Every material Form 8-K Phathom Pharmaceuticals, Inc. has filed with the SEC since October 23, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Phathom Pharmaceuticals reported third quarter 2026 net revenue of $84.7 million, up 71% from $49.5 million a year earlier, and a net loss of $13.9 million, narrowed from $30.0 million. The company reaffirmed its full-year 2026 net revenue guidance of $310–325 million and said it generated positive operating cash flow for the second consecutive quarter.
Q3 2026 net revenue was $84.7 million, up $35.2 million from $49.5 million in Q3 2025.
Q3 2026 net loss was $13.9 million, compared with $30.0 million in Q3 2025; non-GAAP adjusted net income was $3.0 million.
FY 2026 net revenue guidance of $310–325 million was maintained, not changed.
Cash and cash equivalents were $184.6 million as of September 30, 2026.
Phathom Pharmaceuticals said the FDA has opened a public docket to seek comment on legal and regulatory questions tied to a challenge by generic filer BDR Pharmaceuticals over VOQUEZNA's exclusivity. The challenge follows FDA's June 6, 2025 decision that VOQUEZNA has 10 years of NCE exclusivity through May 3, 2032. If the challenge succeeds, exclusivity could be shortened and competing generic applications could be approved earlier than expected.
FDA docket No. FDA-2026-N-13038; comments due November 23, 2026
FDA's June 6, 2025 decision granted Phathom's Citizen Petition, recognizing NCE exclusivity through May 3, 2032
A second purported ANDA filer, Saba Ilac Sanayii Ve Ticaret AS, says it has a related case and plans to seek consolidation with BDR's case
Phathom believes the exclusivity remains in effect and will say so in its FDA comments and in court
Generic drugmaker BDR Pharmaceuticals has sued the FDA in federal court in Washington, D.C., challenging how the agency applied the GAIN Act to extend Phathom's new chemical entity exclusivity for VOQUEZNA tablets. If BDR succeeds, the exclusivity period could be shortened and generic versions could be approved earlier than Phathom currently expects.
BDR filed suit against the FDA in the U.S. District Court for the District of Columbia.
FDA recognized 10 years of NCE exclusivity for VOQUEZNA tablets through May 3, 2032, in a June 6, 2025 decision on Phathom's December 11, 2024 Citizen Petition.
Phathom says it is evaluating the filings and intends to take appropriate action to protect its statutory exclusivities.
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