Phathom Pharmaceuticals, Inc. Stock Price, News & Analysis

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.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced new investigational data regarding vonoprazan for treating erosive esophagitis (EE) at Digestive Disease Week® (DDW) 2022. The findings reveal real-world evidence highlighting unmet treatment needs for H. pylori infections. Phathom's research received multiple 'posters of distinction' recognition from the American Gastroenterological Association. Notable presentations include Phase 3 results of vonoprazan as monotherapy, demonstrating promising efficacy compared to traditional proton pump inhibitors. The conference takes place from May 21-24 in San Diego, CA.

Phathom Pharmaceuticals (PHAT) announced FDA approval for its VOQUEZNA™ TRIPLE PAK and DUAL PAK for treating H. pylori infections in adults. This marks a significant regulatory milestone for the company. Additionally, it secured a revenue interest financing agreement of up to $260 million, providing a strong capital foundation without diluting shareholder equity. Financial results for Q1 2022 reflect a net loss of $40.7 million, an increase from $34.8 million in Q1 2021, indicating ongoing investment in commercial launch and R&D while reducing expenses in certain areas.

Phathom Pharmaceuticals (Nasdaq: PHAT) has secured a revenue interest financing agreement of up to $260 million, including a $100 million upfront payment and $160 million contingent upon FDA approval of vonoprazan for erosive esophagitis (EE). This financing will support the launch of vonoprazan for H. pylori and EE and fund ongoing Phase 3 trials. Investors will receive a 10% royalty on net sales, capped at 2.0x the total payments. Phathom anticipates sufficient capital to fund operations through 2024.

Phathom Pharmaceuticals (NASDAQ: PHAT) has received FDA approval for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, innovative treatment regimens for Helicobacter pylori infection in adults. These regimens, which include vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), show superior eradication rates compared to traditional lansoprazole-based therapies. The launch is anticipated in Q3 2022, providing two options, including a clarithromycin-free regimen, addressing declining eradication rates among the 115 million affected U.S. patients.

Phathom Pharmaceuticals (Nasdaq: PHAT) has appointed Frank Karbe to its Board of Directors. With over 25 years of experience in finance and the life sciences sector, Karbe previously served as President and CFO of Myovant Sciences, where he raised $2 billion and transitioned the company to a publicly traded entity. Phathom's CEO, Terrie Curran, emphasized that Karbe's expertise will be crucial as the company approaches a pivotal moment in its strategy and commercialization plans, particularly regarding its late-stage development of vonoprazan for gastrointestinal disorders.