FLORHAM PARK, N.J. - Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a company specializing in gastrointestinal treatments, has announced the FDA approval of VOQUEZNA® (vonoprazan) 10 mg tablets for Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. This marks the first major advancement in GERD treatment in over three decades and the only FDA-approved treatment of its kind in the United States.
Non-Erosive GERD, the most common form of GERD, affects an estimated 45 million U.S. adults and is characterized by symptoms such as heartburn without esophageal mucosal erosions. The approval of VOQUEZNA is based on the PHALCON-NERD-301 study, which demonstrated a significant reduction in heartburn episodes compared to placebo.
The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of VOQUEZNA in 772 adult patients with Non-Erosive GERD who experienced frequent heartburn. Results showed that VOQUEZNA significantly increased the percentage of 24-hour heartburn-free days over four weeks, with 45% for VOQUEZNA versus 28% for placebo.
Common adverse reactions reported in the trial included abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. Phathom Pharmaceuticals has implemented savings programs for eligible patients to address coverage or affordability issues.
VOQUEZNA, which also holds approvals for other severities of Erosive Esophagitis (EE) and in combination with antibiotics for the eradication of Helicobacter pylori (H. pylori) infection, is now available by prescription in the United States.
This approval provides a new option for the treatment of Non-Erosive GERD, offering potential relief for millions of patients who have not found satisfaction with existing therapies.
The information is based on a press release statement from Phathom Pharmaceuticals.
In other recent news, Phathom Pharmaceuticals has been assigned a Buy rating by financial services firm Stifel, following the successful launch of Voquezna.
Voquezna, developed as a potassium competitive acid blocker (PCAB), marks a significant breakthrough in the field as it introduces the first new mechanism of action in three decades to treat these conditions. Stifel has noted the drug's rapid, superior, and long-lasting effectiveness, potentially setting it as the new standard of care, replacing the current PPIs (proton pump inhibitors).
The analyst firm has also pointed out the positive reception of Voquezna in the physician community as well as its smooth market introduction with relatively minimal restrictions by payers. The success of PCAB in the Japanese market, where sales have reached approximately $850 million, was also noted as a significant factor indicating the unmet need in the market.
Phathom Pharmaceuticals is expected to further expand the market with a new drug application for non-erosive GERD expected by July 19, 2024, and ongoing studies for as-needed GERD dosing and eosinophilic esophagitis (EoE).
InvestingPro Insights
As Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT) celebrates the FDA approval of VOQUEZNA®, the company's financial health and market performance also warrant attention. According to InvestingPro data, Phathom Pharmaceuticals has a market capitalization of 708.73 million USD, indicating a solid presence in the market. Despite this, the company's P/E ratio stands at -2.76, reflecting investor concerns about profitability in the face of its recent achievements.
Analysts have mixed views on the company's outlook, with InvestingPro Tips highlighting that while sales growth is anticipated in the current year, net income is expected to drop, and profitability is not forecasted for this year. This aligns with the company's current cash burn rate, which is a crucial factor for investors to consider. On the upside, Phathom's liquid assets do exceed its short-term obligations, providing some financial stability.
Investors looking for growth may take note of Phathom's strong return over the last three months, with a 27.74% total price return. The recent FDA approval could further influence the company's stock performance, although it is trading at a high revenue valuation multiple. For those interested in a deeper dive into Phathom Pharmaceuticals' financials and future prospects, additional InvestingPro Tips can be found at https://www.investing.com/pro/PHAT. And for a limited time, readers can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, unlocking even more investment insights.
It's worth noting that Phathom Pharmaceuticals does not pay a dividend, which could be a determining factor for income-focused investors. With the company's next earnings date slated for August 8, 2024, stakeholders will be keen to see how the commercialization of VOQUEZNA® impacts financial outcomes. For those considering an investment in Phathom Pharmaceuticals, keeping abreast of both the company's innovative strides in healthcare and its financial trajectory is essential.
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