VivaGel® BV phase 3 trials for prevention of BV completed
Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced completion of its international, multicentre, phase 3 clinical studies evaluating VivaGel® BV for the prevention of recurrent bacterial vaginosis (rBV). Starpharma expects topline results of the trials to be available in the second quarter of 2017.
Interim Report and Half-Yearly Financial Results
Starpharma released its interim report and financial results for the half-year ended 31 December 2016.
Financial Summary
- Reported loss of $9.0M (Dec 2015: $10.0M)
- R&D tax incentives of $1.7M reported in the half-year (Dec 2015: $1.8M)
- Cash position at 31 December 2016 of $36.3M (June 2016: $46.0M)
- Receipt of $3.5M R&D tax incentive refund from FY16
Appendix 4C - Quarterly Cashflow Report
Starpharma released its Appendix 4C – Quarterly Cashflow report for the period ended 31 December 2016.
Shareholder Update January 2017
In this issue:
›› Enrolment completed for phase 3 program: VivaGel® BV for prevention of recurrence
›› VivaGel® BV granted QIDP and Fast Track designation by US FDA
›› Favourable revision to FDA guidance for BV Treatment
›› VivaGel® condom approved in Canada; licensed in China and Iran
›› New DEP® partnered programs with AstraZeneca and world leading antibody-drug conjugate companies
›› DEP® docetaxel phase 1 program in final expansion phase; preparations underway for phase 2
›› DEP® cabazitaxel shows no neutropenia
›› DEP® irinotecan internal program shows superior performance
Download: Shareholder January 2017 (pdf file, 751kb)
Starpharma VivaGel® BV gets FDA fast track
The Australian reports that Bell Potter sees further upside for Starpharma, setting its share price target at $1.05, given the company had been granted Qualified Infectious Disease Product (QIDP) and fast track designation for VivaGel® BV by the US Food and Drug Administration.
VivaGel® BV granted QIDP and Fast Track designation by US FDA
Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced it has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel® BV by the US Food and Drug Administration (FDA).
Starpharma receives $3.5M R&D tax incentive refund
Starpharma Holdings Ltd today announced it has received the anticipated $3.5M of R&D tax incentive refund related to FY16 expenditures.
AGM Chairman’s address and CEO presentation
Chairman’s address and the CEO’s presentation to the 2016 Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY).
Starpharma signs license for VivaGel® Condom in Iran
Starpharma Holdings Ltd today announced the signing of a License and Supply Agreement with Koushan Pharmed for the sales and marketing rights to the VivaGel® condom in Iran.
Starpharma to present at Bio-Europe conference
Starpharma will be presenting at the Bio-Europe® conference held in Cologne, Germany this week. At the conference Starpharma will also be conducting licensing discussions for DEP™ and VivaGel® with pharmaceutical companies.