| Vanda Pharmaceuticals Inc. (VNDA) Q1 2025 Earnings Call Transcript |
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q1 2025 Results Conference Call May 7, 2025 4:30 PM ET Company Participants Kevin Moran - CFO Mihael Polymeropoulos - President, Chairman and CEO Tim Williams - Senior Vice President and General Counsel Conference Call Participants Andrew Tsai - Jefferies Charles Duncan - Cantor Fitzgerald Operator Good afternoon, and welcome to the Quarter One 2025 Vanda Pharmaceuticals Incorporated Earnings Conference Call. I am Franz, and I will be the operator assisting you today. |
seekingalpha.com |
2025-05-07 23:55:19 |
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| Vanda Pharmaceuticals (VNDA) Reports Q1 Loss, Tops Revenue Estimates |
Vanda Pharmaceuticals (VNDA) came out with a quarterly loss of $0.50 per share versus the Zacks Consensus Estimate of a loss of $0.55. This compares to loss of $0.07 per share a year ago. |
zacks.com |
2025-05-07 22:10:33 |
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| Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results |
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 BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON , May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. |
prnewswire.com |
2025-05-07 20:01:00 |
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| Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026 |
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. |
prnewswire.com |
2025-05-05 12:00:00 |
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| Vanda Pharmaceuticals to Announce First Quarter 2025 Financial Results on May 7, 2025 |
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 activities. |
prnewswire.com |
2025-05-02 12:46:00 |
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| FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA |
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. |
prnewswire.com |
2025-04-23 19:52:00 |
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| Vanda Pharmaceuticals Announces Presentation at 2025 AAN Annual Meeting |
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 ASO-based Therapeutic Rescue" Poster Presentation Session: P-12 Poster Number: 11-017 Presenter: Dr. Sandra Paulina Smieszek, Head of Genetics This poster describes the data around a novel breakthrough therapeutic (VCA-894A) customized to a specific genetic mutation of a patient with Charcot-Marie-Tooth disease type 2S (CMT2S). |
prnewswire.com |
2025-04-07 12:00:00 |
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| 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. (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™. |
prnewswire.com |
2025-03-31 12:00:00 |
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| Vanda Pharmaceuticals announces the publication of an article titled "Potential ASO-based personalized treatment for Charcot-Marie-Tooth disease type 2S" |
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 Acids1, a Cell Press partner journal, that describes the development of a novel antisense oligonucleotide (ASO) therapeutic, VCA-894A, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S). In 1886, Jean-Martin Charcot, Pierre Marie, and Henry Tooth independently described this hereditary motor and sensory neuropathy in their patients, paving the way for Charcot-Marie-Tooth (CMT) disease research.2,3 It was not until 1968 that a distinction was made in CMT disease, creating the classification of CMT1 and CMT2.4 Since then, CMT disease (OMIM: 616155) has been used as a model disease to describe genetic heterogeneity.5 However, the high genetic and allelic heterogeneity of CMT disease poses a challenge for both diagnosis and treatment. |
prnewswire.com |
2025-02-24 09:00:00 |
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| Vanda Pharmaceuticals, Inc. (VNDA) Q4 2024 Earnings Call Transcript |
Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA ) Q4 2024 Earnings Conference Call February 13, 2025 4:30 PM ET Company Participants Kevin Moran - SVP, CFO & Treasurer Mihael Polymeropoulos - Founder, President, CEO & Chairman Conference Call Participants Charles Duncan - Cantor Fitzgerald Raghuram Selvaraju - H.C. Wainwright Andrew Tsai - Jefferies Operator Hello, and thank you for standing by. |
seekingalpha.com |
2025-02-14 00:29:58 |
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| Vanda Pharmaceuticals (VNDA) Reports Q4 Loss, Tops Revenue Estimates |
Vanda Pharmaceuticals (VNDA) came out with a quarterly loss of $0.08 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.04 per share a year ago. |
zacks.com |
2025-02-13 20:21:18 |
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| Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results |
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 submitted in Q4 2024 BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025 HETLIOZ® MAA for Smith-Magenis syndrome submitted in Q4 2024 Tradipitant NDA for motion sickness submitted in Q4 2024 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON , Feb. 13, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2024. "Strong revenue growth for Fanapt is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of Hetlioz and Ponvory. |
prnewswire.com |
2025-02-13 18:01:00 |
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| Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2024 Financial Results on February 13, 2025 |
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 financial results and other corporate activities. |
prnewswire.com |
2025-02-05 18:30:00 |
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| Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist |
Imsidolimab has successfully completed two global Phase 3 studies in Generalized Pustular Psoriasis Vanda expects to immediately begin preparing BLA and MAA applications for the US and EU Anaptys to receive $15 million from Vanda, comprised of a $10 million upfront payment and $5 million for existing drug supply Anaptys to receive a 10% royalty on global net sales of imsidolimab WASHINGTON and SAN DIEGO , Feb. 3, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and AnaptysBio, Inc. (Anaptys) (Nasdaq: ANAB) today announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP). GPP is a rare skin disorder often caused by mutations in the IL36RN gene that codes for a regulatory protein that balances the activity of the proinflammatory IL-36 family of cytokines. |
prnewswire.com |
2025-02-03 09:30:00 |
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| Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis |
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. |
prnewswire.com |
2025-01-27 09:00:00 |
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| Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review |
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. |
prnewswire.com |
2025-01-08 18:17:00 |
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| Is it a Good Idea to Invest in Vanda Pharmaceuticals Stock Now? |
Here, we discuss some reasons why investing in the VNDA stock now may turn out to be a prudent move. |
zacks.com |
2025-01-06 15:11:25 |
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| Nvidia stock inflows reach $30B: Vanda Research |
Retail investors flocked to Nvidia (NVDA) in 2024. According to Vanda Research, the chip giant saw nearly $30 billion in inflows during the year. |
youtube.com |
2024-12-27 15:30:50 |
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| 3 Under-$10 Drug Stocks Wall Street Analysts Recommend Buying |
We present three small biotech stocks, which according to Wall Street analysts, have upside potential for 2025. |
zacks.com |
2024-12-24 10:50:25 |
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| Vanda Pharmaceuticals: Net-Net Status Presents A Trading Opportunity |
Vanda Pharmaceuticals has returned to net-net status. Vanda has been building out their sales team to ramp up Fanapt and PONVORY distribution. I'm interested in buying the stock prior to FY 2024 results being announced in February. |
seekingalpha.com |
2024-12-20 15:26:29 |
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| Vanda Pharmaceuticals Announces Orphan Drug Designation Granted for VGT-1849A, a Novel and Selective Antisense Oligonucleotide Candidate for the Treatment of Polycythemia Vera |
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 myeloproliferative disorder characterized by aberrant hematopoiesis of myeloid lineage with exuberant red cell production and increased release of pro-inflammatory cytokines. More than 95% of PV patients harbor the JAK2 V617F gain-of-function mutation leading to aberrant JAK2 production.2 Inhibiting JAK2 acts to suppress hematopoiesis, consequently reducing red blood cell, neutrophil, platelet, and lymphocyte production. |
prnewswire.com |
2024-12-20 11:13:00 |
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| Glancy Prongay & Murray LLP Announces Investigation of Vanda Pharmaceuticals Inc. |
NEW YORK--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”) announces its investigation of Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) concerning the Company and its directors' and officers' possible violations of state laws. If you own Vanda Pharmaceuticals stock, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Tom Kennedy, of GPM, 230 Park Avenue, Suite 358, New York,. |
businesswire.com |
2024-12-16 23:29:00 |
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| New Strong Buy Stocks for November 14th |
VNDA, TSQ, SPPJY, VMEO and TBI have been added to the Zacks Rank #1 (Strong Buy) List on November 14, 2024. |
zacks.com |
2024-11-14 09:00:16 |
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| Vanda Pharmaceuticals Announces Participation at November 2024 Investor Conferences |
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. |
prnewswire.com |
2024-11-12 18:58:00 |
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| Vanda Pharmaceuticals Inc. (VNDA) Q3 2024 Earnings Call Transcript |
Vanda Pharmaceuticals Inc. (VNDA) Q3 2024 Earnings Call Transcript |
seekingalpha.com |
2024-11-06 22:20:27 |
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| Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results |
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 expected to be submitted in early 2025; initiation of major depressive disorder program expected in Q4 2024 PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024 PONVORY® IND applications for psoriasis and ulcerative colitis expected to be submitted in Q4 2024 Tradipitant NDA for motion sickness expected to be submitted in Q4 2024 WASHINGTON , Nov. 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2024. "We are very pleased with the lead indicators of the initial market response to our commercial launch of Fanapt in bipolar I disorder, a testament to the strong clinical evidence and the strength of our commercial strategy, and we look forward to continuous growth in the coming quarters. |
prnewswire.com |
2024-11-06 18:02:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK, NY / ACCESSWIRE / November 4, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
accesswire.com |
2024-11-04 18:45:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK , Nov. 2, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ: VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
prnewswire.com |
2024-11-02 13:00:00 |
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| Over 200% Stock Upside - Vanda Pharmaceuticals Undervalued With Robust Portfolio And Pipeline: Analyst |
HC Wainwright initiated coverage on Vanda Pharmaceuticals, Inc. VNDA, a commercial-stage biopharmaceutical firm primarily focusing on neurological and neuropsychiatry disorders. |
benzinga.com |
2024-11-01 16:05:03 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK, NY / ACCESSWIRE / October 31, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
accesswire.com |
2024-10-31 22:00:00 |
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| Vanda Pharmaceuticals to Announce Third Quarter 2024 Financial Results on November 6, 2024 |
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 corporate activities. |
prnewswire.com |
2024-10-30 18:30:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK, NY / ACCESSWIRE / October 29, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
accesswire.com |
2024-10-29 14:00:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK, NY / ACCESSWIRE / October 27, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
accesswire.com |
2024-10-27 14:00:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK , Oct. 25, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ: VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
prnewswire.com |
2024-10-25 21:52:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK, NY / ACCESSWIRE / October 23, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
accesswire.com |
2024-10-23 22:20:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK, NY / ACCESSWIRE / October 21, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
accesswire.com |
2024-10-21 20:45:00 |
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| SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA |
NEW YORK, NY / ACCESSWIRE / October 19, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
accesswire.com |
2024-10-19 16:00:00 |
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