Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation

Rhea-AI Summary

Vanda Pharmaceuticals (Nasdaq: VNDA) announced FDA approval of BYSANTI™ (milsaperidone) for acute treatment of manic or mixed episodes in bipolar I disorder and for schizophrenia in adults. BYSANTI™ is a new chemical entity shown to be bioequivalent to iloperidone and aligns with iloperidone's safety profile.

Vanda expects commercial availability in Q3 2026, ongoing adjunctive trials in treatment‑resistant major depressive disorder due to complete by year‑end, and patent protection through 2044.

Positive

• FDA approval for bipolar I manic/mixed episodes and schizophrenia
• Bioequivalence to iloperidone across therapeutic dosing spectrum
• Commercial availability anticipated in Q3 2026
• Patent protection extending through 2044
• Ongoing adjunctive study in treatment‑resistant major depressive disorder

Negative

• None.

Market Reaction – VNDA

+43.06% $8.24 1.7x vol

15m delay 55 alerts

+43.06% Since News

+33.9% Peak in 43 min

$8.24 Last Price

$5.73 $8.97 Day Range

+$102M Valuation Impact

$340M Market Cap

1.7x Rel. Volume

Following this news, VNDA has gained 43.06%, reflecting a significant positive market reaction. Argus tracked a peak move of +33.9% during the session. Our momentum scanner has triggered 55 alerts so far, indicating high trading interest and price volatility. The stock is currently trading at $8.24. This price movement has added approximately $102M to the company's valuation. Trading volume is above average at 1.7x the average, suggesting increased trading activity.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Real-world exposure: more than 100,000 patient-years Adjunctive MDD study: once-daily regimen Patent protection: through 2044 +5 more

8 metrics

Real-world exposure more than 100,000 patient-years Fanapt® (iloperidone) clinical and real-world use referenced for BYSANTI™

Adjunctive MDD study once-daily regimen Ongoing trial in treatment-resistant major depressive disorder

Patent protection through 2044 Latest BYSANTI™ US patents expected to expire in 2044

Commercial timing Q3 2026 Anticipated commercial availability of BYSANTI™

New drug approvals second in less than 2 months BYSANTI™ follows NEREUS™ approval in December 2025

Shelf capacity $200,000,000 Maximum aggregate offering under S-3 shelf filed Feb 12, 2026

Price move -5.57% Share price change on day of BYSANTI™ FDA approval

Volume multiple 1.89x Today’s trading volume vs 20-day average

Market Reality Check

Price: $5.76 Vol: Volume 2,243,548 is 1.89x...

high vol

$5.76 Last Close

Volume Volume 2,243,548 is 1.89x the 20-day average, indicating elevated trading activity ahead of this FDA approval. high

Technical Price at $5.76 is trading above the 200-day MA of $5.34, despite a -5.57% move on the day.

Peers on Argus

VNDA fell 5.57% while momentum-screened biotech peers FENC, TNXP, and ANNX each ...

3 Up

VNDA fell 5.57% while momentum-screened biotech peers FENC, TNXP, and ANNX each moved up, pointing to a stock-specific reaction rather than a sector-wide move.

Previous Fda approval Reports

5 past events · Latest: Dec 30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 30	Drug FDA approval	Positive	-2.4%	FDA approved NEREUS™ for motion‑induced vomiting prevention.
May 05	NDA accepted	Positive	+0.4%	FDA accepted Bysanti™ NDA with decision date set for Feb 2026.
Apr 23	FDA delay dispute	Negative	-1.8%	Company criticized FDA for delaying tradipitant hearing request.
Mar 31	NDA submission	Positive	-2.1%	Submitted NDA for Bysanti™ in bipolar I disorder and schizophrenia.
Jan 27	Hearing acceptance	Negative	+1.1%	Accepted FDA hearing opportunity after tradipitant CRL in gastroparesis.

Pattern Detected

FDA-related catalysts for VNDA have often produced muted or negative next-day moves, even on positive outcomes.

Recent Company History

Over the last year, VNDA has had multiple FDA‑related milestones. Prior fda approval news for NEREUS™ on Dec 30, 2025 and several Bysanti™ NDA steps often saw flat to negative price reactions (average around small single‑digit moves). Regulatory friction around tradipitant hearings also weighed on sentiment. Today’s BYSANTI™ approval completes the NDA path highlighted in 2025 filings, adding another approved CNS asset alongside NEREUS™, and follows a broader strategy of expanding Vanda’s late‑stage and commercial portfolio.

Historical Comparison

-0.9% avg move · Past FDA‑related headlines for VNDA averaged about -0.94% next‑day moves; today’s -5.57% reaction to...

fda approval

-0.9%

Average Historical Move fda approval

Past FDA‑related headlines for VNDA averaged about -0.94% next‑day moves; today’s -5.57% reaction to BYSANTI™ approval is a notably larger downside response.

BYSANTI™ progressed from NDA submission and acceptance in early 2025 to full FDA approval for bipolar I disorder and schizophrenia, extending Vanda’s track record of CNS‑focused approvals.

Regulatory & Risk Context

Active S-3 Shelf · $200,000,000

Shelf Active

Active S-3 Shelf Registration 2026-02-12

$200,000,000 registered capacity

Vanda filed an S-3 shelf on Feb 12, 2026 to offer up to $200,000,000 of securities in future transactions. The shelf is currently marked as not effective, with 0 recorded usages and no disclosed drawdowns to date.

Market Pulse Summary

The stock is surging +43.1% following this news. A strong positive reaction aligns with the transfor...

Analysis

The stock is surging +43.1% following this news. A strong positive reaction aligns with the transformational nature of BYSANTI™’s FDA approval, adding a new CNS franchise on top of recent NEREUS™ success. Historically, VNDA’s FDA‑related headlines around approvals and filings have produced only modest average moves of about -0.94%, so a large upside response would represent an upside outlier. Investors would likely weigh patent protection through 2044 and the newly filed $200,000,000 shelf as key factors for long‑term valuation and potential future financings.

Key Terms

bipolar I disorder, schizophrenia, new chemical entity, atypical antipsychotics

4 terms

bipolar I disorder medical

"for the acute treatment of manic or mixed episodes associated with bipolar I disorder"

A mental health condition marked by at least one episode of mania—periods of unusually high energy, impulsive behavior and racing thoughts—often alternating with episodes of depression. Investors watch it because treatments, diagnostic tools and care models for this condition shape pharmaceutical and medical-device markets, clinical trial activity, insurance costs and workplace productivity; think of it as a visible driver of healthcare spending and regulatory risk in mental-health-related investments.

schizophrenia medical

"and for the treatment of schizophrenia in adults."

A chronic brain disorder that changes how a person thinks, perceives reality, feels and interacts with others, often causing hallucinations, false beliefs and trouble organizing thoughts or daily life. It matters to investors because the condition creates demand for long‑term treatments, diagnostics and support services; developing effective therapies can be costly, risky and highly regulated, but successful drugs or devices can open large, steady markets—think of it like fixing a deep, complex software bug that many users rely on.

new chemical entity regulatory

"BYSANTI™ is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics."

A new chemical entity (NCE) is a drug whose active ingredient has never been previously approved or marketed; it’s a wholly new molecule rather than a new use of an existing compound. For investors, NCEs matter because they offer fresh commercial opportunities, potential patent and regulatory exclusivity, and correspondingly higher upside if successful — but they also carry greater development and regulatory risk, like betting on an untested recipe.

atypical antipsychotics medical

"new chemical entity (NCE) that belongs in the class of atypical antipsychotics."

Atypical antipsychotics are a group of prescription medications used to treat conditions that affect mood, thinking, and perception, such as schizophrenia and bipolar disorder. They matter to investors because their safety profile, patent status, regulatory approvals, and side-effect risks can greatly affect sales and a company’s valuation — like how the quality and recall risk of a car model can change an automaker’s fortunes.

AI-generated analysis. Not financial advice.

WASHINGTON, Feb. 20, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.

BYSANTI™ is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics. In clinical studies BYSANTI™ demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum enabling it to leverage well-established knowledge of efficacy and safety derived from a rich clinical development program and more than 100,000 patient-years of real-world experience with Fanapt^® (iloperidone). As such BYSANTI™ represents a novel therapeutic option with a trusted safety profile in the treatment of these serious psychiatric conditions.

"The BYSANTI™ approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "BYSANTI™ exemplifies a new era of accelerated innovation in drug development that can transform how we address unmet needs in behavioral health."

BYSANTI™ is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to complete by the end of this year.

BYSANTI™ (milsaperidone), a new chemical entity, rapidly interconverts to iloperidone, providing dual active molecules that work in tandem by antagonizing dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors to modulate key pathways in these disorders. Its safety profile aligns closely with that established for iloperidone.

BYSANTI™'s unique in-class receptor binding profile, featuring strong alpha-adrenergic binding in excess of dopamine and serotonin receptor binding, makes it suitable for further investigation in conditions that include symptoms of hostility, agitation, and hyperarousal.

Vanda anticipates commercial availability of BYSANTI™ in Q3 of 2026. BYSANTI™ marketing exclusivity is expected to be protected by regulatory data exclusivity and issued US patents, with the latest expiring in 2044, providing a robust foundation for long-term innovation and patient benefit.

BYSANTI™ is the second new drug approval for Vanda in less than 2 months following the approval of NEREUS™ in December of 2025.

About BYSANTI™

To access the full Prescribing Information, including BOXED WARNING, visit www.bysanti.com.

About Bipolar I Disorder and Schizophrenia

Bipolar I disorder impacts a significant portion of the roughly 10 million Americans with bipolar disorder, characterized by manic or mixed episodes that require effective symptom management to enhance outcomes.¹ Schizophrenia affects approximately 1% of the U.S. adult population (about 2.8 million people), often causing substantial functional impairment, frequent hospitalizations, and diminished quality of life.²³⁴⁵

References

1. Harvard Medical School, 2007. National Comorbidity Survey (NSC). (2017, August 21).
2. Potkin SG, et al. Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S4-S11. doi:10.1097/JCP.0b013e3181692787. 
3. Cutler AJ, et al. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-S28. doi:10.1097/JCP.0b013e318169278d. 
4. Weiden PJ, et al. A Randomized Trial of Iloperidone for Prevention of Relapse in Schizophrenia: The REPRIEVE Study. J Clin Psychopharmacol. 2016;36(4):302-308. doi:10.1097/JCP.0000000000000516. (PMC4982888). 
5. Torres R, et al. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024;85(1):23m14966. doi:10.4088/JCP.23m14966.

INDICATION AND IMPORTANT SAFETY INFORMATION

BYSANTI™ (milsaperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. BYSANTI™ is not approved for use in patients with dementia-related psychosis.

CONTRAINDICATIONS

• Known hypersensitivity to milsaperidone or the inactive ingredients in BYSANTI™.

WARNINGS AND PRECAUTIONS

• Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack).
• QTc Interval Prolongation: may be associated with torsade de pointes and sudden death. Avoid concomitant use of BYSANTI™ with other drugs that prolong the QTc interval, and in patients with a significant risk of developing torsade de pointes; consider decreasing the BYSANTI™ dosage when prescribing BYSANTI™ with other drugs that inhibit milsaperidone metabolism or in CYP2D6 poor metabolizers. Monitor serum potassium and magnesium at baseline and during treatment in patients at risk for significant electrolyte disturbances.
• Neuroleptic Malignant Syndrome (NMS): If NMS is suspected, immediately discontinue BYSANTI™ and provide intensive symptomatic treatment and close monitoring.
• Tardive Dyskinesia: Discontinue if clinically appropriate.
• Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
• Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure in patients who are vulnerable to hypotension, and in those with known cardiovascular or cerebrovascular disease.
• Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
• Leukopenia, Neutropenia, and Agranulocytosis: Patients with a pre-existing low white blood cell count (WBC) or absolute neutrophil count or a history of drug induced leukopenia or neutropenia should have frequent monitoring of their complete blood count during the first few months of BYSANTI™ therapy and should discontinue BYSANTI™ at the first sign of a decline in WBC in the absence of other causative factors. Discontinue BYSANTI™ in patients with absolute ANC <1000/mm3 and follow their WBC until recovery.
• Priapism: Severe priapism may require surgical intervention.
• Potential for Cognitive and Motor Impairment: Use caution about driving a motor vehicle or operating hazardous machinery until patients are reasonably certain that therapy with BYSANTI™ does not adversely affect them.
• Intraoperative Floppy Iris Syndrome (IFIS): It is not recommended to initiate therapy in patients scheduled to have cataract or glaucoma surgery. IFIS during cataract surgery may require modifications to the surgical cataract technique.
• Falls: BYSANTI™ may increase the risk of falls, which could cause fractures or other injuries.
• Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, BYSANTI™ elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds.
• Body Temperature Regulation: Atypical antipsychotics may disrupt the body's ability to reduce core body temperature.
• Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.

ADVERSE REACTIONS

• Commonly observed adverse reactions (incidence ≥5% and 2-fold greater than placebo) were:
  • Schizophrenia: dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
  • Bipolar mania: tachycardia, dizziness, dry mouth, hepatic enzymes increased, nasal congestion, weight increased, hypotension, and somnolence.

DRUG INTERACTIONS

• Strong CYP2D6 Inhibitors: Reduce the dosage of BYSANTI™ when administered with a strong CYP2D6 inhibitor.
• Strong CYP3A4 Inhibitors: Reduce the dosage of BYSANTI™ when administered with a strong CYP3A4 inhibitor.
• Strong CYP2D6 and Strong CYP3A4 Inhibitors: Reduce the dosage of BYSANTI™ if administered concomitantly with both a CYP2D6 and a CYP3A4 inhibitor by one-half.
• Drugs that Lower Blood Pressure: Avoid concomitant administration of BYSANTI™ with alpha-adrenergic blocking agents and consider lowering the dosage of other drugs that lower blood pressure.

USE IN SPECIFIC POPULATIONS

• CYP2D6 poor metabolizers: Consider CYP2D6 genetic testing to determine the patient's CYP2D6 metabolizer status prior to BYSANTI dosing. Follow the titration schedule for CYP2D6 poor metabolizers.
• Pregnancy: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms following delivery.
• Lactation: Advise not to breastfeed during BYSANTI™ treatment and for 6 days after the last dose in CYP2D6 normal metabolizers and 8 days after the last dose in CYP2D6 poor metabolizers.
• Hepatic Impairment: BYSANTI™ is not recommended for patients with severe hepatic impairment.

To report suspected adverse reactions, contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See full Prescribing Information including boxed warning.

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this press release, including but not limited to statements regarding patient and provider access to BYSANTI™; develop additional indications for BYSANTI™, including treatment-resistant major depressive disorder and conditions involving hostility, agitation and hyperarousal; the prevalence of bipolar I disorder and schizophrenia; Vanda's commercial launch plans for BYSANTI™ and the timing thereof; and the potential to extend patent exclusivity for BYSANTI™ until 2044, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to successfully execute the commercial launch of BYSANTI™ and to execute such launch within the expected timeframe; the accuracy of the estimates of the prevalence of bipolar I disorder and schizophrenia; and Vanda's ability to satisfy the conditions necessary to extend BYSANTI™'s patent exclusivity until 2044. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate Contact:

Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com 

Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
Follow us on X @vandapharma

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

What indications did BYSANTI (VNDA) receive FDA approval for on February 20, 2026?

BYSANTI received approval for acute manic or mixed episodes in bipolar I disorder and schizophrenia in adults. According to the company, the approval covers both indications and positions BYSANTI as a first‑line therapy in these psychiatric conditions.

When will BYSANTI (VNDA) be commercially available following the February 20, 2026 approval?

Vanda expects commercial availability of BYSANTI in Q3 2026. According to the company, manufacturing and launch preparations aim to make the product available to providers and patients during that quarter.

How is BYSANTI (milsaperidone) related to iloperidone and what does that mean for safety?

BYSANTI rapidly interconverts to iloperidone and demonstrated bioequivalence across dosing. According to the company, this leverages established efficacy and safety knowledge from iloperidone's clinical heritage.

What intellectual property protections does BYSANTI (VNDA) have after FDA approval?

BYSANTI's marketing exclusivity is expected to be supported by regulatory data exclusivity and issued US patents. According to the company, the latest BYSANTI patent expires in 2044.

Is BYSANTI being studied for other psychiatric uses beyond bipolar I and schizophrenia?

Yes. BYSANTI is being tested as once‑daily adjunctive therapy in treatment‑resistant major depressive disorder. According to the company, the ongoing study is expected to complete by the end of 2026.

How significant is BYSANTI approval for Vanda (VNDA) following recent company milestones?

BYSANTI is Vanda's second new drug approval within two months, following NEREUS in December 2025. According to the company, this reflects accelerated innovation and expansion of its psychiatric portfolio.