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Acer Therapeutics Inc.

https://www.acertx.com/

Latest From Acer Therapeutics Inc.

Menopause Drug A Priority For Astellas

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.

FDA Drug Review

Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles

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.

Rare Diseases Complete Response Letters

Keeping Track: Longer US FDA Reviews For Tislelizumab, Toripalimab, Olipudase; Perrigo Wants OC To Go OTC

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

US FDA Performance Tracker Approvals

Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles

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.

Rare Diseases Complete Response Letters
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  • Other Names / Subsidiaries
    • Opexa Therapeutics, Inc.
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