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dimerix600
October 18th, 2022

Dimerix – Recruitment Accelerating in Phase III Study

Dimerix (DXB: $0.165) has reached around 40% recruitment into the first part of its Phase III focal segmental glomerulosclerosis (FSGS) study (as of mid September). The global study is seeking to recruit 286 patients for final analysis across 70 sites. The interim readout will be on 72 patients measuring proteinurea after 35 weeks of treatment.

Antisense
October 18th, 2022

Antisense Therapeutics Revises Clinical Program in DMD

With a deterioration in capital markets, Antisense Therapeutics (ANP: $0.86) has adjusted its clinical program in Duchenne's Muscular Dystrophy with its lead drug candidate ATL1102. The company had previously intended to conduct a potentially pivotal Phase IIb/III study in 114 patients. That has now been changed to a Phase IIb program that will seek to enroll 45 subjects.

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October 5th, 2022

Pharmaxis - Encouraging Early Data from Scar Removal Study

Pharmaxis (PXS: $0.081) has released some data on the first eight patients treated with its drug candidate, PXS-6302, to remove existing scars. The first eight patients were all treated with PXS-6302 whilst the next 42 being recruited are blinded between placebo or active arms.

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October 5th, 2022

Anteris Technologies - Aortic Valve Outperforms Surgical and TAVR Competitors

Aortic heart valve company Anteris Technologies (AVR: $23.10) had multiple presentations at the major US conference TCT (Transcatheter Cardiovascular Therapeutics) held in Boston last month. The event has around 11,000 specialists in the field attending and was founded by Dr Martin Leon, who has joined the Anteris Medical Advisory Board earlier this year.

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October 5th, 2022

Eisai Delivers Positive Phase III Alzheimer's Data

Cogstate's (CGS: $2.09) partner, Eisai Co Ltd, has for the first time in this disease area, delivered unequivocally positive data for its Alzheimer's disease treatment, lecanamab.

Eisai will now seek to file the therapy for full approval with the FDA by the end of March. Eisai will use Cogstate's electronic cognitive test battery to help identify potential patients for treatment, under a US$45 million deal signed in 2020 between the two companies.

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September 19th, 2022

Pharmaxis: Can PXS-6302 'Un-scar the Scar'?

Pharmaxis (PXS: $0.084) is using its lysyl oxidase platform to develop a topical application for the removal of scars. Results are due around year's end and may be a driver for this stock over coming months.

ResApp
September 19th, 2022

ResApp Health Sold to Pfizer for $180 Million

ResApp Heath has been acquired by Pfizer at a fully diluted value of $180 million, or $0.208 per share. The company was acquired via a Scheme of Arrangement with an 82% approval based on total shares voted (75% required) and 62% of shareholders voting in favour (50% required). The Scheme was approved by the Supreme Court of NSW last week.

ResApp Diagnostics made a backdoor listing onto the ASX in 2015 through an acquisition by Narhex Life Sciences and being renamed ResApp Health. At the end of December last year the company had accumulated losses of $40.4 million with $3.4 million in cash.

Pharmaxis
September 19th, 2022

Pharmaxis: Can PXS-6302 'Un-scar the Scar'?

Pharmaxis (PXS: $0.084) is using its lysyl oxidase platform to develop a topical application for the removal of scars. Results are due around year's end and may be a driver for this stock over coming months.

Pharmaxis CEO Gary Phillips said that the company has the first-in-class and best-in-class compounds in this field. According to Phillips at an R&D day earlier this year, the reason why Pharmaxis has extended its R&D programs into scarring is because it's where the science has led the company to.

imugene
September 19th, 2022

Imugene to Raise $80 Million

Imugene (IMU: $0.22) has announced it intends to raise $80 million through a private placement that includes two specialist biotech investment funds with commitments secured. The funds to be raised will support the company's portfolio of immuno-oncology drug development assets. Imugene will have a proforma (June 30) cash balance of $175 million.

Cogstate
September 19th, 2022

Cogstate - Investors Await Lecanemab Phase III Data

Cogstate (CGS: $1.46) has seen its share price oscillate in recent weeks, in sync with the share prices of Eisai Co and Biogen. All three companies will be impacted by the results of the Phase III study with the Alzheimer's disease drug candidate, lecanemab, which is jointly owned by Eisai and Biogen and in clinical development by Eisai. Topline results are due at the end of this month.

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September 9th, 2022

Pharmaxis Repurposes PXS-4728 for Parkinson's Disease

Since Boehringer Ingelheim returned the Pharmaxis (PXS: $0.076) drug candidate PXS-4728 in 2020, Pharmaxis has been seeking to find a new indication to trial for the compound, given the level of development work that had been carried out on the compound by Boehringer.

patrys
September 9th, 2022

Patrys Passes Final Manufacturing Tests for PAT-DX1

Patrys' (PAB: $0.024) lead drug antibody drug candidate, PAT-DX1, has passed the final manufacturing assessment meeting all of the specification requirements. This allows Patrys to move into final preclinical toxicology testing ahead of the first clinical study planned for the second half of 2023.

anteris
September 9th, 2022

Anteris Technologies to Present Key Data at TCT this Month

Anteris Technologies (AVR: $21.50) presented at the inaugural E&P Healthcare conference this week.

CEO Wayne Paterson believes that the technical risk for the company's novel aortic valve, the DurAVR 3D, has been significantly diminished, down to only 5%-10% following successful implantation into 13 patients. The remaining risk for the company relates primarily to execution.

Anteris is developing a single piece aortic valve that is implanted via catheter, rather than open-chest surgery.

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September 9th, 2022

Patrys Passes Final Manufacturing Tests for PAT-DX1

Patrys' (PAB: $0.024) lead drug antibody drug candidate, PAT-DX1, has passed the final manufacturing assessment meeting all of the specification requirements. This allows Patrys to move into final preclinical toxicology testing ahead of the first clinical study planned for the second half of 2023.

opthea
August 19th, 2022

Opthea – Novel Funding to Access US$260 Million

Opthea (OPT: $1.25) has gained access of up to US$260 million ($371 million) to reach top-line results of two Phase III trials with its drug candidate OPT-302. The top-line results are now due in mid 2024. The funds will also be used for pre-commercialisation activities.

It's the largest capital raise for the sector (excluding raises conducted by CSL, Cochlear and ResMed), for non-asset purchases.

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August 19th, 2022

Anteris Technologies to Move to Pivotal Study as Positive Results Continue

For the six and 12 months to 30 June this year, medical device company Anteris Technologies (AVR: $24.60) has been the best performing stock, with a share price gain of 122% over the last six months and 310% over the financial year.

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August 5th, 2022

Pharmaxis Sells Orbital Technology for US$5 Million

Pharmaxis (PXS: $0.077) has executed a deal for the license and sale of its Orbital drug inhalation device with Aptar Pharma for US$5 million.

neuren
August 5th, 2022

Neuren Pharmaceuticals - Partner Files Trofinetide for US Approval

Neuren Pharmaceuticals (NEU: $5.45) has some very clear objectives set for the next 17 months. The most significant of these is gaining US approval of its lead drug candidate, trofinetide, which is being commercialised in North America under license from Neuren by Acadia Pharmaceuticals for the treatment of Rett syndrome in children and adults.

Acadia filed trofinetide for approval last month. The next stage is notice from the FDA that the application is in order and has been accepted (in September), which will trigger a US$10 million payment to Neuren from Acadia.

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August 5th, 2022

Imricor - Europe the Key Focus

Imricor Medical Systems (IMR: $0.29) is pioneering MRI-guided cardiac ablation, rather than ablation procedures conducted using x-ray fluoroscopy imaging. It is the only company in the world that sells MRI-compatible consumable devices used for cardiac ablation.

Cardiac ablation is a minimally invasive procedure whereby electrical abnormalities in the heart, which cause abnormal heart rhythms, are corrected by heating or freezing cardiac tissue inside the heart via a catheter. The issue with using x-ray to help guide the procedures is that the heart is almost invisible to x-rays.

vbn
August 5th, 2022

Aroa Biosurgery - Cash Receipts up 162% for Quarter to NZ$13.9 Million

Wound healing products company Aroa Biosurgery (ARX: $0.86) continues to deliver consistent and strong top-line growth. Cash receipts in the June quarter were NZ$13.9 million (up 162% over the PCP). Net cash outflow was NZ$1.3 million from operations and investment in equipment, down from NZ$3.7 million in the PCP and down from NZ$6.5 million in the previous quarter.

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