The Japanese group has used a priority review voucher for fezolinetant to move further ahead of Bayer’s elinzanetant as it seeks regulatory approval to bring a non-hormonal therapy for menopausal symptoms such as hot flashes and night sweats to market.

Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.

Private Company Edition: The amount of venture capital raised by biopharma firms fell but individual companies grabbed a lot of cash, making for a remarkable Q2 relative to pre-pandemic times. Recent Q3 rounds includes Frontera’s $160m series B. Also, Oxford Science Enterprises added €250m to its fund.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker