Clarithromycin

Hikma launches Deflazacort Tablets in the US London, UK, 14 October 2026 – Hikma Pharmaceuticals PLC (Hikma, Group), a multinational pharmaceutical company, today announced the US launch of Deflazacort Tablets in four strengths (6mg, 18mg, 30mg, and 36mg), expanding its rare disease portfolio. The product is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Please see Important Safety Information below and full Prescribing Information at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00df3169-b8e3-4584-823b-91b71807d1a6 “Duchenne muscular dystrophy is a rare, progressive condition, and the families managing it depend on uninterrupted access to standard-of-care medicines,” said Hafrun Fridriksdottir, US President and Chief R&D Officer at Hikma. “This is our latest rare disease launch and reflects our ongoing focus on more complex products where reliable supply matters most. We are manufacturing Deflazacort Tablets in the US, at our state-of-the-art facility in Columbus, Ohio, and adding a further qualified, domestic supplier to this market helps support continuity for patients and their caregivers.” According to IQVIA, US sales of Deflazacort Tablets were approximately $25 million in the 12 months ending June 2026. Hikma supplies a broad range of increasingly complex non-injectable products to the US market. Our Columbus, Ohio facility supports this portfolio, and we are committed to continued investment in US manufacturing. – ENDS – This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P and BBB/stable Fitch) Download full press release Enquiries Hikma Pharmaceuticals PLC Susan Ringdal EVP, Strategic Planning and Global Affairs +44 (0)20 7399 2760/ +44 7776 477050 Steven Weiss US Communications +1 732 788 8279 IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR DEFLAZACORT TABLETS INDICATIONS Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. CONTRAINDICATIONS Deflazacort tablets are contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients. WARNINGS AND PRECAUTIONS Alterations in Endocrine Function—Corticosteroids, such as deflazacort tablets, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients for Cushing’s syndrome, hyperglycemia and adrenal insufficiency after deflazacort tablets withdrawal. In addition, patients with hypopituitarism, primary adrenal insufficiency or congenital adrenal hyperplasia, altered thyroid function or pheochromocytoma may be at increased risk for adverse endocrine events. Corticosteroids produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, with the potential for the development of secondary adrenal insufficiency after withdrawal of corticosteroid treatment. Acute adrenal insufficiency can occur if corticosteroids are withdrawn abruptly, and can be fatal. The degree and duration of adrenocortical insufficiency produced varies and depends on the dose, frequency and duration of corticosteroid therapy. The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. This insufficiency may persist, however, for months after discontinuation of prolonged therapy; therefore, in any situation of stress occurring during that period of discontinuation, corticosteroid therapy should be reinstituted. For patients already taking corticosteroids during times of stress, the dosage may need to be increased. A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids. Corticosteroids can increase blood glucose, worsen pre-existing diabetes, predispose those on long-term therapy to diabetes mellitus and may reduce the effect of anti-diabetic drugs. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate a dose adjustment of the corticosteroid. When concomitant administration of corticosteroids and levothyroxine is required, administration of corticosteroid should precede the initiation of levothyroxine therapy to reduce the risk of adrenal crisis. There have been reports of pheochromocytoma crisis, which can be fatal, after administration of systemic corticosteroids. In patients with suspected or identified pheochromocytoma, consider the risk of pheochromocytoma prior to administering corticosteroids. Immunosuppression and Increased Risk of Infection—Corticosteroids can reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections or mask some signs of infection. Corticosteroid-associated infections can be mild but can be severe, and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider deflazacort tablets withdrawal or dosage reduction as needed. If deflazacort tablets are used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged deflazacort tablets therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including deflazacort tablets; particular care should be taken to avoid exposure to varicella and measles. Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including deflazacort tablets. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before initiating immunosuppressive treatment with deflazacort tablets. Corticosteroids, including deflazacort tablets, may exacerbate systemic fungal infections; therefore, avoid deflazacort tablets use in the presence of such infections unless deflazacort tablets is needed to control drug reactions. For patients on deflazacort tablets who develop systemic fungal infections, deflazacort tablets withdrawal or dose reduction is recommended. Corticosteroids, including deflazacort tablets, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating deflazacort tablets in patients who have spent time in the tropics or patients with unexplained diarrhea. Corticosteroids, including deflazacort tablets, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. Corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Avoid corticosteroids, including deflazacort tablets, in patients with cerebral malaria. Alteration in Cardiovascular/Renal Function—Monitor blood pressure and assess for signs and symptoms of volume overload. Monitor serum potassium levels. Dietary salt restriction and potassium supplementation may be necessary. Use deflazacort tablets with caution in patients with congestive heart failure, hypertension or renal insufficiency. Literature reports suggest an association between corticosteroid use and left ventricular free wall rupture after a recent myocardial infarction; therefore, deflazacort tablets should be used with great caution in these patients. Gastrointestinal Perforation—There is an increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses and non-specific ulcerative colitis. Signs of gastrointestinal perforation may be masked. Avoid corticosteroids if there is a probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses or active or latent peptic ulcer. Behavioral or Mood Disturbances—Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including deflazacort tablets. Symptoms typically emerge within a few days or weeks of starting treatment and may be dose-related. Psychiatric reactions usually involve hypomanic or manic symptoms during treatment and depressive episodes after discontinuation of treatment. Inform patients or caregivers and encourage them to seek medical attention if psychiatric symptoms develop, especially if depressed mood or suicidal ideation is suspected. Effects on Bones—Corticosteroids, including deflazacort tablets, have the potential to cause inhibition of bone growth in pediatric patients and the development of bone loss at any age. Bone loss can predispose patients to vertebral and long bone fractures. Consider a patient’s risk of osteoporosis before initiating corticosteroid therapy. Monitor bone mineral density in patients on long-term treatment with deflazacort tablets. Corticosteroids, including deflazacort tablets, may cause avascular necrosis. Ophthalmic Effects—Corticosteroids, including deflazacort tablets, may produce posterior subcapsular cataracts. Corticosteroids may also cause glaucoma with possible damage to the optic nerves, and may increase the risk of secondary ocular infections caused by bacteria, fungi or viruses. Corticosteroids are not recommended for patients with active ocular herpes simplex. Monitor intraocular pressure if treatment with deflazacort tablets is continued for more than 6 weeks. Immunizations—Administer all immunizations according to immunization guidelines prior to starting deflazacort tablets. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting deflazacort tablets. Patients on deflazacort tablets may receive concurrent vaccinations, except for live-attenuated or live vaccines. Serious Skin Rashes—Toxic epidermal necrolysis has been reported with the use of deflazacort. Discontinue at the first sign of rash, unless the rash is clearly not drug-related. Effects on Growth and Development—Long-term use of corticosteroids, including deflazacort tablets, can have negative effects on growth and development in children. Myopathy—Patients receiving corticosteroids, including deflazacort tablets, and concomitant therapy with neuromuscular blocking agents or patients with disorders of neuromuscular transmission may be at increased risk of developing acute myopathy. Kaposi’s Sarcoma—Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Thromboembolic Events—Observational studies have shown an increased risk of thromboembolism particularly with higher cumulative doses of corticosteroids. Use deflazacort tablets with caution in patients who have or may be predisposed to thromboembolic disorders. Anaphylaxis—Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy, including deflazacort tablets. ADVERSE REACTIONS Serious adverse reactions are described in the Warnings and Precautions section, above, and in the Full Prescribing Information for deflazacort tablets. Clinical Trials Experience Adverse reactions occurring in >5% of DMD patients treated with deflazacort 0.9 mg/kg/day at 12 weeks included Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, nasopharyngitis, hirsutism, central obesity, erythema, irritability, rhinorrhea and abdominal discomfort. DRUG INTERACTIONS Give one-third the recommended dosage of deflazacort tablets when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with deflazacort tablets. Avoid concomitant use of strong or moderate CYP3A4 inducers with deflazacort tablets, as they may reduce efficacy. Patients receiving corticosteroids, including deflazacort tablets, and concomitant therapy with neuromuscular blocking drugs may be at increased risk of developing an acute myopathy. USE IN SPECIFIC POPULATIONS Pregnancy—Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Corticosteroids, including deflazacort tablets, readily cross the placenta. Lactation—Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production or cause other untoward effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for deflazacort tablets and any potential adverse effects on the breastfed infant. Pediatric Use—Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Hepatic Impairment—There is no clinical experience in patients with severe hepatic impairment and a dosing recommendation cannot be provided for these patients. For more information, please see the Full Prescribing Information for deflazacort tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. For more information about deflazacort tablets, please contact Hikma Pharmaceuticals USA Inc. 1-800-962-8364. Distributed by: Hikma Pharmaceuticals USA Inc.; Berkeley Heights, NJ 07922 HK-3651 v1

New analysis projects VOQUEZNA® (vonoprazan) to provide meaningful economic value and be cost-effective vs. proton pump inhibitors (PPIs) for adults with Erosive GERD, with potential cost savings at net price based on clinical healing and maintenance-of-healing data and fewer anticipated downstream complications Additional Phathom-sponsored data highlight VOQUEZNA treatment effect across BMI subgroups in Non-Erosive GERD and real-world patient characteristics Vonoprazan was also the subject of 38 independent, investigator-initiated abstracts presented at ACG 2026, spanning GERD, H. pylori eradication, and other gastrointestinal conditions FLORHAM PARK, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced new cost-effectiveness data for VOQUEZNA ® (vonoprazan), alongside additional clinical and real-world data, presented at the American College of Gastroenterology’s (ACG) 2026 Annual Scientific Meeting, being held October 9-14 in Nashville, Tennessee. A new predictive cost-effectiveness analysis projected VOQUEZNA to provide meaningful economic value and be cost-effective compared with proton pump inhibitors (PPIs) for the healing and maintenance of Erosive Esophagitis or Erosive Gastroesophageal Reflux Disease (GERD) over patients’ lifetimes, with potential cost savings at net price based on clinical healing and maintenance of healing data and fewer anticipated downstream complications. Phathom presented two additional analyses at the meeting, including a post-hoc analysis of VOQUEZNA treatment effects across Body Mass Index (BMI) subgroups in Non-Erosive GERD, and a retrospective study characterizing US patients prescribed VOQUEZNA relative to those prescribed a prescription PPI. Vonoprazan was also the subject of 38 independent, investigator-initiated abstracts presented at ACG 2026 by academic and clinical researchers, reflecting continued scientific interest in vonoprazan and the potassium-competitive acid blocker (PCAB) class across GERD, H. pylori eradication, and other GI conditions. “These new findings highlight the potential cost-effectiveness of VOQUEZNA for patients with Erosive GERD and provide new insights into how clinical outcomes may translate into healthcare savings over time,” said Steve Basta, President and Chief Executive Officer of Phathom . “We’re also encouraged by the continued growth in independent research evaluating vonoprazan across a wide range of GI conditions, which speaks to the broader scientific and clinical interest in this therapeutic class of acid suppression.” Cost-Effectiveness of VOQUEZNA in Erosive Esophagitis A Markov model projected lifetime clinical and economic outcomes of VOQUEZNA versus PPIs in commercially insured U.S. adults with Erosive GERD beginning at a mean age of 51.3 years. Clinical outcomes in the model were generated using treatment-specific probabilities of healing and maintenance of healing, calibrated to rates of Erosive GERD-related complications, including Barrett’s esophagus, esophageal adenocarcinoma and death. The model also incorporated assumptions regarding drug pricing and costs. In both the overall and severe (Los Angeles Grades C and D) Erosive GERD population, VOQUEZNA was projected over a lifetime horizon to result in fewer downstream complications of Erosive GERD, such as esophageal adenocarcinoma and related deaths, compared with PPIs. At an estimated net price, VOQUEZNA was projected to provide healthcare savings over PPIs in both the overall and severe Erosive GERD populations. At WAC price, VOQUEZNA was projected to be cost-effective vs. PPIs with incremental cost-effectiveness ratios (ICERs) per quality-adjusted life year (QALY) 1 of $28,402 and $18,878, for the overall and severe Erosive GERD populations, respectively. _______________ 1 ICER per QALY of <$100,000 is a standard minimum threshold of cost-effectiveness Additional Phathom-Sponsored Data at ACG 2026 Vonoprazan Efficacy Across BMI Subgroups in Non-Erosive Reflux Disease ( Poster P0624 - Presented by Catiele Antunes, MD, Yale School of Medicine ): In a post-hoc analysis of a Phase 3 randomized controlled trial of VOQUEZNA in the treatment of Non-Erosive GERD, improvements in 24-hour heartburn-free days and both daytime and nighttime heartburn control with VOQUEZNA versus placebo were observed across BMI subgroups (<30, ≥30, and ≥35 kg/m²). There was no significant treatment-by-BMI interaction, suggesting that BMI did not modify the treatment effect of VOQUEZNA. Baseline heartburn and regurgitation symptom scores were similar across BMI subgroups, with greater improvement following vonoprazan versus placebo in each group. Characteristics of U.S. Patients With GERD Taking Vonoprazan or a Prescription PPI ( Poster P2921 - Presented by Nicholas J. Shaheen, MD, MPH ): A retrospective cohort study using linked EHR and claims data found that patients initiating VOQUEZNA (n=1,304) had a more severe baseline GERD pro those initiating a prescription PPI (n=1,304,683), including higher rates of Erosive GERD (64.6% vs. 32.3%), hiatal hernia (32.4% vs. 10.7%), and use of two or more prior prescription PPI lines of therapy (62.1% vs. 38.2%). Independent Research on Vonoprazan Presented at ACG 2026: Key areas of independent research presented at ACG 2026 include: Real-world analyses evaluating GI and renal safety outcomes with vonoprazan compared to PPIs, including chronic kidney disease and enteric infection endpoints Multiple independent meta-analyses assessing vonoprazan-based regimens for H. pylori eradication, including comparisons with bismuth quadruple therapy and salvage regimens for treatment-refractory infection Studies evaluating vonoprazan in GI bleeding and peptic ulcers, including in patients receiving antithrombotic therapy and following endoscopic hemostasis Real-world data from China evaluating vonoprazan in patients with reflux esophagitis, including elderly patients and those with comorbid anxiety or depression Independent research evaluating vonoprazan in post-bariatric surgery complications, eosinophilic esophagitis, achalasia, and post-POEM esophagitis management Note: The independent research described in this press release includes investigational uses of vonoprazan that are not approved by the U.S. Food and Drug Administration. Abstract titles are reproduced as presented by the independent investigators and do not represent claims by Phathom. Independent Vonoprazan Abstracts at ACG 2026: GERD Beyond Acid Suppression: Short-Term Gastrointestinal and Renal Outcomes of Vonoprazan Versus Proton Pump Inhibitors in a Propensity-Matched Global Cohort (Maddineni G et al.; P0686) Comparative Risk of Vitamin B12, Iron, and Magnesium Deficiency in Long-Term Users of Vonoprazan Versus Proton Pump Inhibitors ( Naseem Z et al.; P2822 ) Vonoprazan Versus Proton Pump Inhibitors and Risk of Incident Chronic Kidney Disease: A New User, Active Comparator Study With Negative Control Calibration ( Kalu J et al.; P2888 ) Beyond Acid Suppression: Real-World Enteric Infection and All-Cause Mortality Outcomes With Vonoprazan Versus Proton Pump Inhibitor in Gastroesophageal Reflux Disease ( Ayad E et al.; P2894 ) Near-Maximal Acid Suppression With Twice-Daily Low-Dose Vonoprazan: A New Era of Gastric Acid Control? ( Jafri K et al.; P2995 ) Longitudinal Gut Resistome Remodeling and Phenotype-Specific Refractory GERD Outcomes During P-CAB Versus PPI Therapy: Prospective Multicenter Data from India ( Kandukuri V et al.; P5150 ) Effectiveness of Vonoprazan in Chinese Patients With Gastroesophageal Reflux Disease: Post Hoc Analysis of a Multicentre, Prospective, Real-World Study ( Zhou F et al.; P5199 ) Effectiveness of Vonoprazan in Gastroesophageal Reflux Disease Patients With Anxiety and/or Depression in China: Post Hoc Analysis of the VIEW Study ( Zhou F et al.; P5200 ) Ultra-Rapid Heartburn Relief and Early Mucosal Healing: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing P-CABs and PPIs ( Talaat M et al.; P5245 ) Comparative Efficacy and Safety of Pharmacological Therapies for Non-Erosive Reflux Disease: A Systematic Review and Network Meta-Analysis ( Arsalan M et al.; P0643 ) Endoscopic Sleeve Gastroplasty Worsens Gastroesophageal Reflux Disease Compared to GLP-1 Agonists and Roux-en-Y Gastric Bypass: Results From a Large Population-Based Database ( Saha B et al.; P3726 ) Safety & Comparative Outcomes Not All Proton Pump Inhibitors Are Equal: A Head-to-Head Safety Comparison of All Six Oral Agents in 954,252 Propensity-Matched Adults ( Ahmed H et al.; P5142 ) Potassium-Competitive Acid Blockers Were Associated With Lower Major Adverse Safety Events Compared With Proton Pump Inhibitors: A Propensity-Matched Cohort Study ( Alsakarneh S et al.; P6705 ) H. pylori Eradication Effect of Amoxicillin Dosing Frequency in Vonoprazan Dual Therapy for H. pylori : A Systematic Review and Meta-Analysis ( Marupuru S et al.; P1298 ) Vonoprazan Versus Esomeprazole for H. pylori Eradication in Treatment Naïve Patients: A Regimen-Stratified Meta-Analysis of Randomized Controlled Trials ( Arsalan M et al.; P1305 ) Vonoprazan-Based Dual Therapy as a Rescue Regimen for Treatment-Experienced Helicobacter pylori Infection: A Systematic Review and Meta-Analysis ( Abosheaishaa H et al.; P1316 ) Refractory Duodenal Stricture Secondary to Persistent Helicobacter pylori Infection Treated With Vonoprazan-Based Therapy, Serial Dilations, and Steroid Injection ( Afzal A et al.; P2129 ) H. pylori : Why Treatment Fails (and What to Do Next) ( Hameed A et al.; P2144 ) Real-World Comparative Effectiveness of Vonoprazan-Based vs PPI-Based Triple Therapy for H. pylori Eradication: A Propensity Score-Matched (PSM) Analysis Using TriNetX Database ( Patel M et al.; P2155 ) Vonoprazan-Amoxicillin Dual Therapy Versus Bismuth Quadruple Therapy for First-Line Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis of Randomized Controlled Trials ( Yadav J et al.; P2169 ) Smoking Status as the Critical Effect Modifier of P-CAB Superiority Over PPIs in Helicobacter pylori Eradication: A Smoking-Stratified Mantel-Haenszel Meta-Analysis ( Yathindra M et al.; P4419 ) Vonoprazan-Based Triple Therapy Versus Proton Pump Inhibitor Regimens for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis ( Sarwar A et al.; P3621 ) Efficacy and Safety of Vonoprazan-Based Dual Therapy vs Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: Systematic Review, Meta-Analysis, GRADE Assessment, and Trial Sequential Analysis ( Navabi S et al.; P3636 ) Simplified Vonoprazan Rescue Regimens for Persistent/Refractory Helicobacter pylori : A Rescue-Specific Meta-Analysis of Randomized Trials ( Abugharbieh H et al.; P4398 ) Efficacy and Safety of Vonoprazan-Amoxicillin Dual Therapy Compared With Other Eradication Regimens for Helicobacter pylori Infection: A Systematic Review and Meta-Analysis ( Faisal A et al.; P4403 ) Efficacy and Safety of Vonoprazan-Amoxicillin Dual vs Bismuth Quadruple Therapy for First-Line H. pylori Eradication in Treatment-Naïve Adults: Updated Systematic Review and Meta-Analysis ( Chiluveru S et al.; P5841 ) Efficacy and Safety of Modern Salvage Therapies After Multiple Helicobacter pylori Eradication Failures: A Systematic Review and Meta-Analysis ( Khokhar I et al.; P6672 ) Vonoprazan-Based Rescue Regimens Versus Bismuth Quadruple Therapy for Refractory Helicobacter pylori Infection: A Systematic Review and Meta-Analysis of Randomized Controlled Trials ( Maghari I et al.; P6678 ) Peptic Ulcer, GI Bleeding & Procedural Care Vonoprazan Is Superior to Proton Pump Inhibitors for Prevention of Upper Gastrointestinal Bleeding in Patients With Atheroembolic Cardiovascular Disease Receiving Antithrombotic ( Alsakarneh S et al.; P5496 ) Adjunct Vonoprazan in the Treatment of Gastrojejunal Anastomotic Ulcers: A Novel Use ( Atlan A et al.; P3317 ) Healing of Anastomotic Ulcer With Vonoprazan: A Case Report ( Haj-Rubaeih M et al.; P4376 ) Oral Vonoprazan Versus High-Dose Intravenous PPIs After Endoscopic Hemostasis for High-Risk Peptic Ulcer Bleeding: A Systematic Review and Meta-analysis ( Meda S et al.; P5495 ) Proactive Versus Reactive Proton Pump Inhibitor (PPI) Management for Post-Peroral Endoscopic Myotomy (POEM) Objective Gastroesophageal Reflux: A Systematic Review and Network Meta-Analysis ( Quirequire G et al.; P2957 ) When PPIs Fail: Rapid Resolution of Refractory Post-POEM Esophagitis With Vonoprazan ( Lerttiendamrong B et al.; P2978 ) Other GI Conditions Efficacy of Potassium-Competitive Acid Blocker Therapy in PPI-Refractory Post-Bariatric Surgery Complications ( Matar A et al.; P0657 ) Insurance Coverage and Patient Out-of-Pocket Costs Influence Physicians in Choosing Off-Label Over FDA-Approved Treatments for Patients With Eosinophilic Esophagitis: Results From a U.S. Physician Survey ( Hughes G et al.; P2927 ) Gastroesophageal Intussusception After Peroral Endoscopic Myotomy for Achalasia in an Adult: Case Report and Literature Review ( Qaqish F et al.; P5294 ) Early-Onset Gastroesophageal Junction Adenocarcinoma in a 27-Year-Old Female: A Rising Trend ( Rehman A et al.; P6741 ) About VOQUEZNA® VOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Any other uses of vonoprazan as described in the independent research presented at ACG 2026 are investigational in the U.S., and Phathom makes no representations concerning the safety or efficacy of such investigational uses. Phathom in-licensed the U.S. rights to vonoprazan from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America. INDICATIONS AND USAGE VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated in adults: for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD. to maintain healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD. for the relief of heartburn associated with Non-Erosive GERD. in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection. in combination with amoxicillin for the treatment of H. pylori infection. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA, or in patients receiving rilpivirine-containing products. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with VOQUEZNA, refer to the Contraindications section of the corresponding prescribing information. WARNINGS AND PRECAUTIONS Presence of Gastric Malignancy: In adults, symptomatic response to therapy with VOQUEZNA does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in patients who have a suboptimal response or an early symptomatic relapse after completing treatment with VOQUEZNA. In older patients, also consider endoscopy. Acute Tubulointerstitial Nephritis: Acute tubulointerstitial nephritis (TIN) has been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and evaluate patients with suspected acute TIN. Clostridioides difficile -Associated Diarrhea: Published observational studies suggest that proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridioides difficile -associated diarrhea (CDAD), especially in hospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider CDAD in patients with diarrhea that does not improve. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with VOQUEZNA, refer to Warnings and Precautions section of the corresponding prescribing information. Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, especially in patients receiving high dose (multiple daily doses) and long-term therapy (a year or longer). Bone fracture, including osteoporosis-related fracture, has also been reported with vonoprazan. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines. Severe Cutaneous Adverse Reactions (SCAR): Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation. Vitamin B12 (Cobalamin) Deficiency: Long-term use of acid-suppressing drugs can lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria. Vitamin B12 deficiency has been reported postmarketing with vonoprazan. If clinical symptoms consistent with vitamin B12 deficiency are observed in patients treated with VOQUEZNA, consider further workup. Hypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported postmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. Consider monitoring magnesium levels prior to initiation of VOQUEZNA and periodically in patients expected to be on prolonged treatment, in patients taking drugs that may have increased toxicity in the presence of hypomagnesemia or drugs that may cause hypomagnesemia. Treatment of hypomagnesemia may require magnesium replacement and discontinuation of VOQUEZNA. Consider monitoring magnesium and calcium levels prior to initiation of VOQUEZNA and periodically while on treatment in patients with a preexisting risk of hypocalcemia. Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing VOQUEZNA. Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily discontinue VOQUEZNA treatment at least 4 weeks before assessing CgA levels and consider repeating the test if initial CgA levels are high. Fundic Gland Polyps: Use of VOQUEZNA is associated with a risk of fundic gland polyps that increases with long-term use, especially beyond one year. Fundic gland polyps have been reported with vonoprazan in clinical trials and during postmarketing use with PPIs. Most patients who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. ADVERSE REACTIONS Healing of Erosive GERD : The most common adverse reactions (≥2% of patients in the VOQUEZNA arm) include gastritis (3%), diarrhea (2%), abdominal distention (2%), abdominal pain (2%), and nausea (2%). Maintenance of Healed Erosive GERD : The most common adverse reactions (≥3% of patients in the VOQUEZNA arm) include gastritis (6%), abdominal pain (4%), dyspepsia (4%), hypertension (3%), and urinary tract infection (3%). Relief of Heartburn Associated with Non-Erosive GERD: The most common adverse reactions (≥2% of patients in the VOQUEZNA arm) include abdominal pain (2%), constipation (2%), diarrhea (2%), nausea (2%), and urinary tract infection (2%). Treatment of H. Pylori Infection (VOQUEZNA and Amoxicillin): The most common adverse reactions (≥2% in any treatment arm) include diarrhea (5%), abdominal pain (3%), vulvovaginal candidiasis (2%), nasopharyngitis (2%), dysgeusia (1%), headache (1%), and hypertension (1%). Treatment of H. Pylori Infection (VOQUEZNA, Amoxicillin and Clarithromycin): The most common adverse reactions (≥2% in any treatment arm) include dysgeusia (5%), diarrhea (4%), vulvovaginal candidiasis (3%), headache (3%), abdominal pain (2%), hypertension (2%), and nasopharyngitis (<1%). For more information on adverse reactions and laboratory changes with amoxicillin or clarithromycin, refer to Adverse Reactions section of the corresponding prescribing information. DRUG INTERACTIONS VOQUEZNA has the potential for clinically important drug interactions, including interactions with drugs dependent on gastric pH for absorption, drugs that are substrates for certain CYP enzymes, and some diagnostic tests. Avoid concomitant use of VOQUEZNA with atazanavir or nelfinavir. See full Prescribing Information for more details about important drug interactions. Consult the labeling of concomitantly used drugs to obtain further information about interactions with vonoprazan. For information about drug interactions, contraindications, and warnings and precautions of antibacterial agents (amoxicillin or clarithromycin) indicated in combination with VOQUEZNA, refer to their corresponding prescribing information. USE IN SPECIFIC POPULATIONS Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA during pregnancy. Healthcare providers are encouraged to register patients by calling 1-866-609-1612 or visiting . Lactation: There are no data on the effects of vonoprazan on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VOQUEZNA and any potential adverse effects on the breastfed child from VOQUEZNA or from the underlying maternal condition. Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR < 30 mL/min). Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with severe renal impairment. Hepatic Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C). Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with moderate to severe hepatic impairment. You are encouraged to report suspected adverse reactions by contacting P hathom Pharmaceuticals at 1-888-775-PHAT (7428) or FDA at 1-800-FDA-1088 or . Please click here for full Prescribing Information for VOQUEZNA. 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), for the U.S., Europe and Canada. Phathom currently markets vonoprazan 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, and as part of 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 , and follow on LinkedIn and X . Forward-Looking Statement This press release contains forward-looking statements, including without limitation statements regarding the potential economic value and cost-effectiveness of VOQUEZNA, including projected healthcare savings from potential clinical outcomes and reductions in downstream complications. These statements involve known and unknown risks, uncertainties and other important factors that may cause actual results or outcomes to be materially different from those expressed or implied by the forward-looking statements, including the risk that actual clinical outcomes associated with use of VOQUEZNA may differ materially from those projected by the cost-effectiveness model or achieved in clinical trials; there may be other differences between the assumptions and inputs used in the model and actual experience, including with respect to clinical outcomes, treatment patterns, drug pricing, healthcare costs and the incidence and costs of downstream complications; and other factors may arise or occur that could cause actual results or outcomes to differ materially from those projected or anticipated. For additional discussion of these and other risks related to our business, see the risk disclosure in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date made, and we undertake no obligation to revise or update forward-looking statements to reflect events or circumstances after such date. 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 media@phathompharma.com INVESTOR CONTACT Eric Sciorilli 1-877-742-8466 ir@phathompharma.com © 2026 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.