Mei Pharma ( MEIP Quick Quote 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.
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MEI Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are
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