Monday, November 10, 2025 9:23:03 PM
Cash plus schizo is worth 2.00 so can't go wrong with these.
Are you factoring in the $150 M ATM (or whatever portion already raised) and the Rett voucher (~$150 M) into that $2.00 per-share estimate?
For context, here’s the 2025 Oral Explanation (OE) record between January and July 2025:
Out of 15 total Pre-authorisation procedure oral explanations drugs,
8 that were already FDA-approved ? 100 % received a positive CHMP opinion,
7 that were not FDA-approved ? only 1 (˜ 14 %) received a positive CHMP opinion.
Drug (brand) CHMP outcome (100% CHMP positive - FDA approved Drugs)
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Donanemab (Kisunla) | Initial negative (Mar 2025) ? Positive after re-exam (Jul 2025)
Vorasidenib (Voranigo) | Positive opinion (Jul 2025)
Givinostat (Duvyzat) | Positive opinion (Apr 2025)
Inavolisib (Itovebi) | Positive opinion (May 2025)
L-Acetylleucine (Aqneu | Positive opinion (Jul 2025)
Nirogacestat (Ogsiveo) | Positive opinion (Jun 2025)
Clascoterone (Winlevi) | Positive after re-examination (Aug 2025)
Deutetrabenazine | Positive opinion (Jun 2025)
Drug (brand) CHMP outcome (14% CHMP positive - Non-FDA approval Drugs)
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Insulin human (Rechon) | Application withdrawn (Mar 2025)
Troriluzole | Application withdrawn (May 2025)
Atropine sulfate FGK | Negative opinion (May 2025)
Low-dose atropine | Positive opinion (Apr 2025) ? EC approval (Jun 2025)
Teriparatide Ascend | Application withdrawn (May 2025)
Resminostat (Kinselby) | Negative opinion (May 2025)
Pridopidine (Nurzigma) | Negative opinion (Jul 2025)
Recent AVXL News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2026 12:15:26 PM
- Anavex Life Sciences Receives Expected Nasdaq Delinquency Notification • GlobeNewswire Inc. • 05/22/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2026 08:15:25 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/14/2026 08:15:30 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/11/2026 08:30:22 PM
- CEO Transition and Delayed SEC Filing Put Anavex (AVXL) Leadership Changes in Focus • IH Market News • 05/06/2026 02:52:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2026 11:04:59 AM
- Anavex Life Sciences Board of Directors Appoints Former Senior Vice President of Clinical Development Terrie Kellmeyer, PhD, as Interim Chief Executive Officer • GlobeNewswire Inc. • 05/06/2026 11:00:00 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/01/2026 11:18:47 PM
- Anavex Life Sciences Highlights New Scientific Findings on Shared Biology Between Autism and Alzheimer’s Disease • GlobeNewswire Inc. • 04/14/2026 11:30:00 AM
- Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/07/2026 11:30:00 AM
- Anavex withdraws EU approval filing for Alzheimer’s therapy • IH Market News • 03/30/2026 12:39:26 PM
- Anavex Life Sciences Provides Comprehensive Regulatory Update • GlobeNewswire Inc. • 03/30/2026 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 08:06:00 PM
- Anavex withdraws EU marketing application for Alzheimer’s therapy blarcamesine • IH Market News • 03/25/2026 02:06:58 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/25/2026 11:30:00 AM
- Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral Blarcamesine and Preservation of Brain Volume in Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/23/2026 11:30:00 AM
- New Scientific Findings Highlight Hypothesis of Autophagy Failure as a Precursor of Amyloid Beta and Tau Pathology in Alzheimer’s Disease • GlobeNewswire Inc. • 03/20/2026 11:30:00 AM
- Anavex Life Sciences Presents Significant Treatment Effects of Blarcamesine in New Advanced Alpha-Synuclein Model of Parkinson’s Disease at AD/PD 2026 Conference • GlobeNewswire Inc. • 03/17/2026 11:30:00 AM
- Anavex Life Sciences to Present at the Citizens Life Sciences Conference • GlobeNewswire Inc. • 03/03/2026 12:30:00 PM
- Anavex Life Sciences to Present at the 46th TD Cowen Annual Health Care Conference • GlobeNewswire Inc. • 02/25/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 11:07:01 AM
- Anavex Life Sciences Appoints Seasoned Healthcare Leader to Board of Directors • GlobeNewswire Inc. • 02/23/2026 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/09/2026 09:40:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2026 12:31:17 PM
