Tag: NASDAQ:ACIU

  • AC Immune (ACIU) Sees Stock Boost Following Positive Trial Data

    AC Immune (ACIU) Sees Stock Boost Following Positive Trial Data

    Following the release of positive preliminary findings from its Phase 2 VacSYn clinical study, shares of AC Immune SA (NASDAQ: ACIU) saw a notable increase, jumping 13.42% on the charts. The anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056, which targets early-stage Parkinson’s disease (PD), is being evaluated in this experiment. ACIU stock ended Thursday’s trading session at $3.55 after the news.

    AC Immune Shares Promising Interim Data

    The interim results from the VacSYn trial provided positive data on the safety and immunogenicity of ACI-7104.056. These findings, which were gathered after just three months of treatment, demonstrate the promising immunogenicity levels and continued favorable safety profile.

    These findings establish ACI-7104.056 as a top choice for patients with early-stage Parkinson’s disease and confirm its potential as a best-in-class treatment candidate. In the first half of 2025, AC Immune intends to provide more information, which might include a decision to move forward with the trial’s second phase.

    VacSYn Study Design and Results

    VacSYn is an adaptive, placebo-controlled, biomarker-driven Phase 2 study targeting early Parkinson’s disease. The trial includes two phases, with Part 1 having already completed an analysis of over 30 patients, who were randomized to receive either ACI-7104.056 or a placebo.

    Notably, no significant safety concerns were identified, aside from mild side effects like injection site reactions (49%) and headaches (18%). The interim data indicated that ACI-7104.056 was effective in inducing a robust antibody response, with anti-a-syn antibodies reaching levels 16 times higher than the placebo after three immunizations.

    Future Plans and Expansion of the Study

    Looking ahead, AC Immune may expand Part 2 of the VacSYn trial, potentially involving up to 150 patients. This phase will explore additional outcomes, including the progression of motor and non-motor symptoms, as well as the use of digital, imaging, and fluid biomarkers. These efforts aim to establish early proof-of-concept and identify key biomarkers, supporting a swift transition into a pivotal study.

  • Strategic Boost: AC Immune’s (ACIU) Share Price Surges Pre-Market

    Strategic Boost: AC Immune’s (ACIU) Share Price Surges Pre-Market

    In response to recent strategic maneuvers, the shares of AC Immune SA (NASDAQ: ACIU) have experienced a notable surge in the pre-market session. At present, ACIU stock reflects an impressive uptick of 53.25% on the US charts, trading at $3.54.

    Revolutionary Collaboration Announced

    Today, AC Immune (ACIU) and Takeda established an exclusive global option and license arrangement. The businesses got into the arrangement with an emphasis on the AC Immune-developed active immunotherapies that target dangerous types of amyloid beta (Abeta). That also include its ACI-24.060, which is intended to treat Alzheimer’s disease.

    ACI-24.060 represents an anti-Abeta active immunotherapy candidate meticulously engineered to instigate a robust antibody response against the toxic forms of Abeta, recognized as catalysts for plaque formation and the progression of Alzheimer’s disease. Its mechanism, aimed at inducing plaque clearance and effectively impeding plaque formation in the brain, harbors the potential to retard or mitigate the advancement of Alzheimer’s disease.

    Pioneering Active Immunotherapy

    As pioneers in the realm of active immunotherapy, AC Immune is pioneering an innovative approach poised to revolutionize the treatment landscape for Alzheimer’s disease, addressing the multifaceted burden confronting patients and the wider community. The optimal realization of ACI-24.060’s impact is envisaged through collaboration with Takeda, facilitating an expedited progression into Phase 3 trials.

    AC Immune will oversee the completion of the ABATE trial. Subsequent to the exercise of the option, Takeda will spearhead and finance all ensuing clinical development endeavors, while assuming accountability for global regulatory undertakings and worldwide commercialization.

    Financial Implications

    Per the terms delineated in the agreement, AC Immune is slated to receive an upfront payment of $100 million, in addition to potential option exercise fees and a spectrum of development, commercial, and sales-based milestones, culminating in a cumulative sum of approximately $2.1 billion if all benchmarks are successfully met throughout the pact’s duration. Upon commercialization, AC Immune stands to garner tiered double-digit royalties on worldwide net sales.

  • Why AC Immune SA (ACIU) stock had a BAD Friday?

    AC Immune SA (ACIU) shares plunged 5.26% in after-hours on Friday, June 25, 2021, and closed the week at $7.75 per share. Earlier, in the morning session, ACIU’s stock lost 2.27% to close Friday’s session at $8.18 per share. ACIU shares have risen 20.12% over the last 12 months, and they have moved up 3.15% in the past week. Over the past three months, the stock has gained 7.21%, while over the past six months, it has declined 48.73%.

    Let’s see what’s happening recently with ACIU?

    Annual General Meeting

    On June 25, 2021, AC Immune held its Annual General Meeting per Swiss law. Shareholders cast their votes through the independent proxy appointed by the shareholders.

    Douglas Williams, Martin Velasco, Peter Bollmann, Alan Colowick, Tom Graney, Carl June, Werner Lanthaler, Andrea Pfeifer, and Roy Twyman were re-elected on the Board of Directors by the shareholders. Douglas Williams and Martin Velasco will continue to serve as Chairman and Vice-Chairman of the Board, respectively.

    Update on Alzheimer’s disease Vaccine candidates 

    On June 02, 2021, AC Immune SA provided key clinical and preclinical updates for its SupraAntigen®-derived liposomal vaccine candidates, which are designed to convey active, long-lasting immunization against pathological forms of amyloid-beta (Abeta).

    AC Immune is completing a Phase 2 study of its first clinical candidate, ACI-24, in people with mild Alzheimer’s disease (AD), and is also advancing an optimized ACI-24 formulation, which demonstrates enhanced and sustained immunogenicity in non-human primate studies, particularly against key pathological forms of Abeta such as oligomeric and pyroglutamate Abeta.

    Phase 1b/2a clinical trial expansion of anti-phosphorylated-Tau (pTau) vaccine candidate

    On May 17, 2021, AC Immune SA and its strategic partner Janssen Pharmaceuticals, Inc. expanded the ongoing Phase 1b/2a clinical trial of the Companies’ first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease (AD).

    Recent financial results

    On April 28, 2021, AC Immune SA announced its financial results for the quarter ended March 31, 2021.

    Q1 2021 financial highlights

    • There was no contract revenue for Q1 2021 compared to CHF 12.3 million in Q1 2020.
    • The company spent CHF 13.3 million in R&D expenses compared to CHF 2 million for Q1 2020.
    • General and administrative expenses were CHF 4.3 million for Q1 2021 compared to CHF 4.5 million for Q1 2020.
    • Net loss for the reported quarter was CHF 16.7 million compared with a net loss of CHF 7.7 million for the comparable period in 2020.
    • As of March 31, 2021, the company had a total cash balance of CHF 216.1 million, composed of CHF 151.1 million in cash and cash equivalents and CHF 65 million in short-term financial assets.

    Conclusion

    As of this writing, there was no news or development which could be linked with its poor performance on Friday. so we are unable to predict how ACIU stock will perform in the coming days.