DUBLIN – Seventure Partners has raised more than half of its target of over €200 million (US$226.6 million) for its second microbiome-focused venture capital fund, Health for Life Capital II, and aims to reach a final close before the summer.
DUBLIN – Nightstar Therapeutics plc is the latest contender to join the gene therapy tango, as Biogen Inc. stepped up with a $25.50 per-share bid that values the company at $877 million, or $800 million minus transaction expenses and anticipated cash at closing.
DUBLIN – The EMA closed the doors on its London office for the last time on Friday, bringing to an end a 24-year history during which drug regulation in Europe evolved from a set of stand-alone, national competencies to a seamless shared endeavor across the European Union's member states.
DUBLIN – The concept of harnessing interleukin-2 (IL-2) signaling to boost immune responses to cancer is almost as old as the biotechnology industry. Up until now, however, the idea has only been imperfectly realized because of the limitations of using recombinant IL-2.
DUBLIN – Ipsen SA is putting down $25 per share, or $1.04 billion in cash, to acquire Clementia Pharmaceuticals Inc. and is on the hook for a contingent value right (CVR) worth another $6 per share, or $263 million, which is tied to FDA acceptance of Clementia's NDA for its lead drug, palovarotene, in multiple osteochondromas (MO).
DUBLIN – Interleukin-15 (IL-15) inhibition is back on the menu. Calypso Biotech BV closed a €20 million (US$22.7 million) series A round to take what it claims is a best-in-class IL-15 antagonist, CALY-002, into clinical development for autoimmune disease.
DUBLIN – Pfizer Inc.'s and Eli Lilly and Co.'s venerable antibody, tanezumab, a longtime clinical candidate for various pain indications, is lumbering toward the finish line. The two partners reported a second positive phase III readout inside a month. This time around, it's in patients with chronic lower back pain. The higher dose of the drug (10 mg) used in the study attained the primary endpoint of a statistically significant improvement in pain at 16 weeks, as compared with placebo. A lower dose (5 mg) did not attain statistical significance at the same time point.
DUBLIN – Motif Bio plc's stock collapsed during early trading in London Tuesday on news that the FDA issued a complete response letter (CRL) requesting more liver toxicity data in its NDA for iclaprim, an antibiotic in development to treat acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive pathogens. Shares in the company (LONDON:MTFB; NASDAQ:MTFB) fell by as much as 88 percent during early trading on AIM before ending the day at 10.8 pence (US$0.14), down 73 percent. The stock's ADRs took a similar tumble on Wall Street (NASDAQ:MTFB), where they closed at $2.72.
DUBLIN – Finnish-Swiss firm Aurealis Pharma AG is spinning out its lead asset, AUP-16, a genetically engineered bacterial species in development for diabetic foot ulcer, into a new company, Aurealis Therapeutics AG, which has raised CHF7.8 million (US$7.8 million) in new cash to finance an upcoming phase I/IIa trial of the three-in-one combination therapy.
DUBLIN – The mood music coming out of Uniqure NV's phase IIb trial for its hemophilia B gene therapy, AMT-061, remains positive. A second interim readout last week, after an initial peek at the data sparked a share-buying frenzy last November, showed continued improvement in levels of factor IX (FIX) expression in two of the three patients enrolled in the study. The third patient has plateaued but has maintained his response to the therapy, which comprises an adeno-associated virus 5 (AAV5) vector encoding the highly active Padua variant of FIX.
