Welcome to the latest edition of our weekly EuroBiotech Report. We start this week in Denmark, where Lundbeck (CPH:LUN) was rocked by the FDA's decision to reject a filing to expand the label for its antidepressant Brintellix. With an advisory committee having voted in favor of the expansion earlier this year, investors were primed for the FDA to follow suit, resulting in Lundbeck's share price suffering its biggest fall in three years when the negative news emerged. Across the border in Germany, Boehringer Ingelheim took a punt on a Swiss biotech that thinks it can crack the peptide-based cancer vaccine conundrum. Immunocore enrolled the first patient in a dose-finding study, which is designed to set it up to get a pivotal trial underway by the end of the year. BioLineRx ($BLRX) saw its stock seesaw as investors digested the significance, or lack thereof, of a release regarding a Phase II trial. Israel talked up its ability to attract cannabis R&D dollars. And more. Nick Taylor (email | Twitter)
1. Lundbeck slides after FDA rejects label claim against AdComm recommendation
Lundbeck suffered the biggest drop in its share price in three years after FDA rejected its filing to expand the label for Brintellix. The decision, which followed a favorable vote by an advisory committee, puts a dent in Lundbeck's ambition to market its Brintellix as a treatment for certain aspects of cognitive dysfunction that affect people with major depressive disorder.
2. Boehringer's VC fund leads Series A investment in cancer vaccine startup
Boehringer Ingelheim Venture Fund has led a Series A investment intended to propel peptide-based cancer vaccine startup Amal Therapeutics toward clinical trials. The startup landed the investment on the strength of technology it thinks can address some of the historic failings of cancer vaccines.
3. Immunocore kicks off dose-finding ocular melanoma trial as pivotal study looms into view
Immunocore has enrolled the first participant in a dose-finding trial of its lead program IMCgp100 in the treatment of uveal melanoma. And, with the company aiming to identify the optimal dose in the next 6 to 8 months, it is now positioned to advance into a pivotal Phase II trial in the orphan indication by the end of the year.
4. Israel leverages relaxed regulations, scientific skills to lure cannabis R&D dollars
Israel is looking to lure cannabis R&D investment on the strength of its relatively relaxed research regulations and scientific experience in the field. The mix of characteristics has helped Israel pull in a reported $50 million (€44 million) from U.S. investors since 2014, a sum observers are tipping to grow to $100 million in the coming year.
5. BioLineRx jumps then slumps after investors dig into details of PhII trial
Shares in BioLineRx went on a brief roller-coaster ride following the release of Phase II data, popping by 16% in premarket trading before dropping a similar amount once the day began proper. The seesawing stock price was triggered by a press release about BioLineRx's Phase II acute myeloid leukemia study, in which the company called the trial a success but presented little data.
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