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Phathom (PHAT) Up 8% on Erosive Esophagitis Drug's CRL Update
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Phathom Pharmaceuticals (PHAT - Free Report) stock jumped 8.42% on Tuesday after the company announced a positive outcome from a recent meeting with the FDA regarding the resubmission of its new drug application (NDA) for vonoprazan for the treatment of erosive esophagitis and H. pylori infection indications. Vonoprazan is under review for the treatment of erosive esophagitis, while Voquesna Tripple PAK and Voquezna Dual PAK are approved for the treatment of adults with H. pylori infection.
Phathom’s meeting with the FDA was regarding the complete response letters (CRLs) for Phathom’s erosive esophagitis NDA and H. pylori post-approval supplement to Voquezna Triple PAK and Voquezna Dual PAK NDAs. The company further affirmed that the higher-than-acceptable level of N-nitroso-vonoprazan (NVP) impurity was the sole cause of both CRLs.
In the past year, shares of Phathom have plunged 48.1% compared with the industry’s 15.4% decline.
Image Source: Zacks Investment Research
Phathom had previously submitted an NDA to the FDA for the use of vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis in March 2022, with a decision expected in January 2023. In May 2022, Phathom received FDA approval for Voquesna Tripple PAK and Voquezna Dual PAK for the treatment of H. pylori infection in adults under priority review. It had also been previously granted as a qualified infectious disease product by the FDA.
However, after the commercial launch of Voquesna Tripple PAK and Voquezna Dual PAK in the third quarter of 2022, the FDA found unacceptable levels of NVP in commercial batches. Following this, the FDA issued CRLs to both the vonoprazan NDA and the approved products, Voquesna Tripple PAK and Voquezna Dual PAK.
As an initial response to the CRL, Phathom met with the FDA to obtain approval for a proposed acceptable daily intake limit, test method and controls to address this impurity before releasing vonoprazan-based products to the market. The acceptable daily intake limit was established at 96 ng/day by the FDA while requesting additional stability data demonstrating levels of NVP remain below that limit throughout the proposed shelf life of the product from Phathom.
In Tuesday’s press release, Phathom reported conducting extensive root cause investigations and implementing mitigation measures, including a minor tablet reformulation, to inhibit the growth of NVP since first detecting trace levels of NVP. The company has presented these stability data to the FDA on the reformulation.
The FDA has reportedly provided feedback on the resubmission requirements, including the expected stability data requirements. Based on the feedback, the company expects to resubmit the NDA for erosive esophagitis in the second quarter of 2023. Subject to approval, this could lead to a combined commercial launch of vonoprazan for the erosive esophagitis and H. pylori indications in the fourth quarter of 2023.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 56 cents. In the past year, shares of Aptinyx have fallen by 94.9%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the Zacks Consensus Estimate for ACADIA’s 2023 loss per share has narrowed from 87 cents to 44 cents. In the past year, shares of ACADIA have fallen by 32.1%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average earnings negative surprise of 6.33%.
In the past 90 days, the consensus estimate for ADMA’s 2023 loss per share has narrowed from 20 cents to 14 cents. In the past year, shares of ADMA have increased by 66.4%.
ADMA beat estimates in three out of the trailing four quarters, delivering an average earnings surprise of 2.88%.
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Phathom (PHAT) Up 8% on Erosive Esophagitis Drug's CRL Update
Phathom Pharmaceuticals (PHAT - Free Report) stock jumped 8.42% on Tuesday after the company announced a positive outcome from a recent meeting with the FDA regarding the resubmission of its new drug application (NDA) for vonoprazan for the treatment of erosive esophagitis and H. pylori infection indications. Vonoprazan is under review for the treatment of erosive esophagitis, while Voquesna Tripple PAK and Voquezna Dual PAK are approved for the treatment of adults with H. pylori infection.
Phathom’s meeting with the FDA was regarding the complete response letters (CRLs) for Phathom’s erosive esophagitis NDA and H. pylori post-approval supplement to Voquezna Triple PAK and Voquezna Dual PAK NDAs. The company further affirmed that the higher-than-acceptable level of N-nitroso-vonoprazan (NVP) impurity was the sole cause of both CRLs.
In the past year, shares of Phathom have plunged 48.1% compared with the industry’s 15.4% decline.
Image Source: Zacks Investment Research
Phathom had previously submitted an NDA to the FDA for the use of vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis in March 2022, with a decision expected in January 2023. In May 2022, Phathom received FDA approval for Voquesna Tripple PAK and Voquezna Dual PAK for the treatment of H. pylori infection in adults under priority review. It had also been previously granted as a qualified infectious disease product by the FDA.
However, after the commercial launch of Voquesna Tripple PAK and Voquezna Dual PAK in the third quarter of 2022, the FDA found unacceptable levels of NVP in commercial batches. Following this, the FDA issued CRLs to both the vonoprazan NDA and the approved products, Voquesna Tripple PAK and Voquezna Dual PAK.
As an initial response to the CRL, Phathom met with the FDA to obtain approval for a proposed acceptable daily intake limit, test method and controls to address this impurity before releasing vonoprazan-based products to the market. The acceptable daily intake limit was established at 96 ng/day by the FDA while requesting additional stability data demonstrating levels of NVP remain below that limit throughout the proposed shelf life of the product from Phathom.
In Tuesday’s press release, Phathom reported conducting extensive root cause investigations and implementing mitigation measures, including a minor tablet reformulation, to inhibit the growth of NVP since first detecting trace levels of NVP. The company has presented these stability data to the FDA on the reformulation.
The FDA has reportedly provided feedback on the resubmission requirements, including the expected stability data requirements. Based on the feedback, the company expects to resubmit the NDA for erosive esophagitis in the second quarter of 2023. Subject to approval, this could lead to a combined commercial launch of vonoprazan for the erosive esophagitis and H. pylori indications in the fourth quarter of 2023.
Phathom Pharmaceuticals, Inc. Price and Consensus
Phathom Pharmaceuticals, Inc. price-consensus-chart | Phathom Pharmaceuticals, Inc. Quote
Zacks Rank and Other Stocks to Consider
Phathom currently has a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the same industry are Aptinyx , ACADIA Pharmaceuticals (ACAD - Free Report) and ADMA Biologics (ADMA - Free Report) , all carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 56 cents. In the past year, shares of Aptinyx have fallen by 94.9%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the Zacks Consensus Estimate for ACADIA’s 2023 loss per share has narrowed from 87 cents to 44 cents. In the past year, shares of ACADIA have fallen by 32.1%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average earnings negative surprise of 6.33%.
In the past 90 days, the consensus estimate for ADMA’s 2023 loss per share has narrowed from 20 cents to 14 cents. In the past year, shares of ADMA have increased by 66.4%.
ADMA beat estimates in three out of the trailing four quarters, delivering an average earnings surprise of 2.88%.