Phathom Pharmaceuticals, Inc. - PHAT STOCK NEWS

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) announced favorable feedback from the U.S. FDA that paves the way for a planned resubmission of its erosive esophagitis new drug application (NDA) within this quarter. The approval could facilitate a combined commercial launch of vonoprazan for erosive esophagitis and H. pylori indications in Q4 2023. Following extensive investigations into nitrosamine impurities, Phathom has mitigated the related issues and presented stability data to the FDA. The company remains optimistic about fulfilling all requirements for regulatory approvals by year-end.

Phathom Pharmaceuticals (Nasdaq: PHAT) reported its 2022 financial results, revealing a net loss of $197.7 million, an increase from $143.9 million in 2021. In Q4 alone, losses reached $55 million, influenced by elevated R&D and administrative expenses. Major highlights included positive topline results from a Phase 3 trial for vonoprazan in treating non-erosive gastroesophageal reflux disease (GERD), alongside FDA approvals for related products. A meeting with the FDA is scheduled for March 2023 to discuss resubmission requirements for new drug applications, although the commercial launch is paused due to a nitrosamine impurity issue.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced regulatory updates regarding its products for treating H. pylori infection and erosive esophagitis. The FDA issued complete response letters for its New Drug Application (NDA) for vonoprazan and a post-approval supplement, citing the need for additional stability data related to a detected impurity, N-nitroso-vonoprazan (NVP). Phathom has investigated the impurity's source and implemented controls to mitigate its levels. The company anticipates a meeting with the FDA to discuss a resubmission plan, expressing confidence in meeting FDA requirements for potential product approval.

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.