Phathom Pharmaceuticals announced FDA approval of a Citizen Petition extending VOQUEZNA® exclusivity to May 3, 2032.
Quiver AI Summary
Phathom Pharmaceuticals, Inc. announced that the FDA has approved its Citizen Petition, recognizing 10 years of New Chemical Entity exclusivity for its medication VOQUEZNA® (vonoprazan) tablets, which will extend the exclusivity until May 3, 2032. Phathom focuses on developing treatments for gastrointestinal diseases and markets vonoprazan for treating conditions such as Non-Erosive GERD and H. pylori infections through its VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK®. The press release also includes cautionary forward-looking statements regarding the company’s commercialization plans and associated risks, emphasizing that actual results may vary due to numerous uncertainties. For more information, Phathom encourages visiting their website and following them on LinkedIn and X.
Potential Positives
- The FDA's approval of Phathom's Citizen Petition confirms the recognition of 10 years of New Chemical Entity exclusivity for VOQUEZNA®, extending protection through May 3, 2032.
- This exclusivity period enhances Phathom's market position by potentially reducing competition for VOQUEZNA®, which is essential for the treatment of gastrointestinal diseases.
- The announcement underscores Phathom's commitment to developing novel treatments, reinforcing investor confidence in the company's future prospects.
Potential Negatives
- The FDA approval of the Citizen Petition does not guarantee the success of VOQUEZNA’s commercialization, highlighting potential risks in market acceptance and reimbursement issues.
- The press release emphasizes significant uncertainties regarding Phathom's ability to maintain patent protection and regulatory exclusivity, which may expose the company to increased competition.
- There are warnings about the potential for adverse side effects or inadequate efficacy of vonoprazan, which could limit its commercialization or result in recalls, posing risks to the company's reputation and financial stability.
FAQ
What recent FDA approval did Phathom Pharmaceuticals receive?
Phathom Pharmaceuticals received FDA approval for its Citizen Petition, correcting the Orange Book to recognize 10 years of exclusivity for VOQUEZNA®.
What is VOQUEZNA® used for?
VOQUEZNA® is indicated for heartburn relief, healing and maintenance of Erosive GERD, and treating H. pylori infection in adults.
How long is the exclusivity period for VOQUEZNA®?
The exclusivity period for VOQUEZNA® extends through May 3, 2032, as per the FDA's correction to the Orange Book.
What is Phathom Pharmaceuticals' focus?
Phathom Pharmaceuticals focuses on developing and commercializing novel treatments for gastrointestinal diseases.
Where can I find more information about Phathom?
More information about Phathom can be found on their website at www.phathompharma.com and on LinkedIn and X.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$PHAT Insider Trading Activity
$PHAT insiders have traded $PHAT stock on the open market 17 times in the past 6 months. Of those trades, 11 have been purchases and 6 have been sales.
Here’s a breakdown of recent trading of $PHAT stock by insiders over the last 6 months:
- JAMES N TOPPER has made 6 purchases buying 59,403 shares for an estimated $191,988 and 0 sales.
- ASIT PARIKH has made 4 purchases buying 30,000 shares for an estimated $150,432 and 0 sales.
- TERRIE CURRAN (President and Chief Executive) sold 19,109 shares for an estimated $125,884
- FRANK KARBE purchased 12,500 shares for an estimated $99,083
- MOLLY HENDERSON (CFO and CBO) has made 0 purchases and 3 sales selling 11,552 shares for an estimated $70,438.
- AZMI NABULSI (Chief Operating Officer) has made 0 purchases and 2 sales selling 9,004 shares for an estimated $60,900.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$PHAT Hedge Fund Activity
We have seen 70 institutional investors add shares of $PHAT stock to their portfolio, and 84 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CHECKPOINT CAPITAL L.P. removed 2,274,157 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $14,258,964
- PORTOLAN CAPITAL MANAGEMENT, LLC removed 1,699,918 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $13,803,334
- ORBIMED ADVISORS LLC removed 1,449,073 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $11,766,472
- FEDERATED HERMES, INC. removed 1,403,638 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $11,397,540
- SATURN V CAPITAL MANAGEMENT LP removed 874,590 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $7,101,670
- KENNEDY CAPITAL MANAGEMENT LLC removed 728,490 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $5,915,338
- TANG CAPITAL MANAGEMENT LLC added 700,000 shares (+140.0%) to their portfolio in Q1 2025, for an estimated $4,389,000
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$PHAT Analyst Ratings
Wall Street analysts have issued reports on $PHAT in the last several months. We have seen 2 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- H.C. Wainwright issued a "Buy" rating on 05/02/2025
- Craig-Hallum issued a "Buy" rating on 03/07/2025
To track analyst ratings and price targets for $PHAT, check out Quiver Quantitative's $PHAT forecast page.
Full Release
FLORHAM PARK, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced that the U.S. Food and Drug Administration (FDA) has approved Phathom’s Citizen Petition filed on December 11, 2024 and communicated the Agency’s intention to correct the Orange Book to recognize the proper 10 years of New Chemical Entity exclusivity for VOQUEZNA ® (vonoprazan) tablets, extending through May 3, 2032.
About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA
®
(vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA
®
TRIPLE PAK
®
(vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA
®
DUAL PAK
®
(vonoprazan tablets, amoxicillin capsules) for the treatment of
H. pylori
infection in adults. For more information about Phathom, visit the company’s website at
www.phathompharma.com
and follow on
LinkedIn
and
X
.
Forward-Looking Statements
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Phathom’s commercialization plans. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the timing of the correction to the Orange Book; the expected duration of patent term extension for VOQUEZNA; we may not be able to successfully commercialize VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to obtain and maintain intellectual property protection, including patent term extensions, and non-patent regulatory exclusivity for vonoprazan; Phathom may face competition earlier than expected if it loses or fails to obtain any of its patent protection or non-patent regulatory exclusivity for VOQUEZNA tablets; Phathom’s ability to obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
MEDIA CONTACT
Nick Benedetto
1-877-742-8466
[email protected]
INVESTOR CONTACT
Eric Sciorilli
1-877-742-8466
[email protected]
© 2025 Phathom Pharmaceuticals. All rights reserved.
VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.
