Praxis Precision Medicines, Inc.
PRAX evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for PRAX—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · PRAX
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) disorders, with two NDAs accepted for FDA review and a pipeline of late-stage programs.
Key risk: No product revenue
BioSniper Score
Based on 6 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 10 clinical trials · 8 catalysts for Praxis Precision Medicines, Inc..
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) disorders, with two NDAs accepted for FDA review and a pipeline of late-stage programs.
- Cash and equivalents of $474.8M as of 2026-06-30 [sec].
- Net loss of $83.7M for the quarter ended 2026-06-30 [sec].
- Shareholders' equity of $404.2M as of 2026-06-30 [sec].
- NDAs for ulixacaltamide (essential tremor) and relutrigine (epilepsy) have been submitted and accepted for FDA review [sec_mda · as of 2026-08-06].
- Multiple Phase 3 topline readouts are expected through 2028, including for vormatrigine and elsunersen [upcoming catalysts].
What works
- Two product candidates (ulixacaltamide and relutrigine) have NDAs accepted for FDA review, indicating regulatory alignment and potential near-term commercialization [sec_mda · as of 2026-08-06].
- Strong cash position of $474.8M as of 2026-06-30 provides runway to support ongoing clinical programs and pre-commercial activities [sec].
- Pipeline includes multiple late-stage programs with topline data expected through 2028, offering diversification across CNS indications [upcoming catalysts].
What to weigh
- The company has incurred recurring operating losses since inception and has not generated any product revenue [sec_mda · as of 2026-02-19].
- Future profitability depends on successful development and commercialization of product candidates, which is uncertain [sec_mda · as of 2026-08-06].
- The company may need to raise additional capital through equity or debt, and failure to do so could delay or scale back development [sec_mda · as of 2026-08-06].
From the filings
Quoted directly from source documents.
NDAs for ulixacaltamide and relutrigine have been accepted for FDA review.
“prepare for the potential commercialization of ulixacaltamide, for which we have submitted an NDA to the FDA that has been accepted for review”
SEC MD&A · August 6, 2026
The company has incurred recurring operating losses since inception.
“We have incurred recurring operating losses since inception, including net los”
SEC MD&A · February 19, 2026
The company may need to raise additional capital and could face delays if unable.
“If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates”
SEC MD&A · August 6, 2026
Catalyst timeline
- 2026-12-27 · PDUFA · relutrigine — FDA decision on the NDA for relutrigine, a treatment for epilepsy.
- 2027-01-29 · PDUFA · ulixacaltamide hcl — FDA decision on the NDA for ulixacaltamide hcl, a treatment for essential tremor.
- 2027-03-01 · Phase3_Topline — Topline results from a Phase 2/3 trial exploring safety, tolerability, and efficacy of an undisclosed candidate.
- 2027-05-01 · Phase3_Topline · vormatrigine — Topline results from a Phase 3 trial of vormatrigine in adult epilepsy patients.
- 2027-11-01 · Phase3_Topline — Topline results from a Phase 3 placebo-controlled trial for an undisclosed candidate.
- 2028-07-01 · Phase3_Topline — Topline results from a decentralized Phase 3 trial with randomized withdrawal design.
- 2028-12-01 · Phase3_Topline — Topline results from a single-arm Phase 3 trial of elsunersen.
- 2028-12-31 · Phase3_Topline · vormatrigine — Topline results from an open-label extension trial of vormatrigine in adult epilepsy patients.
Risks & what to watch (4)›
Key risks
- No product revenue — The company has not generated any revenue from product sales and relies on financing to fund operations [sec_mda · as of 2026-02-19].
- Regulatory approval uncertainty — Approval of ulixacaltamide and relutrigine NDAs is not guaranteed; FDA may require additional data or deny approval [sec_mda · as of 2026-08-06].
- Capital needs — Future capital requirements may necessitate dilutive financing; failure to raise funds could delay programs [sec_mda · as of 2026-08-06].
- Clinical trial risks — Late-stage trials may fail to meet endpoints, impacting regulatory submissions and pipeline value [sec_mda · as of 2026-08-06].
What to watch
- PDUFA date for relutrigine on 2026-12-27 [upcoming catalysts].
- PDUFA date for ulixacaltamide hcl on 2027-01-29 [upcoming catalysts].
- Phase 3 topline data for vormatrigine in epilepsy expected by 2027-05-01 [upcoming catalysts].
- Phase 3 topline data for elsunersen expected by 2028-12-01 [upcoming catalysts].
Sources: SEC filings · SEC MD&A · Generated August 26, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
29.0 months
D/E 0.04 · 0% dilution
Lead: Phase 3
4 candidates
8 upcoming, next in ~119d
0 buys · 12 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
296
Total value held
$10.38B
| Holder | Shares | Value |
|---|---|---|
| perceptive advisors llc | 4,071,972 | $1.31B |
| janus henderson group plc | 3,543,810 | $1.14B |
| vanguard capital management llc | 2,443,888 | $787.4M |
| blackrock, inc. | 2,324,929 | $749.1M |
| fmr llc | 2,160,943 | $696.2M |
| baker bros. advisors lp | 1,753,198 | $564.9M |
| deerfield management company, l.p. | 963,351 | $310.4M |
| driehaus capital management llc | 949,225 | $305.8M |
| state street corp | 884,238 | $284.9M |
| morgan stanley | 833,491 | $268.5M |
Showing top 10 of 296 institutional holders of Praxis Precision Medicines, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 13.6%
- Days to cover
- 9.3
- Shares short
- 3,775,673
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
PRAX short interestGovernance
Frequently asked questions
What is the AI investment thesis for Praxis Precision Medicines, Inc.?
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) disorders, with two NDAs accepted for FDA review and a pipeline of late-stage programs.
What is Praxis Precision Medicines, Inc.'s lead drug candidate?
Praxis Precision Medicines, Inc.'s most advanced tracked candidate is Elsunersen (Phase 3) for Epileptic Encephalopathy.
What is Praxis Precision Medicines, Inc.'s next catalyst?
Praxis Precision Medicines, Inc.'s next tracked catalyst is a PDUFA event — "PDUFA Date: relutrigine" — expected December 27, 2026.
Who is the CEO of Praxis Precision Medicines, Inc.?
Mr. Marcio Silva De'Souza M.B.A. is the chief executive officer of Praxis Precision Medicines, Inc. (PRAX).
Where is Praxis Precision Medicines, Inc. headquartered?
Praxis Precision Medicines, Inc. (PRAX) is headquartered in Boston, MA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.