Phathom Pharmaceuticals reports lawsuit over Voquezna exclusivity

Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT) announced Friday that BDR Pharmaceuticals International Pvt. Ltd. has filed a lawsuit against the U.S. Food and Drug Administration (FDA) and related federal defendants in the United States District Court for the District of Columbia. The suit challenges the FDA’s alleged refusal to accept an abbreviated new drug application (ANDA) referencing Phathom’s new drug application (NDA) for VOQUEZNA (vonoprazan fumarate) tablets.

According to the press release statement, BDR alleges that the FDA improperly applied the Generating Antibiotic Incentives Now (GAIN) Act to extend Phathom’s New Chemical Entity (NCE) exclusivity for VOQUEZNA. Phathom stated that the FDA had previously granted its request for 10 years of NCE exclusivity for VOQUEZNA tablets, lasting through May 3, 2032, following a citizen petition filed by the company in December 2024 and granted on June 6, 2025.

Phathom said it is reviewing the BDR filings and intends to take appropriate action to protect its statutory exclusivities.

The company’s common stock trades on The Nasdaq Global Select Market under the symbol PHAT. This information is based on a statement provided in a recent SEC filing.

In other recent news, Phathom Pharmaceuticals reported a significant increase in second-quarter 2026 revenue, marking an 88% rise compared to the previous year and a 27% increase from the first quarter. The company achieved operating profitability, excluding stock-based compensation, and surpassed consensus revenue estimates with $74.27 million. Despite these positive results, Phathom adjusted its full-year revenue guidance to between $310 million and $325 million, down from earlier projections, due to logistical challenges in prescribing and prior authorization processes. Analyst firms have responded to these developments; Jefferies lowered its price target for Phathom to $16 while maintaining a Buy rating, anticipating third-quarter results to meet consensus estimates. Guggenheim also reduced its price target to $22, maintaining a Buy rating, while H.C. Wainwright reiterated a Buy rating with a $26 price target, citing strong revenue growth. Additionally, Phathom has initiated a Phase 3 clinical trial for its VOQUEZNA tablets in treating non-erosive gastroesophageal reflux disease, aiming to enroll approximately 500 participants across 80 sites in the United States.