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Mei Pharma (MEIP) to Delay Filing With FDA for Lymphoma Drug
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Shares of Mei Pharma (MEIP - Free Report) plunged more than 45% in after-market trading on Thursday after it announced that the FDA has discouraged its plans to file for an approval of its PI3K inhibitor zandelisib for follicular lymphoma (FL) indication.
The above feedback provided by the FDA was part of Mei Pharma’s recent meeting with theregulatory agency officials. MEIP was initially planning to file for an accelerated approval of zandelisib to address FL indication based on data from the single-arm phase II TIDAL study. This study, which evaluated zandelisib as a single agent for FL patients who received at least two prior systemic therapies, achieved an objective response rate of 70.3%.
The FDA stated in its discussions that Mei Pharma data from single-arm studies was not sufficient to evaluate the risks and benefits for approving a candidate under an accelerated pathway and therefore, requested management to conduct a randomized study to support the accelerated approval of zandelisib for the given indication. Moreover, the FDA recommended that MEIP continues its dose exploration to further support the current dose and regimen.
Accordingly, Mei Pharma will not seek approval for the candidate based on the single arm TIDAL study. Moreover, MEIP will continue to conduct the ongoing phase III COASTAL study, which is evaluating zandelisib in patients with relapsed or refractory FL or marginal zone lymphoma (MZL) who received more than one prior line of therapy. Management believes, MEIP will be able to complete enrolment in the COASTAL study in 2024.
The stock has declined 32.2% so far this year compared with the industry’s 13.2% decrease.
Image Source: Zacks Investment Research
We remind investors that the FDA already granted zandelisib both Fast Track and Orphan Drug designations for FL indication.
Mei Pharma is collaborating with Japan-based Kyowa Kirin to develop and commercialize zandelisib. Per the agreement terms, Mei Pharma will record U.S. sales of the drug while Kyowa Kirin will hold exclusive rights to ex-U.S.sales.
MEI Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are Collegium Pharmaceutical (COLL - Free Report) , Gamida Cell and Vertex Pharmaceuticals (VRTX - Free Report) . While Collegium Pharmaceutical sports a Zacks Rank #1 (Strong Buy), both Gamida Cell and Vertex Pharmaceuticals carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $5.53 to $5.76 in the past 30 days. The same for 2023 has increased from $6.82 to $7.96 in the past 30 days. Shares of COLL have risen 2.3% year to date.
Earnings of Collegium Pharmaceutical beat estimates in three of the last four quarters while the same missed the mark on one occasion, the negative surprise being 57.6%.
Gamida Cell’s loss per share estimates for 2022 have narrowed from $1.35 to $1.17 in the past 30 days. Shares of GMDA have risen 70.9% year to date.
Earnings of Gamida Cell beat estimates in three of the last four quarters, missing the mark in one, the average surprise being 12.9%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 13.3% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.
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Mei Pharma (MEIP) to Delay Filing With FDA for Lymphoma Drug
Shares of Mei Pharma (MEIP - Free Report) plunged more than 45% in after-market trading on Thursday after it announced that the FDA has discouraged its plans to file for an approval of its PI3K inhibitor zandelisib for follicular lymphoma (FL) indication.
The above feedback provided by the FDA was part of Mei Pharma’s recent meeting with theregulatory agency officials. MEIP was initially planning to file for an accelerated approval of zandelisib to address FL indication based on data from the single-arm phase II TIDAL study. This study, which evaluated zandelisib as a single agent for FL patients who received at least two prior systemic therapies, achieved an objective response rate of 70.3%.
The FDA stated in its discussions that Mei Pharma data from single-arm studies was not sufficient to evaluate the risks and benefits for approving a candidate under an accelerated pathway and therefore, requested management to conduct a randomized study to support the accelerated approval of zandelisib for the given indication. Moreover, the FDA recommended that MEIP continues its dose exploration to further support the current dose and regimen.
Accordingly, Mei Pharma will not seek approval for the candidate based on the single arm TIDAL study. Moreover, MEIP will continue to conduct the ongoing phase III COASTAL study, which is evaluating zandelisib in patients with relapsed or refractory FL or marginal zone lymphoma (MZL) who received more than one prior line of therapy. Management believes, MEIP will be able to complete enrolment in the COASTAL study in 2024.
The stock has declined 32.2% so far this year compared with the industry’s 13.2% decrease.
Image Source: Zacks Investment Research
We remind investors that the FDA already granted zandelisib both Fast Track and Orphan Drug designations for FL indication.
Mei Pharma is collaborating with Japan-based Kyowa Kirin to develop and commercialize zandelisib. Per the agreement terms, Mei Pharma will record U.S. sales of the drug while Kyowa Kirin will hold exclusive rights to ex-U.S.sales.
MEI Pharma, Inc. Price
MEI Pharma, Inc. price | MEI Pharma, Inc. Quote
Zacks Rank & Key Picks
MEI Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are Collegium Pharmaceutical (COLL - Free Report) , Gamida Cell and Vertex Pharmaceuticals (VRTX - Free Report) . While Collegium Pharmaceutical sports a Zacks Rank #1 (Strong Buy), both Gamida Cell and Vertex Pharmaceuticals carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $5.53 to $5.76 in the past 30 days. The same for 2023 has increased from $6.82 to $7.96 in the past 30 days. Shares of COLL have risen 2.3% year to date.
Earnings of Collegium Pharmaceutical beat estimates in three of the last four quarters while the same missed the mark on one occasion, the negative surprise being 57.6%.
Gamida Cell’s loss per share estimates for 2022 have narrowed from $1.35 to $1.17 in the past 30 days. Shares of GMDA have risen 70.9% year to date.
Earnings of Gamida Cell beat estimates in three of the last four quarters, missing the mark in one, the average surprise being 12.9%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 13.3% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.