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Tag: Acadia Pharmaceuticals Inc.

  • ACADIA Pharmaceuticals Inc. (ACAD) Stock Rocketing Higher in Aftermarket, Here’s the Reason

    ACADIA Pharmaceuticals Inc. (ACAD) Stock Rocketing Higher in Aftermarket, Here’s the Reason

    ACADIA Pharmaceuticals Inc. (ACAD), a biopharmaceutical company, has soared 21.80% in aftermarket trading session. Consequently, ACAD stock is trading at $23.63 at the time of the writing. On Monday, ACAD stock closed the day at $19.40 after gaining an increase of 3.25% during regular trading hours. The increase in ACAD stock could be attributed to the positive topline results from the phase 3 Lavender trial.

    Why ACAD on a Rise?

    On Monday, ACAD announced the positive topline results from the pivotal phase-3 Lavender study. The study highlighted the efficacy and safety of trofinetide in 187 girls and young women aged 5-20 years with Rett syndrome. The placebo-controlled study was conducted for 12 week period and it demonstrated significantly improved results over the placebo for both the co-primary endpoints. The change in the Rett Syndrome Behaviour Questionnaire (RSBQ) from baseline to week 12 was -5.1 vs. -1.7.

    Q3 2021 Operational Results

    On 8th November, ACAD released the operational results for the third quarter of the fiscal year 2021. The quarter ended on 30th September 2021. The company generated total revenue of $131.1 million during the period against $120.5 million for the same period of 2020. The total operating expenses for the period were $146.9 million against $206.4 million for the same period of 2020. The net loss suffered by the company during the three months was $14.4 million (or $0.09 per basic and diluted share) against $84.6 million (or $0.54 per basic and diluted share) for the same period of 2020.

    Executive Commentary

    Steve Davis, Chief Executive Officer of ACAD, while commenting on the results said that the company’s performance during the third quarter depicts the volume growth across all of the channels. Its strong relative performance highlights the ability of its commercial team to drive the sales of its products in challenging circumstances. He hoped that the company is looking forward to meeting some extremely important goals during the upcoming few weeks.  

    Future Outlook for ACAD

    The last three months have seen ACAD stock surge more than 19%. That’s good news for the investors of Acadia because looking at the company appears to be well on track to success after a gruesome 12 month period, in which its stock value declined more than 60%. Potential investors should keep a close eye on the performance of ACAD stock during the upcoming months.

  • Acadia Pharmaceuticals Inc. (ACAD) stock declines in the pre market trading. Let’s find out why?

    Acadia Pharmaceuticals Inc. (ACAD) stock declined by 14.42% in the pre market trading session after Acadia Pharmaceuticals has received a response letter from FDA for its supplement new drug application (sNDA). Acadia is breaking new ground in neuroscience to improve people’s lives. ACAD has been at the forefront of healthcare for over 25 years, bringing critical ideas to those who need them most. We developed and marketed the first and only FDA-approved treatment for hallucinations and delusions associated with psychosis caused by Parkinson’s disease.

    What is happening?

    The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Acadia Pharmaceuticals addressing its supplementary New Drug Application (sNDA) for NUPLAZID, which is used to treat hallucinations and delusions associated with dementia-related psychosis. In their response, FDA mentioned that they had finished reviewing the application and sent a CRL, while concluded that it could not be accepted in its current state.

    According to the previous agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design, which sought to examine a large DRP patient population as a single group, the Division identified a lack of statistical significance in some dementia subgroups and inadequate numbers of patients with some less common dementia subtypes as lack of significant evidence of efficacy in order to support the approval.

    The pivotal HARMONY trial for the DRP reached its preset primary and secondary endpoints, demonstrating pimavanserin’s clinical and statistical superiority over placebo, which was a prerequisite for the DRP indication. The predefined criteria did not include statistical separation by dementia subgroups or a minimum number of patients with distinct subtypes.

    Conclusion

    With ACAD’s new drug application sNDA not getting approved, it is quite possible that the stock price has declined following this disapproval. Although ACAD is working to find its way out with the cooperation of FDA to get the approval but for now it has become a matter of disinterest for investors and therefore they are not making any bets in ACAD stock.