PRAXIS PRECISION MEDICINES, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) - Marketscreener.com

Item 7.01. Regulation FD Disclosure.

On November 28, 2022, Praxis Precision Medicines, Inc. (the "Company") updated its firm presumption for usage successful meetings with investors, analysts and others. The presumption is disposable successful the "Investors + Media" information of the Company's website astatine investors.praxismedicines.com and a transcript is furnished as Exhibit 99.1 to this Current Report connected Form 8-K.

The accusation successful this Current Report connected Form 8-K nether Item 7.01, including Exhibit 99.1 attached hereto, is intended to beryllium furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, arsenic amended (the "Exchange Act"), oregon different taxable to the liabilities of that section, nor shall it beryllium deemed incorporated by notation successful immoderate filing under the Securities Act of 1933, arsenic amended, oregon the Exchange Act, but as expressly acceptable distant by circumstantial notation successful specified filing.

Item 8.01. Other Events.

On November 28, 2022, the Company announced plans to initiate the PRAX-562 Phase 2 EMBOLD survey for the attraction of pediatric patients with developmental and epileptic encephalopathies ("DEEs"), pursuing U.S. Food and Drug Administration authorization to proceed with the survey arsenic projected by the Company, up to the planned maximum dose of 1.0 mg/kg/day. The EMBOLD Study is expected to initiate in the U.S successful the archetypal 4th of 2023, with 2 chiseled cohorts in early-onset SCN2A-DEE and SCN8A-DEE patients. Topline results for some cohorts are expected successful the 2nd fractional of 2023.

The EMBOLD survey is simply a randomized, double-blind, placebo-controlled Phase 2 clinical proceedings to measure the safety, tolerability, efficacy (motor seizure frequency) and pharmacokinetics of PRAX-562 successful pediatric participants aged 2 to 18 years with DEEs, followed by an open-label extension. Approximately 20 participants volition beryllium enrolled successful a full of 2 chiseled cohorts (n?10 for SCN2A-DEE and n?10 for SCN8A-DEE).

Forward-Looking Statements

This Current Report connected Form 8-K contains forward-looking statements wrong the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the PRAX-562 Phase 2 EMBOLD study. The forward-looking statements included successful this Current Report on Form 8-K are taxable to a fig of risks, uncertainties and assumptions, including, without limitation, uncertainties inherent successful objective trials, the expected timing of submission for regulatory support oregon reappraisal by governmental authorities and different risks arsenic described successful the Company's Quarterly Report on Form 10-Q for the 4th ended June 30, 2022 and its different filings with the Securities and Exchange Commission. These statements are based lone connected facts currently known by the Company and talk lone arsenic of the day of this Current Report connected Form 8-K. As a result, you are cautioned not to trust connected these forward-looking statements and the Company undertakes nary work to publicly update oregon revise immoderate forward-looking statement, whether arsenic a effect of new information, aboriginal developments oregon otherwise.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits Exhibit No. Description 99.1 Praxis Precision Medicines, Inc. November 2022 Corporate Presentation 104 Cover leafage from this Current Report connected Form 8-K, formatted successful Inline XBRL

--------------------------------------------------------------------------------

© Edgar Online, root Glimpses