Praxis Precision Medicines, Inc. Stock Price, News & Analysis

Praxis Precision Medicines (NASDAQ: PRAX) announced a proposed public offering of common stock and, for certain investors, pre-funded warrants. All securities will be offered by Praxis, with underwriters granted a 30-day option to buy additional shares up to 15% of the shares sold. The offering is subject to market and customary closing conditions and may not be completed.

The offering is being made under a shelf registration on Form S-3ASR that automatically became effective on Dec 23, 2024. Final terms will be disclosed in a prospectus supplement to be filed with the SEC.

Praxis Precision Medicines (NASDAQ: PRAX) announced the FDA has granted Breakthrough Therapy Designation (BTD) for ulixacaltamide HCl for treatment of essential tremor (ET), based on positive topline results from the Essential3 Phase 3 program.

The company completed a pre-NDA meeting with the FDA in December 2025, received written feedback and an in-person meeting, aligned on NDA content, and expects to submit the ulixacaltamide NDA in early 2026. The BTD enables expedited development and regulatory review but is not an approval.

Praxis Precision Medicines (NASDAQ: PRAX) announced that following a planned discussion with the FDA on Dec 11, 2025, the agency confirmed the company may file a New Drug Application (NDA) for relutrigine in early 2026 for SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The company said EMBOLD study data will serve as the basis for efficacy and safety, and described EMBOLD results as statistically significant and clinically meaningful improvements. Management characterized the FDA interaction as collaborative and supportive of the planned NDA timeline.

Praxis Precision Medicines (NASDAQ: PRAX) announced FDA alignment to convert the EMBRAVE3 registrational study of elsunersen in early-onset SCN2A developmental and epileptic encephalopathy to a single-arm, baseline-controlled design.

Key changes: enrollment target reduced to 30 patients from 40, all screening patients will receive elsunersen for 24 weeks then enter an open-label extension, and the primary endpoint is change from baseline in countable motor seizures. Enrollment is accelerating and topline results are expected in 2026; EMBRAVE Part A (n=9) topline readout is expected in 1H 2026.

Praxis (NASDAQ: PRAX) reported clinical updates presented at AES on December 6, 2025, covering relutrigine (EMBOLD) and vormatrigine (RADIANT).

EMBOLD: relutrigine (n=51) produced a 53% placebo‑adjusted seizure reduction over 16 weeks (p<0.0002), a 66% increase in motor seizure‑free days (p=0.034), broad functional improvements, and no drug‑related serious adverse events; Praxis will meet the FDA to discuss an NDA and then decide filing timing.

RADIANT: vormatrigine (FOS n=62) delivered a 54% median seizure reduction at 8 weeks, 58% ≥50% responders in week 1 rising to 61% by week 8, with 100% median weekly seizure reduction by week 8 maintained to 16 weeks; generalized epilepsy cohort (n=3) showed similar effects. POWER1 recruiting complete; POWER2 on track to finish H2 2026; POWER3 monotherapy to start H1 2026.

Praxis Precision Medicines (NASDAQ: PRAX) announced positive topline results from the registrational cohort of the EMBOLD study evaluating relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).

A Data Monitoring Committee recommended an early stop for efficacy. Praxis will present topline results at the American Epilepsy Society Annual Meeting on December 6, 2025 and has a confirmed meeting with the FDA to review the data and discuss next steps; the company will decide on NDA timing after that meeting.

Praxis Precision Medicines (NASDAQ: PRAX) completed a pre-NDA meeting with the FDA for ulixacaltamide in essential tremor and received written feedback plus an in-person discussion. The company said it gained alignment with the agency on NDA content and expects to submit the NDA in early 2026. Praxis highlighted momentum from the positive Essential3 program, where ulixacaltamide showed statistically significant, clinically meaningful improvements in daily functioning. Management framed the FDA feedback as advancing the program toward a potential new treatment for millions living with essential tremor.

Praxis Precision Medicines (Nasdaq: PRAX) announced on Dec 1, 2025 that its Compensation Committee granted restricted stock unit awards covering 3,594 shares to six new non-executive employees under the 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

The awards were issued as inducements material to the employees joining Praxis and will vest in four equal annual installments, subject to continued employment on each vesting date. The 2024 Inducement Plan is limited to equity awards for individuals not previously employed by Praxis or returning after a bona fide break in service.

Praxis Precision Medicines (NASDAQ: PRAX) will present new preclinical and clinical data across its precision epilepsy portfolio at the American Epilepsy Society Annual Meeting, Dec 5–9, 2025 in Atlanta.

Praxis will host a scientific exhibit and booth #217, and deliver multiple poster and late-breaking presentations including full RADIANT results showing vormatrigine seizure reductions, EMBOLD OLE relutrigine data, PAC-DEE preclinical framework updates, antisense oligonucleotide emergency use cases for SCN2A DEE, and DDI and preclinical findings across programs.