Kaival Brands Shares Rise 25% on FDA Ruling for Bidi Vapor Products
October 27 2021 - 1:48PM
Dow Jones News
By Chris Wack
Kaival Brands Innovations Group Inc. shares were up 25% to $1.90
after the company said Bidi Vapor LLC, the manufacturer of the
premium BIDI Stick electronic nicotine delivery system, said the
U.S. Food and Drug Administration issued an administrative stay of
its marketing denial order for non-tobacco flavored BIDI
Sticks.
Kaival Brands is a global distributor of Bidi Vapor
products.
Volume for the stock was 87 million shares at 1:15 p.m. ET,
compared to its 65-day average volume of 3.3 million shares. The
stock has a public float of 7.8 million shares.
Kaival Brands share hit their 52-week low of $1.21 on Oct. 8,
and traded as high as $2.95 on Wednesday.
The hold will remain pending the FDA's review of the company's
request that the marketing denial order be rescinded based on
product-specific scientific evidence in its Premarket Tobacco
Product Applications.
The FDA confirmed that while it reviews Bidi Vapor's request,
its flavored BIDI Sticks can remain on the market without the
threat of enforcement.
Prior to the court-ordered Sept. 9, 2020, premarket tobacco
product application deadline, Bidi Vapor submitted premarket
tobacco product applications for all 11 flavor varieties of its
BIDI Stick, which is intended exclusively for adult cigarette
smokers and tobacco users, 21 and over. Despite submitting the
premarket tobacco product applications and keeping the FDA informed
about its ongoing clinical and behavioral studies, Bidi Vapor
received an MDO for its flavored BIDI Sticks, along with nearly all
other manufacturers of flavored ENDS, in early September 2021.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 27, 2021 13:33 ET (17:33 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.