Pasithea Therapeutics Announces Grant of Fast Track Designation by FDA to PAS-004 for Treatment of Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) Causing Significant Morbidity

Rhea-AI Summary

Pasithea Therapeutics (NASDAQ: KTTA) announced the FDA granted Fast Track designation to PAS-004 for treatment of NF1-associated plexiform neurofibromas (PN) causing significant morbidity on April 1, 2026. The designation enables frequent FDA communications and rolling review and may allow accelerated approval or priority review if criteria are met. The company is conducting a Phase 1/1b dose-escalation trial (NCT06961565).

Positive

• Fast Track designation granted by FDA for PAS-004
• Rolling review eligibility enabling earlier submission review
• Frequent FDA interactions to facilitate development
• Ongoing Phase 1/1b multicenter dose-escalation trial (NCT06961565)

Negative

• PAS-004 remains in early-stage Phase 1/1b testing with no regulatory approval
• Fast Track does not guarantee approval or successful clinical outcome

News Market Reaction – KTTA

+0.30% 30.1x vol

17 alerts

+0.30% Session close to close

+4.9% Peak Tracked

-40.0% Trough Tracked

$18.56M Market Cap

30.1x Rel. Volume

In the Apr 1 session, KTTA gained 0.30%, reflecting a mild positive market reaction. Argus tracked a peak move of +4.9% during that session. Argus tracked a trough of -40.0% from its starting point during tracking. Our momentum scanner triggered 17 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 30.1x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights a key regulatory milestone: Fast Track designation for PAS-004 in NF1-a...

Analysis

This announcement highlights a key regulatory milestone: Fast Track designation for PAS-004 in NF1-associated plexiform neurofibromas, alongside an ongoing Phase 1/1b dose-escalation trial. Historically, KTTA has issued multiple positive PAS-004 updates, yet market reactions have been mixed, with an average clinical-news move of about -4.58%. Investors may watch for upcoming Phase 1/1b data, continued trial site expansion, and any financing developments as important signals for the PAS-004 program’s trajectory.

Previous Clinical trial Reports

5 past events · Latest: Nov 24 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Nov 24	Phase 1 cohort data	Positive	+45.3%	Completion of Cohort 7 in PAS-004 Phase 1 with positive safety, PK, PD data.
Nov 21	PK tablet data	Positive	-29.6%	Positive tablet pharmacokinetic data in ongoing Phase 1/1b NF1 study.
Nov 20	Interim Phase 1 efficacy	Positive	-29.6%	Interim Phase 1 data showing monotherapy activity and favorable safety in cancer.
Nov 04	U.S. site activation	Positive	-5.9%	Activation of UAB clinical site for NF1 Phase 1/1b PAS-004 trial.
Sep 16	Korea site activations	Positive	-3.2%	Activation of two South Korea sites for Phase 1/1b PAS-004 NF1 study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial news has often seen negative next-day moves despite positive data, with only one of five recent clinical updates producing a positive reaction.

Recent Company History

Over recent months, Pasithea has steadily advanced PAS-004 clinical programs, including site activations in South Korea and at UAB, positive PK and Phase 1 efficacy/safety readouts, and completion of higher-dose cohorts with strong PK/PD signals. Yet four of five clinical trial headlines with positive implications saw share-price declines within 24 hours. Today’s Fast Track designation for PAS-004 in NF1-PN fits the ongoing clinical progress narrative but comes against a backdrop of historically mixed market reactions to similar trial updates.

Key Terms

fast track designation, fda, macrocyclic mek inhibitor, phase 1/1b, +4 more

8 terms

fast track designation regulatory

"has granted Fast Track designation to PAS-004 for the treatment of NF1-associated"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

fda regulatory

"Fast Track designation is one of the FDA’s expedited programs meant to facilitate"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

macrocyclic mek inhibitor medical

"developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced"

A macrocyclic MEK inhibitor is a type of cancer drug built around a large ring-shaped molecule that blocks the MEK protein, a key switch in a cell growth pathway often hijacked by tumors. For investors, these drugs matter because they can slow or stop tumor growth where that pathway is active, so clinical results, safety issues, and regulatory decisions can quickly change a biotech’s value—think of it as cutting the fuel line to an engine driving tumor growth.

phase 1/1b medical

"The Company is currently conducting a Phase 1/1b multicenter, open-label, dose"

Phase 1/1b describes early-stage clinical testing in humans where researchers first assess a drug’s safety, tolerable dose range and how the body processes it; phase 1b often means small expansion groups to explore the best dose and look for initial signs the treatment might work. For investors, these studies are like the first road tests of a new product—positive results reduce risk and increase value potential, while negative or unclear results raise uncertainty about future development.

open-label medical

"conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

dose escalation medical

"multicenter, open-label, dose escalation trial of PAS-004 in adult participants"

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

marketing application regulatory

"allows portions of a marketing application to be reviewed and assessed by the FDA"

A marketing application is a formal submission to a government regulator requesting permission to sell a drug, medical device, or other regulated product, and it includes the safety, effectiveness, manufacturing and labeling information regulators need to decide. For investors it matters because approval is the legal green light that allows commercial sales and revenue; a rejection or delay can postpone or prevent market access much like not having a required license prevents a business from operating.

accelerated approval regulatory

"may potentially be eligible for accelerated approval and/or priority review if"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Fast Track designation is one of the FDA’s expedited programs meant to facilitate development and expedite review of new drugs that have the potential to address an unmet medical need in the treatment of a serious or life-threatening condition

MIAMI, April 01, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PAS-004 for the treatment of NF1-associated PN causing significant morbidity.

"We appreciate the FDA’s decision that PAS-004 meets the criteria for Fast Track designation for this indication,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “The ability to have early and frequent interactions with the FDA supports our goal to expeditiously develop PAS-004 for patients with NF1-associated PN causing significant morbidity.”

Fast Track designation includes the following opportunities to facilitate Fast Track product development:

• Frequent communications with the FDA review team throughout the product development process
  
  
• Rolling Review, which allows portions of a marketing application to be reviewed and assessed by the FDA before the company submits the complete application
  
  
• In addition, a Fast Track designation product may potentially be eligible for accelerated approval and/or priority review if relevant criteria are met. For more information, see the FDA’s website at
  https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
  
  

The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565).

About NF1- PN

Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

About Pasithea Therapeutics Corp.

Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in patients with advanced cancer (NCT06299839), and a Phase 1/1b clinical trial in patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas with symptomatic and inoperable, incompletely resected, or recurrent PN (NCT06961565).

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company’s ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company’s ongoing Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth and financing opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements, whether as a result of new information, future events, or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Contact

Patrick Gaynes
Investor Relations
pgaynes@pasithea.com

FAQ

What does FDA Fast Track designation for PAS-004 mean for Pasithea (KTTA)?

It means PAS-004 receives expedited development support and review pathways. According to the company, Fast Track enables frequent FDA communications and rolling review, which can accelerate regulatory interactions and may make the program eligible for accelerated approval or priority review if criteria are met.

When did Pasithea Therapeutics (KTTA) announce FDA Fast Track for PAS-004?

Pasithea announced the Fast Track designation on April 1, 2026. According to the company, the designation was granted for PAS-004 to treat NF1-associated PN causing significant morbidity and is intended to facilitate faster development and review.

How could rolling review help PAS-004's regulatory timeline for KTTA?

Rolling review lets the FDA assess portions of an application before full submission. According to the company, this allows earlier feedback on submitted modules, potentially shortening total review time versus a standard, single-file submission process.

Is PAS-004 approved by the FDA after the Fast Track designation for KTTA?

No, Fast Track is not an approval; it is an expedited pathway. According to the company, PAS-004 remains in a Phase 1/1b dose-escalation trial (NCT06961565) and Fast Track may improve development timelines but does not guarantee approval.

What clinical trial is ongoing for PAS-004 and who is eligible?

A Phase 1/1b multicenter, open-label dose-escalation trial is underway. According to the company, the study enrolls adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-associated plexiform neurofibromas.