Vanda Pharmaceuticals

Vanda Pharmaceuticals, Inc. engages in the development and commercialization of therapies for high unmet medical needs. The firm intends to treat schizophrenia, jet lag disorder, atopic dermatitis, central nervous system disorders, and circadian rhythm sleep disorder. Its product portfolio includes HETLIOZ, Fanapt, Tradipitant, Trichostatin, and AQW051. The company was founded by Mihael Hristos Polymeropoulos and Argeris N. Karabelas in 2002 and is headquartered in Washington, DC.

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Vanda Pharmaceuticals reports mixed Q4 results amid legal challenges and opportunities

Vanda Pharmaceuticals faces financial challenges with declining revenues and HETLIOZ sales, offset by increased cash reserves and positive clinical trial outcomes.
Legal battles and uncertainties add complexity to the company's financial outlook, requiring strategic planning and risk management.
Despite hurdles, opportunities for growth exist through new drug applications, market expansion, and potential partnerships to drive future success.

Vanda Pharmaceuticals reports resilient Q1 performance amidst generic challenges

Vanda Pharmaceuticals delivered a strong performance in Q1 2023, navigating challenges from generic competition while focusing on growth opportunities.
The company's financial results and strategic initiatives position it well for future expansion and innovation in the pharmaceutical industry.
Despite uncertainties surrounding litigation and generic competition, Vanda remains resilient and committed to driving long-term value for stakeholders.

Vanda Pharmaceuticals navigates revenue decline, eyes regulatory approvals for growth

Vanda Pharmaceuticals faced revenue challenges due to generic competition impacting HETLIOZ sales, leading to a revenue decline.
Despite legal uncertainties and revenue setbacks, the company showcased strength in pipeline progress and operational cost management.
Management's confidence in regulatory outcomes and strategic flexibility positions Vanda for potential growth opportunities.

Vanda Pharmaceuticals reports revenue decline but maintains positive net income

Vanda Pharmaceuticals faces revenue challenges with declining total revenues and net product sales in 2023.
Despite this, the company maintains positive net income and focuses on upcoming FDA decisions for growth.
Strong leadership, operational efficiency, and a diversified product portfolio are key strengths for Vanda.
Exploring growth opportunities through FDA decisions, market expansion, and strategic initiatives is crucial for future success.

Vanda Pharmaceuticals reports revenue decline, pursues new treatments amid challenges

Vanda Pharmaceuticals faced revenue declines and net losses in Q4 2023, driven by challenges in product sales and market conditions.
Despite these setbacks, the company is strategically expanding its product portfolio and pursuing new treatments to drive future growth.
Navigating legal battles, generic competition, and market uncertainties will be key focus areas for Vanda in the coming year.

Vanda Pharmaceuticals navigates revenue challenges, eyes growth through strategic initiatives

Vanda Pharmaceuticals faced revenue challenges due to generic competition but remains focused on driving growth through commercial strategies.
The company's psychiatry portfolio expansion and ongoing clinical programs position it well for future market opportunities.
Addressing shareholder activism and evaluating takeover proposals while maintaining operational focus are key challenges ahead.
Engaging with the FDA for product approvals and planning strategic marketing initiatives offer avenues for revenue growth.

Vanda Pharmaceuticals reports revenue growth and strategic expansion plans

Vanda Pharmaceuticals is navigating a mixed financial performance with revenue growth but a net loss in Q2 2024. The company's focus on expanding its commercial organization and advancing clinical development indicates a strategic approach to drive future growth amidst challenges from generic competition.

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A PDUFA date of September 18th, 2024 has been set by the FDA to review whether or not the tradipitant should be approved for gastroparesis. The global gastroparesis treatment market is projected to reach $7.19 billion by 2029. An sNDA for the review of HETLIOZ for the treatment of insomnia characterized by difficulties with sleep initiation has a PDUFA date of March 4th, 2024.

Vanda Pharmaceuticals: FDA Approvals On Deck In 2024 Makes This A Must Watch

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.

Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY® (ponesimod), a Selective S1P1R Modulator Approved for Patients with Relapsing Multiple Sclerosis

The FDA accepts Vanda's (VNDA) new drug application ("NDA") for tradipitant for treating the symptoms of gastroparesis. The company's shares rise in after-hours trading.

Vanda (VNDA) Rises as FDA Accepts NDA for Gastroparesis Drug

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).

Vanda Pharmaceuticals Announces that U.S. Food and Drug Administration Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis

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.

Vanda Pharmaceuticals Announces Participation at November 2023 Investor Conferences

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q3 2023 Results Conference Call November 8, 2023 4:30 PM ET Company Participants Kevin Moran - SVP, CFO and Treasurer Dr. Mihael Polymeropoulos - President, CEO and Chairman Tim Williams - General Counsel Operator Ladies and gentlemen, thank you for standing by. My name is Desiree, and I will be your conference operator today.

Vanda Pharmaceuticals Inc. (VNDA) Q3 2023 Earnings Call Transcript

Vanda Pharmaceuticals (VNDA) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to earnings of $0.06 per share a year ago.

Vanda Pharmaceuticals (VNDA) Reports Break-Even Earnings for Q3

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 for bipolar I disorder and insomnia with PDUFA dates in the first half of 2024.

Vanda Pharmaceuticals Reports Third Quarter 2023 Financial Results

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 corporate activities.

Vanda Pharmaceuticals to Announce Third Quarter 2023 Financial Results on November 8, 2023

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 standard in assessing obviousness when it affirmed a lower court decision finding several of Vanda's HETLIOZ® patents invalid. Vanda's petition seeks to show that the Federal Circuit's approach to obviousness has deviated materially from KSR Int'l Co. v.

Vanda Pharmaceuticals Intends to Petition the U.S. Supreme Court in its HETLIOZ® ANDA Litigation

Vanda Pharmaceuticals (VNDA) is a net-net opportunity with a market cap of $250mm and $387mm in net cash. The market is worried about declining sales of the company's top drug. Despite the challenges, VNDA has multiple positive catalysts on the horizon, including lawsuit success and drug approvals.

Vanda Pharmaceuticals: Value In The Biotech Space

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.

Vanda Pharmaceuticals Announces Participation in the Jefferies Inaugural Biotech CNS/Neuro Summit

Vanda is being dropped from the S&P 600 SmallCap 600. The company is suing the federal government over what it says was the release of trade secrets regarding its therapies.

Why Shares of Vanda Pharmaceuticals Are Dropping on Tuesday

The heavy selling pressure might have exhausted for Vanda (VNDA) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

After Plunging -7.98% in 4 Weeks, Here's Why the Trend Might Reverse for Vanda (VNDA)

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Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q2 2023 Earnings Call July 27, 2023 4:30 PM ET Company Participants Mihael H. Polymeropoulos - President, Chief Executive Officer and Chairman of the Board Kevin Moran - Senior Vice President, Chief Financial Officer and Treasurer Tim Williams - General Counsel Conference Call Participants Andrew Tsai - Jefferies Operator Good afternoon.

Vanda Pharmaceuticals Inc. (VNDA) Q2 2023 Earnings Call Transcript

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 our commercial interests in the HETLIOZ® franchise in the face of the at-risk generic launch.

Vanda Pharmaceuticals Reports Second Quarter 2023 Financial Results

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 activities.

Vanda Pharmaceuticals to Announce Second Quarter 2023 Financial Results on July 27, 2023

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.

Vanda Pharmaceuticals Announces Participation in the Jefferies 2023 Global Healthcare Conference

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 Poster Session Presentation Time: 5:00 PM – 6:00 PM ET June 6, 2023 Presentation Title: "Dim Light Melatonin Onset Analysis in Individuals Diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD)" Poster Number: 307 Presenter: Dr. Sandra Paulina Smieszek, Head of Genetics Poster Session Presentation Time: 12:00 PM – 1:15 PM ET Presentation Title: "Effect of Iloperidone on Sleep Symptoms in Bipolar Patients with Manic and Mixed Episodes: A Randomized, Placebo Controlled Study" Poster Number: 372 Presenter: Dr. Sandra Paulina Smieszek, Head of Genetics Poster Session Presentation Time: 5:00 PM – 6:00 PM ET For more information on SLEEP 2023, please refer to https://www.sleepmeeting.org/.

Vanda Pharmaceuticals Announces Presentations at SLEEP 2023

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 for which there is no available treatment.

Vanda Pharmaceuticals Announces Orphan Drug Designation Granted for VCA-894A, a Novel Antisense Oligonucleotide Candidate for the Treatment of Charcot-Marie-Tooth Disease, Type 2S

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 United States (U.S.).

Vanda Pharmaceuticals Reports Results from a Phase III study of Tradipitant in Motion Sickness

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 asserted claims of Vanda's U.S. Patent Nos.

Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Appeal

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: Su1618Presenter: Dr. Sandra Paulina Smieszek, Head of GeneticsSession Type: Poster SessionSession Title: AGA Gastroparesis and Small Intestinal DysmotilitySession Time: 12:30 PM to 1:30 PM CDT Presentation Title: "POOLED EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS STUDY VP-VLY-686-3301 AND VP-VLY-686-2301" Poster Number: Su1632Presenter: Dr. Jesse L.

Vanda Pharmaceuticals Announces Presentations at DDW 2023

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q1 2023 Earnings Conference Call May 3, 2023 4:30 AM ET Company Participants Kevin Moran - CFO Mihael Polymeropoulos - President, CEO and Chairman Timothy Williams - General Counsel Conference Call Participants Operator Good afternoon. My name is David and I'll be your conference operator today.

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