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Aytu BioPharma Highlights Opportunity for EXXUATM (gepirone) as New Way to Treat Major Depressive Disorder That Avoids Common Side Effects of Sexual Dysfunction and Significant Weight Gain following launch of EXXUA

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Aytu BioPharma (Nasdaq:AYTU) launched EXXUA (gepirone) nationwide on January 20, 2026, following completion of launch training. EXXUA is the first FDA‑approved selective 5‑HT1A agonist for treatment of major depressive disorder in adults and is available through retail and participating Aytu RxConnect pharmacies.

The company positions EXXUA as a once‑daily monotherapy that selectively targets 5‑HT1A receptors while minimizing activity at serotonin receptors tied to sexual dysfunction and weight gain, side effects that the release says commonly drive treatment discontinuation.

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Positive

  • FDA approval as the first selective 5‑HT1A agonist for adult MDD
  • Nationwide commercial launch with retail and Aytu RxConnect pharmacy availability
  • Once‑daily monotherapy mechanism aiming to reduce sexual dysfunction and weight gain

Negative

  • EXXUA is approved only for adults, not for pediatric or young adult patients
  • Antidepressants carry a risk of suicidal thoughts and behaviors in pediatric and young adult patients, per the release

News Market Reaction

+0.75%
2 alerts
+0.75% News Effect
+$216K Valuation Impact
$29M Market Cap
0.6x Rel. Volume

On the day this news was published, AYTU gained 0.75%, reflecting a mild positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $216K to the company's valuation, bringing the market cap to $29M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MDD population: 21 million Americans Sexual dysfunction rate: up to 70% Weight gain rate: more than 65% +2 more
5 metrics
MDD population 21 million Americans Americans living with major depressive disorder
Sexual dysfunction rate up to 70% MDD patients experiencing treatment-emergent sexual dysfunction
Weight gain rate more than 65% MDD patients affected by weight gain on first-line medications
Treatment discontinuation drivers nearly half of patients Patients discontinuing first-line MDD medications due to side effects
Dosing frequency once-daily EXXUA monotherapy dosing schedule

Market Reality Check

Price: $2.39 Vol: Volume 156,322 is about 1...
normal vol
$2.39 Last Close
Volume Volume 156,322 is about 1.17x the 20-day average of 134,154, indicating only slightly elevated trading ahead of the EXXUA launch news. normal
Technical Shares at $2.66 are trading above the 200-day MA of $2.08, and sit about 13% below the 52-week high of $3.065 while well above the 52-week low of $0.95.

Peers on Argus

AYTU fell 3.62% while several peers in Pharmaceutical Preparations also traded l...

AYTU fell 3.62% while several peers in Pharmaceutical Preparations also traded lower: TLPH -1.96%, GELS -7.96%, FLGC -1.94%, TXMD -0.45%, IXHL -1.87%. However, the momentum scanner did not flag a coordinated sector move.

Historical Context

5 past events · Latest: Jan 13 (Neutral)
Pattern 5 events
Date Event Sentiment Move Catalyst
Jan 13 Conference participation Neutral +4.6% CEO fireside chat at Lytham Partners 2026 Investor Healthcare Summit.
Jan 12 Investor day details Neutral +1.5% Agenda and focus on EXXUA for upcoming New York City Investor Day.
Dec 18 Investor day announcement Neutral -3.9% Announcement of Jan 20, 2026 Investor Day centered on EXXUA.
Dec 15 Product availability Neutral +1.3% Initial U.S. commercial availability of EXXUA for MDD in adults.
Nov 24 Conference presentation Neutral +2.5% Management presentation at NobleCon21 emerging growth equity conference.
Pattern Detected

Recent AYTU news has centered on EXXUA commercialization and investor events, with generally modest single-digit price moves following announcements and no clear pattern of outsized reactions.

Recent Company History

Over the past few months, Aytu’s news flow has increasingly focused on EXXUA. On Dec 15, 2025, the company announced EXXUA’s commercial availability, highlighting clinical data across more than 5,000 patients. Subsequent items, including the Dec 18, 2025 Investor Day announcement and conference participations, saw mixed but moderate price reactions between roughly +1–5% and -4%. The current nationwide launch and positioning of EXXUA as a differentiated MDD treatment builds directly on this commercialization and investor-relations narrative.

Market Pulse Summary

This announcement marks the nationwide commercial launch of EXXUA, described as the first and only s...
Analysis

This announcement marks the nationwide commercial launch of EXXUA, described as the first and only selective 5-HT1A agonist FDA‑approved for adult major depressive disorder. It emphasizes differentiation by avoiding common side effects like sexual dysfunction and weight gain that affect large portions of the 21 million Americans with MDD. In context of earlier availability and Investor Day plans, key metrics to watch include pharmacy distribution breadth, prescriber uptake, and how clinical positioning resonates against established SSRIs and SNRIs.

Key Terms

major depressive disorder, 5-HT1A, 5-HT2A, serotonin receptors, +2 more
6 terms
major depressive disorder medical
"approved by the United States Food and Drug Administration for the treatment of major depressive disorder"
A clinical condition characterized by persistent, severe low mood, loss of interest in daily activities, and reduced ability to function at work or home, lasting weeks or longer. It matters to investors because it drives demand for treatments and mental health services, affects workforce productivity and absenteeism, influences health-care and insurance costs, and shapes risks and opportunities for companies developing drugs, therapies or workplace programs—like a long-lasting storm that lowers economic output.
5-HT1A medical
"the first and only selective 5-HT1A agonist approved by the United States Food and Drug Administration"
5-HT1A is a specific protein on nerve cells that responds to serotonin, a brain chemical involved in mood, anxiety and other functions. Investors care because drugs that activate or block this receptor can change symptoms, side effects and how well a medicine works, so success or failure of such drugs can strongly affect a biotech’s prospects — think of the receptor as a lock and a drug as the key that can turn symptoms up or down.
5-HT2A medical
"minimizing activity at serotonin receptors (eg, 5-HT2A) linked to side effects"
5-HT2A is a specific protein on brain cells that acts like a lock for the chemical serotonin, helping control mood, perception, and cognition; when the lock is turned it changes how brain circuits behave. Investors care because many psychiatric and neurological drugs, including certain antidepressants, antipsychotics and experimental psychedelic therapies, target this receptor to produce therapeutic effects or side effects, so drug candidates that affect 5-HT2A can drive clinical value, regulatory risk, and market opportunity.
serotonin receptors medical
"while minimizing activity at serotonin receptors (eg, 5-HT2A) linked to side effects"
Serotonin receptors are protein 'locks' on the surface of cells that detect and respond to the chemical messenger serotonin, which helps regulate mood, digestion, sleep and other bodily functions. They matter to investors because many drugs target specific receptor types to treat disorders—success, safety or failure of those drugs, or new scientific insights about these receptors, can directly affect the commercial value and regulatory prospects of companies developing related treatments.
monotherapy medical
"EXXUA is a once-daily monotherapy with a unique mechanism of action"
Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.
United States Food and Drug Administration regulatory
"selective 5-HT1A agonist approved by the United States Food and Drug Administration"
The United States Food and Drug Administration is the federal agency that reviews and authorizes foods, prescription and over‑the‑counter medicines, vaccines, medical devices and certain other health products for safety and effectiveness. Think of it as a national quality inspector whose approvals or rejections can determine whether a product can be sold, how quickly it reaches the market, and the size of its potential revenue—factors that directly affect a company’s risk and value for investors.

AI-generated analysis. Not financial advice.

EXXUA addresses frequent causes of treatment discontinuation with first-line SSRIs and SNRIs

Now commercially available through retail pharmacies and participating Aytu RxConnect® pharmacies to support patient access

DENVER, COLORADO / ACCESS Newswire / January 20, 2026 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines to treat complex central nervous system disorders and improve the quality of life of patients, today announced the nationwide commercial launch of EXXUA and successful completion of its launch meeting last week that finalized sales training and launch preparations for EXXUA, the first and only selective 5-HT1A agonist approved by the United States Food and Drug Administration for the treatment of major depressive disorder ("MDD") in adults, representing a new way to treat MDD.

EXXUA is a once-daily monotherapy with a unique mechanism of action that selectively targets 5-HT1A receptors, important regulators of mood and emotion,1-3 while minimizing activity at serotonin receptors (eg, 5-HT2A) linked to side effects such as sexual dysfunction4 and weight gain5,6 that are common with many first-line antidepressants. EXXUA is only approved for use in adults. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.

Of the 21 million Americans living with MDD, up to 70%2,7 experience treatment-emergent sexual dysfunction and more than 65%8 are affected by weight gain, two side effects of first-line MDD medications that drive nearly half of patients to discontinue their treatment.9

"The burden of MDD is not limited to psychological symptoms," said Dr. Stephen Stahl, Professor of Psychiatry, University of California and founder of the Neuroscience Education Institute, a recognized expert neuropsychopharmacologist. "Sexual dysfunction and weight gain are frequently experienced as core features of depression, reflecting the disorder's broad impact on both emotional and physical health. Left unaddressed, these symptoms can then intensify the depressive experience and perpetuate its impact. The tragedy for many patients is that today's treatments-while effective for depression-often exacerbate these very physical symptoms, asking patients to trade one burden for another. The ability to manage depression effectively without disrupting the intimacy and connection patients value is tremendous in terms of quality of life."

"Completing our EXXUA launch meeting marks a significant milestone for Aytu as we transition from preparation to execution," said Josh Disbrow, CEO of Aytu BioPharma. "Our team is well-equipped to have informed, meaningful conversations with clinicians about EXXUA, supported by strong clinical evidence and a clear understanding of MDD patients' needs."

To learn more about the science behind EXXUA and how it was studied, please visit EXXUA.com.

About Aytu BioPharma

Aytu is a specialty pharmaceutical company focused on advancing innovative medicines for complex central nervous system disorders to improve the quality of life for patients. The Company's prescription products include EXXUA™ (gepirone) extended-release tablets (see Full Prescribing Information, including Boxed Warning) for the treatment of major depressive disorder (MDD), and treatments for attention-deficit/hyperactivity disorder (ADHD). Aytu is committed to delivering the Company's medications through best-in-class patient access programs that help to enable optimal patient outcomes. For more information, please visit aytubio.com or follow us on LinkedIn.

About EXXUA

EXXUA is a novel oral selective serotonin 5-HT1A receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. EXXUA is not approved for use in pediatric patients.

INDICATIONS AND USAGE

EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.

DOSAGE AND ADMINISTRATION

Important Recommendations Prior to Initiating and During Treatment with EXXUA

Electrocardiogram and Electrolyte Monitoring

Correct electrolyte abnormalities prior to initiating EXXUA. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA.

Perform an electrocardiogram (ECG) prior to initiating EXXUA, during dosage titration, and periodically during treatment. Do not initiate EXXUA if QTc is > 450 msec at baseline. Monitor ECGs more frequently if EXXUA is used:

concomitantly with drugs known to prolong the QT interval

in patients who develop QTc ≥ 450 msec during treatment

in patients with a significant risk of developing torsade de pointes

Do not escalate the EXXUA dosage if the QTcF is > 450 msec.

Bipolar Disorder, Mania, and Hypomania Screening

Screen patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with EXXUA.

Important Administration Instructions

Take EXXUA orally with food at approximately the same time each day. Swallow tablets whole. Do not split, crush, or chew EXXUA.

Recommended Dosage

The recommended starting dosage of EXXUA is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to 36.3 mg orally once daily on Day 4 and further titrated to 54.5 mg orally once daily after Day 7 and to 72.6 mg orally once daily after an additional week. The maximum recommended daily dosage of EXXUA is 72.6 mg once daily.

Dosage Recommendations in Geriatric Patients

The recommended starting dosage of EXXUA in geriatric patients is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to maximum recommended dosage of 36.3 mg orally once daily after Day 7.

Recommended Dosage in Patients with Renal Impairment

The recommended starting dosage of EXXUA in patients with creatinine clearance < 50 mL/min is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. The recommended dosage in patients with creatinine clearance ≥ 50 mL/min is the same as in patients with normal renal function.

Recommended Dosage in Patients with Hepatic Impairment

The recommended starting dose of EXXUA in patients with moderate (Child-Pugh B) hepatic impairment is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. EXXUA is contraindicated in patients with severe (Child-Pugh C) hepatic impairment. The recommended dosage in patients with mild (Child-Pugh A) hepatic impairment is the same as patients with normal hepatic function.

Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors

Reduce the EXXUA dose by 50% when used concomitantly with a moderate CYP3A4 inhibitor. EXXUA is contraindicated in patients receiving strong CYP3A4 inhibitors.

Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

At least 14 days must elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with EXXUA. Conversely, at least 14 days must be allowed after stopping EXXUA before starting an MAOI antidepressant.

CONTRAINDICATIONS

EXXUA is contraindicated in patients:

with known hypersensitivity to gepirone or components of EXXUA.

with prolonged QTc interval > 450 msec at baseline.

with congenital long QT syndrome.

receiving concomitant strong CYP3A4 inhibitors.

with severe hepatic impairment.

taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome. Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated.

WARNINGS AND PRECAUTIONS

Suicidal Thoughts and Behaviors in Adolescents and Young Adults

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients aged 24 years and younger was greater than in placebo-treated patients.

There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD.

*EXXUA is not approved for use in pediatric patients.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing EXXUA, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

QT Prolongation

EXXUA prolongs the QTc interval.

EXXUA is contraindicated in patients with congenital long QT syndrome and in patients with severe hepatic impairment or in patients receiving concomitant strong CYP3A4 inhibitors as they increase EXXUA plasma concentrations.

Do not initiate EXXUA if QTc is > 450 msec at baseline.

Correct electrolyte abnormalities prior to EXXUA initiation. In patients with electrolyte abnormalities, who are receiving diuretics or glucocorticoids, or have a history or hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA.

Perform an ECG prior to EXXUA initiation, during dosage titration, and periodically during treatment. Monitor patients with ECGs more frequently:

o

If EXXUA is used concomitantly with drugs known to prolong the QT interval.

o

In patients who develop QTc ≥ 450 msec during treatment with EXXUA. Do not escalate the EXXUA dosage if QTcF is > 450 msec.

o

In patients with a significant risk of developing torsade de pointes, including those with uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism.

Reduce the EXXUA dosage when used concomitantly with moderate CYP3A4 inhibitors, as they may increase EXXUA concentrations.

Serotonin Syndrome

Concomitant use of EXXUA with SSRIs or tricyclic antidepressants may cause serotonin syndrome, a potentially life-threatening condition with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor. The concomitant use of EXXUA with MAOIs is contraindicated. In addition, do not initiate EXXUA in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking EXXUA discontinue EXXUA before initiating treatment with the MAOI.

If concomitant use of EXXUA with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms. Discontinue EXXUA and/or concomitant serotonergic drug immediately if the above symptoms occur and initiate supportive symptomatic treatment.

Activation of Mania or Hypomania

Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating treatment with EXXUA, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). EXXUA is not approved for use in treating bipolar depression.

ADVERSE REACTIONS

Most common adverse reactions (incidence of ≥5% and at least twice incidence of placebo) were dizziness, nausea, insomnia, abdominal pain, and dyspepsia.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Suicidal Thoughts and Behaviors in Adolescents and Young Adults

QT Prolongation

Serotonin Syndrome

Activation of Mania or Hypomania

To report SUSPECTED ADVERSE REACTIONS, contact Aytu BioPharma at 1-855-298-8246 or http://www.exxua.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including EXXUA, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

Lactation

There is no data on the presence of gepirone in human milk, the effects on the breastfed infant, or the effects on milk production. Gepirone is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are reports of breastfed infants exposed to other serotonergic antidepressants experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EXXUA and any adverse effects on the breastfed infant from EXXUA or from the underlying maternal condition.

OVERDOSAGE

In clinical studies, cases of acute ingestions up to 454 mg (6.25 times the maximum recommended dose) of EXXUA alone or in combination with other drugs, were reported. Signs and symptoms reported with overdose of EXXUA at doses up to 454 mg included vomiting and transient incomplete bundle branch block; an unknown dose of EXXUA produced altered level of consciousness and a 60-second convulsion. No specific antidotes for EXXUA are known. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Please see Full Prescribing Information for EXXUA.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act"). All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as "may," "will," "should," "forecast," "could," "expect," "suggest," "believe," "estimate," "continue," "anticipate," "intend," "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements, other than statements of historical facts contained in this press release, are forward-looking statements. These statements are predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks are described in "Risk Factors" in Part I, Item 1A of the Company's most recent Annual Report on Form 10‑K and in the other reports and documents it files with the United States Securities and Exchange Commission.

Contacts for Investors

Ryan Selhorn, Chief Financial Officer
Aytu BioPharma, Inc.
rselhorn@aytubio.com

Robert Blum
Lytham Partners
aytu@lythampartners.com

REFERENCES: 1. EXXUA™ (gepirone). Prescribing Information. Fabre-Kramer Pharmaceuticals, Inc. 2. Lorenz TK, et al. J Clin Psychiatry. 2024;85(4):24m15357. 3. Albert PR, François BL, Millar AM. Transcriptional dysregulation of 5-HT1A autoreceptors in mental illness. Mol Brain. 2011;4:21. doi: 10.1186/1756-6606-4-21. 4. Fabre LF, Clayton AH, Smith LC, Goldstein I, Derogatis LR. The effect of gepirone-ER in the treatment of sexual dysfunction in depressed men. J Sex Med. 2012;9(3):821-829. doi: 10.1111/j.1743-6109.2011.02624.x. 5. Data on file. Clinical Trial Report 134001. Organon Inc. 2001. 6. Data on file. Clinical Study Report FKGBE007. Fabre-Kramer Pharmaceuticals, Inc. 2005. 7. Jacobsen PL, et al. Neurol, Psychiatry, and Brain Res. 2020;36:57-64. 8. Gill H, et al. Obesity. 2020;28(11):2064-2072. 9. Gauthier, et al. BMC Psychiatry. 2017;17(222):1-12.

SOURCE: Aytu BioPharma, Inc.



View the original press release on ACCESS Newswire

FAQ

What is EXXUA (gepirone) and what is its FDA indication for AYTU (Nasdaq:AYTU)?

EXXUA is a selective 5‑HT1A agonist approved for the treatment of major depressive disorder in adults.

When did Aytu BioPharma (AYTU) commercially launch EXXUA nationwide?

Aytu announced the nationwide commercial launch of EXXUA on January 20, 2026, after completing launch training.

How is EXXUA administered and what is its dosing frequency for MDD?

EXXUA is described as a once‑daily monotherapy for adults with major depressive disorder.

Does EXXUA claim to avoid sexual dysfunction and weight gain reported with other antidepressants?

The company states EXXUA selectively targets 5‑HT1A and minimizes activity at receptors linked to sexual dysfunction and weight gain.

Where can patients obtain EXXUA after the AYTU launch?

EXXUA is available through retail pharmacies and participating Aytu RxConnect pharmacies to support access.

Is EXXUA approved for children or young adults according to AYTU (Nasdaq:AYTU)?

No. EXXUA is approved only for adults, and antidepressants increase risk of suicidal thoughts and behaviors in pediatric and young adult patients per the release.
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