Phathom reports Q3 2026 results, advances VOQUEZNA pipeline and defends exclusivity
Phathom started a Phase 3 as-needed GERD trial, expects EoE Phase 2 data in Q4, and is fighting an exclusivity challenge, while reaffirming full-year guidance.
Phathom Pharmaceuticals reported financial results for the third quarter ended September 30, 2026, alongside a business update issued October 29, 2026.
On the pipeline, Phathom announced on September 29, 2026, the initiation of a registrational Phase 3 study, called "pHalcon-NERD-302," testing VOQUEZNA for as-needed use in patients with Non-Erosive Gastroesophageal Reflux Disease, building on earlier Phase 2 results.1 The first patient has been dosed and sites are enrolling across the U.S., with topline results expected in the first quarter of 2028.1 Separately, in eosinophilic esophagitis, Phathom said it expects to report topline results in the fourth quarter of 2026 from the 12-week blinded treatment portion of its Phase 2 trial, "pHalcon-EoE-201," testing VOQUEZNA in that condition.1
On regulatory exclusivity, on October 26, 2026, the U.S. District Court for the District of Columbia granted a motion by Phathom to intervene in litigation that BDR Pharmaceuticals filed against the FDA over VOQUEZNA's regulatory exclusivity.1 The FDA also opened a public comment docket on the litigation issues on October 23, 2026, with comments due November 23, 2026.1 Phathom said the FDA correctly evaluated the matter in its June 6, 2025 decision granting the company's Citizen Petition, recognizing 10 years of NCE exclusivity for VOQUEZNA tablets through May 3, 2032, and said it intends to vigorously defend its exclusivities.1
On finances, cash and cash equivalents were $184.6 million as of September 30, 2026, up $2.1 million from the second quarter.1 The company said it continues to believe cash on hand along with anticipated future operating cash flow will be sufficient to fund its business and satisfy outstanding debt obligations without additional financing.1 Phathom is maintaining full-year 2026 guidance of $310 to $325 million in net revenue, a gross-to-net discount of 55 to 59 percent, gross margin of about 80 percent, and non-GAAP operating expenses excluding stock-based compensation of $235 to $245 million.1
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