|Over a week ago|
Phathom Pharmaceuticals provides clinical, regulatory updates » 08:0911/0811/08/21
The U.S. Food and Drug…
The U.S. Food and Drug Administration accepted NDAs for two convenience packs containing vonoprazan-based treatment regimens for adults with H. pylori infection: vonoprazan in combination with amoxicillin and clarithromycin and vonoprazan in combination with amoxicillin. The NDAs were granted Priority Review designation with a Prescription Drug User Fee Act target action date of May 3, 2022. Phathom submitted the NDAs to the FDA on September 3, 2021. The FDA previously designated vonoprazan dual and triple therapy as qualified infectious disease products which, if approved, will provide vonoprazan five additional years of regulatory exclusivity. If approved, the U.S. commercial launch for vonoprazan dual and triple therapy is anticipated in the second half of 2022. Vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal Phase 3 trial evaluating vonoprazan for the healing and maintenance of healing of erosive esophagitis. Based on these results, Phathom expects to submit an NDA in the first quarter of 2022 seeking the following indications for vonoprazan: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. Topline results from the Phase 2 PHALCON-NERD on-demand trial evaluating various doses of vonoprazan as an on-demand therapy for patients with non-erosive reflux disease are expected in the first quarter of 2022.
Phathom Pharmaceuticals expects cash to meet requirements into mid-2023 » 08:0711/0811/08/21
As of September 30, 2021,…
As of September 30, 2021, cash and cash equivalents were $224.6 million. Cash and cash equivalents combined with the future drawdown of the remaining $100 million under the Loan Agreement are expected to be sufficient to meet anticipated cash requirements into mid-2023 based on current operating plans.
Phathom Pharmaceuticals reports Q3 EPS (98c), consensus (98c) » 08:0711/0811/08/21
"Phathom continued its strong execution through the third quarter of 2021, delivering impressive topline results from our pivotal Phase 3 PHALCON-EE study. The PHALCON-EE data adds to our excitement about vonoprazan's potential to satisfy large unmet patient needs in the U.S. and European erosive esophagitis market," said Terrie Curran, Phathom's President and Chief Executive Officer. "With the recent acceptance of both NDAs for vonoprazan-based treatments in H. pylori, and the planned submission of an NDA for vonoprazan in EE in the first quarter of 2022, we are enthusiastic about vonoprazan's potential to offer a novel treatment option to address the significant unmet needs that exist for so many patients across these prevalent acid-related disorders."
|Over a month ago|
Phathom Pharmaceuticals files to sell 5M shares of common stock » 16:0110/2610/26/21
Jefferies, Evercore ISI,…
Jefferies, Evercore ISI, Guggenheim Securities and BMO Capital Markets are acting as joint bookrunning managers for the offering. Needham & Company is acting as lead manager for the offering.
Phathom Pharmaceuticals announces data from Phase 3 PHALCON-HP trial » 16:4210/2410/24/21
Phathom Pharmaceuticals announced data from the PHALCON-HP Phase 3 study, the largest U.S. registrational trial ever conducted for H. pylori, that will be presented during an oral session at the ACG 2021 Annual Scientific Meeting organized by the American College of Gastroenterology, in Las Vegas, Nevada, Oct. 22-27. PHALCON-HP showed that both vonoprazan in combination with amoxicillin and clarithromycin and vonoprazan in combination with amoxicillin demonstrated superior eradication rates in all patients compared to a current standard of care therapy consisting of the proton pump inhibitor, lansoprazole, in combination with amoxicillin and clarithromycin. In the primary endpoint analyses of the PHALCON-HP study comparing the non-inferiority of vonoprazan-based therapies to lansoprazole triple therapy in patients with H. pylori without strains resistant to antibiotics, eradication rates with vonoprazan triple therapy and vonoprazan dual therapy were 84.7% and 78.5%, respectively, compared to 78.8% for lansoprazole triple therapy. In the secondary endpoint analyses comparing the superiority of vonoprazan-based therapies to lansoprazole triple therapy in all patients, eradication rates with vonoprazan triple therapy and dual therapy were 80.8% and 77.2%, respectively, compared to 68.5% for lansoprazole triple therapy. Both vonoprazan-based regimens were generally well tolerated with a safety profile comparable to lansoprazole-based triple therapy in the trial. Phathom is also presenting results from the Study of Acid-Related Disorders which explored perceptions of disease burden for H. pylori and erosive esophagitis among physicians and patients. Physicians completed an online survey recording treatment goals, preferences, satisfaction, and perceived disease burden. A subset completed chart review data of patients with H. pylori and dyspepsia or erosive esophagitis who had received a PPI as part of their treatment. The same patients completed a survey capturing data on treatment goals, satisfaction, and adherence. In this study, only 29% of physicians strongly agreed that they were satisfied with current H. pylori treatment options and 57% of patients stated they were not completely satisfied. When it came to erosive esophagitis, 84% of patients wanted long-lasting treatment options while only 44% considered their current therapy a long-lasting solution for their disease. The study uncovered many unmet needs from the perspective of both physicians and patients in the treatment of H. pylori and erosive esophagitis suggesting that new treatment options are needed.
Phathom Pharmaceuticals to present new data at ACG 2021 annual meeting » 08:0710/2110/21/21
Phathom Pharmaceuticals announced that data for vonoprazan, an investigational potassium competitive acid blocker in late clinical-stage development for the treatment of gastric acid-related disorders, will be presented at the ACG 2021 Annual Scientific Meeting in Las Vegas, Nevada, organized by the American College of Gastroenterology, October 22-27. During the scientific congress, new data on vonoprazan will be shared in addition to novel insights into the burden of acid-related diseases, analysis of treatment patterns, and other newfound developments. In addition to four poster sessions and one oral presentation, Phathom will sponsor a product theater highlighting unmet needs in the treatment of H. pylori and will also have a presence on the exhibit floor at booth #929 throughout the conference and virtually via RethinkGIAcid.com. Phathom will attend ACG 2021 having recently announced positive data from its pivotal Phase 3 PHALCON-EE trial which studied vonoprazan as a treatment option for erosive esophagitis. Two New Drug Applications for vonoprazan-based regimens for the treatment of H. pylori infection were submitted to the U.S. FDA in September 2021. Based on the positive PHALCON-EE trial, Phathom also plans to submit an NDA to the FDA for the healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn by the end of the first half of 2022.
Phathom Pharmaceuticals price target raised to $75 from $66 at Guggenheim » 12:0810/1810/18/21
Guggenheim analyst Yatin…
Guggenheim analyst Yatin Suneja raised the firm's price target on Phathom Pharmaceuticals to $75 from $66 and keeps a Buy rating on the shares after the company announced that vonoprazan met its primary endpoints and key secondary superiority endpoints in a phase 3 trial evaluating vonoprazan versus lansoprazole for the treatment of erosive esophagitis. Following the "highly positive" topline results, Suneja feels confident in a $1.1B U.S. peak sales estimate for the drug in the erosive esophagitis indication and raised the view on the odds of success in that indication to 95% from 85%.
Phathom Pharmaceuticals trading resumes 07:3010/1810/18/21
Phathom says vonoprazan met primary endpoints in PHALCON-EE Phase 3 trial » 07:2410/1810/18/21
Phathom Pharmaceuticals announced that vonoprazan met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal phase 3 trial evaluating vonoprazan versus lansoprazole for the treatment of erosive esophagitis. Based on the positive PHALCON-EE data, Phathom plans to submit an NDA to the U.S. Food and Drug Administration seeking the following indications: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. PHALCON-EE was a trial with two phases. In the first phase, vonoprazan 20 mg was compared to lansoprazole 30 mg in the healing of EE after up to 8 weeks of treatment. In the Healing Phase, patients were assessed via endoscopy to determine complete healing following 2 weeks of treatment and, if complete healing was not achieved, a second endoscopy occurred at 8 weeks of treatment. Patients who achieved complete healing were re-randomized into the second phase of the trial, where vonoprazan 10 mg and 20 mg were compared to lansoprazole 15 mg to assess maintenance of healing via endoscopy following 24 weeks of treatment. Heartburn symptom relief was assessed via secondary endpoints in both the Healing and Maintenance Phases of the study based on twice daily e-diary data collection. The primary endpoint of the Healing Phase was non-inferiority of vonoprazan 20 mg compared to lansoprazole 30 mg in the percentage of all patients who have complete healing of EE by Week 8. Vonoprazan met the Healing Phase primary endpoint with a healing rate of 93% compared to 85% for lansoprazole. In a preplanned exploratory superiority test, the difference between vonoprazan and lansoprazole was also significant. Vonoprazan met the secondary superiority endpoint of healing in patients with moderate-to-severe disease at Week 2, demonstrating significantly faster healing than lansoprazole. Vonoprazan 20 mg was also compared to lansoprazole 30 mg in a superiority test for onset of sustained resolution of heartburn by day 3 but did not achieve statistical significance. In additional secondary endpoint superiority comparisons, vonoprazan 20 mg healing rates were numerically greater than lansoprazole 30 mg in all patients at Week 2 and in moderate-to-severe patients2 by Week 8 although deemed nominally significant due to the sequential testing method. Vonoprazan also met the secondary endpoint of showing non-inferiority to lansoprazole 30 mg in the mean percentage of 24-hour heartburn free days over the healing period. Vonoprazan met the primary and all secondary endpoints in the Maintenance Phase. The primary endpoint of the Maintenance Phase was non-inferiority of vonoprazan 10 mg and 20 mg compared to lansoprazole 15 mg in the percentage of all patients who maintained healing of EE through Week 24. Both vonoprazan doses met the Maintenance Phase primary endpoint of non-inferiority while also meeting the secondary comparison demonstrating superiority of maintenance of healing versus lansoprazole. Both vonoprazan doses also met the secondary endpoint of demonstrating superiority of the percentage of patients with moderate-to-severe disease4 who maintained healing of EE through Week 24. Additionally, both vonoprazan doses also met the secondary endpoint of showing non-inferiority to lansoprazole 15 mg in the mean percentage of 24-hour heartburn free days over the maintenance period. Overall, the safety results for vonoprazan observed in PHALCON-EE were consistent with the results observed in prior clinical studies. The most common reported adverse event in the Healing Phase was diarrhea. The most commonly reported adverse events in the Maintenance Phase were COVID-19 infection, gastritis, and abdominal pain. Frequency of serious adverse events in the Healing Phase were the same between vonoprazan 20 mg and lansoprazole 30 mg at 0.6%. In the Maintenance Phase, SAEs were reported in 4.7% of patients for vonoprazan 20 mg, 3.4% for vonoprazan 10 mg and 2.4% for lansoprazole 15 mg. COVID-19 infection was the only SAE reported in more than one patient per group. There were 7 COVID-19 SAEs across both phases of the study. Two deaths occurred among the reported COVID-19 SAE cases. None of the COVID-19 SAEs were deemed related to the study drug by the investigator. Phathom plans to present the full results from the PHALCON-EE study at a medical meeting next year and submit them for publication in a peer-reviewed journal. The positive PHALCON-EE data provides Phathom with access to an additional $50 million from its term loan facility with Hercules Capital. As of September 30, 2021, Phathom had approximately $225 million in available cash and cash equivalents, exclusive of the additional $50 million available from the term loan facility.
Phathom Pharmaceuticals trading halted, news pending 06:5510/1810/18/21