aibioPraxis Precision Medicines PRAX offering news
Top story · Jul 2, 2026 · SEC filing 8-K
Praxis Precision Medicines changes its auditor
Dismissal of Independent Registered Public Accounting Firm On June 29, 2026, the Audit Committee of the Board of Directors (the "Audit Committee") of Praxis Precision Medicines, Inc.
- Ticker
- PRAX
- Listing
- NASDAQ, United States
- Next date
- Q4 2026
- Chief executive
- Marcio Souza
Desk view · Opinion · Updated Oct 22, 2026
Praxis faces two FDA decisions five weeks apart
Praxis has two applications under FDA review. It says its mid-cycle meetings found no major concerns and that no advisory committees are planned, and it held about $1.4 billion at June 30. The risk is concentrated in two FDA decisions about five weeks apart and in an epilepsy franchise in which vormatrigine, aimed at common adult epilepsies, missed its POWER1 primary endpoint in June. Praxis plans no regulatory updates until the PDUFA dates, so the FDA decisions are the next regulatory news, with the EMERALD topline due in the fourth quarter.
Read the full desk viewaibio.space Investor Rank · Opinion
7/10 Positive view
Two applications are under FDA review with no major concerns reported and cash into 2028, but the story is concentrated on two decisions and vormatrigine missed.
- Technology
- 2/2
- Odds
- 1/2
- Balance sheet
- 2/2
- Risk
- 1/2
- Momentum
- 1/2
Opinion only. The Investor Rank is aibio.space's opinion of the company's business position, drawn from the public sources on this page. It is not a recommendation to buy, sell or hold any security and it is not investment advice. It does not consider the share price, valuation or your circumstances, and it can change at any time. Payments from companies never affect it. How the rank works.
- Technology
- Praxis reports positive registrational results behind two applications now under FDA review, ulixacaltamide and relutrigine, while vormatrigine missed its POWER1 primary endpoint.
- Odds
- Favorable but binary. Praxis says mid-cycle meetings found no major concerns to date, BIO data put approval of filed drugs at 90.6%, and two decisions land about five weeks apart.
- Balance sheet
- Praxis says it is funded into 2028. About $1.4 billion at June 30 against a second-quarter net loss of $83.7 million.
- Main risk
- Event concentration. A complete response on either application would hit the story, and the relutrigine review has already been extended once.
- Watch next
- Dec. 27, 2026. FDA target action date for relutrigine, with the EMERALD topline due in the same quarter.
Top news on Praxis
- Financings
Praxis prices $575 million stock offering at $260 a share ahead of two NDA filings
Praxis Precision Medicines sold 2.2 million shares to fund launch plans for two Breakthrough-designated drugs. Net proceeds later came to $621.2 million.
Questions investors ask
What is aibio.space's Investor Rank for Praxis Precision Medicines?
7 out of 10, our positive view. Two applications are under FDA review with no major concerns reported and cash into 2028, but the story is concentrated on two decisions and vormatrigine missed. This is opinion only, not a recommendation to buy, sell or hold, and it does not consider the share price or valuation. Source
When will the FDA decide on Praxis's relutrigine application?
The FDA's target action date is Dec. 27, 2026. It was moved from Sept. 27 after the agency treated additional sensitivity analyses of existing data as a major amendment. Praxis said no new studies were requested. Source
When is the FDA decision on ulixacaltamide for essential tremor?
The target action date is Jan. 29, 2027. Praxis said after a mid-cycle meeting that the FDA identified no major safety or efficacy concerns to date and does not plan an advisory committee meeting. Source
What happened in Praxis's POWER1 trial?
POWER1, a phase 2/3 study of vormatrigine in focal onset seizures, missed its primary endpoint of change in monthly seizure frequency. It met the secondary 50% responder endpoint. Praxis paused POWER2 enrollment and now plans to restart it in Q4 2026. Source
How much cash does Praxis have?
Praxis reported about $1.4 billion in cash, cash equivalents and marketable securities at June 30, 2026. It says that funds operations into 2028. Its second-quarter net loss was $83.7 million. Source
What is elsunersen?
Elsunersen (PRAX-222) is an antisense oligonucleotide for seizures in SCN2A gain-of-function epilepsy. The FDA granted it Breakthrough Therapy Designation in June 2026. Its registrational EMBRAVE3 trial is expected to report in 2027. Source
What is the latest Praxis Precision Medicines (PRAX) stock news?
Our latest story on Praxis Precision Medicines, dated Jan 6, 2026: "Praxis prices $575 million stock offering at $260 a share ahead of two NDA filings". Praxis Precision Medicines sold 2.2 million shares to fund launch plans for two Breakthrough-designated drugs. Net proceeds later came to $621.2 million. Source
What is Praxis Precision Medicines's latest stock offering or financing news?
Our latest financing story, dated Jan 6, 2026: "Praxis prices $575 million stock offering at $260 a share ahead of two NDA filings". Praxis Precision Medicines sold 2.2 million shares to fund launch plans for two Breakthrough-designated drugs. Net proceeds later came to $621.2 million. Source
Who were the underwriters or placement agents on Praxis Precision Medicines's offering?
From our story: Piper Sandler, TD Cowen, Guggenheim Securities and Truist Securities were the joint book-running managers. Source
How long will Praxis Precision Medicines's cash last?
From our story of Jan 6, 2026: In its February year-end release, Praxis said its resources should fund operations into 2028. Source
How much cash does Praxis Precision Medicines have?
From our story of Jan 6, 2026: Praxis ended 2025 with $926.1 million in cash, cash equivalents and marketable securities, up from $469.5 million a year earlier, according to the same year-end filing. Source
What is Praxis Precision Medicines's market cap?
We do not publish live share prices. In its annual report, Praxis Precision Medicines, Inc. put the market value of shares held by non-affiliates (public float) at $883.2 million as of Jun 30, 2025. Source
Is Praxis Precision Medicines a smaller reporting company?
SEC records list Praxis Precision Medicines, Inc.'s filer category as: Large accelerated filer. Source
Where is Praxis Precision Medicines headquartered?
SEC records list its business address as 99 HIGH STREET, 30TH FLOOR, BOSTON, MA, 02110. Source
When does Praxis Precision Medicines's fiscal year end?
Praxis Precision Medicines, Inc.'s fiscal year ends on December 31, per SEC records. Source
Legal and investor matters
Part II, Item 1 of the 10-Q filed 2026-08-06 states that, as of the date of that report, the company is not party to any material legal matters or claims. Source
- Governance
Praxis replaces Ernst & Young with KPMG as auditor
On 2026-06-29 the audit committee dismissed Ernst & Young as Praxis's independent registered public accounting firm and engaged KPMG LLP the same day. EY's reports for 2025 and 2024 contained no adverse opinion or disclaimer. The company reported no disagreements or reportable events with EY through 2026-06-29. The 8-K was filed on 2026-07-02.
- Regulatory
FDA extends review of Praxis relutrigine NDA by three months
Praxis announced on 2026-06-29 that the FDA extended by three months the review of its NDA for relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies, moving the PDUFA date from 2026-09-27 to 2026-12-27. The extension followed submission of additional sensitivity analyses, which the FDA deemed a major amendment. The company said no new studies were requested and the FDA cited no safety or manufacturing concerns.
- Other
Praxis reports POWER1 vormatrigine study missed its primary measure
Praxis announced on 2026-06-01 results from the Phase 2/3 POWER1 study of vormatrigine in highly refractory focal onset seizures. The study did not meet its primary success measure, though the secondary 50% response rate measure was met. The company said it was pausing enrollment in the POWER2 study to reassess the vormatrigine program and determine potential modifications.
- Financing
Praxis sells 2.2 million shares at $260.00 in public offering
Praxis entered an underwriting agreement on 2026-01-06 for an underwritten offering of 2,212,000 shares at $260.00 per share, all sold by the company. On 2026-01-07 the underwriters exercised their option for 331,800 more shares in full. The company expected net proceeds of approximately $621.2 million including the option shares.
- Financing
Praxis prices offering of 3.0 million shares at $157.00 plus pre-funded warrants
Praxis entered an underwriting agreement on 2025-10-16 for 3,025,480 shares of common stock at $157.00 per share and pre-funded warrants for up to 318,470 shares. The underwriters exercised in full on 2025-10-17 their option for 501,592 additional shares. All securities were sold by the company, and the closing was expected on 2025-10-20.
Pipeline
| Program | Indication | Stage |
|---|---|---|
| Ulixacaltamide (T-type calcium channel inhibitor) | Essential tremor | NDA under review; FDA target action date Jan. 29, 2027; Breakthrough Therapy Designation (Dec. 2025); Praxis says the Praxis says the Praxis says the Praxis says the Praxis says the mid-cycle meeting found no major concerns to date to date to date to date to date Source |
| Relutrigine (sodium channel modulator) | SCN2A and SCN8A developmental and epileptic encephalopathies | NDA under priority review; FDA target action date Dec. 27, 2026 after a three-month extension Source |
| Relutrigine | Broad developmental and epileptic encephalopathies (EMERALD) | About 200 patients enrolled; topline expected in Q4 2026 Source |
| Vormatrigine (sodium channel modulator) | Focal onset seizures | Phase 2/3 POWER1 missed its primary endpoint (June 2026); POWER2 restart and POWER3 start planned for Q4 2026 Source |
| Elsunersen / PRAX-222 (antisense oligonucleotide) | SCN2A gain-of-function epilepsy | Breakthrough Therapy Designation (June 2026); registrational EMBRAVE3 topline expected 2027 Source |
Stock chart
SEC filings and registration
- SEC name
- Praxis Precision Medicines, Inc.
- CIK
- 1689548
- Industry (SIC)
- Pharmaceutical Preparations (2834)
- US tickers
- PRAX (Nasdaq)
- State or country of incorporation
- DE
- Fiscal year ends
- December 31
- Filer category
- Large accelerated filer
- Business address
- 99 HIGH STREET, 30TH FLOOR, BOSTON, MA, 02110
- Phone
- 617-300-8460
- Shares outstanding
- 27,919,988 as of 2026-07-31 (10-Q filed 2026-08-06)
Recent filings
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