Phathom Pharmaceuticals, Inc. Stock Price, News & Analysis

Phathom Pharmaceuticals (Nasdaq: PHAT) announced positive topline results from the Phase 3 PHALCON-NERD-301 study, evaluating vonoprazan for daily treatment of symptomatic non-erosive gastroesophageal reflux disease (NERD). Both 10 mg and 20 mg doses achieved the primary endpoint, significantly increasing heartburn-free days compared to placebo (p<0.0001). With over 45 million U.S. patients suffering from NERD, these results may lead to a regulatory submission following the ongoing 20-week safety extension. Full results are expected later in 2023.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced that the FDA will not take action on its NDA for vonoprazan by the PDUFA target date of January 11, 2023. This follows the detection of nitrosamine impurities in the product. Although an acceptable daily intake for the impurity has been set at 96 ng/day, the FDA has requested more stability data to ensure compliance. Consequently, Phathom has delayed its product launch plans for erosive esophagitis and H. pylori treatments initially expected in Q1 2023. The company remains optimistic about label negotiations and the drug's market potential.

Phathom Pharmaceuticals (PHAT) announced significant developments in its Phase 3 NERD trial, completing patient enrollment with topline data expected in Q1 2023. The company secured up to $40 million in revenue interest financing, raising total potential funding to $300 million to support product launches.

Third quarter results showed a net loss of $51.1 million, increasing from $36.7 million the previous year. Despite rising expenses, Phathom believes it has adequate capital to fund operations through 2024, bolstered by $196.8 million in cash and equivalents and a $100 million term loan.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced participation in several upcoming investor conferences. The Guggenheim Healthcare Talks: 4th Annual Neuro/Immunology Conference will take place on November 14, 2022, at 2:45 PM ET. The Jefferies London Healthcare Conference is scheduled for November 16, 2022, at 9:10 AM BST / 4:10 AM ET. Lastly, the 5th Annual Evercore ISI HealthCONx Conference is set for December 1, 2022, at 1:25 PM ET. Management will hold one-on-one meetings during these events. Webcasts and recordings will be available on Phathom’s website for 90 days post-event.

Phathom Pharmaceuticals (NASDAQ: PHAT) has secured an additional $40 million in non-dilutive financing, increasing total available financing to $300 million. This funding includes $15 million contingent upon FDA approval for vonoprazan in treating erosive esophagitis and $25 million linked to sales milestones. Investors will receive a 10% royalty on net sales, capped at 2.0x of total payments received. This agreement involves Sagard Healthcare Partners, NovaQuest Capital Management, and Hercules Capital.

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.