Phathom Pharmaceuticals (PHAT) FDA Approvals $11.40 +0.01 (+0.09%) Closing price 05/19/2026 04:00 PM EasternExtended Trading$11.40 +0.00 (+0.04%) As of 05/19/2026 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Phathom Pharmaceuticals' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Phathom Pharmaceuticals (PHAT). Over the past two years, Phathom Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as vonoprazan. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Vonoprazan FDA Regulatory Timeline and Events Vonoprazan is a drug developed by Phathom Pharmaceuticals for the following indication: For the Treatment of Heartburn Associated with Non-Erosive GERD. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Results - October 25,2025Results Drug: vonoprazanAnnounced Date: October 25, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc. announced that results of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial evaluating VOQUEZNA® (vonoprazan) tablets in patients with Non-Erosive Reflux Disease (NERD) have been published in the American Journal of Gastroenterology.AI SummaryPhathom Pharmaceuticals announced new results from its Phase 3 pHalcon-NERD-301 trial in the American Journal of Gastroenterology. The study focused on VOQUEZNA® (vonoprazan) tablets for patients with Non-Erosive Reflux Disease (NERD). In the trial, 772 patients were randomly assigned to VOQUEZNA 10 mg, 20 mg, or placebo for four weeks. After that, VOQUEZNA groups continued treatment for 20 weeks, and placebo patients switched to VOQUEZNA. Results showed rapid relief of nighttime GERD symptoms. Over 50% of VOQUEZNA patients had heartburn-free nights after the first dose, compared to 32% on placebo. These gains held through 24 weeks, with median heartburn-free nights above 70%. Exploratory measures also improved. Patients reported lower nighttime symptom severity and fewer sleep disturbances throughout treatment. VOQUEZNA was generally well tolerated, with low rates of mild side effects such as nausea and abdominal pain.Read AnnouncementProvided Update - October 23,2025Provided Update Drug: vonoprazanAnnounced Date: October 23, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc. announced its participation in the American College of Gastroenterology's (ACG) 2025 Annual Scientific Meeting, being held October 24-29 in Phoenix, Arizona.AI SummaryPhathom Pharmaceuticals, Inc. will participate in the American College of Gastroenterology’s 2025 Annual Scientific Meeting, October 24–29 in Phoenix, Arizona. The company plans to highlight its growing leadership in gastrointestinal disease treatments. Phathom’s Medical Affairs and Commercial teams will staff Exhibit Booth #214 from October 26–29, giving attendees a chance to learn about VOQUEZNA® (vonoprazan) tablets. On Monday, October 27 (3:45–4:30 pm MST), Dr. John Erik Pandolfino will lead a VOQUEZNA® product theater titled “Expert Insights on GERD Therapy: A Case-Based Approach with a First-in-Class Acid Suppressant.” Phathom also provided an independent medical education grant for a hybrid Medscape program, “Decision Points in the Management of GERD,” held Saturday, October 25, featuring faculty Charles P. Vega, MD; Rena Yadlapati, MD; and Prakash Gyawali, MD. Steve Basta, Phathom’s President and CEO, said ACG offers a valuable forum to share clinical insights, engage experts, and reinforce the company’s commitment to improving patient outcomes in GI disorders.Read AnnouncementFDA approved - June 16,2025Fda Approved Drug: vonoprazanAnnounced Date: June 16, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets.AI SummaryPhathom Pharmaceuticals announced that the FDA has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) to correctly show the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets. This update confirms that VOQUEZNA is entitled to NCE regulatory exclusivity until May 3, 2032. This correction aligns the Orange Book listing with statutory requirements and reinforces the long-term commercial prospects for the first-in-class treatment. The clarification provides a stable regulatory framework for VOQUEZNA, ensuring that its exclusive market status in treating gastrointestinal conditions is maintained over its full period of protection.Read AnnouncementFDA approved - June 6,2025Fda Approved Drug: vonoprazanAnnounced Date: June 6, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc. 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.AI SummaryPhathom Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved its Citizen Petition filed on December 11, 2024. The FDA stated its plans to update the Orange Book to correctly reflect a full 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets. This exclusivity period will now extend through May 3, 2032, ensuring that the drug receives proper recognition and protection as a first-in-class treatment. With this update, Phathom confirms that VOQUEZNA® will maintain its market exclusivity during this period, solidifying its competitive advantage in treating conditions such as heartburn and gastroesophageal reflux disease. This decision from the FDA supports the company’s ongoing efforts to secure market rights and highlights the value of VOQUEZNA® in the treatment of gastrointestinal diseases.Read AnnouncementData Presentation - April 28,2025Data Presentation Drug: vonoprazanAnnounced Date: April 28, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc announced that the company will present real-world data for its first-in-class treatment VOQUEZNA® (vonoprazan) at Digestive Disease Week® (DDW) being held May 3–6, 2025, in San Diego, CA.AI SummaryPhathom Pharmaceuticals, Inc. will present new real-world data on its first-in-class treatment, VOQUEZNA® (vonoprazan), at Digestive Disease Week® (DDW) in San Diego, CA from May 3–6, 2025. The data focuses on how VOQUEZNA is being used in everyday clinical practice by U.S. patients diagnosed with gastroesophageal reflux disease (GERD), including both Non-Erosive and Erosive forms. Highlighting the treatment's unique benefits, the presentation aims to provide insights into patient characteristics and treatment patterns that differentiate VOQUEZNA from traditional proton pump inhibitors. Additionally, Phathom will showcase two sponsored posters on May 5, and host a Product Theater session, offering healthcare professionals a closer look at the real-world efficacy and potential role of VOQUEZNA in improving symptom control for GERD patients.Read AnnouncementRegulatory Update - December 11,2024Regulatory Update Drug: vonoprazanAnnounced Date: December 11, 2024Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc announced today it has submitted a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA).AI SummaryPhathom Pharmaceuticals announced today that it has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA). The petition requests that the FDA correct the Orange Book listings for VOQUEZNA (vonoprazan) tablets to reflect the full 10‐year New Chemical Entity (NCE) exclusivity period, which ends on May 3, 2032. Phathom argues that since VOQUEZNA tablets contain the same active ingredient as the VOQUEZNA TRIPLE PAK and DUAL PAK products—which were granted a 10-year exclusivity period under the GAIN Act—all vonoprazan-based products should benefit equally. The company believes that the current listings do not accurately show the full period of exclusivity as mandated by law. The FDA is expected to review the petition and respond within 180 days from submission.Read AnnouncementProvided Update - July 30,2024Provided Update Drug: vonoprazanAnnounced Date: July 30, 2024Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementhathom Pharmaceuticals, Inc announces that effective immediately, CVS Caremark has added VOQUEZNA® (vonoprazan) tablets to its commercial formularies. VOQUEZNA is approved for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn.AI SummaryPhathom Pharmaceuticals, Inc. announced that CVS Caremark has immediately added VOQUEZNA® (vonoprazan) tablets to its national formularies. This important step extends access to VOQUEZNA for over 26 million commercially insured members and ultimately more than 116 million lives across the United States. VOQUEZNA is the only FDA-approved potassium-competitive acid blocker available in the U.S. and is used to treat various forms of gastroesophageal reflux disease (GERD). It is approved for providing relief from heartburn linked to Non-Erosive GERD as well as for healing and maintaining treatment of Erosive Esophagitis, commonly known as Erosive GERD. The move also simplifies patient access by requiring a single step through a generic prescription proton pump inhibitor, offering a new effective treatment option for many individuals suffering from acid-related disorders.Read AnnouncementFDA Approval - July 18,2024Fda Approval FDA ApprovedDrug: vonoprazanAnnounced Date: July 18, 2024Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has approved VOQUEZNA® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults.AI SummaryPhathom Pharmaceuticals announced that the FDA has approved VOQUEZNA® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. This decision comes after a successful Phase 3 trial that demonstrated a significant and rapid reduction in heartburn symptoms, marking a breakthrough for millions of patients. In the pivotal study, patients treated with VOQUEZNA experienced a higher percentage of 24-hour heartburn-free days—45% compared to 28% in those who received a placebo. This innovative treatment is the first of its kind in over 30 years, offering a new class of acid suppression therapy. With Non-Erosive GERD affecting a large portion of the U.S. population, this approval gives healthcare providers a promising option to help patients achieve heartburn-free days and improved quality of life.Read Announcement Phathom Pharmaceuticals FDA Events - Frequently Asked Questions Has Phathom Pharmaceuticals received FDA approval? Yes, Phathom Pharmaceuticals (PHAT) has received FDA approval for vonoprazan. This page tracks recent and historical FDA regulatory events related to Phathom Pharmaceuticals' drug portfolio. What drugs has Phathom Pharmaceuticals submitted to the FDA? In the past two years, Phathom Pharmaceuticals (PHAT) has reported FDA regulatory activity for vonoprazan. What is the most recent FDA event for Phathom Pharmaceuticals? The most recent FDA-related event for Phathom Pharmaceuticals occurred on October 25, 2025, involving vonoprazan. The update was categorized as "Results," with the company reporting: "Phathom Pharmaceuticals, Inc. announced that results of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial evaluating VOQUEZNA® (vonoprazan) tablets in patients with Non-Erosive Reflux Disease (NERD) have been published in the American Journal of Gastroenterology." What conditions do Phathom Pharmaceuticals' current drugs treat? Currently, Phathom Pharmaceuticals has one therapy (vonoprazan) targeting the following condition: For the Treatment of Heartburn Associated with Non-Erosive GERD. 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FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies ACADIA Pharmaceuticals FDA Events Catalyst Pharmaceuticals FDA Events Edgewise Therapeutics FDA Events Viking Therapeutics FDA Events Organon & Co. FDA Events Beam Therapeutics FDA Events Tango Therapeutics FDA Events Oruka Therapeutics FDA Events Arcus Biosciences FDA Events Erasca FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:PHAT last updated on 10/27/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredIran's New Leader Just Said Something That Should Terrify Every AmericanIran's Supreme Leader has declared the Strait of Hormuz closed as leverage against the U.S. - and with 40% of ...American Alternative | SponsoredHey, it's Jon Najarian. The SpaceX IPO is right around the corner. But I discovered Elon may have something BIGGER planned. 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Results - October 25,2025Results Drug: vonoprazanAnnounced Date: October 25, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc. announced that results of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial evaluating VOQUEZNA® (vonoprazan) tablets in patients with Non-Erosive Reflux Disease (NERD) have been published in the American Journal of Gastroenterology.AI SummaryPhathom Pharmaceuticals announced new results from its Phase 3 pHalcon-NERD-301 trial in the American Journal of Gastroenterology. The study focused on VOQUEZNA® (vonoprazan) tablets for patients with Non-Erosive Reflux Disease (NERD). In the trial, 772 patients were randomly assigned to VOQUEZNA 10 mg, 20 mg, or placebo for four weeks. After that, VOQUEZNA groups continued treatment for 20 weeks, and placebo patients switched to VOQUEZNA. Results showed rapid relief of nighttime GERD symptoms. Over 50% of VOQUEZNA patients had heartburn-free nights after the first dose, compared to 32% on placebo. These gains held through 24 weeks, with median heartburn-free nights above 70%. Exploratory measures also improved. Patients reported lower nighttime symptom severity and fewer sleep disturbances throughout treatment. VOQUEZNA was generally well tolerated, with low rates of mild side effects such as nausea and abdominal pain.Read Announcement
Provided Update - October 23,2025Provided Update Drug: vonoprazanAnnounced Date: October 23, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc. announced its participation in the American College of Gastroenterology's (ACG) 2025 Annual Scientific Meeting, being held October 24-29 in Phoenix, Arizona.AI SummaryPhathom Pharmaceuticals, Inc. will participate in the American College of Gastroenterology’s 2025 Annual Scientific Meeting, October 24–29 in Phoenix, Arizona. The company plans to highlight its growing leadership in gastrointestinal disease treatments. Phathom’s Medical Affairs and Commercial teams will staff Exhibit Booth #214 from October 26–29, giving attendees a chance to learn about VOQUEZNA® (vonoprazan) tablets. On Monday, October 27 (3:45–4:30 pm MST), Dr. John Erik Pandolfino will lead a VOQUEZNA® product theater titled “Expert Insights on GERD Therapy: A Case-Based Approach with a First-in-Class Acid Suppressant.” Phathom also provided an independent medical education grant for a hybrid Medscape program, “Decision Points in the Management of GERD,” held Saturday, October 25, featuring faculty Charles P. Vega, MD; Rena Yadlapati, MD; and Prakash Gyawali, MD. Steve Basta, Phathom’s President and CEO, said ACG offers a valuable forum to share clinical insights, engage experts, and reinforce the company’s commitment to improving patient outcomes in GI disorders.Read Announcement
FDA approved - June 16,2025Fda Approved Drug: vonoprazanAnnounced Date: June 16, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets.AI SummaryPhathom Pharmaceuticals announced that the FDA has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) to correctly show the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets. This update confirms that VOQUEZNA is entitled to NCE regulatory exclusivity until May 3, 2032. This correction aligns the Orange Book listing with statutory requirements and reinforces the long-term commercial prospects for the first-in-class treatment. The clarification provides a stable regulatory framework for VOQUEZNA, ensuring that its exclusive market status in treating gastrointestinal conditions is maintained over its full period of protection.Read Announcement
FDA approved - June 6,2025Fda Approved Drug: vonoprazanAnnounced Date: June 6, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc. 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.AI SummaryPhathom Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved its Citizen Petition filed on December 11, 2024. The FDA stated its plans to update the Orange Book to correctly reflect a full 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets. This exclusivity period will now extend through May 3, 2032, ensuring that the drug receives proper recognition and protection as a first-in-class treatment. With this update, Phathom confirms that VOQUEZNA® will maintain its market exclusivity during this period, solidifying its competitive advantage in treating conditions such as heartburn and gastroesophageal reflux disease. This decision from the FDA supports the company’s ongoing efforts to secure market rights and highlights the value of VOQUEZNA® in the treatment of gastrointestinal diseases.Read Announcement
Data Presentation - April 28,2025Data Presentation Drug: vonoprazanAnnounced Date: April 28, 2025Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc announced that the company will present real-world data for its first-in-class treatment VOQUEZNA® (vonoprazan) at Digestive Disease Week® (DDW) being held May 3–6, 2025, in San Diego, CA.AI SummaryPhathom Pharmaceuticals, Inc. will present new real-world data on its first-in-class treatment, VOQUEZNA® (vonoprazan), at Digestive Disease Week® (DDW) in San Diego, CA from May 3–6, 2025. The data focuses on how VOQUEZNA is being used in everyday clinical practice by U.S. patients diagnosed with gastroesophageal reflux disease (GERD), including both Non-Erosive and Erosive forms. Highlighting the treatment's unique benefits, the presentation aims to provide insights into patient characteristics and treatment patterns that differentiate VOQUEZNA from traditional proton pump inhibitors. Additionally, Phathom will showcase two sponsored posters on May 5, and host a Product Theater session, offering healthcare professionals a closer look at the real-world efficacy and potential role of VOQUEZNA in improving symptom control for GERD patients.Read Announcement
Regulatory Update - December 11,2024Regulatory Update Drug: vonoprazanAnnounced Date: December 11, 2024Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals, Inc announced today it has submitted a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA).AI SummaryPhathom Pharmaceuticals announced today that it has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA). The petition requests that the FDA correct the Orange Book listings for VOQUEZNA (vonoprazan) tablets to reflect the full 10‐year New Chemical Entity (NCE) exclusivity period, which ends on May 3, 2032. Phathom argues that since VOQUEZNA tablets contain the same active ingredient as the VOQUEZNA TRIPLE PAK and DUAL PAK products—which were granted a 10-year exclusivity period under the GAIN Act—all vonoprazan-based products should benefit equally. The company believes that the current listings do not accurately show the full period of exclusivity as mandated by law. The FDA is expected to review the petition and respond within 180 days from submission.Read Announcement
Provided Update - July 30,2024Provided Update Drug: vonoprazanAnnounced Date: July 30, 2024Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementhathom Pharmaceuticals, Inc announces that effective immediately, CVS Caremark has added VOQUEZNA® (vonoprazan) tablets to its commercial formularies. VOQUEZNA is approved for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn.AI SummaryPhathom Pharmaceuticals, Inc. announced that CVS Caremark has immediately added VOQUEZNA® (vonoprazan) tablets to its national formularies. This important step extends access to VOQUEZNA for over 26 million commercially insured members and ultimately more than 116 million lives across the United States. VOQUEZNA is the only FDA-approved potassium-competitive acid blocker available in the U.S. and is used to treat various forms of gastroesophageal reflux disease (GERD). It is approved for providing relief from heartburn linked to Non-Erosive GERD as well as for healing and maintaining treatment of Erosive Esophagitis, commonly known as Erosive GERD. The move also simplifies patient access by requiring a single step through a generic prescription proton pump inhibitor, offering a new effective treatment option for many individuals suffering from acid-related disorders.Read Announcement
FDA Approval - July 18,2024Fda Approval FDA ApprovedDrug: vonoprazanAnnounced Date: July 18, 2024Indication: For the Treatment of Heartburn Associated with Non-Erosive GERDAnnouncementPhathom Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has approved VOQUEZNA® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults.AI SummaryPhathom Pharmaceuticals announced that the FDA has approved VOQUEZNA® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. This decision comes after a successful Phase 3 trial that demonstrated a significant and rapid reduction in heartburn symptoms, marking a breakthrough for millions of patients. In the pivotal study, patients treated with VOQUEZNA experienced a higher percentage of 24-hour heartburn-free days—45% compared to 28% in those who received a placebo. This innovative treatment is the first of its kind in over 30 years, offering a new class of acid suppression therapy. With Non-Erosive GERD affecting a large portion of the U.S. population, this approval gives healthcare providers a promising option to help patients achieve heartburn-free days and improved quality of life.Read Announcement
