VANDA PHARMACEUTICALS INC - PLAN AIMS TO REMOVE FDA'S 180-DAY NDA REVIEW OBLIGATION

Written by Emily J. Thompson, Senior Investment Analyst

Source: moomoo

Updated: Apr 09 2026

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VNDA+1.54%

Should l Buy VNDA?

Source: moomoo

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.

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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

Truist

Buy

initiated

$18

2026-03-05

Reason

Truist

Price Target

$18

AI Analysis

2026-03-05

initiated

Buy

Reason

Truist initiated coverage of Vanda Pharmaceuticals with a Buy rating and $18 price target. With three commercial drugs commanding $200M in sales plus "a slew of higher value near-commercial-ready assets nearing launch," the firm sees Vanda's reformulation of lead asset Fanapt launching with improved economics into a competitive schizophrenia and bipolar market differentiated by lower weight gain risk. "More interestingly" is Vanda's first-mover advantage of Nereus into adjunct therapy for GLP-1 induced vomiting, as the firm sees this as a derisked $1B opportunity.

B. Riley

Buy

maintain

$14 -> $17

2026-02-25

Reason

B. Riley

Price Target

$14 -> $17

2026-02-25

maintain

Buy

Reason

B. Riley raised the firm's price target on Vanda Pharmaceuticals to $17 from $14 and keeps a Buy rating on the shares. Following BYSANTI's approval, the firm's revenue model for Vanda has been updated, reflecting expected growth in the psychiatry franchise with peak BYSANTI sales now included and probability adjustments removed, the analyst tells investors in a research note. Base assumptions include mid-to-high single-digit quarter over quarter growth in BYSANTI/FANAPT prescriptions through 2026, the firm says.

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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

4 hours agomoomoo

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.

Vanda Pharmaceuticals Urges FDA to Withdraw Legislative Proposal

Apr 10 2026NASDAQ.COM

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.

Healthcare Stocks Mixed as NYSE Health Care Index Edges Up 0.1%

Apr 09 2026Yahoo Finance

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.

Vanda Pharmaceuticals Opposes FDA Proposal to Extend Drug Review Timelines

Apr 09 2026PRnewswire

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.

Vanda Pharmaceuticals Opposes FDA Proposal to Extend Drug Review Timelines

Apr 09 2026Newsfilter

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.