WASHINGTON , Aug. 18, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it secured a landmark victory over the U.S. Food and Drug Administration (FDA) in its longstanding dispute with the agency regarding the approvability of HETLIOZ ® (tasimelteon) to treat jet lag disorder ( Vanda Pharmaceuticals Inc. v. FDA , case no. 24-1049). Vanda submitted its supplemental New Drug Application... Read More

Fanapt ® Q2 2025 net product sales increased by 27% to $29.3 million compared to Q2 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON ,... Read More

Conference Call and Webcast to Follow WASHINGTON , July 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the second quarter 2025 on Thursday, July 31, 2025 , before the market opens. Vanda will host a conference call at 8:00 AM ET on Thursday, July 31, 2025 , during which management will discuss the second quarter 2025 financial results and other corporate... Read More

WASHINGTON , June 10, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S). VCA-894A is being developed for a patient who was first... Read More

WASHINGTON , May 27, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, to be held in Scottsdale, Arizona , from May 27 through May 30, 2025 . The following will be presented: May 27, 2025 Presentation Title: "Pharmacokinetic Results of Single-Dose and Multiple-Dose Bioequivalence Studies of... Read More

WASHINGTON , May 16, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in investor meetings at the Mizuho Neuro & Ophthalmology Summit 2025 in New York City on Wednesday, May 21, 2025 . About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address... Read More

Fanapt ® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024 Fanapt ® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab... Read More

WASHINGTON , May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) 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. Bysanti™ is a new... Read More

Conference Call and Webcast to Follow WASHINGTON , May 2, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2025 on Wednesday, May 7, 2025 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday , May 7, 2025, during which management will discuss the first quarter 2025 financial results and other corporate... Read More

WASHINGTON , April 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr. Martin Makary , and reductions in force. FDA last night represented to a... Read More

WASHINGTON , April 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at the American Academy of Neurology (AAN) Annual Meeting, to be held in San Diego, California from April 5 through April 9 , 2025. The following will be presented: April 9, 2025 Presentation Title: "Translating IGHMBP2 Variants with a CMT2S Patient-specific Organ-on-a-chip Model: Personalized Medicine... Read More

WASHINGTON , March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc . (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.... Read More

WASHINGTON , Feb. 24, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article entitled "Potential ASO-based personalized treatment for Charcot-Marie-Tooth disease type 2S" in Molecular Therapy Nucleic Acids 1 , a Cell Press partner journal, that describes the development of a novel antisense oligonucleotide (ASO) therapeutic, VCA-894A, for a patient with a rare... Read More

Q4 2024 total revenues of $53.2 million , +17% compared to Q4 2023 Q4 2024 Fanapt ® net product sales of $26.6 million , +18% compared to Q4 2023 Full year 2024 total revenues of $198.8 million , +3% compared to full year 2023 Full year 2025 revenue expected to grow to $210 to $250 million Psychiatry portfolio revenue expected to grow to greater than $750 million in 2030 Fanapt ® MAA for bipolar I disorder and schizophrenia... Read More

Conference Call and Webcast to Follow WASHINGTON , Feb. 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2024 on Thursday, February 13, 2025 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Thursday, February 13, 2025 , during which management will discuss the fourth quarter and full year 2024... Read More

Highlights faulty FDA review WASHINGTON , Jan. 27, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provides an update on the tradipitant development program. Gastroparesis is a serious digestive disorder of the stomach. In patients with gastroparesis, food moves too slowly from the stomach to the small intestine, causing a host of gastrointestinal symptoms including nausea, vomiting, bloating,... Read More

WASHINGTON , Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As previously reported, Vanda has sought approval from the U.S. Food and Drug Administration (FDA) for tradipitant for the treatment of patients with gastroparesis. FDA declined to approve Vanda's New Drug Application (NDA) for tradipitant for the treatment of... Read More

WASHINGTON , Dec. 20, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2000 Americans. 1 PV is a chronic... Read More

WASHINGTON , Nov. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in November 2024 : The Stifel 2024 Healthcare Conference on Tuesday, November 19, 2024 . A corporate presentation is scheduled for 9:45 a.m. Eastern Time . The Jefferies 2024 London Healthcare Conference on Thursday, November 21, 2024 . A... Read More

Revenues for Q3 2024 were $47.7 million , an increase of 23% compared to Q3 2023 Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges Fanapt ® launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 Fanapt ® long acting injectable program expected to be initiated in Q4 2024 Milsaperidone NDA for schizophrenia and bipolar I disorder... Read More

Conference Call and Webcast to Follow WASHINGTON , Oct. 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2024 on Wednesday, November 6, 2024 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, November 6, 2024 , during which management will discuss the third quarter 2024 financial results and other... Read More

Board Has Determined That Latest Proposal Is Not in the Best Interests of the Company or Stockholders WASHINGTON , Oct. 14, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it received a second unsolicited, non-binding proposal from Cycle Group Holdings Ltd. ("Cycle Group") to acquire the Company for $8.00 per share in cash. Cycle Group's second proposal was... Read More

WASHINGTON , Sept. 19, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its tradipitant development program. On September 18, 2024 , the U.S. Food and Drug Administration (FDA) declined to approve Vanda's New Drug Application (NDA) of tradipitant for the treatment of symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL). Gastroparesis is a serious... Read More

WASHINGTON , Sept. 11, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the 2024 Cantor Global Healthcare Conference in New York City on Thursday, September 19, 2024 . A fireside chat is scheduled for 8:00 a.m. Eastern Time . The fireside chat given at the 2024 Cantor Global Healthcare Conference may be accessed live on Vanda's corporate website,... Read More

WASHINGTON , Sept. 4, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the H.C. Wainwright Global Investment Conference in New York City on Tuesday, September 10, 2024 . A corporate presentation is scheduled for 2:00 p.m. Eastern Time . The corporate presentation given at the H.C. Wainwright Global Investment Conference may be accessed live on Vanda's... Read More

WASHINGTON , Aug. 29, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Wells Fargo 2024 Healthcare Conference in Boston on Friday, September 6, 2024 . A corporate presentation is scheduled for 11:00 a.m. Eastern Time . The corporate presentation given at the Wells Fargo 2024 Healthcare Conference may be accessed live on Vanda's corporate website,... Read More

Revenues for Q2 2024 were $50.5 million , an increase of 6% compared to Q1 2024 and an increase of 10% compared to Q2 2023 Financial Guidance reinstated for Full Year 2024 Fanapt ® approved for the acute treatment of bipolar I disorder; commercial launch initiated in Q3 2024 PONVORY ® commercial launch in multiple sclerosis initiated in Q3 2024 Tradipitant NDA review for gastroparesis ongoing; PDUFA date of September 18,... Read More

Conference Call and Webcast to Follow WASHINGTON , July 26, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the second quarter 2024 on Wednesday, July 31, 2024 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, July 31, 2024 , during which management will discuss the second quarter 2024 financial results and other... Read More

WASHINGTON , July 1, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. District Court for the District of Delaware (the "Court") denied the motions for judgment on the pleadings that were filed by Teva Pharmaceuticals USA , Inc. ("Teva") and Apotex Inc. and Apotex Corp. ("Apotex") and ordered that Vanda's HETLIOZ ® patent lawsuit may proceed. Vanda brought this suit in... Read More

WASHINGTON , June 19, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Company's Board of Directors (the "Board"), following careful review and consultation with its independent financial and legal advisors, has determined that the unsolicited proposal from Cycle Group Holdings Ltd ("Cycle Group") to acquire Vanda for $8.00 per share in cash and the revised unsolicited proposal... Read More

No Shareholder Action Required at This Time WASHINGTON , June 13, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC ("FP") to acquire Vanda for $8.50 - $9.00 per share in cash plus certain Contingent Value Rights. Consistent with its fiduciary duties, and in consultation with its financial and... Read More

No Shareholder Action Required at This Time WASHINGTON , June 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received an unsolicited, non-binding indication of interest from Cycle Group Holdings Ltd. ("Cycle Group") to acquire the Company for $8.00 per share in cash. Consistent with its fiduciary duties, and in consultation with its independent... Read More

WASHINGTON , May 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Jefferies 2024 Global Healthcare Conference in New York City on Thursday, June 6, 2024 . A corporate presentation is scheduled for 2:00 p.m. Eastern Time . The corporate presentation given at the Jefferies 2024 Global Healthcare Conference may be accessed live on Vanda's... Read More

WASHINGTON , May 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that ownership of the U.S. New Drug Application and Investigational New Drug Applications for PONVORY ® (ponesimod) has been transferred to Vanda from a Johnson & Johnson Company, which now fully allows Vanda to commercialize PONVORY ® in the U.S. "This milestone completes the transfer of the FDA marketing... Read More

WASHINGTON , May 29, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at SLEEP 2024, to be held in Houston, TX from June 1 through June 5, 2024 . The following will be presented: June 4, 2024 Presentation Title: "Drug Screening and CRISPR/Cas9 Screening of HCN Channels" Poster Presentation Session: P-17 Poster Number: 10 Presenter: Dr. Sandra Paulina Smieszek , Head of... Read More

WASHINGTON , May 24, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Company's Board of Directors (the "Board") carefully reviewed the revised unsolicited proposal from Future Pak, LLC ("FP") to acquire the Company for $7.25 to $7.75 per share in cash plus certain Contingent Value Rights ("CVRs") and, after having consulted with the Company's independent financial and legal... Read More

New Drug Application expected to be submitted in Q4 2024 WASHINGTON , May 15, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its second Phase III study of tradipitant in motion sickness, confirming the previously reported results of two efficacy studies demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. This Phase... Read More

Revenues for Q1 2024 were $47.5 million , an increase of 5% compared to Q4 2023 Cash increase of $5.9 million in Q1 2024 to $394.1 million Fanapt ® approved for the acute treatment of bipolar I disorder; commercial launch expected in Q3 2024 Milsaperidone NDA for schizophrenia and bipolar disorder expected to be submitted in early-2025 PONVORY ® commercial launch expected in Q3 2024 Tradipitant NDA review for gastroparesis... Read More

No Shareholder Action Required at This Time WASHINGTON , May 7, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC ("Future Pak") to acquire the Company. The revised proposal consists of a $7.25 to $7.75 per share in cash plus certain Contingent Value Rights ("CVRs"). The amended proposal follows... Read More

Conference Call and Webcast to Follow WASHINGTON , April 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2024 on Wednesday, May 8, 2024 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday , May 8, 2024, during which management will discuss the first quarter 2024 financial results and other corporate... Read More

Reminds Vanda’s Board of Their Fiduciary Duties Given the Mishandling of Future Pak’s Offer to Acquire Vanda’s Underperforming and Undervalued Shares at an ~80-90% Premium Expresses Serious Concerns Over Entrenchment, Misaligned Incentives, and Cronyism at Vanda, Including the CEO’s and His Family’s $46M+ in Disclosed Compensation Amidst $1B+ in Shareholder Value Destruction Believes Vanda’s Board Must Explore Strategic... Read More

WASHINGTON , April 22, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Supreme Court denied Vanda's petition for a writ of certiorari in its HETLIOZ ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA , Inc., Apotex Inc. and Apotex Corp. "We are disappointed that the Supreme Court has decided not to hear our case and clarify the lower court standard... Read More

WASHINGTON , April 17, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today announced that its Board of Directors (the "Board") has adopted a limited duration stockholder rights plan (the "Rights Plan") to protect stockholder interests and maximize value for all stockholders. The Rights Plan is effective immediately. The Board adopted the Rights Plan in response to the unsolicited... Read More

Board Determined Unsolicited Takeover Proposals Significantly Undervalue the Company No Shareholder Action Required at This Time WASHINGTON , April 17, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that, since March 2024 , it received several unsolicited proposals from Future Pak, LLC ("Future Pak"), to acquire all of the outstanding shares of Vanda (the... Read More

Fanapt ® Treatment is Now Available to Adult Patients for the Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder Approval Represents Significant Novel Indication for Vanda's Fanapt ® Franchise WASHINGTON , April 2, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt ® (iloperidone) tablets for... Read More

WASHINGTON , March 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on March 4, 2024 , it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation. In July... Read More

Full year 2023 revenues were $192.6 million PONVORY ® acquisition completed in Q4 2023 and transition ongoing 3 FDA PDUFA target action dates in 2024 Ended 2023 with approximately $388 million in cash and cash equivalents WASHINGTON , Feb. 7, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2023.... Read More

WASHINGTON , Feb. 5, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on February 4, 2024 , it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has... Read More

Conference Call and Webcast to Follow WASHINGTON , Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2023 on Wednesday, February 7, 2024 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, February 7, 2024 , during which management will discuss the fourth quarter and full year 2023... Read More

WASHINGTON , Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis. Onychomycosis, or tinea unguium, is a fungal infection of the nail. Onychomycosis can result in discoloration of the nail, onycholysis (nail separation... Read More

WASHINGTON , Jan. 29, 2024 /PRNewswire/ - - Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the United States District Court for the District of Columbia granted Vanda's motion for summary judgment on its claim against the United States Food and Drug Administration (FDA) for unlawfully delaying a hearing on the approvability of Vanda's supplemental new drug application (sNDA) for HETLIOZ ® to treat jet... Read More

WASHINGTON , Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY ® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses. When... Read More

WASHINGTON , Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" in the Clinical Gastroenterology and Hepatology Journal 1 which follows a previously published study of tradipitant in the treatment of... Read More

WASHINGTON , Jan. 23, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within the IGHMBP2 gene. CMT2S is a rare subtype of... Read More

WASHINGTON , Jan. 19, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the United States Court of Federal Claims in Washington, D.C. denied in part the government's motion to dismiss Vanda's claim against the United States for the Food and Drug Administration's (FDA) uncompensated taking of Vanda's trade secrets and confidential information ( Vanda Pharmaceuticals Inc. v. USA , case... Read More

WASHINGTON , Jan. 17, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study" in the Journal of Clinical Psychiatry. 1 The findings of this pivotal study have been submitted to the U.S. Food and Drug Administration (FDA) as part of Vanda's supplemental New Drug... Read More

WASHINGTON , Jan. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) submitted a comment letter ( here ) on January 5, 2024 , regarding the FDA's recently announced policy—by way of a draft guidance document—that substantially restricts drug manufacturers' ability to communicate truthful, non-misleading information about FDA-approved drugs. Communication of novel scientific findings and emerging... Read More

WASHINGTON , Jan. 4, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the J.P. Morgan Healthcare Conference in San Francisco, California on Tuesday, January 9 , 2024. A corporate presentation is scheduled for 9:45 a.m. Pacific Time ( 12:45 p.m. Eastern Time ). The corporate presentation given at the J.P. Morgan Healthcare Conference may be accessed... Read More

WASHINGTON , Dec. 7, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY ® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. PONVORY ® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically... Read More

WASHINGTON , Dec. 4, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis. The FDA has set September 18, 2024 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA). If approved, tradipitant... Read More

WASHINGTON , Nov. 9, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in November 2023 : The Stifel 2023 Healthcare Conference on Tuesday, November 14, 2023 . A corporate presentation is scheduled for 4:10 p.m. Eastern Time . The Jefferies 2023 London Healthcare Conference on Thursday, November 16, 2023 . A... Read More

Total revenues in the first nine months of 2023 were $147.4 million Vanda provides update on pipeline advancements and regulatory plans WASHINGTON , Nov. 8, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2023 . "We have significantly advanced our development pipeline, now expecting FDA decisions on two sNDAs... Read More

Conference Call and Webcast to Follow WASHINGTON , Nov. 1, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2023 on Wednesday, November 8, 2023 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, November 8, 2023 , during which management will discuss the third quarter 2023 financial results and other... Read More

WASHINGTON , Oct. 20, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced its intention to file a petition for a writ of certiorari in its HETLIOZ ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA , Inc., Apotex Inc. and Apotex Corp. Vanda seeks to demonstrate that the United States Court of Appeals for the Federal Circuit (Federal Circuit) applied a flawed... Read More

WASHINGTON , Oct. 5, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Jefferies Inaugural Biotech CNS/Neuro Summit in New York City on Wednesday, October 11, 2023 . A corporate presentation is scheduled for 1:30 p.m. Eastern Time . The corporate presentation given at the Jefferies Inaugural Biotech CNS/Neuro Summit may be accessed live on Vanda's... Read More

WASHINGTON , Sept. 6, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the H.C. Wainwright Global Investment Conference in New York City on Wednesday, September 13, 2023 . A corporate presentation is scheduled for 4:00 p.m. Eastern Time . The corporate presentation given at the H.C. Wainwright Global Investment Conference may be accessed live on... Read More

Q2 2023 total revenues were $46.1 million Total revenues in the first six months of 2023 were $108.6 million Vanda provides update on pipeline advancements and regulatory plans WASHINGTON , July 27, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2023 . "During the second quarter we continued our efforts to protect... Read More

Conference Call and Webcast to Follow WASHINGTON , July 20, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the second quarter 2023 on Thursday, July 27, 2023 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Thursday, July 27, 2023 , during which management will discuss the second quarter 2023 financial results and other corporate... Read More

WASHINGTON , June 5, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Jefferies 2023 Global Healthcare Conference in New York City on Friday, June 9, 2023 . A corporate presentation is scheduled for 12:15 p.m. Eastern Time . The corporate presentation given at the Jefferies 2023 Global Healthcare Conference may be accessed live on Vanda's... Read More

WASHINGTON , June 1, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at SLEEP 2023, to be held in Indianapolis, IN from June 3 – 7, 2023. The following will be presented: June 5, 2023 Presentation Title: "Melanopsin Genetic Variants and Delayed Sleep Phenotype – Whole Genome Sequencing Analysis" Poster Number: 94 Presenter: Dr. Sandra Paulina Smieszek , Head of Genetics... Read More

WASHINGTON , June 1, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VCA-894A for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within IGHMBP2. CMT2S is a rare subtype of Charcot-Marie-Tooth disease (CMT), an inherited peripheral neuropathy... Read More

WASHINGTON , May 25, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its Phase III study of tradipitant in motion sickness, confirming the previously reported results demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. The Phase III study was conducted in real-world conditions on boats in the coastal waters of the... Read More

WASHINGTON , May 10, 2023 /PRNewswire/ Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its Hetlioz ® Abbreviated New Drug Application appeal. Today a three-judge panel of the United States Court of Appeals for the Federal Circuit issued a written opinion that affirmed a December 13, 2022 , decision of the United Sates District Court for the District of Delaware , which held that the... Read More

WASHINGTON , May 4, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at Digestive Disease Week (DDW) 2023, to be held in Chicago, IL and online from May 6-9, 2023 . The following will be presented: May 7, 2023 Presentation Title: "THE ROLE OF TENASCIN-X IN IDIOPATHIC GASTROPARESIS: WGS ANALYSIS" Poster Number: Su1618 Presenter: Dr. Sandra Paulina Smieszek , Head of Genetics... Read More

Q1 2023 total revenues were $62.5 million Vanda provides update on three upcoming regulatory submissions WASHINGTON , May 3, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2023 . "The first quarter of 2023 was busy and challenging as we are preparing three regulatory submissions for bipolar disorder, insomnia and... Read More

WASHINGTON , May 2, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced its action against the federal government for the uncompensated taking and misuse of Vanda's trade secrets and confidential information. Vanda alleges that the U.S. Food and Drug Administration (FDA) improperly provided confidential details from Vanda's drug master files for its products, HETLIOZ ® and Fanapt ® , to... Read More

Conference Call and Webcast to Follow WASHINGTON , April 27, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2023 on Wednesday, May 3, 2023 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday , May 3, 2023, during which management will discuss the first quarter 2023 financial results and other corporate... Read More

WASHINGTON , March 28, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced a win in its jet lag FOIA litigation against the FDA. On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA") case requesting records created by the Food and Drug Administration ("FDA") during its review of Vanda's application seeking approval of a new use... Read More

WASHINGTON , March 17, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the appointment of Tage Honoré, Ph.D., D.Sc. to its Board of Directors effective March 15, 2023 . Following Dr. Honoré's appointment, Vanda's Board of Directors is now comprised of six directors, five of whom are independent. "Tage is a highly accomplished industry leader and respected scientist with deep experience... Read More

Q4 2022 total revenues were $64.5 million Full year 2022 revenues were $254.4 million Vanda provides update on pipeline advancements and upcoming milestones WASHINGTON , Feb. 8, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2022 . "Our strong full year 2022 commercial performance positions Vanda... Read More

Conference Call and Webcast to Follow WASHINGTON , Feb. 1, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2022 on Wednesday, February 8, 2023 , after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, February 8, 2023 , during which management will discuss the fourth quarter and full year 2022... Read More

WASHINGTON , Jan. 6, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the J.P. Morgan Healthcare Conference in San Francisco, California on Thursday, January 12 , 2023. A corporate presentation is scheduled for 12:00 p.m. Pacific Time ( 3:00 p.m. Eastern Time ). The corporate presentation given at the J.P. Morgan Healthcare Conference may be accessed... Read More

Supplemental New Drug Application (sNDA) planned for 2023 WASHINGTON , Dec. 19, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc . (Vanda) (Nasdaq: VNDA) today reported positive results in a Phase III clinical study of Fanapt ® (iloperidone tablets), a novel atypical antipsychotic, in the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults. Fanapt ® is currently approved by the FDA for the... Read More

WASHINGTON , Dec. 16, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its appeal of the recent HETLIOZ ® ANDA litigation ruling. On December 14, 2022 , Vanda appealed the December 13 th decision of the United States District Court for the District of Delaware in the HETLIOZ ® ANDA litigation to the United States Court of Appeals for the Federal Circuit and requested an... Read More

WASHINGTON , Dec. 13, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its HETLIOZ ® ANDA Litigation. Vanda has brought several Hatch-Waxman lawsuits in the United States District Court for the District of Delaware against Teva Pharmaceuticals USA , Inc. (Teva) and Apotex Inc. (Apotex) asserting infringement of patents covering HETLIOZ ® (tasimelteon) 20 mg capsules. A... Read More

WASHINGTON , Dec. 2, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking. In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers with prior history of... Read More