reports
- Sean Conroy
Actinogen Medical - A$11.1m capital raise completed
Actinogen Medical announced the successful completion of its A$3.0m share purchase plan (SPP), which closed 1.3x oversubscribed. With its previously disclosed A$8.1m share placement, total funds from the combined capital raising reached the targeted A$11.1m in gross proceeds. The company expects that the total proceeds will enable its operating runway to reach the release of top-line results for its XanaMIA Phase IIb/III trial in patients with mild-to-moderate Alzheimer’s disease (AD), expected ...
- Sean Conroy
Actinogen Medical - Funding in place to complete XanaMIA Phase IIb
Actinogen Medical announced a capital increase of up to A$11.1m on 18 September, consisting of the successful completion of an A$8.1m (gross) share placement to existing shareholders and new institutional investors, along with a A$3.0m shareholder purchase plan (SPP) offer to existing shareholders at the same financial terms as the placement. The company expects that the proceeds (assuming full exercise of the SPP) will extend its operating runway to the completion of top-line results for its Xa...
- Sean Conroy
Actinogen Medical - Further positive XanaCIDD results on depression
New data were revealed from Actinogen Medical’s ongoing analysis of the now-completed XanaCIDD study that support the view that the company’s lead drug candidate, Xanamem, may provide consistent and durable benefits in treating depression symptoms compared to placebo. The XanaCIDD study was designed to assess a 10mg daily dose of Xanamem versus placebo in patients with major depressive disorder (MDD) over a six-week treatment period. In line with the top-line results reported on 12 August, the n...
- Sean Conroy
Actinogen Medical - XanaCIDD data narrow the focus in depression
While the results from Actinogen’s XanaCIDD exploratory Phase IIa study in patients with major depressive disorder (MDD) did not meet the primary endpoint in terms of improving cognitive impairment (CI) symptoms, they did show signs of efficacy in terms of treating depression symptoms. Notably, a statistically significant improvement was reported at four weeks after the six-week treatment period. The company’s strategy in MDD will now focus on treating depression symptoms and Actinogen will inve...
- Sean Conroy
Actinogen Medical - Publication of XanADu biomarker analysis
Actinogen Medical announced that the prespecified biomarker subset analyses on stored plasma samples (n=72) from its previous Phase IIa XanADu study (n=185) in patients with mild Alzheimer’s disease (AD) has been published in the peer-reviewed Journal of Alzheimer’s Disease (JAD). As reported in Q422, patients with elevated baseline phosphorylated Tau-181 (pTau-181) protein (at least 6.74pg/mL), representing 34 patients (16 on Xanamem 10mg daily, 18 on placebo), showed a 0.6 mean difference (eff...
- Sean Conroy
Actinogen Medical - Funding in place through key catalysts
Actinogen announced a capital increase of up to A$8.9m on 3 May, consisting of a A$5.0m (gross) placement along with a shareholder rights offering (‘entitlement offer’) designed to raise up to A$3.9m (gross) from existing shareholders. The closing date of the rights offer is 29 May and, given that Actinogen shares are currently trading at c A$0.028, we assume full exercise of the rights offering in Q424 (Q2 CY24). The company expects that the proceeds (assuming full exercise of the rights offeri...
- Sean Conroy
Actinogen Medical - First patient dosed in Phase IIb XanaMIA study
Actinogen Medical announced that the first randomised patient in its Phase IIb XanaMIA trial of lead candidate Xanamem received their first treatment on Friday 12 April. This study is designed to enrol c 220 patients with cognitive impairment (CI) associated with biomarker-positive mild-to-moderate Alzheimer’s disease (AD), as confirmed through an elevated level of phosphorylated Tau-181 (pTau-181) protein in their blood at baseline. The study has commenced at 13 Australian sites and will concen...
- Sean Conroy
Actinogen Medical - Pressing forward with Xanamem
Having shown cognitive activity in prior trials, Actinogen began its XanaMIA Phase IIb study of lead candidate Xanamem in patients with cognitive impairment (CI) associated with mild-to-moderate Alzheimer’s disease (AD). The study will assess c 220 biomarker-positive AD patients, with interim results expected in H1 CY25. Actinogen recently reported results from a human positron emission tomography (PET) imaging study, which affirm the drug’s mechanism of action (MoA) in healthy subjects and pati...
- Sean Conroy
Actinogen Medical - Phase IIb XanaMIA study opens first study site
Actinogen Medical has opened the first investigational study site for its Phase IIb XanaMIA trial of lead candidate Xanamem in patients with cognitive impairment (CI) associated with mild-to-moderate Alzheimer’s disease (AD). The study plans to enrol c 220 patients, who will be randomised to take Xanamem 10mg or placebo once daily for 36 weeks. The trial will concentrate on Australian test sites for the first 100 enrolled patients, and initial efficacy and safety results will be analysed when th...
- Sean Conroy
Actinogen Medical - Taking steps to mitigate funding headwinds
Actinogen is refining the design of its XanaMIA Phase IIb study of lead candidate Xanamem in patients with cognitive impairment (CI) associated with mild-to-moderate Alzheimer’s disease (AD). The study will forego the 5mg dose group and will concentrate on the 10mg dose, which has already shown effectiveness in the subgroup analysis of XanADu as reported in Q422. The XanaMIA Phase IIb study will continue to assess c 110 AD patients in the 10mg dose cohort, as well as a placebo arm, and will conc...
- Sean Conroy
Actinogen Medical - Funding the next stage of Xanamem development
Actinogen recently provided a Q423 quarterly update summarising that its two development programmes for lead candidate Xanamem remain on track, with the Phase IIb XanaMIA study portion assessing the drug in lead indication Alzheimer’s disease (AD) still scheduled to start in H2 CY23, with results still expected in H2 CY25. For the company’s XanaCIDD study in patients with cognitive impairment (CI) associated with major depressive disorder (MDD), enrolment is approaching 25% and the company conti...
- Sean Conroy
Actinogen Medical - Refining the upcoming XanaMIA Phase IIb study
Actinogen intends to start patient enrolment and dosing in H2 CY23 in the Phase IIb XanaMIA study portion assessing Xanamem in lead indication Alzheimer’s disease (AD). The company expects to receive FDA approval in the coming weeks on amendments to the study design protocol and the new Xanamem tablet formulation to be used (replacing the capsule used in prior Xanamem trials). It expects to report top-line efficacy data in H2 CY25, with interim readouts projected in or around late CY24 or early ...
- Sean Conroy
Actinogen Medical - Continued focus on Xanamem
Actinogen’s Q323 update reiterated the company’s focus on advancing its lead asset Xanamem. Patient recruitment in the Phase IIa XanaCIDD study in cognitive impairment (CI) associated with major depressive disorder (MDD) is ongoing, and the company plans to start the Phase IIb portion of the XanaMIA study in Q2 CY23 in the company’s lead indication, Alzheimer’s disease (AD). This study portion is designed to assess Xanamem in a population of patients with mild CI and/or mild AD, who at baseline ...
- Sean Conroy
Actinogen Medical - Getting ready for the next Alzheimer’s study
Actinogen is on track to start US recruitment in Q2 CY23 for the six-month, placebo-controlled Phase IIb portion of the XanaMIA study. The study portion is designed to assess Xanamem in a population of patients with mild cognitive impairment (CI) and/or mild Alzheimer’s disease (AD), who at baseline will have been confirmed as biomarker-positive for progressive AD. We believe market participants will be keen to observe whether this study portion will confirm the positive efficacy findings shown ...
- Sean Conroy
Actinogen Medical - On track to start Phase IIb XanaMIA study
Actinogen’s recent quarterly update confirmed that the company remains on track to start US recruitment in H1 CY23 for its six-month, placebo-controlled Phase IIb portion of the XanaMIA study. The study is designed to assess the safety and efficacy of Xanamem in a population of patients with mild cognitive impairment (CI) and mild Alzheimer’s disease (AD), who at baseline will have been confirmed as biomarker-positive for AD (as determined through elevated blood phosphorylated Tau, or pTau). The...
- Sean Conroy
Actinogen Medical - XanaMIA clears hurdle to start US recruitment
Actinogen has announced that the US FDA has provided the required approvals for it to proceed with US recruitment for its planned six-month, placebo-controlled Phase IIb portion of the XanaMIA study. This study is designed to demonstrate the safety and efficacy of Xanamem in a population of patients with mild cognitive impairment and mild Alzheimer’s disease (AD), who at baseline will have been confirmed as biomarker-positive for AD (as determined through elevated blood phosphorylated Tau, or pT...
- Sean Conroy
Actinogen Medical - XanaCIDD study in MDD now underway
Actinogen announced that the first patient was randomised and treated in its XanaCIDD Phase II study in major depressive disorder (MDD) assessing the effects of lead candidate Xanamem on cognitive performance and depression. The study aims to enrol about 160 patients who have persistent depressive symptoms and cognitive impairment (CI) despite taking standard-of-care (SoC) anti-depression therapy. Having demonstrated the ability to improve cognition in two trials (XanaHES and the Phase Ib portio...
Actinogen Medical (AGW): re-initation — Cognitive enhancer targeting k...
Edison Investment Research Limited Actinogen Medical (AGW): re-initation — Cognitive enhancer targeting key diseases 20-Oct-2022 / 21:00 GMT/BST London, UK, 20 October 2022 Actinogen Medical (AGW): re-initation — Cognitive enhancer targeting key diseases Actinogen Medical is developing its lead asset, small molecule Xanamem, a selective 11β-HSD1 inhibitor designed to cross the blood-brain barrier and target excess brain cortisol, which has been associated with cognitive impairment (CI). Actinogen is targeting two CI indications: for patients with mild CI in the early stages ...
- Sean Conroy
Actinogen Medical - Cognitive enhancer targeting key diseases
Actinogen Medical is developing its lead asset, small molecule Xanamem, a selective 11β-HSD1 inhibitor designed to cross the blood-brain barrier and target excess brain cortisol, which has been associated with cognitive impairment (CI). Actinogen is targeting two CI indications: for patients with mild CI (MCI) in the early stages of Alzheimer’s disease (AD), and for patients with major depressive disorder (MDD). Positive XanaHES and Phase Ib XanaMIA results in healthy adults demonstrate the drug...
Actinogen Limited: 1 director bought
A director at Actinogen Limited bought 2,550,000 shares at 0.028AUD and the significance rating of the trade was 70/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years c...
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