Vanda said it expects Bysanti to be available in the market in the third quarter of 2026.
- Three of four analysts on Koyfin rate the stock ‘Buy,’ with a 12-month target of $13.63, implying 137% upside from the last close.
- The next catalysts include a Phase 3 depression study for Bysanti and a Phase 3 GLP-1 nausea trial for Tradipitant.
- A mid-2026 FDA decision for Imsidolimab in skin disease is also due, along with continued development of Hetlioz across other sleep indications.
Shares of Vanda Pharmaceuticals, Inc. (VNDA) jumped over 40% in overnight trading on Sunday after the U.S. Food and Drug Administration (FDA) approved its Bysanti tablets, putting the stock back into the spotlight as investors weigh what could drive the next leg higher.
The stock surged 45% in after-hours trading on Friday after the FDA cleared Bysanti for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. Vanda said it expects the drug to be available in the market in the third quarter of 2026.
VNDA: Wall Street Sees Strong Upside Potential
According to Koyfin data, four analysts currently cover Vanda. Of those, three rate the stock ‘Buy’ and one rates it ‘Hold’. Price targets range from $7.5 on the low end to $22 on the high end, with a 12-month average target of $13.63, implying an upside of 137% from the stock’s last close.
Koyfin data also show that the stock has returned about 28% over the past year.
Bysanti Adds To Vanda’s Psychiatry Portfolio
Bysanti, an atypical antipsychotic, was shown to work in the body the same way as Iloperidone at both lower and higher doses, based on studies of single and repeated dosing, the company said.
The approval adds to Vanda’s psychiatry portfolio, which includes Fanapt, already approved for schizophrenia and bipolar I disorder. Fanapt is also being developed as a long-acting injectable formulation for relapse prevention in schizophrenia and is currently in Phase III clinical trials. In its fourth-quarter (Q4) earnings report, Vanda said the global antipsychotic category represented an estimated $20 billion total addressable market in 2025.
Beyond bipolar I disorder and schizophrenia, Bysanti is being studied as a once-daily adjunctive treatment in treatment-resistant major depressive disorder. This program is in Phase III development, with the ongoing study expected to be completed by the end of this year.
Vanda Phase 3 GLP-1 Study Planned This Year
In December, the FDA approved Nereus (Tradipitant) for the prevention of motion sickness. Tradipitant is also in Phase II development for vomiting induced by GLP-1 drugs, with Vanda planning to initiate a Phase III program in the first half of 2026. The drug is additionally positioned in the regulatory stage for gastroparesis.
Following approval, B. Riley raised its price target on Vanda to $14 from $11 and maintained a ‘Buy’ rating, describing the company as an “ongoing turnaround story” and highlighting the implications for Tradipitant in GLP-1-related nausea. Cantor Fitzgerald maintained an ‘Overweight’ rating with an $11 target, citing the broad label and potential read-through for the GLP-1 nausea program. Jefferies raised its target to $7.50 from $5 while keeping a ‘Hold’ rating, saying Tradipitant could represent a $100 million to $300 million opportunity in motion-related vomiting.
Skin Disease Filing Adds 2026 Catalyst
Imsidolimab, Vanda’s candidate for generalized pustular psoriasis, is in regulatory review following the submission of a biologics license application in Q4. The company has requested priority review, which could allow for a regulatory decision as early as mid-2026 if granted.
The filing adds another potential FDA decision point to Vanda’s 2026 calendar, alongside Bysanti’s commercial launch and tradipitant’s Phase III initiation.
Hetlioz Still Advances In Other Sleep Uses
In January, the FDA rejected Vanda’s supplemental application seeking approval of Hetlioz for jet lag disorder in its current form, citing concerns that the study design did not sufficiently reflect real-world jet travel conditions.
H.C. Wainwright said the rejection represented only a minor setback and reiterated a ‘Buy’ rating with a $22 price target, noting that its valuation did not include any contribution from tasimelteon sales in jet lag.
Hetlioz remains positioned across other sleep indications, with jet lag disorder and insomnia in the regulatory stage and pediatric insomnia, delayed sleep phase disorder, and pediatric Non-24 in Phase III development.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment for VNDA was ‘extremely bullish’ amid ‘extremely high’ message volume.
One user noted, “More than doubled my position after Nereus was approved taking my average from just under $5 to just under $6.”
Another user said, “could do witha big volume spike monday premarket but everything else looking great.”
VNDA stock has declined 35% so far this year.
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