Praxis Precision Medicines Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events
$PRAX
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 17, 2025
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
Praxis Precision Medicines, Inc.
(Address of principal executive offices, including zip code)
(617 ) 300-8460
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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Item 7.01. Regulation FD Disclosure.
As previously disclosed, Praxis Precision Medicines, Inc. (the “Company”) anticipates reporting topline results from the RADIANT Phase 2 study by mid-year 2025. In advance of this announcement, the Company has commenced an investor quiet period, which is expected to remain in effect for up to three weeks.
Item 8.01. Other Events.
On July 17, 2025, the Company announced that the U.S. Food and Drug Administration has granted breakthrough therapy designation (the “BTD”) for relutrigine, a sodium channel functional state modulator for pediatric use for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (“DEEs”). The BTD enables expedited development and regulatory review for drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that relutrigine may demonstrate substantial improvement on a clinically significant endpoint(s) over existing therapies. The BTD for relutrigine was supported by the positive data from cohort 1 in the Phase 2 EMBOLD study, as well as 11-month data from the open-label extension period of the trial.
The Company also announced that it has initiated the EMERALD study evaluating relutrigine in patients across all DEEs.
Forward-Looking Statements
This Current Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the clinical development of its product candidates. The forward-looking statements included in this Current Report are subject to a number of risks, uncertainties and assumptions, including, without limitation, uncertainties inherent in clinical trials, the expected timing of submission for regulatory approval or review by governmental authorities and other risks as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the Securities and Exchange Commission. These statements are based only on facts currently known by the Company and speak only as of the date of this Current Report. As a result, you are cautioned not to rely on these forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
SIGNATURE
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.
| PRAXIS PRECISION MEDICINES, INC. | |||||||||||
| Date: July 17, 2025 | By: | /s/ Marcio Souza | |||||||||
| Marcio Souza | |||||||||||
| Chief Executive Officer | |||||||||||