ADMA Biologics Shares Drop 7% After FDA Grants Approval for Aseptic Machine
September 08 2021 - 1:24PM
Dow Jones News
By Chris Wack
ADMA Biologics Inc. shares were down 7%, to $1.18, after the
company said the U.S. Food and Drug Administration has granted
approval for its in-house aseptic fill-finish machine, the VanRx
SA25.
Volume for the stock was 40.7 million shares at 1:50 p.m. ET,
compared with its 65-day average volume of 2.3 million shares. The
stock, which was up as much as 20% during premarket trading, hit
its 52-week low of $1.15 on Aug. 20.
The biopharmaceutical company said that with the VanRx
operational, it is anticipating meaningfully improved gross
margins, enhanced patient-supply consistency, accelerated
inventory-production-cycle times, and increased control and
visibility of commercial-product-lot releases, creating more
predictable near-term revenue results.
The VanRx fill-finish machine uses a closed isolator design,
allowing for the removal of human interventions and providing safe
drug products for patients. The VanRx machine has the capability of
rapidly switching between different container and closure formats,
enabling aseptic filling in a variety of different fill volumes and
presentation sizes.
ADMA said it would continue to work with its third-party
contract manufacturing organization fill-finish partner who will
continue to fill a portion of ADMA's production at their site. The
CMO's site would remain in ADMA's FDA-approved product Biologics
License Applications to provide the company with alternatives to
ensure continued supply-chain robustness.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 08, 2021 14:09 ET (18:09 GMT)
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