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Abivax H1 net loss narrows to 5.5 million euros

12:31pm EDT

Sept 20 (Reuters) - ABIVAX SA ::‍H1 2017 NET LOSS OF EUR 5.5M VERSUS EUR 8.3 IN H1 2016​.SAYS IS FULLY FUNDED THROUGH Q3 2018, BASED ON ASSESSMENT OF PLANNED RESEARCH AND DEVELOPMENT NEEDS.‍IN Q4 2017 WE WILL BEGIN ENROLLING FIRST CLINICAL PROOF-OF-CONCEPT STUDY OF ABX464 IN ULCERATIVE COLITIS PATIENTS​.H1 OPERATING LOSS EUR ‍​7.4 MILLION VERSUS LOSS OF EUR 10.6 MILLION YEAR AGO.‍REVENUES, WHICH WERE COMPRISED MAINLY OF A RESEARCH TAX CREDIT, DECREASED TO EUR 1.9M IN H1 2017, COMPARED TO EUR 2.5M IN H1 2016​.END-H1 NET FINANCIAL POSITION EUR 16.1 MILLION VERSUS EUR 22.8 MILLION YEAR AGO.

Zai Lab Ltd American depositary shares open 34.7 pct above IPO price in debut

11:12am EDT

Sept 20 (Reuters) - :Zai Lab Ltd American depositary shares open at $24.25 in debut on the NASDAQ versus IPO price of $18.00 per ADS.

Celcuity shares open 30 pct over IPO price in debut

10:29am EDT

Sept 20 (Reuters) - :Celcuity shares open at $12.35 in debut on NASDAQ versus IPO price of $9.50 per share.

Zai Lab Limited prices 8.3 mln American depositary shares at $18.00/ADS​

9:52am EDT

Sept 20 (Reuters) - Zai Lab Limited::Zai lab limited announces pricing of U.S. initial public offering of ADSs.Announces pricing of U.S. initial public offering of American depositary shares 8.3 million ADSs sold in IPO at price of US$18.00 per ADS​.

Jaguar Health says FDA indicates co's Canalevia drug qualifies as “minor use” for exercise-induced diarrhea in dogs

9:00am EDT

Sept 20 (Reuters) - Jaguar Health Inc ::FDA indicates that jaguar’s Canalevia drug product candidate qualifies as “minor use” for Exercise-Induced Diarrhea (EID) in dogs, rendering Canalevia eligible for conditional approval for this indication.Jaguar Health Inc - expects to conduct commercial launch of Canalevia in first half of 2018 for EID and CID in dogs.

Protagonist Therapeutics announces preliminary phase 1 study results with PTG-300

8:00am EDT

Sept 20 (Reuters) - Protagonist Therapeutics Inc :Protagonist Therapeutics announces preliminary phase 1 study results with novel hepcidin mimetic, PTG-300.Protagonist Therapeutics Inc - ‍expect to report final top line results of amended PTG-300 study in Q4 of 2017​.Protagonist - ‍PTG-300 showed dose-dependent increase in blood exposure, was well tolerated, with no serious adverse events or dose-limiting toxicities​.

KemPharm files IND application for KP484 for the treatment of ADHD

7:30am EDT

Sept 20 (Reuters) - KemPharm Inc :KemPharm files IND for KP484 for the treatment of ADHD, an investigational prodrug of methylphenidate.KemPharm - ‍Kempharm's IND proposal is to develop KP484 along similar clinical trial pathway as KP415,with efficacy studies of KP484 initiating in 2018​.KemPharm Inc - ‍anticipates that data for KP484 will be leveraged from KP415 research, which could allow a potential NDA submission with FDA in 2019.

AVEO Oncology and EUSA Pharma announce TiNivo combination study opt-in

7:10am EDT

Sept 20 (Reuters) - Aveo Pharmaceuticals Inc :Aveo Pharmaceuticals Inc - ‍EUSA Pharma has agreed to pay AVEO up to $388 million in future milestone payments and research and development funding​.Aveo - ‍under terms of agreement, EUSA may utilize data from study for regulatory/commercial purposes in exchange for research and development funding payment of $2.0 million​.Aveo Pharmaceuticals Inc - ‍EUSA Pharma agreed to pay co milestone payments under terms of agreement from Dec 2015 ​.

Regenxbio announces completion of dosing of first cohort in Phase I clinical trial of RGX-314 gene therapy for wet AMD

7:00am EDT

Sept 20 (Reuters) - Regenxbio Inc ::Regenxbio announces completion of dosing of first cohort in Phase I clinical trial of RGX-314 gene therapy for wet AMD.Regenxbio Inc - ‍ plans to share an interim trial update for Phase I clinical trial of RGX-314 by end of 2017​.

Karyopharm reports positive data from ongoing cancer drug study

7:00am EDT

Sept 20 (Reuters) - Karyopharm Therapeutics Inc :Karyopharm announces successful outcome from phase 2 portion of phase 2/3 seal study evaluating selinexor in patients with previously treated advanced dedifferentiated liposarcoma.Karyopharm Therapeutics - ‍phase 3 portion of 2/3 seal​ study commenced; expanded to include North America, Europe, expected to enroll up to 222 patients.Karyopharm Therapeutics Inc - ‍top-line of data expected by end of 2019 for 2/3 seal study​.Karyopharm Therapeutics - ‍FDA has confirmed its acceptance of proposed phase 3 seal study design, including PFS primary endpoint.

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