Published on 18 Oct 2023 on Zacks via Yahoo Finance
It was a busy week for the biotech sector before the third-quarter earnings kicked in. While nothing important came from bigwigs, pipeline and regulatory updates from quite a few other biotechs were in focus.
Recap of the Week’s Most Important Stories:
Aldeyra Plummets on Setback: Shares of Aldeyra Therapeutics, Inc. ALDX plummeted after the company received a setback in its new drug application (NDA) for reproxalap for the treatment of the signs and symptoms of dry eye disease. Aldeyrat received minutes from a late-cycle review meeting with the FDA, which identified substantive review issues in connection with the NDA for reproxalap. In the meeting, the regulatory body stated that the NDA lacks data to support reproxalap’s efficacy for the sought indication. The FDA has also requested certain chemistry, manufacturing and controls (CMC) details.