FDA Grants Hearing for Vanda's Hetlioz Jet Lag Drug
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 03 2026
0mins
Should l Buy VNDA?
Source: seekingalpha
- Hearing Approval: The FDA has granted a public hearing for Vanda Pharmaceuticals regarding its drug Hetlioz (tasimelteon) for jet lag, marking a rare occurrence for the agency and potentially the first in over four decades, indicating a significant scrutiny of the drug approval process.
- Rejection Reasons: In January, the FDA declined to approve the additional indication for Hetlioz, stating that the data submitted did not adequately demonstrate efficacy, which poses challenges for Vanda's market prospects.
- Current Approval Status: Hetlioz is currently approved for non-24-hour sleep-wake disorder and nighttime sleep disturbances associated with Smith-Magenis syndrome, showcasing its potential applications in specific areas.
- Market Reaction: Despite the FDA's approval of the hearing, Vanda's stock fell approximately 4% on Tuesday, reflecting market uncertainty regarding the future development of its drug.
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Analyst Views on VNDA
Wall Street analysts forecast VNDA stock price to rise
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 7.270
Low
7.50
Averages
13.63
High
22.00
Current: 7.270
Low
7.50
Averages
13.63
High
22.00
About VNDA
Vanda Pharmaceuticals Inc. is a global biopharmaceutical company, which is focused on the development and commercialization of therapies to address unmet medical needs and improve the lives of patients. The Company's commercial portfolio consist of four products: Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome, PONVORY for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease , and NEREUS for the prevention of vomiting induced by motion. In addition, it has a number of drugs and/or additional indications for current products in development, including Bysanti, Imsidolimab, VTR-297, VQW-765, and others. Bysanti is the active metabolite of Fanapt.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
ANAPTYS FINALIZES DIVESTITURE OF FIRST TRACKS BIOTHERAPEUTICS AND NOW FOCUSES SOLELY ON GSK AND VANDA FINANCIAL PARTNERSHIPS
Separation of First Tracks: ANAPTY has completed the separation of its first tracks in biotherapeutics.
Management of Financial Collaborations: The company now exclusively manages financial collaborations with GSK and Vanda.
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- Vanda's Position: Vanda Pharmaceuticals argues that this change would exacerbate review delays, reduce transparency, and increase risks for small innovators, with CEO Mihael H. Polymeropoulos emphasizing that the FDA should comply with existing laws rather than seek to amend them to allow for slower reviews.
- Legal Context: Vanda highlights that federal courts have ruled the FDA's practice of exceeding the 180-day timeline as unlawful, and the agency currently takes up to two months just to decide whether to file an application, raising concerns about the proposal's implications.
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- Uncertain Industry Outlook: The future of the healthcare industry faces challenges, particularly in light of changing policies and economic conditions, prompting investors to closely monitor potential impacts from regulatory changes on the sector.
- Long-Term Trends to Watch: Despite the mixed short-term performance of healthcare stocks, the sector is still viewed as having growth potential in the long run, driven by an aging population and increasing health demands.
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- Review Process Changes: The proposal replaces the formal evidentiary hearing process with a weaker internal appeal, potentially reducing transparency and increasing financial risks and uncertainties for small innovative companies like Vanda.
- Legal Compliance Issues: Vanda's CEO Polymeropoulos highlighted that the FDA's current practices have been ruled illegal by federal courts, yet the proposal aims to legalize these delays, indicating a disregard for the law.
- Call to Withdraw Proposal: Vanda urges FDA Commissioner Makary to withdraw the proposal and calls on Congress to reject legislation that could harm patient interests and stifle innovation.
See More
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- Legislative Impact: The FDA's FY 2027 budget proposal seeks to eliminate the 180-day statutory requirement for reviewing new drug applications, which could extend review times to 10-12 months, increasing patient wait times for essential medications.
- Decreased Transparency: The proposal replaces the formal evidentiary hearing process with a weaker internal appeal, potentially diminishing patient transparency and trust in the approval process while entrenching bureaucratic inertia over innovation.
- Legal Compliance Issues: Vanda's CEO Polymeropoulos highlighted that the FDA's current practices have been ruled illegal by federal courts, and this proposal aims to legalize such delays, posing greater financial risks and uncertainties for small innovators.
- Call to Withdraw Proposal: Vanda urges FDA Commissioner Makary to withdraw the proposal and calls on Congress to reject it, emphasizing that it contradicts the goal of improving efficiency and could hinder patient access to necessary drugs.
See More
VANDA PHARMACEUTICALS INC - PLAN AIMS TO REMOVE FDA'S 180-DAY NDA REVIEW OBLIGATION
- Proposal Overview: Vanda Pharmaceuticals has proposed to eliminate the FDA's 180-day new drug application (NDA) review requirement.
- Impact on Drug Approval: This change could streamline the drug approval process, potentially allowing for faster access to new medications.
See More
ANAPTYS FINALIZES DIVESTITURE OF FIRST TRACKS BIOTHERAPEUTICS AND NOW FOCUSES SOLELY ON GSK AND VANDA FINANCIAL PARTNERSHIPS
Separation of First Tracks: ANAPTY has completed the separation of its first tracks in biotherapeutics.
Management of Financial Collaborations: The company now exclusively manages financial collaborations with GSK and Vanda.
See More
Vanda Pharmaceuticals Urges FDA to Withdraw Legislative Proposal
- Proposal Details: The FDA's FY 2027 Congressional Budget proposal seeks to eliminate the 180-day review requirement for new drug applications (NDAs), extending review timelines to 10-12 months, which could delay patient access to new medications.
- Vanda's Position: Vanda Pharmaceuticals argues that this change would exacerbate review delays, reduce transparency, and increase risks for small innovators, with CEO Mihael H. Polymeropoulos emphasizing that the FDA should comply with existing laws rather than seek to amend them to allow for slower reviews.
- Legal Context: Vanda highlights that federal courts have ruled the FDA's practice of exceeding the 180-day timeline as unlawful, and the agency currently takes up to two months just to decide whether to file an application, raising concerns about the proposal's implications.
- Industry Impact: The proposal could lead to longer wait times for patients to access new drugs and greater uncertainty for biotech innovators, prompting Vanda to urge FDA Commissioner Dr. Marty Makary to withdraw the provision and call on Congress to reject it.
See More
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- Mixed Market Performance: Late Thursday afternoon, healthcare stocks showed mixed results, with the NYSE Health Care Index rising by 0.1%, indicating a cautious market sentiment towards the healthcare sector amid economic uncertainties.
- Investor Sentiment Fluctuations: While the overall index saw a slight increase, individual healthcare stocks exhibited varied performances, influenced by company earnings reports and market dynamics, highlighting the volatility and uncertainty in investor sentiment.
- Uncertain Industry Outlook: The future of the healthcare industry faces challenges, particularly in light of changing policies and economic conditions, prompting investors to closely monitor potential impacts from regulatory changes on the sector.
- Long-Term Trends to Watch: Despite the mixed short-term performance of healthcare stocks, the sector is still viewed as having growth potential in the long run, driven by an aging population and increasing health demands.
See More
Vanda Pharmaceuticals Opposes FDA Proposal to Extend Drug Review Timelines
- Legislative Impact: The FDA's proposal in the FY 2027 budget seeks to eliminate the 180-day review requirement for new drug applications (NDAs), extending review times to 10 to 12 months, which could lead to longer waits for patients needing medications.
- Review Process Changes: The proposal replaces the formal evidentiary hearing process with a weaker internal appeal, potentially reducing transparency and increasing financial risks and uncertainties for small innovative companies like Vanda.
- Legal Compliance Issues: Vanda's CEO Polymeropoulos highlighted that the FDA's current practices have been ruled illegal by federal courts, yet the proposal aims to legalize these delays, indicating a disregard for the law.
- Call to Withdraw Proposal: Vanda urges FDA Commissioner Makary to withdraw the proposal and calls on Congress to reject legislation that could harm patient interests and stifle innovation.
See More
Vanda Pharmaceuticals Opposes FDA Proposal to Extend Drug Review Timelines
- Legislative Impact: The FDA's FY 2027 budget proposal seeks to eliminate the 180-day statutory requirement for reviewing new drug applications, which could extend review times to 10-12 months, increasing patient wait times for essential medications.
- Decreased Transparency: The proposal replaces the formal evidentiary hearing process with a weaker internal appeal, potentially diminishing patient transparency and trust in the approval process while entrenching bureaucratic inertia over innovation.
- Legal Compliance Issues: Vanda's CEO Polymeropoulos highlighted that the FDA's current practices have been ruled illegal by federal courts, and this proposal aims to legalize such delays, posing greater financial risks and uncertainties for small innovators.
- Call to Withdraw Proposal: Vanda urges FDA Commissioner Makary to withdraw the proposal and calls on Congress to reject it, emphasizing that it contradicts the goal of improving efficiency and could hinder patient access to necessary drugs.
See More
VANDA PHARMACEUTICALS INC - PLAN AIMS TO REMOVE FDA'S 180-DAY NDA REVIEW OBLIGATION
- Proposal Overview: Vanda Pharmaceuticals has proposed to eliminate the FDA's 180-day new drug application (NDA) review requirement.
- Impact on Drug Approval: This change could streamline the drug approval process, potentially allowing for faster access to new medications.
See More
