Praxis Precision Medicines, Inc. (PRAX) Praxis Precision Medicines, Inc. is a biopharmaceutical firm operating at the clinical stage, dedicated to creating innovative treatments for central nervous system (CNS) conditions that stem from an imbalance in neuronal activity. The company's primary investigational compounds currently undergoing evaluation include: PRAX-114, an extrasynaptic-preferring positive allosteric modulator of the GABAA receptor, which is currently in Phase IIa clinical trials for addressing both major depressive disorder and perimenopausal depression. Additionally, PRAX-944, a small molecule designed to selectively inhibit T-type calcium channels, is also progressing through Phase IIa clinical trials to manage essential tremor. Beyond these, Praxis is also advancing a pipeline of other promising drug candidates, such as: PRAX-562, a persistent sodium current blocker, undergoing Phase I clinical evaluation for treating severe pediatric epilepsy and adult cephalgia (headaches). PRAX-222, an antisense oligonucleotide (ASO) aimed at individuals suffering from gain-of-function (GOF) SCN2A epilepsy. And a program targeting KCNT1 for the treatment of KCNT1 GOF epilepsy. To further its research and development efforts, Praxis maintains several strategic alliances. These include a cooperation and licensing arrangement with RogCon Inc.; a licensing deal with Purdue Neuroscience Company; a comprehensive research collaboration, option, and license agreement with Ionis Pharmaceuticals, Inc.; and a collaborative project with The Florey Institute focused on the creation of three new antisense oligonucleotides (ASOs). Established in 2015, the company's headquarters are situated in Boston, Massachusetts.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Praxis Precision Medicines, Inc. NASDAQ:PRAX Healthcare · Biotechnology
Mkt Cap $7.98B
Vol 0
$ Vol 0
RVOL 0
Earnings 0
Press Release
Praxis Precision Medicines Announces Third Quarter 2026 Financial Results Date, Investor Day and November Conference Participation
Praxis Precision Medicines will report Q3 2026 financial results before market open on Monday, November 9, 2026.
The company also announced an Investor Day in New York on November 12 at 8:00 a.m. ET, covering commercial strategy and launch readiness for ulixacaltamide (Essential Tremor) and relutrigine (SCN2A/SCN8A DEE), both currently under FDA review.
Management will also participate in Guggenheim, UBS, and Jefferies healthcare conferences in November.
• 5d ago AI analysis › Press Release
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Praxis Precision Medicines granted inducement RSU awards covering an aggregate of 3,478 shares to fourteen new non-executive employees on October 1, 2026.
The grants were made under the 2024 Inducement Plan pursuant to Nasdaq Listing Rule 5635(c)(4) and will vest in four equal annual installments.
This is a routine equity compensation disclosure with no bearing on the company's clinical pipeline or financials.
• 0mo ago AI analysis › Press Release
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Praxis Precision Medicines granted restricted stock unit awards covering an aggregate of 11,535 shares to sixty-six new non-executive employees on September 1, 2026.
The awards were made under the company's 2024 Inducement Plan as employment inducements permitted by Nasdaq Listing Rule 5635(c)(4), and will vest in four equal annual installments subject to continued employment.
This is a routine compensation disclosure with no bearing on Praxis's clinical pipeline, which includes four late-stage CNS candidates across epilepsy and movement disorders.
• 1mo ago AI analysis › Press Release ● Major ⚠ 3
Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2026 Financial Results
Praxis reported positive regulatory progress on two late-stage assets, with FDA mid-cycle meetings identifying no major safety or efficacy concerns for both ulixacaltamide (PDUFA January 29, 2027) and relutrigine (PDUFA December 27, 2026).
FDA BIMO inspections for both programs completed successfully with no Form 483 observations, while the company received its third Breakthrough Therapy Designation for elsunersen in SCN2A DEE.
Cash and investments totaled $1.4 billion as of June 30, 2026, providing runway into 2028, following a $447.8 million increase primarily from the January 2026 follow-on offering.
Q2 net loss was $83.7 million with R&D expenses of $69.4 million, while launch preparations are accelerating for both ulixacaltamide and relutrigine with commercial infrastructure build-out underway.
• 2mo ago AI analysis › Press Release
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Praxis granted restricted stock units covering an aggregate of 7,318 shares to 29 new non-executive employees under its 2024 Inducement Plan.
The awards were approved by the Compensation Committee as an inducement material to the employees entering into employment, in accordance with Nasdaq Listing Rule 5635(c)(4).
The restricted stock units will vest in four equal annual installments, subject to continued employment on each vesting date.
• 2mo ago AI analysis › Press Release
Praxis Precision Medicines to Report Second Quarter 2026 Financial Results on Thursday, August 6, 2026
Praxis Precision Medicines announced it will report its second quarter 2026 financial results before the market opens on Thursday, August 6, 2026.
The company will host a conference call and live webcast at 8:30 am ET to review the quarterly results and provide a corporate update.
A replay of the webcast will be available on the Investors + Media section of the company's website for approximately 90 days.
• 3mo ago AI analysis › Press Release
Praxis Precision Medicines and Remagine Labs Announce Strategic Collaboration to Develop Transdermal Ulixacaltamide for Essential Tremor
Praxis Precision Medicines announced a strategic collaboration with Remagine Labs to develop a transdermal patch for its lead asset, ulixacaltamide, targeting essential tremor.
The partnership aims to expand the addressable market and extend the franchise value by offering a differentiated delivery option alongside the oral formulation currently under FDA review.
Praxis also made an equity investment in Remagine Labs to accelerate the collaboration, while the FDA PDUFA target action date for the oral NDA remains January 29, 2027.
• 3mo ago AI analysis › Press Release
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Praxis Precision Medicines granted restricted stock unit awards covering an aggregate of 951 shares of common stock to five new non-executive employees.
The grants were made by the Compensation Committee under the company's 2024 Inducement Plan as an inducement material to the employees entering into employment, pursuant to Nasdaq Listing Rule 5635(c)(4).
The restricted stock units will vest in four equal annual installments, subject to the employee's continued employment with Praxis on each vesting date.
• 4mo ago AI analysis › Press Release ● Major ⚠ 2
Praxis Precision Medicines Announces Extension Period for Relutrigine for Treatment of SCN2A and SCN8A Developmental and Epileptic Encephalopathies
The FDA extended the review period for Praxis Precision Medicines' New Drug Application (NDA) for relutrigine by three months, setting a new PDUFA target action date of December 27, 2026.
The extension follows the company's submission of additional sensitivity analyses classified as a major amendment, with no new clinical studies requested and no safety or manufacturing concerns cited.
Praxis remains confident in the strength of the application and continues to prepare for the commercial launch of relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies.
• 4mo ago AI analysis › Press Release ● Major
Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic Encephalopathy Caused by Gain of Function Variants
Praxis Precision Medicines secured FDA Breakthrough Therapy Designation for elsunersen (PRAX-222) for SCN2A-DEE, driven by topline data showing a 77% sham-adjusted reduction in monthly seizures in the Phase 1/2 EMBRAVE Part A study.
The designation enables a streamlined, single-arm design for the pivotal EMBRAVE3 study, which is enrolling approximately 30 patients to evaluate changes in countable motor seizures over 24 weeks.
Elsunersen now holds Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations from the FDA, as well as Orphan Drug and PRIME designations from the EMA.
• 4mo ago AI analysis › Press Release
Praxis Precision Medicines to Participate in Goldmans Sachs 47th Annual Global Healthcare Conference
Praxis Precision Medicines will present a corporate overview at the Goldman Sachs 47th Annual Global Healthcare Conference.
The presentation is scheduled for June 8, 2026, at 8:00 am ET in Miami, FL.
A live webcast and replay will be available on the company's website for approximately 180 days.
• 4mo ago AI analysis › Press Release
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Praxis Precision Medicines granted 2,754 restricted stock units to 13 new non-executive employees.
The awards were issued under the 2024 Inducement Plan as required by Nasdaq Listing Rule 5635(c)(4) for new hires.
The shares will vest in four equal annual installments, contingent on continued employment.
• 4mo ago AI analysis › Press Release ● Major ⚠ 3
Praxis Precision Medicines Provides Vormatrigine Program Update
Praxis Precision Medicines announced that its Phase 2/3 POWER1 study for vormatrigine failed to meet the primary endpoint of percent change in monthly seizure frequency.
The study did meet the secondary endpoint of a 50% response rate, with more pronounced seizure reduction observed on the higher 30 mg dose during the second half of the trial.
The company is pausing enrollment in the POWER2 study to reassess the program and determine potential modifications, while maintaining focus on upcoming launches for relutrigine and ulixacaltamide.
• 5mo ago AI analysis › Press Release ● Major
Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2026 Financial Results
Praxis announced FDA acceptance of NDAs for ulixacaltamide (Essential Tremor) and relutrigine (DEEs), with PDUFA target dates of January 2027 and September 2026, respectively.
Elsunersen demonstrated a 77% placebo-adjusted reduction in monthly seizures in the EMBRAVE Part A study, with topline POWER1 results for vormatrigine expected in Q2 2026.
The company reported $1.4 billion in cash and investments, extending its runway into 2028, while incurring a Q1 net loss of $92.6 million.
• 5mo ago AI analysis › Press Release
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Praxis Precision Medicines granted restricted stock unit awards covering an aggregate of 5,420 shares to twenty-one new non-executive employees on May 1, 2026.
The grants were made as an inducement material to the employees entering into employment with the company, pursuant to Nasdaq Listing Rule 5635(c)(4).
The RSUs will vest in four equal annual installments, subject to the employees' continued service with Praxis on each vesting date.
• 5mo ago AI analysis › Press Release
Praxis Precision Medicines to Report First Quarter 2026 Financial Results on Thursday, May 7, 2026, and Participate in Upcoming Investor Conference
Praxis Precision Medicines announced that it will report its first quarter 2026 financial results before the market opens on Thursday, May 7, 2026.
The company will host a conference call and live webcast at 8:30 am ET on May 7 to review the financial results and provide a corporate update.
Additionally, Praxis is scheduled to present at the Bank of America Securities Health Care Conference in Las Vegas on May 12, 2026.
• 5mo ago AI analysis › Press Release ● Major
Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor
globenewswire.com • 6mo ago Press Release
Praxis Precision Medicines Announces Positive Results from the EMBRAVE Part A Trial of Elsunersen in Patients with SCN2A Early-Onset Developmental and Epileptic Encephalopathy
globenewswire.com • 6mo ago Press Release ● Major
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
globenewswire.com • 6mo ago Press Release ● Major
Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs
globenewswire.com • 7mo ago Press Release ● Major
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
globenewswire.com • 7mo ago Press Release ● Major
Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial Results
globenewswire.com • 8mo ago Press Release ● Major
Praxis Precision Medicines to Report Fourth Quarter and Full Year 2025 Financial Results on Thursday, February 19, 2026, and Participate in Upcoming Investor Conferences
globenewswire.com • 8mo ago Press Release ● Major
Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
globenewswire.com • 8mo ago Press Release ● Major
SEQSTER Announces Expanded Partnership with Praxis Precision Medicines to Accelerate Clinical Trials in CNS Disorders
businesswire.com • 8mo ago 
