Abeona Therapeutics Shares Drop 13% After FDA Inspection of Cleveland Facility
By Chris Wack
Abeona Therapeutics shares were down 13% to $7.50 after the company said the U.S. Food and Drug Administration has completed a pre-license inspection of its Cleveland, Ohio, manufacturing facility.
The stock hit its 52-week high of $9.01 on March 6, and is up 208% in the past 12 months.
The company said the inspection was in relation to its Biologics License Application for pz-cel, or prademagene zamikeracel, for recessive dystrophic epidermolysis bullosa.
During the inspection, the FDA reviewed the facilities, systems, and processes at the Cleveland site. The FDA also observed the manufacturing process for pz-cel, as well as performance of in-process and release assays.
The two-week inspection ended March 1. Upon completion of the inspection, a Form 483 was issued with observations related to process controls.
On Friday, the company submitted a response to the FDA, outlining already implemented and ongoing steps toward resolution that follow FDA guidance provided during the audit. The FDA's review of Abeona's pz-cel BLA is ongoing, with a target Prescription Drug User Fee Act date of May 25. The FDA doesn't currently plan to conduct an Advisory Committee.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
March 18, 2024 10:39 ET (14:39 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
5 Undervalued Stocks to Buy to Play a Little Defense
-
Markets Brief: AI Leaders Excel In Earnings Season So Far
-
What History Tells Us About the Fed’s Next Move
-
What’s Happening In the Markets This Week
-
Alphabet’s New Dividend: What Investors Need to Know
-
Going Into Earnings, Is Palantir Stock a Buy, a Sell, or Fairly Valued?
-
Going Into Earnings, Is Eli Lilly Stock a Buy, a Sell, or Fairly Valued?
-
What’s the Difference Between the CPI and PCE Indexes?
-
After Earnings, Is GE Aerospace Stock a Buy, a Sell, or Fairly Valued?
-
3 Good Stocks to Buy with Your Tax Refund in 2024 (Or with Any Extra Money)
-
SoFi Earnings: Revenue Growth Slows on Lower Loan Growth and Higher Credit Costs
-
Tesla: Full Self-Driving Approval In China Supports Our View for Deliveries Growth In 2024
-
Philips Earnings: Firm Reaches $1.1 Billion Settlement Agreement
-
AbbVie Earnings: Next-Generation Immunology Drugs Help Offset Humira Biosimilar Pressure
-
Exxon Earnings: Ignore Earnings Shortfall as Long-Term Growth and Improvement on Track
-
American Airlines Earnings: We See Costs Overshadowing Market Share This Year