Praxis Precision Medicines Inc (PRAX)

Praxis Precision Medicines Gains After FDA Grants Breakthrough Therapy DesignationJune 22, 2026 8:47 AM
IH Market News Praxis Precision Medicines, Inc. (NASDAQ:PRAX) shares climbed 4% on Monday after the company announced that the U.S. Food and Drug Administration had granted Breakthrough Therapy Designation to elsunersen for the treatment of seizures linked to SCN2A Developmental and Epileptic Encephalopathy (SCN2A-DEE). The regulatory milestone follows encouraging clinical data and is expected to support the continued development of the experimental therapy. Positive Trial Results Supported FDA Decision The designation was awarded based on findings from Part A of the EMBRAVE study, which evaluated elsunersen, an antisense oligonucleotide therapy designed to target the underlying genetic cause of the disorder. According to the company, patients receiving treatment experienced a 77% reduction in monthly seizure frequency compared with the sham control group. The improvement was maintained during the open-label extension phase for up to one year. Strong Seizure Reduction Observed in Pediatric Patients The randomized, sham-controlled Phase 1/2 trial assessed escalating doses of elsunersen in nine pediatric patients between the ages of two and 12 who were diagnosed with early-seizure-onset SCN2A-DEE. Results showed that 71% of treated patients achieved a reduction in seizure frequency of more than 50%, while 57% experienced at least one seizure-free period lasting 28 days or longer during the six-month treatment phase. The data suggest the therapy may offer meaningful clinical benefits for patients suffering from this severe neurological disorder. Pivotal EMBRAVE3 Study Continues Enrollment Praxis said its registrational EMBRAVE3 trial is currently enrolling patients under a streamlined development pathway agreed with the FDA. Following regulatory discussions completed in December 2025, the study design was modified to a single-arm, baseline-controlled format. All participants receive elsunersen for an initial 24-week treatment period, followed by an additional 24-week extension phase. The company plans to enroll approximately 30 patients in the study. Therapy Receives Multiple Regulatory Designations Elsunersen has now secured several important regulatory designations aimed at accelerating development and review. In the United States, the therapy has received Breakthrough Therapy Designation, Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA. In Europe, the treatment has been granted both Orphan Drug Designation and PRIME status by the European Medicines Agency. Addressing a Significant Unmet Medical Need Early-seizure-onset SCN2A-DEE is a rare and severe form of genetic epilepsy caused by gain-of-function mutations in the SCN2A gene. The condition is associated with frequent seizures, developmental impairment and significant neurological challenges. Currently, no approved therapies specifically target the underlying genetic cause of the disease, highlighting the potential importance of elsunersen if future clinical studies continue to demonstrate positive results. Praxis Precision Medicines stock priceThe post Praxis Precision Medicines Gains After FDA Grants Breakthrough Therapy Designation appeared first on US Editors. Original: Praxis Precision Medicines Gains After FDA Grants Breakthrough Therapy Designation

Day order to sell shares at $318.00 filled.
Profits: 78% within about few months. GLTA

Double Top Breakout on 3 Feb 2026. GLTA

Low Pole Reversal on 27 Jan 2026. GLTA

Double Top Breakout on 14 Jan 2026. GLTA

Low Pole Reversal on 7 Jan 2026. GLTA
Bullish. It may lead to a price breakout. Hopefully soon.
We shall see. Happy New Year.

In Double Bottom Breakdown since 2 Jan 2026. BLTA

Praxis Shares Rise After Receiving Breakthrough Therapy Designation for Ulixacaltamide to Treat Essential Tremor Disorder
MT Newswires 10:33:04 AM ET, 12/29/2025

Praxis Precision Heading for 'Exciting' 2026, Truist Says
03:23 PM EST, 12/29/2025 (MT Newswires) -- Praxis Precision Medicines (PRAX) is set for "exciting" 2026 after securing a Breakthrough Therapy Designation for ulixacaltamide in essential tremor, Truist Securities said in a note Monday.

The note said securing the label is a positive "surprise" because there is an approved drug for essential tremor, propranolol.

"Therefore, to be granted BTD despite the availability of a commercial drug...implies high unmet need in ET and at least some perception of ulixa's superiority," the report said.

The label is typically granted during earlier stages of drug development, the note said. For ulixa to obtain it after trial results imply that the FDA decision may have been based, at least in part, on the positive trial results, it added.

The report also pointed to indication of FDA's "comfort" with the data and pre-new drug application meeting.

"All of the above de-risk forthcoming NDA submission in early 2026," the note said. Truist kept its high conviction buy rating.

Price: 302.97, Change: +34.02, Percent Change: +12.65

Ascending Triple Top Breakout on 29 Dec 2025. GLTA

PS: In Port PRAX, at this time: (unrealized) gains up 71%.

Double Top Breakout on 22 Dec 2025. GLTA

Oppenheimer Adjusts Praxis Precision Medicines PT to $750 From $250, Maintains Outperform Rating
MT Newswire09:46:00 AM ET, 12/15/2025

PS: That's a super jump in share price. Apparently that'll take time. Larger market negative.
We shall see. Market not inspiring confidence neither in politics nor economically. Risky situation.

Triple Top Breakout on 15-Dec-2025. GLTA
Gains Up at this time: 54%

Truist Raises Price Target on Praxis Precision Medicines to $500 From $360, Keeps Buy Rating
08:01 AM EST, 12/08/2025 (MT Newswires) -- Praxis Precision Medicines (PRAX) has an average rating of buy and mean price target of $374.20, according to analysts polled by FactSet.

(MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)

PS: Momentum for PRAX is strongly bullish. The 14-period Slow Stochastic oscillator is above 80, the level which many analysts call overbought. This means that investors have been actively purchasing shares and driving the price higher. The last 10-days have seen significant volume in PRAX, with average daily volume above the average for the last year. Today's volume is no exception; with 1,248,687 shares having been traded already. The On Balance Volume indicator (OBV) is bullish. The slope of the indicator is positive and suggests that buyers are presently more active than sellers.
As of 3:33 PM ET Monday, 12/08/2025

Shares up again about 8% at 268.95. GLTA
My entry cost at $178.56. Profit about 50%

Back to Breaking News
Deutsche Bank Adjusts PT on Praxis Precision Medicines to $303 From $270, Maintains Buy Rating
08:43 AM EST, 12/05/2025 (MT Newswires) -- Praxis Precision Medicines (PRAX) has an average rating of buy and mean price target of $342.13, according to analysts polled by FactSet.

(MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)

Back to Breaking News
Deutsche Bank Adjusts PT on Praxis Precision Medicines to $303 From $270, Maintains Buy Rating
08:43 AM EST, 12/05/2025 (MT Newswires) -- Praxis Precision Medicines (PRAX) has an average rating of buy and mean price target of $342.13, according to analysts polled by FactSet.

(MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)

Momentum for PRAX is strongly bullish. The 14-period Slow Stochastic Oscillator is rising, as investors pay higher prices for shares.
Today's volume is on track to be lighter than usual, with 419,112 shares having traded so far. The On Balance Volume indicator (OBV) is bullish. The slope of the indicator is positive and suggests that buyers are presently more active than sellers as of 1:16 PM ET Thursday, 12/04/2025

Cheers & GLTA

PS: Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
16:01:00 PM ET, 12/03/2025 - GlobeNewswire
BOSTON, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (Nasdaq: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that on December 1, 2025, the Compensation Committee of Praxis’ Board of Directors granted restricted stock unit awards covering an aggregate of 3,594 shares of its common stock to six new non-executive employees under the Praxis Precision Medicines, Inc. 2024 Inducement Plan (the 2024 Inducement Plan). The restricted stock unit awards were granted as inducements material to the employees’ entering into employment with Praxis in accordance with Nasdaq Listing Rule 5635(c)(4).

The 2024 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Praxis, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Praxis, 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.

Low Pole Reversal on 3 Dec 2025. GLTA

In Spread Triple Top Breakout since 28-Nov-2025.

Long Tail Down on 21-Nov-2025. GLTA
This is positive and may lead to a price breakout unless other factors interfere.

Ascending Triple Top Breakout on 17-Nov-2025. GLTA

Double Bottom Breakdown on 05-Nov-2025. BLTA
C'est La Vie!

Low Pole Reversal on 04-Nov-2025. GLTA
This is positive and may lead to a price breakout unless the larger market continues negative tomorrow.

Double Bottom Breakdown on 03-Nov-2025. BLTA
C'est La Vie... in the fast lane of taking risks in the "Shtock" Market.

Question: Praxis Precision Medicines Inc. company potential?

"Praxis Precision Medicines (PRAX) has significant potential driven by recent positive late-stage clinical trial results for its lead drug candidates, especially ulixacaltamide for essential tremor (ET), and a diversified pipeline targeting high-value neurological disorders.

Key Areas of Potential

Ulixacaltamide for Essential Tremor (ET): This is the company's most advanced and promising asset. Recent positive Phase 3 results for ulixacaltamide in two pivotal studies were described by analysts as "groundbreaking".

Market Opportunity: ET affects an estimated seven million people in the U.S. with no highly effective, FDA-approved treatments, representing a multi-billion dollar market opportunity (analysts estimate potential peak sales of $2.5 billion to mid-teens billions)
.
Regulatory Pathway: Praxis plans to submit a New Drug Application (NDA) to the FDA by early 2026. The strong clinical data has led to high analyst conviction for approval.

Differentiation: The drug is a highly selective T-type calcium channel inhibitor designed to target the specific brain circuit involved in tremor activity, offering a novel mechanism compared to existing, less effective treatments.

Vormatrigine for Epilepsy: This is another late-stage candidate with significant potential.
Strong Phase 2 Data: Results from the Phase 2 RADIANT study in August 2025 showed a median seizure frequency reduction of 56.3% in patients with focal onset seizures, with 22% achieving complete seizure freedom.

Advantage: Vormatrigine is a next-generation sodium channel modulator that demonstrated superior efficacy compared to some competitors in trials, even without the need for titration, suggesting a potentially best-in-class profile for broad use in focal epilepsy.

Ongoing Trials: Two Phase 2/3 registrational studies (POWER1 and POWER2) are underway, with topline results for POWER1 anticipated in the second half of 2025.

Diverse Pipeline and Platforms: Beyond these two lead candidates, Praxis has a diversified portfolio for rare pediatric neurological syndromes (e.g., relutrigine for SCN2A/SCN8A-DEEs, elsunersen for SCN2A-DEE) developed through two proprietary platforms (Cerebrum™ small molecule and Solidus™ ASO), providing multiple "shots on goal" and potential future catalysts.

Risks and Considerations

Clinical-Stage Company: Praxis is currently a pre-commercial company and is operating at a loss, burning cash to fund R&D. Its future success is heavily dependent on the successful clinical development and regulatory approval of its candidates.

High Volatility: As a biotech stock with data-driven catalysts, PRAX stock experiences high volatility. It has rallied dramatically in 2025 based on positive news but is also susceptible to significant drops if trial results disappoint.

Competition: While ulixacaltamide has no direct FDA-approved competition for ET, other companies are developing treatments for epilepsy, creating a competitive landscape.

Analyst Disagreement on Valuation: While most analysts are highly bullish, with a consensus "Strong Buy" rating and high price targets, some maintain a "Sell" or "Hold" rating, highlighting the inherent risks and differing views on potential market penetration and valuation.

In summary, Praxis has substantial potential to become a significant player in the neurology space, particularly with its lead essential tremor candidate poised for regulatory submission. However, this potential comes with the inherent risks associated with a clinical-stage biopharmaceutical company."

Note: The response to my above question was obtained from Google.

Double Top Breakout on 31-Oct-2025. GLTA

Third day after a similar breakout.

Interesting!

Double Top Breakout on 28-Oct-2025. GLTA

Double Bottom Breakdown on 24-Oct-2025. BLTA
Wait and watch for lower price, before considering to add.

Shake up in the larger market.
Yet, Prax appears defying it.
Interesting this brat, Prax, lol.

Momentum for PRAX is strongly bullish. The 14-period Slow Stochastic oscillator is above 80, the level which many analysts call overbought. This means that investors have been actively purchasing shares and driving the price higher.

Today's volume is on track to be lighter than usual, with 996,439 shares having traded so far. The On Balance Volume indicator (OBV) is bullish. The slope of the indicator is positive and suggests that buyers are presently more active than sellers as of 3:12 PM ET Tuesday, 10/21/2025

Added more. Now average share cost down to $178.56 for me.
Current share price at this time close to $187
The Daily and Weekly chart looks promising based on Histogram bars showing share price in uptrend.
C'est La Vie. Exciting speculation. We shall see where price may head.

Cheers and GLTA

The PRAX saga continues...
Today's volume is on track to be lighter than usual, with 707,967 shares having traded so far. The On Balance Volume indicator (OBV) is bullish. The slope of the indicator is positive and suggests that buyers are presently more active than sellers as of 11:41 AM ET Monday, 10/20/2025

PS: It can be viewed as positive when volume is shrinking as price is falling down. Providing some excitement for this hobby of mine, lol.
Only 0.97% of Port value at this time.

Day order to buy PRAX shares at $189.00 filled.
I know nothin' about the company. Cwazy of me, lol.

When PRAX makes an offering the stock jumps. When other companies make an offering the stock drops into the toilet. Another proof that only club members get inside info. The rest of us are SOS. Nothing is uniform. It's whatever the controllers want it to be.

$PRAX $MJNA on Epilepsy . https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176819269

PRAX near a 52/week high

PRAX under $2

Do you still have your 10K shares?

Hope this one goes up to new heights in $5+ in the next month or so.

$PRAX: Added 10k here now at 1.22


Technically........ bullish ...... should get to $1.80 min



GO $PRAX

Despite Trial Failure Praxis Still Seeks Advancing Essential Tremor Program Into Phase 3 Study
Vandana Singh
Fri, March 3, 2023 at 8:05 AM PST

https://finance.yahoo.com/news/despite-trial-failure-praxis-still-160535252.html

News today.

Not looking good now.

Getting killed this am.

FDA phase 2 approval due in next week or so.

ATM offering on S-3 didn’t hurt 2022 as avg price was $3.90 per share but not sure on 2023.

Book value at 12/31/22 is $76M. Not bad. They say they have enough cash entering 2023.

$61M cash at 12/31/22 with 49M shares O/S for about $1.30 in cash per share.

I wonder how much cash they have now?

$PRAX has $5 a share cash and easily going from $2 to $3 for my collection....patiently waiting

Looking for a gain.