| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Proposed issue of securities - ACR
|
5 Dec 2024 10:01AM |
$0.045 |
$0.011 |
fallen by
75.56%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Share Placement successfully concluded and SPP launched
|
5 Dec 2024 10:01AM |
$0.045 |
$0.011 |
fallen by
75.56%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux raises $2.65 million through Share Placement.
- A further $2 million to be raised via Share Purchase Plan (SPP).
- Funds aimed at advancing pipeline of topical pharmaceutical products.
- SPP offers eligible shareholders same terms as Placement.
- Directors committed $0.15 million in Placement shares.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
FDA Approval - Nitroglycerin Ointment
|
4 Dec 2024 8:34AM |
$0.045 |
$0.011 |
fallen by
75.56%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux's Nitroglycerin Ointment received FDA approval.
- The product is a generic version of Rectiv® Ointment.
- Indicated for moderate to severe pain from chronic anal fissures.
- Annual market sales for the product exceed USD 23 million.
- This is Acrux's sixth topical ANDA approved by the FDA.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Trading Halt
|
3 Dec 2024 9:08AM |
$0.045 |
$0.011 |
fallen by
75.56%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux Limited requests a trading halt on ordinary shares.
- The trading halt is pending an announcement regarding capital raising.
- The halt will last until December 5, 2024, or until the announcement is made.
- Acrux is not aware of any reasons against the trading halt.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Results of Meeting
|
21 Nov 2024 2:06PM |
$0.045 |
$0.011 |
fallen by
75.56%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
AGM Presentation
|
21 Nov 2024 8:30AM |
$0.045 |
$0.011 |
fallen by
75.56%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux is focused on developing topically applied pharmaceutical products.
- The company launched Dapsone 5% Gel in April 2024.
- Nitroglycerin 0.4% Rectal Ointment was submitted for FDA review.
- Acrux has a portfolio of 16 products, three of which are generating revenue.
- The company divested its Testosterone Topical Solution product due to declining market value.
- Revenue growth is anticipated following the launch of additional products.
- Acrux has a strong track record with five products approved since 2021.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Quarterly Activities/Appendix 4C Cash Flow Report
|
31 Oct 2024 8:29AM |
$0.053 |
$0.011 |
fallen by
79.25%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- FDA approved Dapsone 7.5% Gel in August 2024.
- Launch target date for Dapsone 7.5% Gel is early 2025.
- Dapsone 5% Gel was launched in April 2024.
- Received $2.728 million from the Australian Tax Office for FY24 R&D Tax Incentive.
- Net cash outflows from operating activities totaled $2.234 million for the quarter.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Notice of Annual General Meeting/Proxy Form
|
15 Oct 2024 9:51AM |
$0.058 |
$0.011 |
fallen by
81.03%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
FY24 R&D Tax Incentive rebate received
|
2 Oct 2024 8:53AM |
$0.053 |
$0.011 |
fallen by
79.25%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux Limited received its FY24 R&D Tax Incentive rebate
- Rebate amount received was $2,728,021
- ATO advised that Acrux's application for a new Overseas Finding was successful
- Additional FY24 and future overseas expenditure on this project will be eligible for RDTI
- Acrux repaid the short term funding facility provided by Radium Capital
- RDTI is a program that offers cash rebates for eligible R&D expenditure
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
ASX Small and Mid Cap Conference presentation
|
24 Sep 2024 8:24AM |
$0.053 |
$0.011 |
fallen by
79.25%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux is a leader in developing topically applied prescription pharmaceutical products.
- Founded in 1998, Acrux has a 25+ year track record with US NDA, US ANDA, and EMA product approvals.
- Acrux has a network of Contract Development and Manufacturing Organisations (CDMO) for development and commercial manufacturing.
- The company has a strong pipeline of products under development, with Dapsone 5% Gel launched in April 2024 and Prilocaine 2.5% Lidocaine 2.5% Cream launched in December 2022.
- Acrux focuses on topically applied pharmaceutical products, targeting a significant range of topically applied pharmaceuticals.
- Acrux has 7 ANDA products submitted to the FDA for review, with 5 approved to date.
- Acrux receives royalties on a quarterly basis and expects typical license agreements to consist of a recurring profit share stream.
- The company has a diversified portfolio, with 2 products recently launched in the United States and 2 more launches planned.
- Acrux's objective is to develop a diversified, on-market portfolio of products generating a sustainable revenue stream.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Investor Webinar Information - FY24 Results
|
29 Aug 2024 10:03AM |
$0.060 |
$0.011 |
fallen by
81.67%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
FY24 Full Year Results - Investor Presentation
|
29 Aug 2024 10:02AM |
$0.060 |
$0.011 |
fallen by
81.67%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux is a leader in the development of topically applied prescription pharmaceutical products.
- The company has a 25+ year track record with US NDA, US ANDA, and EMA product approvals.
- Acrux has a network of CDMO for development, scale-up, and commercial manufacturing.
- The company has commercial licensees in over 40 countries.
- Acrux focuses on an underserved market segment in the United States.
- As of the presentation, Acrux has 7 topical prescription products under development.
- Dapsone 5% Gel and Prilocaine/Lidocaine Cream were recently launched in the United States.
- Acrux aims to develop a diversified, on-market portfolio of products generating sustainable revenue streams.
- The company has expertise in regulatory submissions and commercial product launches.
- FDA approval of 5 products since 2021 with 2 recent launches in the United States.
- Market size for topically applied drugs in the US is approximately $16bn.
- Acrux has a TGA approved GMP facility and specialized scientists for development and regulatory submission.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Appendix 4G and Corporate Governance Statement FY24
|
29 Aug 2024 10:00AM |
$0.060 |
$0.011 |
fallen by
81.67%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Appendix 4E and FY24 Full Year Statutory Accounts
|
29 Aug 2024 9:59AM |
$0.060 |
$0.011 |
fallen by
81.67%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux reported a 32% decline in total revenue to $8,098,000.
- Net loss for the period attributable to members increased by 92% to ($5,800,000).
- No dividends were declared or paid for the year ending June 30, 2024.
- Nitroglycerin 0.4% Ointment ANDA was accepted by the FDA for review.
- Dapsone 5% Gel was launched in the US in April 2024.
- Dapsone 7.5% Gel was approved by the FDA in August 2024, planned for FY25 launch.
- Testosterone Topical Solution ANDA was divested.
- Acrux received $2.869 million for FY23 R&D Tax Incentive and $1.487 million for FY24
- Cash and cash equivalents on hand at year end totaled $2.945 million, down $3.287 million from prior year.
- Acrux's product pipeline consists of 15 products at various stages of development and commercialization.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
FDA Approval received for Dapsone Gel, 7.5%
|
27 Aug 2024 9:27AM |
$0.060 |
$0.011 |
fallen by
81.67%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux Limited received FDA approval for Dapsone Gel, 7.5%
- Dapsone Gel, 7.5% is a generic version of Aczone® Gel, 7.5%
- The product is indicated for the treatment of acne vulgaris in patients 9 years and older
- The annual addressable market for Dapsone Gel, 7.5% exceeds USD$37.4 million
- This approval is Acrux’s fifth approved ANDA for a topical product
- The development included bioequivalence data demonstrated through in vitro techniques
- Acrux aims to manufacture and market this product in the United States
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Quarterly Activities Report and Appendix 4C - June 2024
|
26 Jul 2024 8:57AM |
$0.069 |
$0.011 |
fallen by
84.06%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux launched Dapsone Gel, 5% in April 2024 for acne vulgaris.
- Three ANDAs are under FDA review.
- Secured $1.487 million from Radium Capital for R&D Tax Incentive.
- Positive cashflow reported in four of the past eight quarters.
- Financial performance includes significant expenditures on API purchases and R&D.
- FDA approvals and new product launches are expected to drive future revenue growth.
- Fifteen products are in Acrux's development portfolio.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Acrux presentation to Bioshares, 18th Biotech Summit
|
15 Jul 2024 8:59AM |
$0.065 |
$0.011 |
fallen by
83.08%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux is a specialty pharma company developing topically applied products.
- Presentation at the 18th Bioshares Biotech Summit on July 13, 2024.
- Acrux has over 25 years of experience and multiple product approvals.
- The company focuses on the U.S. market with TGA approved GMP facilities.
- Acrux’s core business model includes identification, development, regulatory submission, and commercial launch of drugs.
- Recently launched Dapsone 5% Gel and Prilocaine/Lidocaine Cream in the U.S.
- Seven new topical prescription products are under FDA review.
- Acrux advocates for commercial partnering and product development opportunities.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
RDTI funding facility secured
|
28 Jun 2024 9:28AM |
$0.071 |
$0.011 |
fallen by
84.51%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux Limited has secured an RDTI funding facility with Radium Capital.
- The facility allows Acrux to receive advance payments based on expected R&D tax incentives.
- Improved cash flow will support Acrux's ongoing research and development projects.
- The funding is part of Acrux’s broader strategy to support its pharmaceutical development pipeline.
- The company is focused on innovation and growth through strengthened financial support.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Acrux presentation at Hidden Gems in Lifesciences Forum
|
13 Jun 2024 9:36AM |
$0.083 |
$0.011 |
fallen by
86.75%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux Limited (ASX: ACR) is an Australian pharmaceutical company focused on developing and commercializing topical and transdermal pharmaceuticals.
- The company has a portfolio of approved and pipeline products, primarily targeting the US and global markets.
- Acrux's business model includes both the development of generic and specialty products, with a focus on 505(b)(2) regulatory pathway submissions.
- Key achievements include successful US FDA approvals and launches, with products such as Testosterone Topical Solution, Estradiol Topical Solution, and others.
- Acrux benefits from partnerships and licensing agreements with established pharmaceutical companies to commercialize its products globally.
- The company has a robust development pipeline with multiple ANDAs (Abbreviated New Drug Applications) and 505(b)(2) submissions in progress.
- Revenue growth has been driven by product launches and increased market share in the US.
- Acrux leverages its formulation expertise and intellectual property portfolio to differentiate itself in the competitive pharmaceutical market.
- The company's strategy includes expanding its US presence, further diversifying its portfolio, and entering new geographic markets.
- Management is confident in the company's future prospects and is focused on delivering long-term value to shareholders.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Quarterly Activities and Appendix 4C, reissued
|
30 Apr 2024 11:08AM |
$0.070 |
$0.011 |
fallen by
84.29%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Quarterly Activities/Appendix 4C Cash Flow Report
|
30 Apr 2024 9:48AM |
$0.061 |
$0.011 |
fallen by
81.97%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux Limited is focused on the development and commercialisation of specialty and generic topical pharmaceuticals.
- During the quarter, Acrux submitted an Abbreviated New Drug Application (ANDA) to the US FDA for a generic version of Axiron®, a testosterone topical solution.
- The company continues to progress multiple topical generic products through development and regulatory review.
- Acrux's commercial partners are responsible for the sale and distribution of approved products in various markets.
- The company has ongoing collaborations and licensing agreements with pharmaceutical companies to market its licensed products.
- Cash receipts from customers during the quarter amounted to A$2.2 million, with a closing cash balance of A$11.0 million.
- No significant expenditure was reported on research and development for the quarter.
- Payments to related parties and their associates totalled A$135,000, comprising directors' fees and salaries.
- Acrux continues to maintain a strong financial position to support ongoing product development and regulatory activities.
- The Appendix 4C cash flow report forms part of the quarterly activities update as required by ASX listing rules.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Launch of Dapsone 5%, Gel in the United States
|
3 Apr 2024 8:34AM |
$0.047 |
$0.011 |
fallen by
76.60%
|
|
ACR - Price-sensitive ASX Announcement
Full Release
Key Points
- Acrux Limited announced the launch of Dapsone 5% Gel in the United States.
- Dapsone 5% Gel is the first generic version of Aczone® Gel 5%.
- The product was launched by Acrux’s partner, Perrigo Company plc.
- Dapsone 5% Gel is indicated for the topical treatment of acne vulgaris.
- Acrux developed the product and submitted the ANDA (Abbreviated New Drug Application) to the FDA.
- FDA approval was granted for the ANDA, enabling the product’s U.S. launch.
- Acrux is entitled to receive milestone payments and royalties based on sales.
- The partnership demonstrates Acrux’s capability in developing and commercializing topical generic drugs for the U.S. market.
- The launch of Dapsone 5% Gel expands Acrux’s presence in the North American dermatology market.
- Acrux continues to work on other pipeline products in partnership with Perrigo and other collaborators.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Appendix 3Y Dobinson
|
5 Mar 2024 3:12PM |
$0.053 |
$0.011 |
fallen by
79.25%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Appendix 3Y Brumley
|
5 Mar 2024 3:11PM |
$0.053 |
$0.011 |
fallen by
79.25%
|
|
| Acrux Limited (ACR) ORDINARY FULLY PAID |
Health Care |
$5 |
Application for quotation of securities - ACR
|
5 Mar 2024 3:09PM |
$0.053 |
$0.011 |
fallen by
79.25%
|
|
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