Phathom Pharmaceuticals, Inc. Stock Price, News & Analysis

Phathom Pharmaceuticals (Nasdaq: PHAT) has completed enrollment in its Phase 3 PHALCON-NERD trial focused on the treatment of non-erosive gastroesophageal reflux disease (NERD) using its investigational drug vonoprazan. The trial enrolled 776 patients and aims to evaluate the efficacy of vonoprazan in providing heartburn relief. Topline data is expected in Q1 2023, with full results anticipated in late 2023. Phathom plans to submit a supplemental New Drug Application (sNDA) for vonoprazan based on the trial's success, addressing a significant unmet medical need in NERD management.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced results from the Phase 2 PHALCON-NERD study on vonoprazan at the ACG 2022 Annual Scientific Meeting. The study involved 207 patients and demonstrated that all three doses of vonoprazan achieved significant heartburn relief: 56% (10 mg), 60.6% (20 mg), and 70% (40 mg) within three hours, compared to 27.3% for placebo (p<0.0001). The trial showed no significant adverse events related to vonoprazan. Phathom is also conducting a Phase 3 trial, with topline data expected in early 2023.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced its participation in the ACG 2022 Annual Scientific Meeting from October 21-26 in Charlotte, NC. The company will present new data on vonoprazan, a potassium-competitive acid blocker, aimed at treating gastric acid-related disorders. This research addresses conditions such as non-erosive gastroesophageal reflux disease (NERD). Presentations are scheduled for October 24 and 25, with a booth presence at the event. Phathom has a New Drug Application under FDA review for vonoprazan's use in erosive esophagitis.

Phathom Pharmaceuticals (Nasdaq: PHAT) has appointed Dr. James Topper to its Board of Directors. Dr. Topper, Managing Partner at Frazier Life Sciences, returns after previously serving on Phathom's board from 2018 to 2021. His extensive experience includes investments in over 35 biopharma companies and leadership roles in renowned organizations. This appointment comes as Phathom transitions from a clinical-stage to a commercial entity, aiming to launch its products in the first quarter of next year.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference. The management team's on-demand presentation will be available starting September 12, 2022, at 7:00 a.m. ET. The conference runs from September 12-14, and management will also engage in one-on-one meetings. Phathom is focused on novel treatments for gastrointestinal diseases, including its lead product, vonoprazan, which is approved for H. pylori treatment and has an FDA review pending for erosive esophagitis.

Phathom Pharmaceuticals (PHAT) has achieved significant milestones, including the FDA's acceptance of its New Drug Application for vonoprazan in erosive esophagitis (EE), with a PDUFA date set for January 11, 2023. This follows the approval of VOQUEZNA DUAL and TRIPLE PAK for H. pylori infections. Despite detecting trace nitrosamine levels, the company is collaborating with the FDA to ensure compliance and aims for a combined product launch in Q1 2023. The Q2 2022 financial results showed a net loss of $50.9 million, while R&D expenses decreased to $18.8 million.

Phathom Pharmaceuticals (Nasdaq: PHAT) will participate in a fireside chat at the Jefferies Healthcare Conference on June 8, 2022, at 1:30 p.m. ET. Management will also engage in one-on-one meetings throughout the conference, which runs from June 8-10, 2022. The live webcast and archived recording of the chat will be accessible via the Phathom website for 90 days post-event. Phathom is focused on novel gastrointestinal treatments and has exclusive rights to vonoprazan for H. pylori infection and is awaiting FDA review for erosive esophagitis treatment.

On May 25, 2022, Phathom Pharmaceuticals (Nasdaq: PHAT) announced the FDA's acceptance of its New Drug Application for vonoprazan, targeting erosive esophagitis (EE) and heartburn relief in adults. This application, assigned a standard review, has a PDUFA action date of January 11, 2023. Vonoprazan is a first-in-class potassium-competitive acid blocker, representing the first significant GERD treatment innovation in over 30 years. The application is backed by positive Phase 3 trial results, indicating potential to meet unmet patient needs.

Phathom Pharmaceuticals (Nasdaq: PHAT) presented significant data on vonoprazan at Digestive Disease Week 2022, demonstrating its effectiveness against erosive esophagitis (EE). The Phase 3 PHALCON-EE trial found vonoprazan achieved 92.9% healing by week 8, outperforming lansoprazole (84.6%). At week 24, 80.7% of patients maintained healing with vonoprazan compared to 72.0% with lansoprazole. Additionally, vonoprazan showed superior acid suppression and presented promising data regarding Helicobacter pylori treatment patterns in the U.S., indicating the need for improved management. These findings strengthen vonoprazan's potential in treating EE.