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Phathom (PHAT) Down on Regulatory Update on Vonoprazan NDA
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Phathom Pharmaceuticals, Inc. (PHAT - Free Report) announced that the FDA has notified the company that it will not take any action on Phathom's new drug application (NDA) for vonoprazan on or before the target action date. Shares declined 31.11% on Jan 4 in response to the news.
The NDA is currently under review, seeking approval of the candidate for the treatment of erosive esophagitis. The current target action date is Jan 11, 2023.
Vonoprazan is an oral small molecule potassium-competitive acid blocker, or P-CAB. P-CABs are a novel class of medicines that block acid secretion in the stomach.
In August, Phantom announced that it had detected trace levels of a nitrosamine impurity, N-nitroso-vonoprazan (NVP), in commercial batches and was working closely with the FDA to obtain approval of a proposed acceptable daily intake limit, test method, and controls to address this impurity prior to releasing vonoprazan-based products to the market. The FDA has set an acceptable daily intake limit for NVP at 96 ng/day. However, the FDA then requested additional stability data demonstrating that levels of NVP remain below that limit throughout the proposed shelf life of the product.
Hence, the company is actively in the process of both generating additional stability data and discussing with the FDA the nature and extent of such requested data. As a result, Phathom no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023.
On May 3, 2022, the company obtained FDA approval for vonoprazan triple therapy, under the brand name Voquezna TRIPLE PAK and vonoprazan dual therapy, under the brand name Voquezna DUAL PAK, in each case for the treatment of H. pylori infection in adults.
Shares have plunged 52.4% in the year so far compared with the industry’s decline of 16.6%.
Image Source: Zacks Investment Research
Last October, the company announced it had completed enrollment in its PHALCON-NERD daily dosing phase III study of vonoprazan in non-erosive gastroesophageal reflux disease (NERD). The trial enrolled a total of 776 patients with NERD at study sites across the United States. Top-line data for the primary endpoint is expected in the ongoing quarter, with full trial results later in the year.
Potentially successful results from the study will form the basis of a supplemental new drug application (sNDA) for vonoprazan as once-daily therapy for the treatment of symptomatic NERD in adults, with a planned submission in 2023.
Takeda Pharmaceutical Company LimitedTAK developed vonoprazan and has received marketing approval in numerous countries in Asia and Latin America, as well as Russia. In May 2019, Phathom in-licensed the U.S., European and Canadian rights to vonoprazan from Takeda.
Loss per share estimates for Syndax Pharmaceuticals for 2022 and 2023 have narrowed by 11 cents and 20 cents, respectively, over the past 60 days. Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Immunocore have narrowed by 77 cents and 92 cents, respectively, in the past 60 days. Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
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Phathom (PHAT) Down on Regulatory Update on Vonoprazan NDA
Phathom Pharmaceuticals, Inc. (PHAT - Free Report) announced that the FDA has notified the company that it will not take any action on Phathom's new drug application (NDA) for vonoprazan on or before the target action date. Shares declined 31.11% on Jan 4 in response to the news.
The NDA is currently under review, seeking approval of the candidate for the treatment of erosive esophagitis. The current target action date is Jan 11, 2023.
Vonoprazan is an oral small molecule potassium-competitive acid blocker, or P-CAB. P-CABs are a novel class of medicines that block acid secretion in the stomach.
Phathom Pharmaceuticals, Inc. Price and Consensus
Phathom Pharmaceuticals, Inc. price-consensus-chart | Phathom Pharmaceuticals, Inc. Quote
In August, Phantom announced that it had detected trace levels of a nitrosamine impurity, N-nitroso-vonoprazan (NVP), in commercial batches and was working closely with the FDA to obtain approval of a proposed acceptable daily intake limit, test method, and controls to address this impurity prior to releasing vonoprazan-based products to the market. The FDA has set an acceptable daily intake limit for NVP at 96 ng/day. However, the FDA then requested additional stability data demonstrating that levels of NVP remain below that limit throughout the proposed shelf life of the product.
Hence, the company is actively in the process of both generating additional stability data and discussing with the FDA the nature and extent of such requested data. As a result, Phathom no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023.
On May 3, 2022, the company obtained FDA approval for vonoprazan triple therapy, under the brand name Voquezna TRIPLE PAK and vonoprazan dual therapy, under the brand name Voquezna DUAL PAK, in each case for the treatment of H. pylori infection in adults.
Shares have plunged 52.4% in the year so far compared with the industry’s decline of 16.6%.
Image Source: Zacks Investment Research
Last October, the company announced it had completed enrollment in its PHALCON-NERD daily dosing phase III study of vonoprazan in non-erosive gastroesophageal reflux disease (NERD). The trial enrolled a total of 776 patients with NERD at study sites across the United States. Top-line data for the primary endpoint is expected in the ongoing quarter, with full trial results later in the year.
Potentially successful results from the study will form the basis of a supplemental new drug application (sNDA) for vonoprazan as once-daily therapy for the treatment of symptomatic NERD in adults, with a planned submission in 2023.
Takeda Pharmaceutical Company Limited TAK developed vonoprazan and has received marketing approval in numerous countries in Asia and Latin America, as well as Russia. In May 2019, Phathom in-licensed the U.S., European and Canadian rights to vonoprazan from Takeda.
Zacks Rank and Stocks to Consider
Phathom currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) and Immunocore Holdings plc (IMCR - Free Report) . Both carry a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals for 2022 and 2023 have narrowed by 11 cents and 20 cents, respectively, over the past 60 days. Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Immunocore have narrowed by 77 cents and 92 cents, respectively, in the past 60 days. Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.