Minerva Neurosciences Inc. (NERV) stock prices were down by 1.69% as of the market closing on September 30th, 2021. This brought the price per share down to USD$1.74 at the end of the trading day. Subsequent premarket fluctuations saw the stock rise by 6.90%, bringing it up to USD$1.86
NERV Stock’s Clinical Study
September 30th, 2021 saw NERV stock announce results from a pivotal bioequivalence study. The study was designed to compare the roluperidone formulations used in its late-stage Phase 2b and Phase 3 trials with the planned commercial formulation. The study reported having met all of its key pharmacokinetic (PK) objectives, with the data demonstrating bioequivalence across the various formulations.
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Positive Roluperidone Data
The positive results demonstrate bioequivalence as measured by exposure between the formulations used in the company’s two trials. The first is a late-stage Phase 2b and the other is a Phase 3 efficacy and safety trials with roluperidone. The company is confident that the data will serve to address certain FDA observations following a Type C meeting in November 2020. The results represent key progress along NERV stock’s critical path towards the submission of an NDA for roluperidone. The treatment is being designed to address the negative symptoms of schizophrenia, for which there are currently no approved treatment options in the United States.
Details of NERV Stock’s Treatment
The efficacy of roluperidone is primarily driven by plasma exposure of the drug, whereas safety margins are improved by reducing C(max) of the drug. The treatment is intended for chronic use and the assessed formulations are controlled release. AUC(inf) is the most relevant of the AUCs when single dose data are collected. This data is then used in determining the bioequivalence of the treatment.
One of the most important objectives for the study was to establish the comparability under fasted conditions of roluperidone. 64 mg tablets of the Phase 3 formulations of the treatment were compared to the 64 mg dose administered as two 32 mg tablets of the treatment used in the Phase 2b study. The other most important objective observed the comparability under fasted conditions of the same treatment. A 64mg tablet of the planned commercial formulation of the treatment was compared to the administration of two 32 mg tablets from its Phase 2b study.
Future Outlook for NERV Stock
The company reported a promising quarter, consolidated by the positive results from its pivotal bioequivalence study for roluperidone. NERV stock is poised to capitalize on the opportunities afforded to it as a result of this development. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal. This is hoped to usher in a maintaining of the course of the company’s trajectory of success.