DUBLIN – Gesynta Pharma AB raised SEK190 million (US$20.6 million) in new funding to move GS-248, a selective inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), into a phase IIa trial in systemic sclerosis. The study is due to get underway toward the year end. “It’s going to be in the second half of the fourth quarter,” said Patric Stenberg, CEO of Lund, Sweden-based Gesynta.
DUBLIN – Osivax SAS has assembled a public funding package of more than €32 million (US$36.3 million) to pursue ongoing clinical development of its universal flu vaccine and to take forward a coronavirus vaccine program based on a similar approach, involving vaccine-like particle (VLP) technology.
DUBLIN – Idorsia Ltd. plans to file an NDA before the year-end for its insomnia drug, daridorexant, following a read-out of top-line data from a second phase III study, which the company said closely tracked an earlier phase III study, although it failed to meet one of two primary endpoints with statistical significance.
DUBLIN – Even by any normal measure of European biotechnology investment, the first two quarters of 2020 were memorable. If it maintains the present momentum, Europe’s drug development sector is on course for a record-breaking year, having already raised $5.034 billion in publicly disclosed equity investments. That puts it well ahead of any other year – the sector edged to a new high in 2019 when it raised $7.739 billion over the full 12 months – but, of course, comparisons with any other year seem irrelevant. This year is like no other. The COVID-19 pandemic has changed everything.
DUBLIN – Gene therapy developer Freeline Therapeutics Ltd. added $80 million in new investment to take its series C round to $120 million in total. The new cash will help to fund a pivotal trial of its lead gene therapy program in hemophilia B, enable it to continue a phase I/II trial of a gene therapy in Fabry disease and allow it to progress its preclinical programs in Gaucher disease and hemophilia A, while also making ongoing investments in its adeno-associated virus (AAV) gene therapy technology and its manufacturing platform.
DUBLIN – Emer Cooke, named this week as the next executive director of the EMA, is the first woman to lead the organization since its creation in 1994. She is due to take up the post in November, but her appointment must first be ratified by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). She is due to present a statement to the group on July 13.
DUBLIN – Biogeneration Ventures (BGV) raised €105 million (US$118.7 million) for its fourth fund, further brightening the prospects for early stage investing in European biotech. The fund’s closing immediately follows that of Epidarex Capital, which earlier this week announced it had raised £102.1 million (US$126.3 million) for its third fund.
DUBLIN – Translate Bio Inc. is the first beneficiary to gain from Sanofi SA’s massive $11.7 billion addition to its balance sheet, following its recent disposal of its holdings in long-time partner Regeneron Pharmaceuticals Inc. Lexington, Mass.-based Translate Bio is getting $300 million up front, another $125 million in equity investment and up to $1.9 billion in milestones under a major expansion of an existing agreement with Paris-based Sanofi to develop mRNA-based vaccines for infectious disease.
DUBLIN – Top-line data from a phase II pivotal trial of CP-101, Finch Therapeutics Group Inc.’s oral microbiome therapy for chronic Clostridioides difficile infection (CDI), are technically good, but how good is the big question.