SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) January 28, 2021
BioXcel Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of
|(Commission File Number)||(IRS Employer|
555 Long Wharf Drive
New Haven, CT 06511
(Address of principal executive offices, including Zip Code)
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.001||BTAI||The Nasdaq Capital Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
|Item 7.01||Regulation FD Disclosure.|
On January 28, 2021, BioXcel Therapeutics, Inc. (the “Company”) announced that it had received notice that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation for the Company’s product candidate, BXCL701, previously studied as Talabostat, for the treatment of soft tissue sarcoma. Under the Orphan Drug Act, the FDA may grant orphan drug designation upon request by a sponsor to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation, however, does not convey any advantage in or shorten the duration of the regulatory review and approval process. Once granted, orphan drug designation qualifies the sponsor for various incentives, including potential tax credits, a reduction in certain regulatory fees, and eligibility for a seven-year exclusive marketing period for that drug and use upon marketing approval.
The information in this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: January 28, 2021||BIOXCEL THERAPEUTICS, INC.|
|/s/ Richard Steinhart|
|Chief Financial Officer|