PRAX equity raise alongside Phase 3 ET win: 55% kept response
Praxis Precision Medicines launched a primary offering of common stock and is also offering pre-funded warrants, with an underwriters’ 30‑day option to buy additional shares. The pre-funded warrants carry a $0.0001 per‑share exercise price and are subject to ownership limits. Proceeds are earmarked for R&D, late‑stage commercialization preparation, earlier‑stage programs, working capital and general corporate purposes.
The company reported positive topline Phase 3 Essential3 results for ulixacaltamide in essential tremor. In Study 1, the primary endpoint showed a 4.3‑point mean improvement in mADL11 at Week 8 (p<0.0001), sustained through 12 weeks, with all key secondary endpoints statistically significant. In Study 2, 55% maintained response on ulixacaltamide vs 33% on placebo (p=0.0369; OR=2.7).
Safety was generally consistent with prior experience: most common adverse events included constipation, dizziness, euphoric mood, brain fog, headache, paraesthesia and insomnia; there were no deaths and no drug‑related serious adverse events. Praxis has submitted a pre‑NDA meeting request to the FDA and plans to submit the NDA by early 2026.
Positive
- Ulixacaltamide met Phase 3 endpoints in essential tremor: 4.3‑point mADL11 improvement at Week 8 (p<0.0001) and 55% vs 33% response maintenance (p=0.0369).
Negative
- None.
Insights
Positive Phase 3 in ET paired with an equity raise to fund next steps.
Praxis is conducting a primary offering of common stock and pre-funded warrants to fund R&D and potential commercialization. Concurrently, ulixacaltamide delivered positive Phase 3 results in essential tremor: Study 1 showed a 4.3‑point improvement in mADL11 at Week 8 (p<0.0001), sustained through 12 weeks, with key secondaries significant.
Study 2 supported durability: 55% maintained response on treatment vs
The company has requested a pre‑NDA meeting and plans an NDA submission by
Pre-Funded Warrants to Purchase up to Shares of Common Stock
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Total
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| Public offering price | | | | $ | | | | | $ | | | | | $ | | | |||
| Underwriting discounts and commissions(1) | | | | $ | | | | | $ | | | | | $ | | | |||
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Proceeds to Praxis Precision Medicines, Inc. before expenses
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TD Cowen
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Piper Sandler
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Guggenheim Securities
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Truist Securities
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ABOUT THIS PROSPECTUS SUPPLEMENT
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PROSPECTUS SUPPLEMENT SUMMARY
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THE OFFERING
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RISK FACTORS
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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USE OF PROCEEDS
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DIVIDEND POLICY
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DILUTION
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DESCRIPTION OF PRE-FUNDED WARRANTS
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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES
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UNDERWRITING
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LEGAL MATTERS
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EXPERTS
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WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
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ABOUT THIS PROSPECTUS
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
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THE COMPANY
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RISK FACTORS
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USE OF PROCEEDS
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DESCRIPTION OF CAPITAL STOCK
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DESCRIPTION OF DEBT SECURITIES
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DESCRIPTION OF OTHER SECURITIES
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GLOBAL SECURITIES
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PLAN OF DISTRIBUTION
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LEGAL MATTERS
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EXPERTS
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mITT population
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Ulixacaltamide
(n=199) |
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Placebo
(n=233) |
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p-value
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| Primary Endpoint | | | | | | | | | | | | | | | | | | | |
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Day 56 CFB mADL11
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| | | | -4.3 | | | | | | -1.7 | | | | | | <0.0001 | | |
| Key Secondary Endpoints | | | | | | | | | | | | | | | | | | | |
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Rate of Disease Improvement, Baseline to Day 56 mADL11
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| | | | -4.0 | | | | | | -1.7 | | | | | | <0.0001 | | |
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PGI-C Day 56
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| | | | 3.3 | | | | | | 3.9 | | | | | | <0.0001 | | |
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CGI-S CFB to Day 56
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| | | | -0.41 | | | | | | -0.12 | | | | | | 0.0007 | | |
| Select Sensitivity Analyses | | | | | | | | | | | | | | | | | | | |
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Imputation of missing data for primary analysis*
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| | | | -3.3 | | | | | | -1.6 | | | | | | 0.0026 | | |
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Day 84 CFB mADL11**
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| | | | -3.4 | | | | | | -1.9 | | | | | | 0.0049 | | |
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mITT population
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Ulixacaltamide
(n=40) |
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Placebo
(n=40) |
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p-value
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| Primary Endpoint | | | | | | | | | | | | | | | | | | | |
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Maintenance of Response
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| | | | 55% | | | | | | 33% | | | | | | 0.037 | | |
| Key Secondary Endpoints | | | | | | | | | | | | | | | | | | | |
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Rate of Disease Improvement, RW Baseline to Day 84
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| | | | 2.8 | | | | | | 5.2 | | | | | | 0.004 | | |
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PGI-C Day 84
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| | | | 3.24 | | | | | | 3.67 | | | | | | 0.087 | | |
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CGI-S Day 56 to Day 84
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| | | | 0.39 | | | | | | 0.73 | | | | | | 0.055 | | |
| Select Exploratory Endpoint | | | | | | | | | | | | | | | | | | | |
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PGI-S Day 56 to Day 84
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| | | | 0.24 | | | | | | 0.59 | | | | | | 0.027 | | |
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Study 1
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Study 2
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Category
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Ulixacaltamide
(n = 233) |
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Placebo
(n = 234) |
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Ulixacaltamide
(n = 231) |
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Participants with any TEAE
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221 (94.9%)
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177 (75.6%)
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209 (90.5%)
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Mild TEAEs
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98 (42.0%)
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89 (38.0%)
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87 (37.7%)
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Moderate TEAEs
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109 (46.8%)
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78 (33.3%)
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105 (45.5%)
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Severe TEAEs
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14 (6.0%)
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10 (4.3%)
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17 (7.4%)
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Participants with any SAE*
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2 (0.86%)
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8 (3.4%)
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4 (1.73%)
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Participants with drug-related TEAEs leading to discontinuation
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63 (27.0%)
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4 (1.7%)
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65 (28.1%)
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Discontinued from the study
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83 (35.6%)
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13 (5.6%)
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88 (38.1%)
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by us
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Public offering price per share
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Net tangible book value per share as of June 30, 2025
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| | | $ | 19.21 | | | | | | | | |
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Increase in as adjusted net tangible book value per share attributable to this
offering |
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As adjusted net tangible book value per share after this offering
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Dilution per share to new investors participating in this offering
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Underwriter
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Number of
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Number of
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TD Securities (USA) LLC
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Piper Sandler & Co.
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Guggenheim Securities, LLC
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Truist Securities, Inc.
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Total
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Total
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Per Share
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Per Pre-Funded
Warrant |
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Without Option
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With Option
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Public offering price
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Underwriting discounts and commissions
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Proceeds, before expenses, to Praxis Precision Medicines, Inc
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99 HIGH STREET, 30TH FLOOR
BOSTON, MASSACHUSETTS 02110
TELEPHONE: (617) 300-8460
Preferred Stock
Debt Securities
Warrants
Units
| |
ABOUT THIS PROSPECTUS
|
| | | | 1 | | |
| |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
| | | | 2 | | |
| |
WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
|
| | | | 4 | | |
| |
THE COMPANY
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| | | | 6 | | |
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RISK FACTORS
|
| | | | 7 | | |
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USE OF PROCEEDS
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| | | | 8 | | |
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DESCRIPTION OF CAPITAL STOCK
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| | | | 9 | | |
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DESCRIPTION OF DEBT SECURITIES
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| | | | 13 | | |
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DESCRIPTION OF OTHER SECURITIES
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| | | | 20 | | |
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GLOBAL SECURITIES
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| | | | 21 | | |
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PLAN OF DISTRIBUTION
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| | | | 25 | | |
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LEGAL MATTERS
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| | | | 26 | | |
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EXPERTS
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99 High Street, 30th Floor
Boston, MA 02110
(617) 300-8460
Pre-Funded Warrants to Purchase up to Shares of Common Stock
| |
TD Cowen
|
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Piper Sandler
|
| |
Guggenheim Securities
|
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Truist Securities
|
|
FAQ
What is Praxis (PRAX) offering in this 424B5?
Praxis is conducting a primary offering of common stock and is also offering pre-funded warrants to purchase shares of common stock, plus a 30‑day option for underwriters to buy additional shares.
Will Praxis receive proceeds from the pre-funded warrants?
Exercises are at
How will Praxis use the proceeds from this offering (PRAX)?
Praxis intends to fund R&D, commercialization preparation for late‑stage assets, earlier‑stage programs, working capital, and general corporate purposes.
What were the key Phase 3 results for ulixacaltamide in essential tremor?
Study 1: 4.3‑point mADL11 improvement at Week 8 (p<0.0001). Study 2: 55% maintained response vs 33% on placebo (p=0.0369; OR=2.7).
What safety outcomes were reported for ulixacaltamide?
Ulixacaltamide was generally well tolerated with no drug‑related serious adverse events and no deaths. Common events included dizziness and brain fog.
Are there ownership limits on the pre-funded warrants?
Yes. Exercise is limited to avoid beneficial ownership above
Is an NDA planned for ulixacaltamide?
Praxis has submitted a pre‑NDA meeting request to the FDA and plans to submit the NDA by