Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year. 

MoonLake of Switzerland is heading to the NASDAQ armed with $230m to take its tri-specific IL17A/IL-17F nanobody sonelokimab, acquired from Merck KGaA, into the highly competitive spaces of psoriatic arthritis, ankylosing spondylitis and hidradenitis suppurativa.

While Amicus will transfer the gene therapy portfolio’s R&D risk to Caritas, it retains a financial interest in many of the spinout’s programs. Pompe candidate AT-GAA accepted for FDA review.

Teva has dismissed its suit against Amicus Therapeutics after the latter agreed to provide requested quantities of its Fabry disease treatment Galafold. The quick resolution of the complaint illustrates the success of the CREATES Act in halting the drug supply dispute but leaves some unanswered questions.