Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift from Animal Testing to Human-Relevant Methods Vanda Pharmaceuticals (Nasdaq: VNDA) criticized the FDA's March 18, 2026 draft guidance on New Approach Methodologies (NAMs), arguing it lacks concrete examples, validation criteria, and citations needed to replace animal tests.Vanda called for withdrawal and substantial revision, urging clear acceptance pathways, specific validated NAM examples, and collaboration with industry and animal welfare groups.

#VNDA Vanda Pharmaceuticals Calls for Stronger FDA Action to Accelerate Shift from Animal Testing to Human-Relevant Methods

www.stocktitan.net/news/VNDA/vanda-pharmace...

Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years WASHINGTON, March 3, 2026/ PRNewswire/-- Vanda Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration has granted the company's request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research's proposal to refuse approval of Vanda's supplemental new drug application for HETLIOZ ® in the...

#VNDA Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years

www.stocktitan.net/news/VNDA/vanda-announce...

Vanda Pharmaceuticals Announces Participation in the 2026 Citizens Life Sciences Conference Vanda Pharmaceuticals (Nasdaq: VNDA) will participate in the 2026 Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026. A corporate presentation is scheduled for 2:15 p.m. Eastern Time and will be accessible live via Vanda's website under the Investors tab.Investors are advised to register at the conference site at least 15 minutes early to download required software; an archived link will be available on Vanda's site for approximately 30 days.

#VNDA Vanda Pharmaceuticals Announces Participation in the 2026 Citizens Life Sciences Conference

www.stocktitan.net/news/VNDA/vanda-pharmace...

📢 Stocks Trending NOW: #NVO #LLY #VNDA #NOVO-B.CO #DPZ #ACLX #IBRX #GOSS #D #TIRX

Vanda’s Hetlioz Jet Lag Bid Rejected Again by FDA; Shares Slide on Regulatory Setback Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) faced another regulatory setback as the U.S. Food and Drug Administration (FDA) declined to approve its supplemental N

Vanda’s ( #VNDA) Hetlioz Jet Lag Bid Rejected Again by FDA; Shares Slide on Regulatory Setback
prismmarketview.com/vandas-hetli...

FDA pushes back on new drug that aimed to ease jet lag for travelers FDA says HETLIOZ’s jet lag sNDA can’t be approved based on 5- and 8-hour phase advance data; Vanda cites transatlantic travel results and 10+ years of safety use.

#VNDA Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder

www.stocktitan.net/news/VNDA/vanda-pharmace...

BREAKING NEWS: ( NASDAQ: #VNDA ) Buy Recommendation Issued On VNDA By B. Riley

Breaking News: ( NASDAQ: #VNDA ) Hold Recommendation Issued On VNDA By Jefferies

🎯 Momentum #Options Activity trade ideas! Heavy institutional #optionsvolume far above daily averag

🎯 Momentum #Options Activity trade ideas! Heavy institutional #optionsvolume far above daily average with strong consensus on direction.

AM Algo #TradeIdea from 🔥 INSIDERFINANCE.COM 🔥
#ONDS, #RKT, #OTLK, #VNDA, #LYV

#OptionFlow #OptionsTrading #Trading

📢 Stocks Trending NOW: #AFJK #VNDA #CORT #ESHA #NKE #ANGH #NIO #ULY #ONDS #TSM

💊 $VNDA FDA approves NEREUS (tradipitant) for motion sickness | First new pharmacologic treatment in 40+ years | Jefferies raises PT to $7.50 | Launch coming 2026

Vanda Advances Toward Approval as Imsidolimab BLA Filed for Rare Skin Disease Vanda Pharmaceuticals (Nasdaq: VNDA) shares rose about 7% in premarket trading after the company announced the submission of a Biologics License Application to

Vanda #VNDA submitted a BLA to the FDA for imsidolimab to treat generalized pustular psoriasis. Shares jumped ~7% in premarket trading. prismmarketview.com/vanda-advanc...

#ANAB #VNDA Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis

www.stocktitan.net/news/ANAB/vanda-announce...

Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness Vanda Pharmaceuticals (Nasdaq: VNDA) provided regulatory updates on tradipitant for motion sickness on November 28, 2025.The FDA is conducting an expedited re-review of a partial clinical hold that limits long-term tradipitant studies; the target completion date was extended from November 26, 2025 to December 5, 2025 at the FDA's request to accommodate CDER personnel and leadership transitions. Separately, the New Drug Application (NDA) review remains on schedule with an unchanged PDUFA target action date of December 30, 2025. The FDA has issued labeling comments and formal labeling discussions with Vanda have begun.Vanda said it looks forward to potentially delivering the first new pharmacologic treatment for motion sickness in over four decades.

#VNDA Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness

www.stocktitan.net/news/VNDA/vanda-pharmace...

Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting Vanda Pharmaceuticals (Nasdaq: VNDA) reported positive topline results from a randomized, double-blind study (VP-VLY-686-2601) testing oral tradipitant to prevent GLP-1 agonist–induced nausea and vomiting in overweight/obese adults given a 1 mg Wegovy® injection.The trial (N=116) met its primary endpoint: vomiting occurred in 29.3% of tradipitant patients vs 58.6% placebo (p=0.0016), a ~50% relative reduction. A key secondary endpoint (vomiting plus significant nausea) was 22.4% vs 48.3% (p=0.0039). Tradipitant showed a favorable safety profile and Vanda plans a Phase III program anticipated to start in H1 2026.

#VNDA Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting

www.stocktitan.net/news/VNDA/vanda-pharmace...

🎯 #UnusualOptionsActivity trade ideas! Strong census from institutions on #options with short expir

🎯 #UnusualOptionsActivity trade ideas! Strong census from institutions on #options with short expirations.

PM Algo #TradeIdea from 🔥 INSIDERFINANCE.COM 🔥
#GLXY, #HUT, #CYPH, #CRDO, #VNDA

#OptionFlow #OptionsTrading #Trading

Vanda Pharmaceuticals Announces Participation in the Stifel 2025 Healthcare Conference Vanda Pharmaceuticals (Nasdaq: VNDA) will participate in the Stifel 2025 Healthcare Conference in New York City on Wednesday, November 12, 2025.A corporate presentation is scheduled for 4:40 p.m. Eastern Time and will be accessible live on Vanda's investor website via the Investors tab under Recent Events. Attendees are advised to arrive at the conference website at least 15 minutes early to register and download any required software or materials. Archived conference links will be available on Vanda's website for approximately 30 days after the event.

#VNDA Vanda Pharmaceuticals Announces Participation in the Stifel 2025 Healthcare Conference

www.stocktitan.net/news/VNDA/vanda-pharmace...

🚨 Institutions #optionsvolume surge detected! Weekly Top Momentum Activity from 🔥 INSIDERFINANCE.

🚨 Institutions #optionsvolume surge detected!

Weekly Top Momentum Activity from 🔥 INSIDERFINANCE.COM 🔥
1. #MRAM 639.2x
2. #ORBS 303.4x
3. #UMC 196.8x
4. #CDZI 60.0x
5. #VNDA 47.8x

#OptionFlow #OptionsTrading #Trading

Major Regulatory Breakthrough: Vanda Pharmaceuticals Secures FDA Fast-Track Review for Multiple Drugs Vanda Pharmaceuticals establishes expedited FDA review timeline for HETLIOZ and tradipitant, with decisions expected by Jan 2026. Agreement resolves multiple pending lawsuits and regulatory disputes.

#VNDA Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration

www.stocktitan.net/news/VNDA/vanda-pharmace...

Vanda Pharmaceuticals Set to Present at Three Major Investor Conferences in September 2025 Vanda Pharmaceuticals will showcase its corporate presentations at key investor conferences in New York and Boston this September, enhancing investor engagement.

Vanda Pharmaceuticals Set to Present at Three Major Investor Conferences in September 2025 #USA #New_York #Investor_Conferences #Vanda_Pharmaceuticals #VNDA

Breakthrough JAK2-Selective Drug: Vanda's VGT-1849B Receives FDA Orphan Status for Blood Disorder Treatment FDA grants orphan drug designation to Vanda's VGT-1849B, a selective JAK2 inhibitor for polycythemia vera affecting 57/100K people. Novel therapy promises targeted efficacy with improved safety.

#VNDA Vanda Pharmaceuticals Announces FDA Granted Orphan Drug Designation for VGT-1849B, a Novel and Selective Candidate for the Treatment of Polycythemia Vera

www.stocktitan.net/news/VNDA/vanda-pharmace...

Biotech Vanda Takes Fight to FDA Commissioner Over Controversial Generic Drug Safety Data Vanda Pharmaceuticals challenges FDA CDER director's pre-retirement decision on generic Hetlioz approvals, citing flawed bioequivalence studies and data inconsistencies in Indian trials.

#VNDA Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®

www.stocktitan.net/news/VNDA/vanda-seeks-fd...

Vanda Scores Major Court Victory Against FDA, Paving Path for Jet Lag Treatment Vanda Pharmaceuticals (NASDAQ: VNDA), announced a landmark win as the U.S. Court of Appeals overturned the FDA’s refusal to approve HETLIOZ® (tasimelteon) fo

(NASDAQ: #VNDA)
#VandaPharma wins big as the U.S. Court of Appeals overturns the FDA’s jet lag drug rejection. HETLIOZ® could become the first approved jet lag treatment, unlocking a major new market.
prismmarketview.com/vanda-scores...

Federal Court Overturns FDA: Vanda's Jet Lag Drug Hetlioz Shows 'Significant Improvement' in Trials Federal Appeals Court rules FDA must reconsider Hetlioz for jet lag disorder, citing statistically significant trial results. Decision forces FDA to approve or grant hearing.

#VNDA In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder

www.stocktitan.net/news/VNDA/in-a-major-win...

Vanda's Breakthrough: First-Ever Personalized Treatment Trial Launches for Ultra-Rare CMT2S Disease Novel antisense therapy targets ultra-rare genetic disorder affecting 1 in 1M patients. Personalized medicine approach shows promise in early studies. See trial details.

#VNDA Vanda Pharmaceuticals Announces First Patient Dosed in a Trial Evaluating VCA-894A in Charcot-Marie-Tooth disease Type 2S

www.stocktitan.net/news/VNDA/vanda-pharmace...

Clinical Data: Vanda Unveils Key Bioequivalence Study Results for Next-Gen Psychiatric Drug at Major Conference New pharmacokinetic data reveals bioequivalence findings for Milsaperidone and Iloperidone tablets. Get exclusive insights from ASCP 2025 presentation.

#VNDA Vanda Pharmaceuticals Announces Presentation at 2025 ASCP Annual Meeting

www.stocktitan.net/news/VNDA/vanda-pharmace...

Vanda Pharmaceuticals Announces Participation in the Mizuho Neuro & Ophthalmology Summit 2025 Vanda Pharmaceuticals (Nasdaq: VNDA) announced its upcoming participation in investor meetings at the Mizuho Neuro & Ophthalmology Summit 2025. The event will take place in New York City on Wednesday, May 21, 2025. This conference provides an opportunity for Vanda to engage with investors and discuss their developments in the neurological and ophthalmological therapeutic areas.

#VNDA Vanda Pharmaceuticals Announces Participation in the Mizuho Neuro & Ophthalmology Summit 2025

www.stocktitan.net/news/VNDA/vanda-pharmace...

Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results Vanda Pharmaceuticals (VNDA) reported Q1 2025 financial results with total net product sales of $50.0 million, up 5% year-over-year. Fanapt showed strong growth with sales of $23.5 million (+14% YoY) and prescription growth reaching 2,000 weekly prescriptions. The company reported a net loss of $29.5 million, compared to $4.1 million in Q1 2024, partly due to a $15 million payment for imsidolimab licensing. Key regulatory milestones include FDA acceptance of NDAs for tradipitant (PDUFA: Dec 30, 2025) and Bysanti (PDUFA: Feb 21, 2026). Cash position stands at $340.9 million. The company maintains its 2025 revenue guidance of $210-250 million and expects year-end cash of $280-320 million.

#VNDA Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results

www.stocktitan.net/news/VNDA/vanda-pharmace...

Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026 WASHINGTON, May 5, 2025/ PRNewswire/-- Vanda Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration informed Vanda that the New Drug Application for Bysanti™ has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application.

#VNDA Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026

www.stocktitan.net/news/VNDA/vanda-announce...

Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia WASHINGTON, March 31, 2025/ PRNewswire/-- Vanda Pharmaceuticals Inc. today announced that a New Drug Application was submitted to the U.S. Food and Drug Administration requesting marketing approval of Bysanti™ for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety...

#VNDA Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia

www.stocktitan.net/news/VNDA/vanda-pharmace...