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AC Immune SA (ACIU)

NasdaqGM - NasdaqGM Real-time price. Currency in USD
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3.0500-0.0200 (-0.65%)
At close: 04:00PM EDT
3.1700 +0.12 (+3.93%)
After hours: 05:53PM EDT

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  • B
    They had some interesting insights about ACIU on Definitely made me think twice about the company.
  • H
    ACIU If it pops 3.08-.10. DT targets 2.25 &3.65+ Support 2.80-85.
  • B
    Bullish Editor
  • R
    Nice to see ACIU moved up nicely in pre-market today. Not just a one shot buy, but started at 6:00 am and steadily moved up. The last pre-market trade was at 8:00 am at $3.64, 14% higher. Any pending good news? This is a small under-covered biotech with a multitude of trials going on in AD and other neurological diseases partnered with many large pharmas. At this depressed price, any positive data from trials will move the share price up significantly.
  • W
    AC Immune - Pioneering precision medicine for neurodegenerative diseases

    1. Significant market potential for Alzheimer's disease (AD) and other neurodegenerative diseases
    >>> Broadest pipeline in the field addressing Tau, Abeta, a-syn, TDP-43 and neuro inflammation

    2. Highly differentiated precision medicine approach
    >>> Dual clinically validated platforms generate First/Best-in-Class therapeutics and diagnostics

    3. Most comprehensive portfolio of candidates targeting Tau at key points in disease pathway
    >>> Clinical-stage antibody, vaccine, small molecule inhibitor and diagnostic imaging agent

    4. Multiple clinical catalysts anticipated in 2020 to drive near term value inflection
    >>> Key upcoming data readouts: Abeta vaccine (Phase 1b, DS and Phase 2, AD);
    Tau small molecule (Phase 1); Tau PET tracer (Phase 1, PSP)

    5. Marquis partnerships with leading global pharma companies
    >>> Secured CHF 334 million to date in non-dilutive funding with >CHF 3 billion in potential
    milestone payments plus royalties

    6. Experienced management with strong tract record of developing and out-licensing assets
  • n
    Excellent forecast : Prof. Pfeifer continued, “We anticipate multiple catalysts in 2019 and 2020, highlighted by expected Phase 2 data for semorinemab, our anti-Tau antibody partnered with Genentech/Roche, which we anticipate will be the first Phase 2 data available for a Tau-targeted therapy in Alzheimer’s disease (AD). We also anticipate achieving further progress across our development pipeline with both early and late stage data readouts that we believe will build substantial value for the Company.”
  • B
    Biotechinvest Net
    BTW, when Biogen tested anti-tau Ab in Ad they failed:
    "Gosuranemab did not meet its primary efficacy endpoint of change from baseline at week 78 on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) compared to placebo in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia. No treatment benefit was seen on exploratory efficacy endpoints, including the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog 13), the Alzheimer Disease Cooperative Study Activity of Daily Living (ADCS-ADL), the Mini-Mental State Examination (MMSE) and the Functional Assessment Questionnaire (FAQ). Gosuranemab was well-tolerated overall, and safety outcomes were consistent with previous studies of the molecule.
    Gosuranemab is an antibody directed against the N-terminus of tau. Target engagement was demonstrated with lowering of N-terminal tau in cerebrospinal fluid (CSF), consistent with prior studies. However, in the TANGO Study, no statistically significant treatment effect was observed on tau-PET at week 78 for any of the dose groups."
    Why Biogen Ab failed? Most likely that they targeted different epitope in N-terminus of tau. ACIU just choose correct epitope and got very good results.
  • C
    AC Immune Appoints Experienced Biotech and Investment Executive Dr. Alan Colowick to Board of Directors

    Dr. Colowick has more than 20 years of experience in large and emerging biotech companies

    Led investments for several clinical-stage companies as a Partner at Sofinnova Investments

    LAUSANNE, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that Alan Colowick, MD, MPH, a deeply experienced biotech and investment executive, was elected to the Company's Board of Directors at an extraordinary shareholders' meeting today.

    Dr Colowick has more than 20 years of industry experience in both large and emerging biotech companies, serving in a broad array of board, senior executive, clinical, regulatory, and commercial positions. He has a deep understanding of value creation and growth strategies, serving as a Partner at Sofinnova Investments, where he led investments for several clinical-stage companies.

    Douglas Williams, Ph.D., Chairman of AC Immune SA, commented: "The wealth of experience and credibility Dr. Colowick brings to AC Immune's Board will be invaluable as we continue to execute on our corporate strategy and reinforce our scientific leadership in the field of neurodegenerative diseases. His extensive expertise in biotech from both industry and investment standpoints -- including from Celgene, Amgen and Sofinnova -- will bring an important perspective to our pipeline and corporate development. We are thrilled to welcome him as our newest Director."

    Dr. Colowick commented: "I am delighted to be elected to the Board of Directors at what is a particularly exciting moment for AC Immune. By pioneering a personalized medicine approach that properly recognizes the complexity of neurodegenerative disease, the Company has positioned itself at the forefront of the field, poised for sustained growth. I look forward to working with my new colleagues as we continue to advance one of the industry's broadest and most diversified pipelines in neurodegeneration."

    Prior to his time at Sofinnova, Dr. Colowick was Executive Vice President and served in various leadership roles at Celgene Corporation, including as President for Celgene's Europe, Mid-East, and Africa regions and as Senior Vice President of Global Medical Affairs. Before joining Celgene, he was the Chief Executive Officer at Gloucester Pharmaceuticals, Inc. where he led a private round of financing prior to the company's acquisition by Celgene in 2010. Dr. Colowick has also served as the President of Oncology at Geron Corporation, as Chief Medical Officer of Threshold Pharmaceuticals, and in numerous positions of increasing responsibility at Amgen culminating with his role as VP, Medical Affairs Europe.

    Dr. Colowick also has extensive Board experience that includes current roles on the Board of Directors for Personalis, Inc., XyloCor Therapeutics, and InCarda Therapeutics, and prior roles as Chairman of the Board including VelosBio (sold to Merck in 2020 for $2.75 billion) and Principia Biopharma (sold to Sanofi in 2020 for $3.7 billion). He received his medical degree from Stanford University, a Master's in Public Health from Harvard University, and a B.S. in Molecular Biology from the University of Colorado. Additionally, Dr. Colowick has completed specialty training in Hematology-Oncology at Harvard Medical School, the Dana Farber Cancer Institute, and Brigham and Women's Hospital in Boston, USA.

    Prior to the meeting, the Board withdrew agenda item 2.
  • J
    I don't understand it. Look at SAVA, it's got only 9 employees and came out with similar news, the stock jumped more than 200% and now has a market cap of almost 2B.

    ACIU has more than 100 employees and with the good news the stock is actually down from premarket?
  • c
    Difference in the run up with SAVA vs AC - SAVA started around $100MC while AC started at $500MC. And SAVA has a much lower share float making supply/demand effect more explosive. Biggest point is that SAVA reported cognitive improvement which is much more important than saying antibodies were present. Big difference. AC didn’t provide any statistical results which is more of a pump at the moment. I like AC and hold shares. I think they will get there and do have a much deeper pipeline of products than SAVA but what I’ve said above is exactly why u cannot compare this to SAVA’s current run up. Another really big deal too is that SAVA still holds all the rights to their drug so the possibility of a partnership adds even more value. AC is handcuffed to J&J- if their drug is successful, revenue is already defined by the rights agreement. They will get milestones and capped royalties. Hope I’m wrong and someone can explain differently.
  • W
    ACIU is way a lot to offer than SAVA. LOOK AT THE PIPELINE PEOPLE!!!
    Partners: Eli Lilly, Janssen ( a Johnson&Johnson Co.), Regeneron (a Roche Co. )
    ACIU and partners are way ahead in clinical studies than SAVA
  • j
    ACIU is undervalued and should be $18 suggested by Analysts. Planning ACI-35.030 into Phase 2/3 clinical trials on the way should rise above $30 soon. Not selling 1 share under $30 Buy more and hold.
  • #
  • B
    Biotechinvest Net
    If you have $8k and want 10x gain - just buy 1000 shares of ACIU. There are no so many biotechs that have real AD drugs in their portfolios and ACIU is definitely one of them. Why not SAVA? This is scam biotech with completely fake AD drug. Company founders will make big money and all investors will lose them. It will be the same story as AXON scam with its fake AD drug. So, if you want lose all your money just buy SAVA and after Ph3 AD results you will lose >95%.
    Why ACIU AD treatment is not a fake? Because p-tau is a main players in AD etiology - tau aggregates from dead neurons spreads through the brain and healthy neurons swallows them. Inside of healthy neurons defect tau starts to convert normal tau to aggregates. The mechanisms are similar to prion disease. Anti-p-tau antibodies should stop spread of pathogenic p-tau filaments through the brain and stop/slow down AD.
    What is SAVA filamin A (FLNA)? This protein never was known as AD player. SAVA founders just published several papers that showed that this protein can play some role in AD. But most likely these papers were fake results. If you open Wiki and ask about filamin A (FLNA) you will know that:
    "Filamins are a class of proteins that hold two actin filaments at large angles.[1] Filamin protein in mammals is made up of an actin-binding domain at its N-terminus that is followed by 24 immunoglobulin-like repeat modules of roughly 95 amino acids. There are two hinge regions; between repeats 15-16 and 23-24. Filamin gets cleaved at these hinge regions to generate smaller fragments of the protein. Filamin has two actin-binding sites with a V-linkage between them, so that it cross-links actin filaments into a network with the filaments orientated almost at right angles to one another"
    Filamin proteins include:
    Over-expression of FLNA stops the regeneration of bladder carcinoma (BC) cells, by inhibiting the cell cycle and inducing apoptosis of BC cells.[3] FLNA has also been shown to reduce the mobility and invasion abilities of BC cells."
    Nothing about AD and being "a scaffolding protein, in the brain."
  • E
    8/21/20 9:14 am EST: AC Immune upcoming readout risk-reward skews positive, says SVB Leerink 09:14 ACIU SVB Leerink analyst Marc Goodman maintained an Outperform rating and $13 price target on AC Immune ahead of the upcoming data readout for the company's semorinemab Phase 2 study, TAURIEL, in treating prodromal-to-mild Alzheimer's disease in the second half of 2020. The analyst likes the risk/reward of the readout, as he expects limited downside of around 10% with a negative trial, but a 45%-50% move upward with a positive trial.

    Read more at:
    AC Immune upcoming readout risk-reward skews positive, says SVB Leerink SVB Leerink ACIU
    AC Immune upcoming readout risk-reward skews positive, says SVB Leerink SVB Leerink ACIU
  • E
    AC Immune Says Phase 2 Study of Alzheimer's Drug Fails to Meet Primary Endpoint, Stock Drops Pre-Bell
    23 Sep 2020 08:56 HE
    08:56 AM EDT, 09/23/2020 (MT Newswires) -- AC Immune (ACIU) said Wednesday a phase 2 study conducted by its joint venture partner Genentech on its proprietary antibody semorinemab in early Alzheimer's disease failed to meet the primary endpoint.

    The company said that semorinemab was not able to reduce the decline on the Clinical Dementia Rating-Sum of Boxes, a scale used to characterize Alzheimer disease and related dementias. Secondary endpoints using scales that measure cognitive ability and the competence of patients in daily living activities were also not met.

    An evaluation of semorinemab for moderate Alzheimer's disease in a phase 2 study is currently underway, the company said.

    Shares dropped 42.7% in pre-market trading.
  • G
    ACI-35.030 and ACI-24 data presentation are yet to come this week and the data presented today is encouraging for mild to moderate AD treatment as it resulted in 43% decline in the cognition statistically.
  • A
    Updated pipeline slide on the homepage:

    obviously there are now two (2) tau morphomers programs in development, at the brink to the clinic for "rare tauopathies" and in preclinical development for AD. However, both programs seem to be partnered with Eli Lilly.

    As from the AC-3024 PR on the healthy volunteer clinical phase 1 from last year, it appeared as if this compound would not be continued in AD but explored for the rare tauopathies. however, on the ACIU homepage it's not listed as AC-3024 but just as a tau morphomer, so it's unclear whether this is a backup compound of AC-3024.

    All in all, I think this looks very promising for ACIU, as Eli Lilly seems to partner on both the more advanced (rare tauopathies) and the backup (for AD) molecules.

    Can't wait for 10.
  • B
    Biotechinvest Net
    BTW, Biogen anti-amyloid Ab never showed "significant reduction in cognitive decline from baseline by 43.6% compared to placebo (p<0.0025) as measured by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-item Version (ADAS-Cog11)". If is absolutely useless medication that only slightly decrease amyloid in AD brain. FDA approval was fraud action and now investigated
    "Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the U.S. agency and Biogen representatives prior to the drug’s approval on June 7."
    ACIU Phase 2 data allow them to start Phase 3 trial for Semorinemab. And ACIU has a high probability to success in Phase 3 in comparison with SAVA and ANVS (both have fake AD drugs).
    Biogen shares fell Friday after the head of the FDA called for an investigation into the recent approval of the company's Alzheimer's drug, Aduhelm.
    Biogen shares fell Friday after the head of the FDA called for an investigation into the recent approval of the company's Alzheimer's drug, Aduhelm.
  • C
    How will this help ACIU since they work with LLY?
    Eli Lilly & Co. said it has received breakthrough therapy designation for its Alzheimer's treatment from the U.S. Food and Drug Administration.

    The designation means preliminary clinical evidence indicates the drug could show substantial improvement over available therapies on a clinically significant endpoint, and is meant to expedite the development and review of drugs for serious conditions, according to the FDA.

    Lilly on Thursday said it plans to submit a biologics license application for the drug, donanemab, under the accelerated approval path later this year based on data from its Phase 2 trial. It said the safety, tolerability and efficacy of donanemab are being evaluated in an ongoing Phase 3 study.