Phathom Pharmaceuticals, Inc. - PHAT STOCK NEWS

Phathom Pharmaceuticals (PHAT) reported positive developments, with the FDA accepting two New Drug Applications (NDAs) for vonoprazan-based treatments for H. pylori infections, granting Priority Review status. A PDUFA target date is set for May 3, 2022. Following a successful Phase 3 trial for erosive esophagitis, an NDA submission is targeted for Q1 2022. Despite a net loss of $36.7 million for Q3 2021, down from $34.1 million in Q3 2020, reduced R&D expenses were noted. Cash reserves are projected to sustain operations through mid-2023.

Phathom Pharmaceuticals (Nasdaq: PHAT) has withdrawn its previously planned public offering, citing adverse market conditions. The company announced a robust balance sheet with cash and equivalents of $225 million as of September 30, 2021, sufficient to fund operations into mid-2023, along with an additional $100 million available under its term loan facility. Phathom is focused on developing novel treatments for gastrointestinal diseases, particularly through its late-stage asset, vonoprazan. However, the cash figures are preliminary and subject to change.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced an underwritten public offering of 5,000,000 shares of common stock, with 4,000,000 shares from Phathom and 1,000,000 shares from Takeda Pharmaceutical Company. An additional 600,000 shares may be purchased by underwriters within 30 days. Proceeds will finance the clinical development and commercialization of vonoprazan, a treatment for gastrointestinal diseases. Phathom will not receive proceeds from shares sold by Takeda. The offering is subject to market conditions.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced data from the Phase 3 PHALCON-HP trial, the largest U.S. trial for H. pylori infection, which received the ACG Governors Award for Excellence in Clinical Research. The study demonstrated that vonoprazan-based therapies had superior eradication rates compared to current standard treatments. Key findings include eradication rates of 84.7% and 78.5% for vonoprazan triple and dual therapies, respectively. The company submitted new drug applications for vonoprazan for H. pylori treatment, highlighting its commitment to addressing unmet medical needs.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced that new data on vonoprazan, a potassium competitive acid blocker (P-CAB), will be presented at the ACG 2021 Annual Scientific Meeting in Las Vegas from October 22-27. The presentation includes insights into acid-related diseases and treatment patterns. Phathom will conduct four poster sessions and one oral presentation while sponsoring a product theater. The company has submitted two NDAs to the FDA for vonoprazan-based regimens targeting H. pylori and plans to submit another NDA for erosive esophagitis treatment by mid-2022.

Phathom Pharmaceuticals (PHAT) announced that vonoprazan met its primary endpoints in the pivotal PHALCON-EE Phase 3 trial, demonstrating superior healing rates compared to lansoprazole in treating erosive esophagitis. Healing rates at Week 8 were 93% for vonoprazan versus 85% for lansoprazole. Additionally, vonoprazan maintained healing at Week 24 with rates of 81% compared to 72% for lansoprazole. A New Drug Application (NDA) is planned for H1 2022 targeting healing and maintenance of erosive esophagitis and heartburn relief, potentially addressing significant unmet needs in the market.

Phathom Pharmaceuticals (Nasdaq: PHAT) announced positive results from its Phase 1 trial (VONO-103), where vonoprazan 20 mg demonstrated superior acid suppression compared to lansoprazole 30 mg over a 7-day period. The study showed a mean 24-hour gastric pH value of 5.9 for vonoprazan versus 3.8 for lansoprazole on Day 7 (p<0.0001). Both treatments were well tolerated with no serious adverse events. Phathom is also conducting the Phase 3 PHALCON-EE study, and topline results are expected in October 2021.

Phathom Pharmaceuticals (Nasdaq: PHAT) has secured a $200 million term loan facility from Hercules Capital to bolster its balance sheet ahead of crucial upcoming milestones. The funding allows for a potential commercial launch of vonoprazan, an innovative treatment for acid-related disorders, and extends the company’s cash runway to mid-2023. Key catalysts include pivotal data from the PHALCON-EE Phase 3 trial in October 2021 and plans for regulatory submissions for H. pylori treatments in late 2022.

Phathom Pharmaceuticals (Nasdaq: PHAT) has submitted two new drug applications (NDAs) to the FDA for vonoprazan-based therapies aimed at treating Helicobacter pylori infection in adults. The vonoprazan triple therapy and dual therapy show superior eradication rates compared to current treatments. If approved, Phathom expects to launch these therapies in the U.S. in the latter half of 2022. The submissions follow positive results from the pivotal Phase 3 PHALCON-HP trial, the largest U.S. study for H. pylori. The FDA has also granted these therapies Fast Track designation and qualified infectious disease product status.