tiprankstipranks
Praxis Precision Medicines (PRAX)
NASDAQ:PRAX
US Market
Want to see PRAX full AI Analyst Report?

Praxis Precision Medicines (PRAX) AI Stock Analysis

1,048 Followers

Top Page

PRAX

Praxis Precision Medicines

(NASDAQ:PRAX)

Select Model
Select Model
Select Model
Neutral 69 (OpenAI - 5.2)
Rating:69Neutral
Price Target:
$405.00
▲(24.50% Upside)
Action:Reiterated
Date:08/07/26
Overall score is driven primarily by strong earnings-call/regulatory momentum (late-stage NDAs with positive FDA feedback, clean inspection, and substantial cash runway) and supportive technical strength (price well above key moving averages with positive MACD). These positives are tempered by weak current financial performance (no TTM revenue, large losses and free-cash-flow burn) and limited valuation support due to negative earnings and no dividend yield.
Positive Factors
Late-stage regulatory progress
Favorable FDA feedback on two late-stage applications materially reduces regulatory uncertainty and supports potential transition from clinical development to commercial operations, while the absence of advisory committees may simplify the approval process.
Negative Factors
No durable revenue base
Praxis remains dependent on successful regulatory approvals and future commercialization because it currently lacks recurring product revenue. Large operating losses limit internal funding capacity and leave results highly exposed to development and launch execution.
Read all positive and negative factors
Positive Factors
Negative Factors
Late-stage regulatory progress
Favorable FDA feedback on two late-stage applications materially reduces regulatory uncertainty and supports potential transition from clinical development to commercial operations, while the absence of advisory committees may simplify the approval process.
Read all positive factors

Praxis Precision Medicines (PRAX) vs. SPDR S&P 500 ETF (SPY)

Praxis Precision Medicines Business Overview & Revenue Model

Company Description
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 p...
How the Company Makes Money
null...

Praxis Precision Medicines Earnings Call Summary

Earnings Call Date:Aug 06, 2026
(Q2-2026)
|
% Change Since: |
Next Earnings Date:Nov 11, 2026
Earnings Call Sentiment Positive
The call showed strong positive momentum: two late-stage NDAs with favorable FDA mid-cycle feedback and no advisory committees, a clean FDA BIMO inspection, solid commercial build and a robust cash position providing runway into 2028. Clinical progress was highlighted by EMERALD over-enrollment and another BTD for elsunersen. Offsetting risks include a failed primary in vormatrigine (being addressed by redesign), higher near-term operating spend and a relutrigine review extension. On balance, the significant regulatory, commercial and financial positives outweigh the operational and clinical setbacks.
Positive Updates
Two NDAs in Late-Stage FDA Review with Positive Mid-Cycle Feedback
Ulixacaltamide (essential tremor) and relutrigine (SCN2A/SCN8A) NDAs are in late-stage review; FDA mid-cycle communications were positive for both, the agency identified no efficacy-related significant issues and does not plan to hold advisory committee meetings for either application. Relutrigine PDUFA target date set for December 27, 2026; ulixacaltamide approval expected around January 2027.
Negative Updates
Vormatrigine POWER1 Primary Endpoint Miss
POWER1 failed to meet its primary endpoint (reduction in monthly focal seizure frequency from baseline to week 12). Management attributes the miss to dose, duration and study design issues (e.g., six-week exposure at dose), not lack of drug activity, and will amend POWER2 and POWER3 with plans to restart by Q4 2026 — implying additional time, operational complexity and cost.
Read all updates
Q2-2026 Updates
Negative
Two NDAs in Late-Stage FDA Review with Positive Mid-Cycle Feedback
Ulixacaltamide (essential tremor) and relutrigine (SCN2A/SCN8A) NDAs are in late-stage review; FDA mid-cycle communications were positive for both, the agency identified no efficacy-related significant issues and does not plan to hold advisory committee meetings for either application. Relutrigine PDUFA target date set for December 27, 2026; ulixacaltamide approval expected around January 2027.
Read all positive updates
Company Guidance
On the Aug 6, 2026 call Praxis gave clear near‑term regulatory and commercial guidance: two NDAs are in late‑stage review with approvals expected in ~six months (ulixacaltamide ~Jan 2027; relutrigine PDUFA now Dec 27, 2026), the FDA completed mid‑cycle reviews with no efficacy issues or planned advisory committees and a BIMO inspection closed with no findings (no Form 483). Key clinical metrics: EMERALD exceeded its target with ~200 patients across >50 genetic etiologies (median baseline countable seizures >50/28 days); POWER1 (vormatrigine) missed its primary endpoint but met a key secondary (significantly more patients achieving ≥50% seizure reduction) and POWER2/POWER3 will be amended and restarted by Q4 2026; elsunersen received Breakthrough Therapy Designation in June and EMBRAVE3 topline is expected next year. Commercial and financial guidance: commercial leadership is in place, inventory and distribution are being built, a ulixacaltamide field force ~300 will target ~13,000–15,000 accounts addressing a launch population ~2M (total ET prevalence >7M), pricing planning in the $50k–$100k/year range, Q2 OpEx was $96.9M (R&D $69.4M; G&A $27.5M), operating cash used $78M (vs $55M in Q2 2025), ending cash/marketable securities $1.4B (vs $926M at 12/31/2025) supporting a runway into 2028; relutrigine and elsunersen remain eligible for pediatric/orphan PRVs.

Praxis Precision Medicines Financial Statement Overview

Summary
Mixed fundamentals typical of a late-stage biotech: a very strong, lightly levered balance sheet (debt ~$1.1M vs equity ~$1.34B) supports operations, but profitability and cash generation remain weak with $0 TTM revenue, large operating losses (EBIT ~-$378M), and sizable negative free cash flow (~-$306M), implying continued dependence on funding until commercialization.
Income Statement
18
Very Negative
Balance Sheet
82
Very Positive
Cash Flow
27
Negative
BreakdownTTMDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue0.000.008.55M2.45M0.000.00
Gross Profit-143.34M-140.00K-143.86M-84.32M-154.44M0.00
EBITDA-339.01M-303.13M-182.46M-122.84M-213.57M-166.88M
Net Income-339.13M-303.27M-182.82M-123.28M-214.03M-167.06M
Balance Sheet
Total Assets1.39B937.91M483.11M87.95M115.13M292.75M
Cash, Cash Equivalents and Short-Term Investments758.55M599.33M392.57M81.30M100.49M275.91M
Total Debt1.09M110.00K1.37M2.50M3.50M4.31M
Total Liabilities49.06M59.77M37.66M18.28M39.02M41.94M
Stockholders Equity1.34B878.14M445.45M69.67M76.11M250.81M
Cash Flow
Free Cash Flow-306.00M-249.12M-131.76M-111.19M-185.49M-125.60M
Operating Cash Flow-305.69M-249.07M-131.76M-111.14M-185.04M-124.55M
Investing Cash Flow-611.27M-311.15M-248.49M38.95M96.89M-140.52M
Financing Cash Flow1.23B702.17M514.32M91.87M10.46M107.59M

Praxis Precision Medicines Technical Analysis

Technical Analysis Sentiment
Positive
Last Price325.30
Price Trends
50DMA
330.60
Positive
100DMA
324.59
Positive
200DMA
301.81
Positive
Market Momentum
MACD
14.39
Positive
RSI
59.31
Neutral
STOCH
42.65
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PRAX, the sentiment is Positive. The current price of 325.3 is below the 20-day moving average (MA) of 356.35, below the 50-day MA of 330.60, and above the 200-day MA of 301.81, indicating a bullish trend. The MACD of 14.39 indicates Positive momentum. The RSI at 59.31 is Neutral, neither overbought nor oversold. The STOCH value of 42.65 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for PRAX.

Praxis Precision Medicines Risk Analysis

Praxis Precision Medicines disclosed 1 risk factors in its most recent earnings report. Praxis Precision Medicines reported the most risks in the "Legal & Regulatory" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Praxis Precision Medicines Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
69
Neutral
$10.28B-29.14-34.15%-100.00%-5.32%
65
Neutral
$1.93B-74.54-6.31%13520.11%74.95%
58
Neutral
$4.05B-22.67-17.49%101.28%2.49%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
50
Neutral
$2.20B-3.43-189.68%-93.33%-127.13%
47
Neutral
$393.26M-2.46-48.40%15.98%-40.75%
46
Neutral
$568.84M-2.77-256.67%4.08%-343.67%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PRAX
Praxis Precision Medicines
377.37
330.45
704.28%
SPRY
ARS Pharmaceuticals
6.03
-7.41
-55.13%
ABCL
AbCellera Biologics
12.24
7.89
181.38%
ZBIO
Zenas BioPharma, Inc.
33.04
16.33
97.73%
UPB
Upstream Bio, Inc.
7.13
-9.57
-57.31%
SEPN
Septerna, Inc.
40.25
27.63
218.94%

Praxis Precision Medicines Corporate Events

Business Operations and StrategyFinancial DisclosuresRegulatory Filings and Compliance
Praxis Highlights Strong Q2 Update and FDA Progress
Positive
Aug 6, 2026
On August 6, 2026, Praxis Precision Medicines reported second-quarter 2026 results and a broad corporate update, highlighting FDA mid-cycle reviews for ulixacaltamide in Essential Tremor and relutrigine in SCN2A and SCN8A developmental and epilept...
Business Operations and StrategyProduct-Related Announcements
Praxis Precision, Remagine Labs Partner on Ulixacaltamide Patch
Positive
Jul 7, 2026
On July 7, 2026, Praxis Precision Medicines announced a research collaboration and license agreement with Remagine Labs, Inc., a specialist in electronically controlled transdermal drug delivery systems, to develop an iontophoretic transdermal pat...
Product-Related AnnouncementsRegulatory Filings and Compliance
FDA Extends Review Timeline for Praxis’ Relutrigine NDA
Neutral
Jun 29, 2026
On June 29, 2026, Praxis Precision Medicines said the U.S. Food and Drug Administration extended by three months the review period for its New Drug Application for relutrigine, a treatment candidate for SCN2A and SCN8A developmental and epileptic ...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Praxis Wins FDA Breakthrough Status for Elsunersen Epilepsy Drug
Positive
Jun 22, 2026
On June 22, 2026, Praxis Precision Medicines, Inc. said the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to elsunersen (PRAX-222), an antisense oligonucleotide for treating seizures associated with SCN2A developmental...
Executive/Board ChangesShareholder Meetings
Praxis Precision Medicines Shareholders Back Directors and Governance
Positive
Jun 12, 2026
On June 10, 2026, Praxis Precision Medicines, Inc. held its 2026 Annual Meeting of Stockholders, where shareholders elected Gregory Norden, Marcio Souza and William Young as Class III directors to serve until the 2029 annual meeting, maintaining c...
Business Operations and StrategyProduct-Related Announcements
Praxis Precision Reassesses Vormatrigine After Mixed POWER1 Data
Negative
Jun 1, 2026
On June 1, 2026, Praxis Precision Medicines, Inc. reported topline results from its Phase 2/3 POWER1 study of vormatrigine in patients with focal onset seizures, a highly refractory epilepsy population. The trial did not achieve its primary succes...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Aug 07, 2026