{"success":true,"data":{"pressRelease":{"id":"155243","rtpr_id":"nGNX6VvMBx-20260929","ticker":"PHAT","exchange":"NASDAQ","all_tickers":["PHAT"],"title":"Phathom Pharmaceuticals Announces Initiation of Registrational Phase 3 Study of VOQUEZNA® (vonoprazan) for As-Needed Treatment of Non-Erosive GERD","author":"Globe Newswire","published_at":"2026-09-29T12:00:02.600Z","article_body":"* Initiation of registrational Phase 3 study of VOQUEZNA® (vonoprazan) for\nas-needed (PRN) use in Non-Erosive Reflux Disease (NERD) builds on previously\nreported positive Phase 2 data\n\n\n* Topline results expected in the first quarter of 2028\n\n\n* pHalcon-NERD-302, if successful, is intended to support a potential VOQUEZNA\nlabel expansion to include as-needed treatment of heartburn episodes in\npatients with Non-Erosive GERD, a treatment regimen of interest to patients\nfor which proton pump inhibitors (PPIs) are not currently approved in the U.S.\nFLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Phathom\nPharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on\nthe development and commercialization of novel treatments for gastrointestinal\ndiseases, today announced the initiation of patient screening in\npHalcon-NERD-302, a registrational Phase 3 study evaluating an as-needed (PRN\nor on-demand) investigational dosing regimen of VOQUEZNA® (vonoprazan)\ntablets in adults with Non-Erosive Gastroesophageal Reflux Disease, or\nNon-Erosive GERD (NERD). Topline results are expected in the first quarter of\n2028. If successful, the study is intended to support a potential regulatory\nsubmission seeking a label expansion for VOQUEZNA tablets for this treatment\nregimen.\n\n“With pHalcon-NERD-302, we are studying what we believe could be an\nimportant new treatment approach for patients with Non-Erosive GERD. The study\nis designed to assess whether as-needed VOQUEZNA can provide rapid relief of\nheartburn when symptoms occur, with relief sustained over 24 hours. We have\nheard from many physicians and patients about the desire for an as-needed\noption. If successful, this study could support a potential label expansion\nfor VOQUEZNA and an important opportunity to potentially broaden how VOQUEZNA\nmay be used in the future to meet the needs of patients with Non-Erosive\nGERD,” said Steve Basta, President and Chief Executive Officer of Phathom\nPharmaceuticals.\n\nVOQUEZNA Phase 3 As-Needed Program\nBuilding on previously reported positive Phase 2 results\n(https://www.globenewswire.com/Tracker?data=p6SARxV3EmESFatREafuPcTdB4khpk34iHvxyaM100lVfpo9UZbD58_HMg7531jE7-ozT_UGt38cmGa_nxH9k_Xl_9D7our6GSg34tYn3ccc-PQJ-S20OWjtLFlKE0tffdyXE6D2F_-eRQakgGee1-07CS6-RtUsGtm0iGARGPDIq8HemeQsT1zwIz-zb4XT2r4M1tcRKiUXtu01hFkvx6kt4hq5GkXUGve1CGOtB_hczuSLYB6Z3kCx02hbnV0V),\npHalcon-NERD-302 is a multicenter, randomized, double-blind,\nplacebo-controlled Phase 3 study investigating VOQUEZNA 10 mg as an as-needed\ntreatment in adults with Non-Erosive GERD. The Phase 3 pHalcon-NERD-302 study\nis expected to enroll approximately 500 adults with Non-Erosive GERD who\nreport heartburn at least four days per week. The study is planned to be\nconducted at approximately 80 sites in the U.S. Following a four-week,\nopen-label run-in period with VOQUEZNA 10 mg once daily, patients without\nheartburn during the final seven days of the run-in period will be randomized\n1:1 to receive VOQUEZNA 10 mg or placebo, as-needed, for 24 weeks of\ntreatment. The primary endpoint, assessed at Week 12, is the percentage of\nheartburn episodes in which patients experience complete relief within two\nhours and sustained relief for 24 hours post-dosing.\n\n“Non-Erosive GERD is characterized by episodic, often unpredictable\nheartburn. Proton-pump inhibitor acid-suppressing therapies generally rely on\ncontinuous daily use,” said Ronnie Fass, M.D., Division Director of\nGastroenterology and Hepatology and Medical Director of the Digestive Health\nCenter at MetroHealth Medical Center, Professor of Medicine at Case Western\nReserve University School of Medicine, and an investigator for\npHalcon-NERD-302. “An as-needed treatment approach would need to provide\nacid suppression that starts rapidly and is sustained long enough to control\nheartburn over 24 hours. The results from the earlier Phase 2 as-needed study\nof VOQUEZNA provide a strong rationale for evaluating its efficacy and safety\nin this Phase 3 trial.”\n\n“One of the practical questions in managing Non-Erosive GERD is whether\npatients with intermittent symptoms need continuous daily therapy. This\nregistrational study is designed to evaluate whether an as-needed treatment\napproach can provide effective heartburn relief when symptoms occur,” said\nPhilip O. Katz, M.D., Professor of Medicine in the Division of\nGastroenterology and Hepatology at Weill Cornell Medicine, gastroenterologist\nat NewYork-Presbyterian/Weill Cornell Medical Center, and an investigator for\npHalcon-NERD-302. Dr. Katz serves as a consultant for Phathom Pharmaceuticals.\n\nFor more information about the pHalcon-NERD-302 study (NCT07752407), visit\nClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=L8Cjcz8z5eTD2Pp9vvtzG3EgaW_hZ_kqOLM0khld6emcE94oSxY9QJGSr8HgVFAiUPnyeNbWIZt3rkHT-temIpSqDRImxsEZGFDaK0XPrr-STy3XjLrLpMOeV5ffLEtm).\n\nAbout Non-Erosive Gastroesophageal Reflux Disease\nNon-Erosive Gastroesophageal Reflux Disease (NERD) is the largest subcategory\nof gastroesophageal reflux disease (GERD) and is characterized by\nreflux-related symptoms in the absence of esophageal mucosal erosions. More\nthan 22 million U.S. patients are estimated to be treated annually with\nprescription medication for GERD, and approximately 15 million of these\npatients are believed to have NERD. Symptoms of NERD may impact overall\nquality of life and can include episodic heartburn, regurgitation, problems\nswallowing, and chest pain.\n\nINDICATIONS AND USAGE\n\nVOQUEZNA(®) (vonoprazan) is a potassium-competitive acid blocker (PCAB)\nindicated in adults:\n* for the healing of all grades of Erosive Esophagitis (Erosive\nGastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn\nassociated with Erosive GERD.\n* to maintain healing of all grades of Erosive GERD and relief of heartburn\nassociated with Erosive GERD.\n* for the relief of heartburn associated with Non-Erosive GERD.\n* in combination with amoxicillin and clarithromycin for the treatment of\nHelicobacter pylori (H. pylori) infection.\n* in combination with amoxicillin for the treatment of H. pylori infection.\nIMPORTANT SAFETY INFORMATION\n\nCONTRAINDICATIONS\n\nVOQUEZNA is contraindicated in patients with a known hypersensitivity to\nvonoprazan or any component of VOQUEZNA, or in patients receiving\nrilpivirine-containing products.\n\nFor information about contraindications of antibacterial agents\n(clarithromycin and amoxicillin) indicated in combination with VOQUEZNA, refer\nto the Contraindications section of the corresponding prescribing information.\n\nWARNINGS AND PRECAUTIONS\n\nPresence of Gastric Malignancy: In adults, symptomatic response to therapy\nwith VOQUEZNA does not preclude the presence of gastric malignancy. Consider\nadditional follow-up and diagnostic testing in patients who have a suboptimal\nresponse or an early symptomatic relapse after completing treatment with\nVOQUEZNA. In older patients, also consider endoscopy.\n\nAcute Tubulointerstitial Nephritis: Acute tubulointerstitial nephritis (TIN)\nhas been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and\nevaluate patients with suspected acute TIN.\n\nClostridioides difficile-Associated Diarrhea: Published observational studies\nsuggest that proton pump inhibitors (PPIs) may be associated with an increased\nrisk of Clostridioides difficile-associated diarrhea (CDAD), especially in\nhospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider\nCDAD in patients with diarrhea that does not improve. Use the shortest\nduration of VOQUEZNA appropriate to the condition being treated.\n\nCDAD has been reported with use of nearly all antibacterial agents. For more\ninformation specific to antibacterial agents (clarithromycin and amoxicillin)\nindicated for use in combination with VOQUEZNA, refer to Warnings and\nPrecautions section of the corresponding prescribing information.\n\nBone Fracture: Several published observational studies suggest that PPI\ntherapy may be associated with an increased risk for osteoporosis-related\nfractures of the hip, wrist, or spine, especially in patients receiving high\ndose (multiple daily doses) and long-term therapy (a year or longer). Bone\nfracture, including osteoporosis-related fracture, has also been reported with\nvonoprazan. Use the shortest duration of VOQUEZNA appropriate to the condition\nbeing treated. Patients at risk for osteoporosis-related fractures should be\nmanaged according to the established treatment guidelines.\n\nSevere Cutaneous Adverse Reactions (SCAR): Severe cutaneous adverse reactions,\nincluding Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)\nhave been reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or\nsymptoms of SCAR or other signs of hypersensitivity and consider further\nevaluation.\n\nVitamin B12 (Cobalamin) Deficiency: Long-term use of acid-suppressing drugs\ncan lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria.\nVitamin B12 deficiency has been reported postmarketing with vonoprazan. If\nclinical symptoms consistent with vitamin B12 deficiency are observed in\npatients treated with VOQUEZNA, consider further workup.\n\nHypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported\npostmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or\nhypokalemia and may exacerbate underlying hypocalcemia in at-risk patients.\n\nConsider monitoring magnesium levels prior to initiation of VOQUEZNA and\nperiodically in patients expected to be on prolonged treatment, in patients\ntaking drugs that may have increased toxicity in the presence of\nhypomagnesemia or drugs that may cause hypomagnesemia. Treatment of\nhypomagnesemia may require magnesium replacement and discontinuation of\nVOQUEZNA.\n\nConsider monitoring magnesium and calcium levels prior to initiation of\nVOQUEZNA and periodically while on treatment in patients with a preexisting\nrisk of hypocalcemia. Supplement with magnesium and/or calcium, as necessary.\nIf hypocalcemia is refractory to treatment, consider discontinuing VOQUEZNA.\n\nInteractions with Diagnostic Investigations for Neuroendocrine Tumors: Serum\nchromogranin A (CgA) levels increase secondary to drug-induced decreases in\ngastric acidity. The increased CgA level may cause false positive results in\ndiagnostic investigations for neuroendocrine tumors. Temporarily discontinue\nVOQUEZNA treatment at least 4 weeks before assessing CgA levels and consider\nrepeating the test if initial CgA levels are high.\n\nFundic Gland Polyps: Use of VOQUEZNA is associated with a risk of fundic gland\npolyps that increases with long-term use, especially beyond one year. Fundic\ngland polyps have been reported with vonoprazan in clinical trials and during\npostmarketing use with PPIs. Most patients who developed fundic gland polyps\nwere asymptomatic and fundic gland polyps were identified incidentally on\nendoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition\nbeing treated.\n\nADVERSE REACTIONS\n\nHealing of Erosive GERD: The most common adverse reactions (≥2% of patients\nin the VOQUEZNA arm) include gastritis (3%), diarrhea (2%), abdominal\ndistention (2%), abdominal pain (2%), and nausea (2%).\n\nMaintenance of Healed Erosive GERD: The most common adverse reactions (≥3%\nof patients in the VOQUEZNA arm) include gastritis (6%), abdominal pain (4%),\ndyspepsia (4%), hypertension (3%), and urinary tract infection (3%).\n\nRelief of Heartburn Associated with Non-Erosive GERD: The most common adverse\nreactions (≥2% of patients in the VOQUEZNA arm) include abdominal pain (2%),\nconstipation (2%), diarrhea (2%), nausea (2%), and urinary tract infection\n(2%).\n\nTreatment of H. Pylori Infection (VOQUEZNA and Amoxicillin): The most common\nadverse reactions (≥2% in any treatment arm) include diarrhea (5%),\nabdominal pain (3%), vulvovaginal candidiasis (2%), nasopharyngitis (2%),\ndysgeusia (1%), headache (1%), and hypertension (1%).\n\nTreatment of H. Pylori Infection (VOQUEZNA, Amoxicillin and Clarithromycin):\nThe most common adverse reactions (≥2% in any treatment arm) include\ndysgeusia (5%), diarrhea (4%), vulvovaginal candidiasis (3%), headache (3%),\nabdominal pain (2%), hypertension (2%), and nasopharyngitis (<1%).\n\nFor more information on adverse reactions and laboratory changes with\namoxicillin or clarithromycin, refer to Adverse Reactions section of the\ncorresponding prescribing information.\n\nDRUG INTERACTIONS\n\nVOQUEZNA has the potential for clinically important drug interactions,\nincluding interactions with drugs dependent on gastric pH for absorption,\ndrugs that are substrates for certain CYP enzymes, and some diagnostic tests.\nAvoid concomitant use of VOQUEZNA with atazanavir or nelfinavir. See full\nPrescribing Information for more details about important drug interactions.\nConsult the labeling of concomitantly used drugs to obtain further information\nabout interactions with vonoprazan.\n\nFor information about drug interactions, contraindications, and warnings and\nprecautions of antibacterial agents (amoxicillin or clarithromycin) indicated\nin combination with VOQUEZNA, refer to their corresponding prescribing\ninformation.\n\nUSE IN SPECIFIC POPULATIONS\n\nPregnancy: There is a pregnancy exposure registry that monitors pregnancy\noutcomes in women exposed to VOQUEZNA during pregnancy. Healthcare providers\nare encouraged to register patients by calling 1-866-609-1612 or visiting\nhttps://voqueznapregnancyregistry.com/.\n\nLactation: There are no data on the effects of vonoprazan on the breastfed\nchild or the effects on milk production. The developmental and health benefits\nof breastfeeding should be considered along with the mother’s clinical need\nfor VOQUEZNA and any potential adverse effects on the breastfed child from\nVOQUEZNA or from the underlying maternal condition.\n\nRenal Impairment: For the healing of Erosive GERD, dosage reduction is\nrecommended in patients with severe renal impairment (eGFR < 30 mL/min). Use\nof VOQUEZNA is not recommended for the treatment of H. pylori infection in\npatients with severe renal impairment.\n\nHepatic Impairment: For the healing of Erosive GERD, dosage reduction is\nrecommended in patients with moderate to severe hepatic impairment (Child-Pugh\nClass B and C). Use of VOQUEZNA is not recommended for the treatment of H.\npylori infection in patients with moderate to severe hepatic impairment.\n\nYou are encouraged to report suspected adverse reactions by contacting Phathom\nPharmaceuticals at 1-888- 775-PHAT (7428) or FDA at 1-800-FDA-1088\nor www.fda.gov/medwatch.\n\nPlease click here \n(https://www.globenewswire.com/Tracker?data=z3gu7F3UGg757ZMCx2fxLQc0yegfRl_e5seLyvAqKGojeou3LPYlWGiFVJw41EPX66MT-o5xnSvn1ArWkGfUjKqpOJlBK2KAPMUAwnj2IFWFtQ9mBd7_maZWfZ4d8Nr5Zq0GO9NJ8UV4dffAJsASSouct7ek9VxK5Hv9xuOu7a7fDnRgLXUC0mUZtxWvDSMo)to\nsee full Prescribing Information for VOQUEZNA.\n\nAbout VOQUEZNA®\nVOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule\npotassium-competitive acid blocker (PCAB). PCABs are a novel class of\nmedicines that block acid secretion in the stomach. VOQUEZNA is approved in\nthe U.S. for the treatment of adults with Erosive Esophagitis, also known as\nErosive GERD, the relief of heartburn associated with Erosive GERD, the relief\nof heartburn associated with Non-Erosive GERD, and for the treatment of H.\npylori infection in combination with either amoxicillin or amoxicillin and\nclarithromycin. Phathom in-licensed the rights to vonoprazan for the U.S.,\nEurope and Canada from Takeda, which markets the product in Japan and numerous\nother countries in Asia and Latin America.\n\nAbout Phathom Pharmaceuticals, Inc.\nPhathom Pharmaceuticals is a biopharmaceutical company focused on the\ndevelopment and commercialization of novel treatments for gastrointestinal\ndiseases. Phathom has in-licensed the exclusive rights to vonoprazan, a\nfirst-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe\nand Canada. Phathom currently markets vonoprazan in the United States as\nVOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with\nNon-Erosive GERD in adults, the healing and maintenance of healing of Erosive\nGERD in adults and relief of associated heartburn, and as part of VOQUEZNA®\nTRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin\ntablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules)\nfor the treatment of H. pylori infection in adults. For more information about\nPhathom, visit the company's website at www.phathompharma.com and follow on\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=Rvu4l-1Z0o8Xa74Y68FuL_9Ay0rsHONkEBihWhH5hDlruasJjj2PxaP10eK4PXaKqNvv1QBTej3D0B98_w6V97XDWltYE_JZmLEiJ5AFnMurcMt_vTiYf1XMEfNG39mr)\nand X\n(https://www.globenewswire.com/Tracker?data=fcT_X8qqQDBaxWnYtIRgAMR-5Rp2SdisxDSspz_qA3AI2xak2GFPqG2Cr2ZqflFqYKwQ5C_t7ziituyjIoLYCQ==).\n\nForward-Looking Statements\nThis press release contains forward-looking statements. All statements other\nthan statements of historical fact contained in this press release, including\nstatements regarding: our plans, expectations, and goals for the development\nof VOQUEZNA for as-needed use in Non-Erosive GERD (NERD); potential timelines\nfor the pHalcon-NERD-302 study (the “Study”), including timelines for site\nactivation, screening, enrollment and reporting of topline results; the\npotential for the Study to be successful and to support the filing and\napproval of a label expansion for VOQUEZNA as an as-needed treatment in NERD;\nthe potential role and need for an as-needed treatment option in the treatment\nof NERD; the potential of VOQUEZNA as such a treatment option, if the Study is\nsuccessful and an expanded label is approved; our plans, expectations and\nstrategies with respect to our business, goals, mission and vision; and our\nfuture performance, results and likelihood of success, are forward-looking\nstatements. In some cases, you can identify forward-looking statements by\nterms such as “may,” “will,” “should,” “expect,” “plan,”\n“anticipate,” “could,” “intend,” “target,” “project,”\n“contemplates,” “believes,” “estimates,” “predicts,”\n“potential,” “guidance,” or “continue” or the negative of these\nterms or other similar expressions. These statements involve known and unknown\nrisks, uncertainties and other important factors that may cause our actual\nresults, performance or achievements to be materially different from any\nfuture results, performance or achievements expressed or implied by the\nforward-looking statements, including the risk that: we may encounter issues\nwith the conduct of the Study that delay our timelines, including slower than\nexpected site activation or enrollment, or issues with study conduct or data\nanalysis; the Study may not replicate the results of our Phase 2 study; the\nStudy may produce negative, mixed or otherwise inconclusive results;\nregulatory authorities may not agree that the results are sufficient to\nsupport a regulatory submission or approval of a label expansion for as-needed\nuse in NERD; even if the results of the Study are positive, we may decide not\nto seek a label expansion; the success of the program may be impacted by\npotential safety or tolerability issues, competition from other therapies,\ntreatment approaches, or ongoing clinical trials of other treatments; we may\nencounter manufacturing or other technical issues that negatively impact our\nconduct of the Study; future cash needs may cause us to change our plans; and\nany of the foregoing or other factors may negatively impact our ability to\nachieve our plans, goals, mission, vision and potential. For additional\ndiscussion of these and other risks, see the risk disclosure in our filings\nwith the Securities and Exchange Commission (SEC), including our Annual Report\non Form 10-K and any subsequent filings with the SEC. You are cautioned not to\nplace undue reliance on these forward-looking statements, which speak only as\nof the date hereof, and we undertake no obligation to revise or update this\npress release to reflect events or circumstances after the date hereof. All\nforward-looking statements are qualified in their entirety by this cautionary\nstatement, which is made under the safe harbor provisions of the Private\nSecurities Litigation Reform Act of 1995.\n\nMEDIA CONTACT\nNick Benedetto\n1-877-742-8466\nmedia@phathompharma.com\n\nINVESTOR CONTACT\nEric Sciorilli\n1-877-742-8466\nir@phathompharma.com\n\n9/26 US-VPZ-26-0317\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0baa6f51-c6cb-4b21-a4e0-573a18b8171c)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX6VvMBx-20260929","title":"Phathom Pharmaceuticals Announces Initiation of Registrational Phase 3 Study of VOQUEZNA® (vonoprazan) for As-Needed Treatment of Non-Erosive GERD","author":"Globe Newswire","ticker":"PHAT","created":"2026-09-29T12:00:02.600Z","tickers":["PHAT"],"exchange":"NASDAQ","article_body":"* Initiation of registrational Phase 3 study of VOQUEZNA® (vonoprazan) for\nas-needed (PRN) use in Non-Erosive Reflux Disease (NERD) builds on previously\nreported positive Phase 2 data\n\n\n* Topline results expected in the first quarter of 2028\n\n\n* pHalcon-NERD-302, if successful, is intended to support a potential VOQUEZNA\nlabel expansion to include as-needed treatment of heartburn episodes in\npatients with Non-Erosive GERD, a treatment regimen of interest to patients\nfor which proton pump inhibitors (PPIs) are not currently approved in the U.S.\nFLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Phathom\nPharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on\nthe development and commercialization of novel treatments for gastrointestinal\ndiseases, today announced the initiation of patient screening in\npHalcon-NERD-302, a registrational Phase 3 study evaluating an as-needed (PRN\nor on-demand) investigational dosing regimen of VOQUEZNA® (vonoprazan)\ntablets in adults with Non-Erosive Gastroesophageal Reflux Disease, or\nNon-Erosive GERD (NERD). Topline results are expected in the first quarter of\n2028. If successful, the study is intended to support a potential regulatory\nsubmission seeking a label expansion for VOQUEZNA tablets for this treatment\nregimen.\n\n“With pHalcon-NERD-302, we are studying what we believe could be an\nimportant new treatment approach for patients with Non-Erosive GERD. The study\nis designed to assess whether as-needed VOQUEZNA can provide rapid relief of\nheartburn when symptoms occur, with relief sustained over 24 hours. We have\nheard from many physicians and patients about the desire for an as-needed\noption. If successful, this study could support a potential label expansion\nfor VOQUEZNA and an important opportunity to potentially broaden how VOQUEZNA\nmay be used in the future to meet the needs of patients with Non-Erosive\nGERD,” said Steve Basta, President and Chief Executive Officer of Phathom\nPharmaceuticals.\n\nVOQUEZNA Phase 3 As-Needed Program\nBuilding on previously reported positive Phase 2 results\n(https://www.globenewswire.com/Tracker?data=p6SARxV3EmESFatREafuPcTdB4khpk34iHvxyaM100lVfpo9UZbD58_HMg7531jE7-ozT_UGt38cmGa_nxH9k_Xl_9D7our6GSg34tYn3ccc-PQJ-S20OWjtLFlKE0tffdyXE6D2F_-eRQakgGee1-07CS6-RtUsGtm0iGARGPDIq8HemeQsT1zwIz-zb4XT2r4M1tcRKiUXtu01hFkvx6kt4hq5GkXUGve1CGOtB_hczuSLYB6Z3kCx02hbnV0V),\npHalcon-NERD-302 is a multicenter, randomized, double-blind,\nplacebo-controlled Phase 3 study investigating VOQUEZNA 10 mg as an as-needed\ntreatment in adults with Non-Erosive GERD. The Phase 3 pHalcon-NERD-302 study\nis expected to enroll approximately 500 adults with Non-Erosive GERD who\nreport heartburn at least four days per week. The study is planned to be\nconducted at approximately 80 sites in the U.S. Following a four-week,\nopen-label run-in period with VOQUEZNA 10 mg once daily, patients without\nheartburn during the final seven days of the run-in period will be randomized\n1:1 to receive VOQUEZNA 10 mg or placebo, as-needed, for 24 weeks of\ntreatment. The primary endpoint, assessed at Week 12, is the percentage of\nheartburn episodes in which patients experience complete relief within two\nhours and sustained relief for 24 hours post-dosing.\n\n“Non-Erosive GERD is characterized by episodic, often unpredictable\nheartburn. Proton-pump inhibitor acid-suppressing therapies generally rely on\ncontinuous daily use,” said Ronnie Fass, M.D., Division Director of\nGastroenterology and Hepatology and Medical Director of the Digestive Health\nCenter at MetroHealth Medical Center, Professor of Medicine at Case Western\nReserve University School of Medicine, and an investigator for\npHalcon-NERD-302. “An as-needed treatment approach would need to provide\nacid suppression that starts rapidly and is sustained long enough to control\nheartburn over 24 hours. The results from the earlier Phase 2 as-needed study\nof VOQUEZNA provide a strong rationale for evaluating its efficacy and safety\nin this Phase 3 trial.”\n\n“One of the practical questions in managing Non-Erosive GERD is whether\npatients with intermittent symptoms need continuous daily therapy. This\nregistrational study is designed to evaluate whether an as-needed treatment\napproach can provide effective heartburn relief when symptoms occur,” said\nPhilip O. Katz, M.D., Professor of Medicine in the Division of\nGastroenterology and Hepatology at Weill Cornell Medicine, gastroenterologist\nat NewYork-Presbyterian/Weill Cornell Medical Center, and an investigator for\npHalcon-NERD-302. Dr. Katz serves as a consultant for Phathom Pharmaceuticals.\n\nFor more information about the pHalcon-NERD-302 study (NCT07752407), visit\nClinicalTrials.gov\n(https://www.globenewswire.com/Tracker?data=L8Cjcz8z5eTD2Pp9vvtzG3EgaW_hZ_kqOLM0khld6emcE94oSxY9QJGSr8HgVFAiUPnyeNbWIZt3rkHT-temIpSqDRImxsEZGFDaK0XPrr-STy3XjLrLpMOeV5ffLEtm).\n\nAbout Non-Erosive Gastroesophageal Reflux Disease\nNon-Erosive Gastroesophageal Reflux Disease (NERD) is the largest subcategory\nof gastroesophageal reflux disease (GERD) and is characterized by\nreflux-related symptoms in the absence of esophageal mucosal erosions. More\nthan 22 million U.S. patients are estimated to be treated annually with\nprescription medication for GERD, and approximately 15 million of these\npatients are believed to have NERD. Symptoms of NERD may impact overall\nquality of life and can include episodic heartburn, regurgitation, problems\nswallowing, and chest pain.\n\nINDICATIONS AND USAGE\n\nVOQUEZNA(®) (vonoprazan) is a potassium-competitive acid blocker (PCAB)\nindicated in adults:\n* for the healing of all grades of Erosive Esophagitis (Erosive\nGastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn\nassociated with Erosive GERD.\n* to maintain healing of all grades of Erosive GERD and relief of heartburn\nassociated with Erosive GERD.\n* for the relief of heartburn associated with Non-Erosive GERD.\n* in combination with amoxicillin and clarithromycin for the treatment of\nHelicobacter pylori (H. pylori) infection.\n* in combination with amoxicillin for the treatment of H. pylori infection.\nIMPORTANT SAFETY INFORMATION\n\nCONTRAINDICATIONS\n\nVOQUEZNA is contraindicated in patients with a known hypersensitivity to\nvonoprazan or any component of VOQUEZNA, or in patients receiving\nrilpivirine-containing products.\n\nFor information about contraindications of antibacterial agents\n(clarithromycin and amoxicillin) indicated in combination with VOQUEZNA, refer\nto the Contraindications section of the corresponding prescribing information.\n\nWARNINGS AND PRECAUTIONS\n\nPresence of Gastric Malignancy: In adults, symptomatic response to therapy\nwith VOQUEZNA does not preclude the presence of gastric malignancy. Consider\nadditional follow-up and diagnostic testing in patients who have a suboptimal\nresponse or an early symptomatic relapse after completing treatment with\nVOQUEZNA. In older patients, also consider endoscopy.\n\nAcute Tubulointerstitial Nephritis: Acute tubulointerstitial nephritis (TIN)\nhas been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and\nevaluate patients with suspected acute TIN.\n\nClostridioides difficile-Associated Diarrhea: Published observational studies\nsuggest that proton pump inhibitors (PPIs) may be associated with an increased\nrisk of Clostridioides difficile-associated diarrhea (CDAD), especially in\nhospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider\nCDAD in patients with diarrhea that does not improve. Use the shortest\nduration of VOQUEZNA appropriate to the condition being treated.\n\nCDAD has been reported with use of nearly all antibacterial agents. For more\ninformation specific to antibacterial agents (clarithromycin and amoxicillin)\nindicated for use in combination with VOQUEZNA, refer to Warnings and\nPrecautions section of the corresponding prescribing information.\n\nBone Fracture: Several published observational studies suggest that PPI\ntherapy may be associated with an increased risk for osteoporosis-related\nfractures of the hip, wrist, or spine, especially in patients receiving high\ndose (multiple daily doses) and long-term therapy (a year or longer). Bone\nfracture, including osteoporosis-related fracture, has also been reported with\nvonoprazan. Use the shortest duration of VOQUEZNA appropriate to the condition\nbeing treated. Patients at risk for osteoporosis-related fractures should be\nmanaged according to the established treatment guidelines.\n\nSevere Cutaneous Adverse Reactions (SCAR): Severe cutaneous adverse reactions,\nincluding Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)\nhave been reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or\nsymptoms of SCAR or other signs of hypersensitivity and consider further\nevaluation.\n\nVitamin B12 (Cobalamin) Deficiency: Long-term use of acid-suppressing drugs\ncan lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria.\nVitamin B12 deficiency has been reported postmarketing with vonoprazan. If\nclinical symptoms consistent with vitamin B12 deficiency are observed in\npatients treated with VOQUEZNA, consider further workup.\n\nHypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported\npostmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or\nhypokalemia and may exacerbate underlying hypocalcemia in at-risk patients.\n\nConsider monitoring magnesium levels prior to initiation of VOQUEZNA and\nperiodically in patients expected to be on prolonged treatment, in patients\ntaking drugs that may have increased toxicity in the presence of\nhypomagnesemia or drugs that may cause hypomagnesemia. Treatment of\nhypomagnesemia may require magnesium replacement and discontinuation of\nVOQUEZNA.\n\nConsider monitoring magnesium and calcium levels prior to initiation of\nVOQUEZNA and periodically while on treatment in patients with a preexisting\nrisk of hypocalcemia. Supplement with magnesium and/or calcium, as necessary.\nIf hypocalcemia is refractory to treatment, consider discontinuing VOQUEZNA.\n\nInteractions with Diagnostic Investigations for Neuroendocrine Tumors: Serum\nchromogranin A (CgA) levels increase secondary to drug-induced decreases in\ngastric acidity. The increased CgA level may cause false positive results in\ndiagnostic investigations for neuroendocrine tumors. Temporarily discontinue\nVOQUEZNA treatment at least 4 weeks before assessing CgA levels and consider\nrepeating the test if initial CgA levels are high.\n\nFundic Gland Polyps: Use of VOQUEZNA is associated with a risk of fundic gland\npolyps that increases with long-term use, especially beyond one year. Fundic\ngland polyps have been reported with vonoprazan in clinical trials and during\npostmarketing use with PPIs. Most patients who developed fundic gland polyps\nwere asymptomatic and fundic gland polyps were identified incidentally on\nendoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition\nbeing treated.\n\nADVERSE REACTIONS\n\nHealing of Erosive GERD: The most common adverse reactions (≥2% of patients\nin the VOQUEZNA arm) include gastritis (3%), diarrhea (2%), abdominal\ndistention (2%), abdominal pain (2%), and nausea (2%).\n\nMaintenance of Healed Erosive GERD: The most common adverse reactions (≥3%\nof patients in the VOQUEZNA arm) include gastritis (6%), abdominal pain (4%),\ndyspepsia (4%), hypertension (3%), and urinary tract infection (3%).\n\nRelief of Heartburn Associated with Non-Erosive GERD: The most common adverse\nreactions (≥2% of patients in the VOQUEZNA arm) include abdominal pain (2%),\nconstipation (2%), diarrhea (2%), nausea (2%), and urinary tract infection\n(2%).\n\nTreatment of H. Pylori Infection (VOQUEZNA and Amoxicillin): The most common\nadverse reactions (≥2% in any treatment arm) include diarrhea (5%),\nabdominal pain (3%), vulvovaginal candidiasis (2%), nasopharyngitis (2%),\ndysgeusia (1%), headache (1%), and hypertension (1%).\n\nTreatment of H. Pylori Infection (VOQUEZNA, Amoxicillin and Clarithromycin):\nThe most common adverse reactions (≥2% in any treatment arm) include\ndysgeusia (5%), diarrhea (4%), vulvovaginal candidiasis (3%), headache (3%),\nabdominal pain (2%), hypertension (2%), and nasopharyngitis (<1%).\n\nFor more information on adverse reactions and laboratory changes with\namoxicillin or clarithromycin, refer to Adverse Reactions section of the\ncorresponding prescribing information.\n\nDRUG INTERACTIONS\n\nVOQUEZNA has the potential for clinically important drug interactions,\nincluding interactions with drugs dependent on gastric pH for absorption,\ndrugs that are substrates for certain CYP enzymes, and some diagnostic tests.\nAvoid concomitant use of VOQUEZNA with atazanavir or nelfinavir. See full\nPrescribing Information for more details about important drug interactions.\nConsult the labeling of concomitantly used drugs to obtain further information\nabout interactions with vonoprazan.\n\nFor information about drug interactions, contraindications, and warnings and\nprecautions of antibacterial agents (amoxicillin or clarithromycin) indicated\nin combination with VOQUEZNA, refer to their corresponding prescribing\ninformation.\n\nUSE IN SPECIFIC POPULATIONS\n\nPregnancy: There is a pregnancy exposure registry that monitors pregnancy\noutcomes in women exposed to VOQUEZNA during pregnancy. Healthcare providers\nare encouraged to register patients by calling 1-866-609-1612 or visiting\nhttps://voqueznapregnancyregistry.com/.\n\nLactation: There are no data on the effects of vonoprazan on the breastfed\nchild or the effects on milk production. The developmental and health benefits\nof breastfeeding should be considered along with the mother’s clinical need\nfor VOQUEZNA and any potential adverse effects on the breastfed child from\nVOQUEZNA or from the underlying maternal condition.\n\nRenal Impairment: For the healing of Erosive GERD, dosage reduction is\nrecommended in patients with severe renal impairment (eGFR < 30 mL/min). Use\nof VOQUEZNA is not recommended for the treatment of H. pylori infection in\npatients with severe renal impairment.\n\nHepatic Impairment: For the healing of Erosive GERD, dosage reduction is\nrecommended in patients with moderate to severe hepatic impairment (Child-Pugh\nClass B and C). Use of VOQUEZNA is not recommended for the treatment of H.\npylori infection in patients with moderate to severe hepatic impairment.\n\nYou are encouraged to report suspected adverse reactions by contacting Phathom\nPharmaceuticals at 1-888- 775-PHAT (7428) or FDA at 1-800-FDA-1088\nor www.fda.gov/medwatch.\n\nPlease click here \n(https://www.globenewswire.com/Tracker?data=z3gu7F3UGg757ZMCx2fxLQc0yegfRl_e5seLyvAqKGojeou3LPYlWGiFVJw41EPX66MT-o5xnSvn1ArWkGfUjKqpOJlBK2KAPMUAwnj2IFWFtQ9mBd7_maZWfZ4d8Nr5Zq0GO9NJ8UV4dffAJsASSouct7ek9VxK5Hv9xuOu7a7fDnRgLXUC0mUZtxWvDSMo)to\nsee full Prescribing Information for VOQUEZNA.\n\nAbout VOQUEZNA®\nVOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule\npotassium-competitive acid blocker (PCAB). PCABs are a novel class of\nmedicines that block acid secretion in the stomach. VOQUEZNA is approved in\nthe U.S. for the treatment of adults with Erosive Esophagitis, also known as\nErosive GERD, the relief of heartburn associated with Erosive GERD, the relief\nof heartburn associated with Non-Erosive GERD, and for the treatment of H.\npylori infection in combination with either amoxicillin or amoxicillin and\nclarithromycin. Phathom in-licensed the rights to vonoprazan for the U.S.,\nEurope and Canada from Takeda, which markets the product in Japan and numerous\nother countries in Asia and Latin America.\n\nAbout Phathom Pharmaceuticals, Inc.\nPhathom Pharmaceuticals is a biopharmaceutical company focused on the\ndevelopment and commercialization of novel treatments for gastrointestinal\ndiseases. Phathom has in-licensed the exclusive rights to vonoprazan, a\nfirst-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe\nand Canada. Phathom currently markets vonoprazan in the United States as\nVOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with\nNon-Erosive GERD in adults, the healing and maintenance of healing of Erosive\nGERD in adults and relief of associated heartburn, and as part of VOQUEZNA®\nTRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin\ntablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules)\nfor the treatment of H. pylori infection in adults. For more information about\nPhathom, visit the company's website at www.phathompharma.com and follow on\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=Rvu4l-1Z0o8Xa74Y68FuL_9Ay0rsHONkEBihWhH5hDlruasJjj2PxaP10eK4PXaKqNvv1QBTej3D0B98_w6V97XDWltYE_JZmLEiJ5AFnMurcMt_vTiYf1XMEfNG39mr)\nand X\n(https://www.globenewswire.com/Tracker?data=fcT_X8qqQDBaxWnYtIRgAMR-5Rp2SdisxDSspz_qA3AI2xak2GFPqG2Cr2ZqflFqYKwQ5C_t7ziituyjIoLYCQ==).\n\nForward-Looking Statements\nThis press release contains forward-looking statements. All statements other\nthan statements of historical fact contained in this press release, including\nstatements regarding: our plans, expectations, and goals for the development\nof VOQUEZNA for as-needed use in Non-Erosive GERD (NERD); potential timelines\nfor the pHalcon-NERD-302 study (the “Study”), including timelines for site\nactivation, screening, enrollment and reporting of topline results; the\npotential for the Study to be successful and to support the filing and\napproval of a label expansion for VOQUEZNA as an as-needed treatment in NERD;\nthe potential role and need for an as-needed treatment option in the treatment\nof NERD; the potential of VOQUEZNA as such a treatment option, if the Study is\nsuccessful and an expanded label is approved; our plans, expectations and\nstrategies with respect to our business, goals, mission and vision; and our\nfuture performance, results and likelihood of success, are forward-looking\nstatements. In some cases, you can identify forward-looking statements by\nterms such as “may,” “will,” “should,” “expect,” “plan,”\n“anticipate,” “could,” “intend,” “target,” “project,”\n“contemplates,” “believes,” “estimates,” “predicts,”\n“potential,” “guidance,” or “continue” or the negative of these\nterms or other similar expressions. These statements involve known and unknown\nrisks, uncertainties and other important factors that may cause our actual\nresults, performance or achievements to be materially different from any\nfuture results, performance or achievements expressed or implied by the\nforward-looking statements, including the risk that: we may encounter issues\nwith the conduct of the Study that delay our timelines, including slower than\nexpected site activation or enrollment, or issues with study conduct or data\nanalysis; the Study may not replicate the results of our Phase 2 study; the\nStudy may produce negative, mixed or otherwise inconclusive results;\nregulatory authorities may not agree that the results are sufficient to\nsupport a regulatory submission or approval of a label expansion for as-needed\nuse in NERD; even if the results of the Study are positive, we may decide not\nto seek a label expansion; the success of the program may be impacted by\npotential safety or tolerability issues, competition from other therapies,\ntreatment approaches, or ongoing clinical trials of other treatments; we may\nencounter manufacturing or other technical issues that negatively impact our\nconduct of the Study; future cash needs may cause us to change our plans; and\nany of the foregoing or other factors may negatively impact our ability to\nachieve our plans, goals, mission, vision and potential. For additional\ndiscussion of these and other risks, see the risk disclosure in our filings\nwith the Securities and Exchange Commission (SEC), including our Annual Report\non Form 10-K and any subsequent filings with the SEC. You are cautioned not to\nplace undue reliance on these forward-looking statements, which speak only as\nof the date hereof, and we undertake no obligation to revise or update this\npress release to reflect events or circumstances after the date hereof. All\nforward-looking statements are qualified in their entirety by this cautionary\nstatement, which is made under the safe harbor provisions of the Private\nSecurities Litigation Reform Act of 1995.\n\nMEDIA CONTACT\nNick Benedetto\n1-877-742-8466\nmedia@phathompharma.com\n\nINVESTOR CONTACT\nEric Sciorilli\n1-877-742-8466\nir@phathompharma.com\n\n9/26 US-VPZ-26-0317\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0baa6f51-c6cb-4b21-a4e0-573a18b8171c)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-29T12:00:02.765640958Z","server_sent_at_ms":1790683202765},"received_at":"2026-09-29T12:00:02.817Z","source_url":null},"analysis":{"id":"143974","press_release_id":"155243","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["topline data not expected until Q1 2028 — long catalyst runway","forward-looking statements note risk that study may not replicate Phase 2 results"],"eventType":"clinical_trial","narrative":"Phathom Pharmaceuticals initiated patient screening in pHalcon-NERD-302, a registrational Phase 3 study of as-needed VOQUEZNA (vonoprazan) 10 mg in adults with Non-Erosive GERD, with topline results expected in Q1 2028.\n\nThe trial plans to enroll approximately 500 adults across roughly 80 U.S. sites, testing whether PRN dosing provides rapid, sustained heartburn relief versus placebo, building on positive Phase 2 results.\n\nA successful readout could support a label expansion for as-needed use in NERD, a regimen not currently approved for PPIs in the U.S., potentially broadening VOQUEZNA's addressable population of an estimated 15 million U.S. NERD patients.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Phathom kicks off PRN VOQUEZNA Phase 3 in NERD, extending the label-expansion runway into 2028."},"keyFigures":{"drugName":"VOQUEZNA (vonoprazan)","phaseOfTrial":"Phase 3","customDimensions":{"trial_id":"NCT07752407","study_sites":"approximately 80 U.S. sites","dosing_regimen":"as-needed (PRN) VOQUEZNA 10 mg","expected_enrollment":500,"topline_results_timing":"first quarter of 2028"}},"quotedText":"If successful, this study could support a potential label expansion for VOQUEZNA and an important opportunity to potentially broaden how VOQUEZNA may be used in the future to meet the needs of patients with Non-Erosive GERD","namedEntities":{"people":[{"name":"Steve Basta","role":"President and CEO, Phathom Pharmaceuticals"},{"name":"Ronnie Fass, M.D.","role":"pHalcon-NERD-302 investigator; MetroHealth Medical Center"},{"name":"Philip O. Katz, M.D.","role":"pHalcon-NERD-302 investigator; Weill Cornell Medicine"}],"products":["VOQUEZNA","vonoprazan","VOQUEZNA TRIPLE PAK","VOQUEZNA DUAL PAK"],"companies":[{"name":"Phathom Pharmaceuticals, Inc.","ticker":"PHAT","relationship":"filer"},{"name":"Takeda","relationship":"licensor of vonoprazan rights"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Initiation of a registrational Phase 3 study is a positive pipeline milestone but routine; topline data are not expected until Q1 2028, so near-term impact is limited."},"tickerRelevance":{"others":[],"primary":"PHAT"},"globalImportance":25,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap biotech","eventGravity":"Phase 3 initiation (routine milestone)","catalystTiming":"Q1 2028 topline","commercialRelevance":"potential label expansion in large NERD population"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Phathom Pharmaceuticals initiated patient screening in pHalcon-NERD-302, a registrational Phase 3 study of as-needed VOQUEZNA (vonoprazan) 10 mg in adults with Non-Erosive GERD, with topline results expected in Q1 2028.\n\nThe trial plans to enroll approximately 500 adults across roughly 80 U.S. sites, testing whether PRN dosing provides rapid, sustained heartburn relief versus placebo, building on positive Phase 2 results.\n\nA successful readout could support a label expansion for as-needed use in NERD, a regimen not currently approved for PPIs in the U.S., potentially broadening VOQUEZNA's addressable population of an estimated 15 million U.S. NERD patients.","key_figures":{"drugName":"VOQUEZNA (vonoprazan)","phaseOfTrial":"Phase 3","customDimensions":{"trial_id":"NCT07752407","study_sites":"approximately 80 U.S. sites","dosing_regimen":"as-needed (PRN) VOQUEZNA 10 mg","expected_enrollment":500,"topline_results_timing":"first quarter of 2028"}},"named_entities":{"people":[{"name":"Steve Basta","role":"President and CEO, Phathom Pharmaceuticals"},{"name":"Ronnie Fass, M.D.","role":"pHalcon-NERD-302 investigator; MetroHealth Medical Center"},{"name":"Philip O. Katz, M.D.","role":"pHalcon-NERD-302 investigator; Weill Cornell Medicine"}],"products":["VOQUEZNA","vonoprazan","VOQUEZNA TRIPLE PAK","VOQUEZNA DUAL PAK"],"companies":[{"name":"Phathom Pharmaceuticals, Inc.","ticker":"PHAT","relationship":"filer"},{"name":"Takeda","relationship":"licensor of vonoprazan rights"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-29T12:00:25.914Z","global_importance":25,"audience_relevance":30,"importance_components":{"tickerTier":"small-cap biotech","eventGravity":"Phase 3 initiation (routine milestone)","catalystTiming":"Q1 2028 topline","commercialRelevance":"potential label expansion in large NERD population"}},"durationMs":6678,"modelName":"glm-5.3-flashx"}}