AnaptysBio Inc (ANAB)

Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM EvidenceApril 28, 2026 7:12 PM
PR Newswire (US)

WASHINGTON, April 28, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of the original research article titled "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in New England Journal of Medicine (NEJM) Evidence1.







The findings of this pivotal phase III study are included in the Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), submitted to the U.S. Food and Drug Administration (FDA) with a target action date of December 12, 2026.ReferencesSmieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). About ImsidolimabImsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s. Vanda holds an exclusive global license for the development and commercialization of imsidolimab from AnaptysBio (Nasdaq: ANAB).About Vanda PharmaceuticalsVanda 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 STATEMENTSVarious statements in this press release, including, but not limited to statements regarding the anticipated timing of the completion of the FDA's review of the imsidolimab BLA; Vanda's plans to seek FDA approval of imsidolimab for the treatment of GPP; and the potential to extend regulatory and patent exclusivity for imsidolimab into the late 2030s, 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, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's ability to obtain FDA approval of imsidolimab for the treatment of GPP; and Vanda's ability to satisfy the conditions necessary to extend regulatory and patent exclusivity for imsidolimab into the late 2030s. 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.comJim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-the-publication-of-efficacy-and-safety-of-imsidolimab-for-generalized-pustular-psoriasis-in-nejm-evidence-302756392.htmlSOURCE Vanda Pharmaceuticals Inc.

Original: Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM Evidence

ANAB $16.49 + 33% ...  will host an investor call and live webcast to review top-line data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Wednesday, Feb. 12, 2025, at 8:30am ET / 5:30am PT....

ANAB definite uptrend

HighPeaks, The NY Times article was high profile, but the connection to ANAB isn't readily apparent.

Even with the partial sale/monetization of the revenue stream from dostarlimab in December, the drug is also being studied by Glaxo for other cancer types (endometrial, non-small cell lung, ovarian, and mismatch repair deficient solid tumors). One question to answer is whether the monetization deal with Sagard was only for colorectal, or for all the indications? Probably for all, but I'll have to do more research.

ANAB has numerous other programs and a large pile of cash, so looks interesting. But investing in biotech requires a ton of research, but even then you still don't know what you have, and landmines are everywhere. Better to invest in 'what you know', as Buffett recommends :o)




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Thanks TP. Yeah this has the potential to really be a big mover. So surprised no one has made the connection between this potential miracle drug and $ANAB receiving royalties on it(as it’s originator). GSK is the collaborator who has just commercialized it but it’s ANAB invention.

Tremendous find HighPeaks. .You have been early on quite a few big movers. I'm thinking this is yet another one.

Will be watching this closely...thanks.

According to this link ANAB gets 8-25% royalties from Dostarlimab. This drug has recently shown phenomenal results in a trial at Memorial Sloan Kettering Hospital. All patients fully recovered from rectal cancer.
https://www.globenewswire.com/fr/news-release/2020/10/26/2114250/0/en/AnaptysBio-and-GlaxoSmithKline-Amend-Strategic-Immuno-Oncology-Collaboration.html

$ANAB | #Anaptysbio Spikes After Drug Designation


Nice spike in the afterhours session, lets hope we
can get some continuation tomorrow.
Target $29.00 to Fib Golden Pocket
Also a very large gap to fill at $35.00
AnaptysBio gets orphan drug designation of imsidolimab for pustular psoriasis
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RSI @ 16. laughable. Zacks has positive take. https://finance.yahoo.com/news/anaptysbio-enters-oversold-territory-135501475.html

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LOL! Twitter PnD. Buyer beware.

Once the real bounce starts it will be fast....

$10 to da moon

This will bounce..... 15 AH

trying to bounce back over $11, hoping for more

Ouch -

Nothing happen here?

This stock is making noise! Bought in Sept $ANAB