Ltd. (NASDAQ:AXGT) proposed the...
20:28 , Mar 11, 2019 |  BC Extra  |  Clinical News

Axovant reports first clinical gene therapy data

After rebooting to focus exclusively on gene therapies, Axovant gained $0.21 (14%) to $1.69 on Monday after reporting its first data from its retooled pipeline. The lowest dose of its Parkinson's disease therapy, AXO-Lenti-PD, was...