Phathom's Commercial Success Funds High-Risk Pipeline Expansion Beyond Core GERD

Phathom Reports Record Q2 Revenue and Initiates VOQUEZNA Phase 3 for NERD

Phathom Pharmaceuticals reported strong financial results for the second quarter ended June 30, 2026, with record net revenues of $74.3 million, an 88% increase compared to Q2 2025. The company achieved operating profitability, excluding stock-based compensation, for the first time. VOQUEZNA® continued its commercial success, with approximately 1.7 million total prescriptions filled to date. Phathom also announced the initiation of a registrational Phase 3 clinical program for as-needed VOQUEZNA® in patients with Non-Erosive GERD (NERD), with first subject enrollment expected in Q4 2026. Additionally, enrollment was completed for the Phase 2 pHalcon-EoE-201 trial evaluating VOQUEZNA® in Eosinophilic Esophagitis (EoE), with topline results anticipated in Q4 2026. The company updated its full-year 2026 net revenue guidance to $310–325 million.

• Phathom Pharmaceuticals achieved record net revenues of $74.3 million in Q2 2026, marking an 88% increase from Q2 2025 and a 27% increase from Q1 2026. This strong financial performance led to the company's first-time operating profitability, excluding stock-based compensation, demonstrating successful execution of its commercial strategy and cost management.
• VOQUEZNA® demonstrated significant commercial progress, with approximately 1.7 million total prescriptions filled as of July 17, 2026. During Q2 2026 alone, approximately 325,000 prescriptions were filled, representing an 88% increase compared to Q2 2025 and a 21% increase over Q1 2026, highlighting growing market acceptance and demand.
• The company is initiating a registrational Phase 3 clinical program to evaluate as-needed dosing of VOQUEZNA® for Non-Erosive GERD (NERD), building on positive Phase 2 results. First subject enrollment is expected in Q4 2026, with the potential for label expansion to address unmet patient needs and expand VOQUEZNA's market opportunity, targeting an additional $1 billion annual revenue.
• Phathom completed enrollment in its Phase 2 pHalcon-EoE-201 trial for Eosinophilic Esophagitis (EoE) in June 2026. Topline results from the 12-week blinded treatment portion are expected in Q4 2026. Positive results could lead to discussions with the FDA for future development plans, including pediatric evaluation, potentially supporting a 6-month extension of regulatory exclusivity for VOQUEZNA®.

Addressing Unmet Needs in As-Needed Non-Erosive GERD

Non-erosive reflux disease (NERD) continues to present significant diagnostic and therapeutic challenges, with recent literature highlighting persistent gaps in confirming disease presence, managing PPI-refractory patients, and expanding the treatment armamentarium beyond conventional acid suppression. Emerging diagnostic tools and novel pharmacologic classes are being explored to address these limitations, alongside growing interest in procedural and adjunctive therapeutic options.

Diagnostic Gaps and Approaches

• Acid exposure time remains inconclusive in 4–6% of patients undergoing pH-impedance testing, necessitating complementary diagnostic markers such as mean nocturnal basal impedance (MNBI) to strengthen diagnostic confidence.

• MNBI shows a moderate negative correlation with acid exposure time, reflux episode frequency, and hiatal hernia size, and has demonstrated utility in predicting response to double-dose PPI therapy (71.4% response rate in patients with MNBI <2292 Ohms).

• Standard diagnostic workup for suspected NERD includes upper digestive video endoscopy, high-resolution esophageal manometry, and 24-hour ambulatory pH-impedance measurement following a 4-week PPI washout.

Target Populations

• Adults (>18 years) with typical GERD symptoms who show inadequate response to PPI therapy represent a key population for further diagnostic and therapeutic evaluation.

• Patients with suspected NERD refractory to PPI treatment constitute a specific subgroup requiring alternative management strategies.

• Patients following antireflux surgery (ARS) represent an important population, as 44% become long-term PPI users within 5 years post-ARS, and nearly one-third continue to experience daily heartburn and/or regurgitation despite surgery.

Emerging Therapeutic Options

• Potassium-competitive acid blockers (P-CABs) are gaining traction as a novel therapeutic class, demonstrating non-inferior efficacy to PPIs (RR 1.73; 95% CI 1.27–2.36) with comparable safety profiles (OR for adverse events 1.08; 95% CI 0.88–1.12).

• Zastaprazan, a P-CAB in Phase III development for NERD, offers pharmacodynamic advantages including rapid and sustained acid suppression, independence from CYP2C19 metabolism, and no requirement for active-form conversion; it is already approved in South Korea for erosive esophagitis and gastric ulcer.

• Alginates are recommended as first-line therapy for mild-to-moderate NERD in Southeast Asia and as adjunctive treatment for symptoms only partially responsive to PPIs, reflecting the predominance of mild, non-erosive disease phenotypes in this region.

• Endoscopic fundoplication has shown consistent procedural growth through 2024 (APC +13.25%; 95% CI +3.91–23.44%; p=0.011), signaling increased adoption of minimally invasive interventions.

• Low-dose amitriptyline (10 mg nightly) combined with lansoprazole has been evaluated for extraesophageal GERD symptoms, with 75% of patients overall reporting improvement (65% amitriptyline vs. 85% PPI group; P=0.27), suggesting potential for neuromodulator-based adjunctive approaches in refractory cases.

Designing the Phase 3 Trial for As-Needed VOQUEZNA in NERD

Designing a successful Phase 3 trial for non-erosive gastroesophageal reflux disease (NERD) involves learning from the designs of prior clinical investigations. A review of key NERD trials highlights various approaches to patient selection, treatment duration, and the selection of primary and secondary endpoints, providing valuable context for future study protocols.

Expanding VOQUEZNA's Potential Beyond GERD: The EoE Trial

Beyond its established role in GERD, vonoprazan is being evaluated in several other significant gastrointestinal indications, most notably erosive esophagitis (EE). Clinical development for EE has involved large-scale, randomized controlled trials comparing vonoprazan to the proton-pump inhibitor (PPI) lansoprazole. In a pivotal healing phase study, 1,024 adults with EE were randomized to receive either vonoprazan 20 mg or lansoprazole 30 mg once daily for up to eight weeks. While vonoprazan demonstrated non-inferiority in the primary analysis, an exploratory analysis revealed a superior healing rate (92.9% vs. 84.6%). Subsequently, 878 patients with healed EE were re-randomized into a 24-week maintenance phase, receiving vonoprazan (10 mg or 20 mg) or lansoprazole (15 mg). In this secondary analysis, vonoprazan was superior to lansoprazole in maintaining remission, confirming its potential in both acute treatment and long-term management of EE.

Vonoprazan has also been extensively studied for Helicobacter pylori eradication and the healing of peptic ulcers. For H. pylori infection, multiple randomized controlled trials and non-randomized studies have shown high efficacy for vonoprazan-based dual or triple therapy regimens compared to standard PPI-based therapies. A meta-analysis of vonoprazan triple therapy demonstrated greater overall efficacy (OR 1.94 [95% CI 1.19-3.17]), with specific superiority over regimens containing lansoprazole (OR 2.84 [1.97-4.11]) and rabeprazole (OR 2.63 [1.05-6.58]), though not esomeprazole. In the context of peptic ulcer healing, data from two randomized controlled trials involving 1,120 subjects indicated that vonoprazan was non-inferior to lansoprazole.