Company
Swala Resources
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Emyria raises $3 million in well-supported placement
There was strong demand for the placement, including follow-on investment from Tattarang’s Tenmile Ventures and Sixty-Two Capital.
Orthocell secures inclusion for Remplir™ on the prostheses list
“Inclusion of Remplir on the Prostheses List is the culmination of translational research and a regulatory program to bring this product to the Australian market,” said MD Orthocell
Emyria raises $3 million to progress cannabinoid registration and MDMA-analogue development
“We look forward to advancing our clinical programs focused on neuroscience and mental health levering our unique Ultra-Pure cannabinoid formulations, Real-World Data and our substantial drug discovery pipeline inspired by MDMA,” said MD Dr
Emyria and UWA ship 14 new MDMA analogues for screening, total raised to 140-plus proprietary compounds
The company has shipped more MDMA analogues for safety screening, bringing its library to more than 140 novel compounds. EMD has also sent a selection of priority compounds to PsychoGenics in the US to begin advanced preclinical screening,
Orthocell data demonstrates OrthoATI rotator cuff treatment more effective than steroid injections
“I was so fortunate to be involved in this study, and I wish that more people would be able to take advantage of the treatment. It truly has been life-changing for me,” said powerlifting champion Paul Speering.
Orthocell secures first purchase orders for Striate+ and Remplir under new distribution deals
“We are delighted to be working with our Striate+ and Remplir distribution partners to grow adoption and establish our products as best-in-class medical devices,” said Orthocell MD Paul Anderson.
Emyria expands clinical sites for EMD-RX5 Phase 3 trial
Qualified sites are formally approved to participate in core trial activities such as patient recruitment, treatment dosing and clinical assessments.
Emyria begins US-based preclinical program with leading neuroscience drug discovery research organisation
“Given the increasing research and investment into novel neurological drugs and psychedelic-assisted therapies, we are excited to accelerate the identification of promising neuropsychiatric drugs and next-generation psychedelic-assisted the
Orthocell appoints exclusive Australian distributor for Remplir™ nerve repair device
The company is now well-positioned to gain commercial traction with this product in Australia and to expand into the US, the largest global healthcare market in the world.
Emyria fields positive screening results for third batch from MDMA-inspired drug discovery program
“These latest positive screening results will help guide the creation of the next batch of novel MDMA-inspired compounds for our drug discovery portfolio," MD Dr Michael Winlo said.
Emyria wins ethics approval to begin EMD-RX5 Phase 3 trial for treatment of psychological distress
The successful completion of the trial will support EMD-RX5’s registration with the Therapeutic Goods Administration (TGA) as a schedule 3, over-the-counter treatment (OTC) for the symptoms of psychological distress, for which there is curr
Emyria initiates pre-clinical studies for MDMA-inspired analogues
“Fibrotic diseases represent a major group of unmet medical needs and our early screening results indicate some analogues may have potent antifibrotic activity,” said managing director Dr Michael Winlo.
Orthocell strengthens cash position with A$21.46 million from agreement with BioHorizons for Striate+™
Striate+™ is a market-leading resorbable collagen membrane used in guided bone and tissue regeneration procedures.
Emyria expands MDMA-related drug candidate library with addition of 19 new compounds
“Emyria’s preclinical drug discovery program, inspired by MDMA, is making great progress. We are strengthening Emyria’s intellectual property portfolio and potential slate of proprietary drug candidates targeting major unmet needs,” MD Dr M
Orthocell soars on securing exclusive A$23.1 million global licence and manufacturing agreement with BioHorizons
“The agreements with BioHorizons represent a significant milestone for Orthocell and provide further external commercial and technical validation of the CelGro™ collagen scaffold platform, from which the Striate+ dental products were develo
Orthocell makes progress with portfolio of CelGro® products within the bone tendon and nerve space
The company is well-positioned to establish its CelGro® product as the best-in-class membrane for bone and soft tissue repair and to realise multiple commercial partnering opportunities.
Emyria advances CBD and MDMA-inspired treatments
The company’s current drug registration programs span its EMD-003 CBD medicine targeting mental health, EMD-004 for IBS and EMDMA-001 MDMA psychedelic-assisted therapy program targeting sufferers of treatment-resistant PTSD.
Orthocell welcomes final "life-altering" data for nerve reconstruction study
“The treatment I received to repair my nerve damage has been completely life-altering. I had lost full function of my hand, making the simplest of tasks impossible – from tying my own shoelaces to changing my baby’s nappy,” says trial parti
Orthocell receives $2.2 million R&D grant for scale up and development
MD Paul Anderson says the receipt of the R&D tax incentive refund will further strengthen the company's capital position and support the scale up of key assets, delivering significant shareholder value.
Emyria and University of Western Australia expand MDMA analogue collaboration
“Emyria's clinical development expertise, funding and international networks have taken our MDMA analogue research to the next level,” says UWA Professor Matt Piggott.
Emyria's cannabinoid candidate EMD-RX5 demonstrates excellent safety and bioavailability in Phase 1 study
“These pharmacokinetic data show Emyria has rapidly developed a unique, ultra-pure cannabidiol capsule with excellent safety and tolerability and highly favourable drug delivery and absorption characteristics," says MD Dr Michael Winlo.
Emyria’s latest MDMA analogue findings bring it one step closer to preclinical programs
Last year, Emyria recently secured exclusive rights to a library of more than 100 novel MDMA analogues (and counting) from the University of Western Australia, creating a unique drug-discovery pipeline.
Medical cannabis and health companies continue momentum in March quarter
State governments passed legislation which permits medicinal cannabis to be prescribed to certain patient groups or under certain circumstances and thus it is medical use that most Australian listed cannabis companies are focusing on, as th
Emyria to complete dosing phase in ultra-pure CBD capsule trial
Emyria believes EMD-RX5 has the potential to address multiple clinical indications as a registered medicine where low doses of CBD appear to be effective.
Emyria signs on Clinitrials to lead multi-site phase three trial for cannabis medicine EMD-RX5
EMD-RX5 is initially designed as an over-the-counter (Schedule 3) treatment that treats psychological distress, which affects 15% of adults, and for which there is currently no over-the-counter treatments.
Emyria kicks off participant dosing in Phase 1 trial of CBD capsule for mental health
The asset, EMD-RX5, is Emyria’s first solid, oral dose form of ultra-pure CBD. It will target psychological distress, for which there is currently no over-the-counter remedy.
Orthocell surges on receiving Australian regulatory approval for Remplir™ nerve repair device
“Remplir™ is the first of its kind biological scaffold designed by an Australian team of researchers to mimic the outer layer of the peripheral nerve and facilitate high-quality nerve repair. Remplir™ is the only Australian manufactured med
Emyria launches second highly bioavailable, ultra-pure CBD capsule EMD-RX7
“Now, with EMD-RX7, we have a convenient dose form that we believe can deliver higher CBD exposures more efficiently allowing us to target a range of prescription-only indications - in other words, help the broad range of major unmet needs
ASX bucks the trend to finish higher as energy companies weigh in on rising prices
Woodside has weighed in with chief executive Meg O'Neill saying, "We've seen gas prices that have spiked at levels that are even more unprecedented than the oil prices, so the Asian price marker hit $US82 per million British thermal units.
Emyria begins recruiting for EMD-RX5 Phase 1 clinical safety and bioavailability study
“Emyria’s first registration program is aimed at developing an over-the-counter, Schedule 3 treatment targeting the symptoms of psychological distress – a growing global mental health concern affecting about 15% of all adults in Australia a
Emyria receives ethics approval for phase one study of CBD medication EMD-RX5
Emyria’s Phase 1 clinical trial will directly compare the bioavailability of EMD-RX5’s proprietary formulation to the only successfully registered and reimbursed CBD oil in the global market to date, Epidyolex,” says MD.
Orthocell sees “exciting year ahead” as it hits US key opinion leader sales growth milestone of 1,500 Striate+™
It has also received approvals to upgrade its existing facility and scale-up Striate+™ manufacturing capacity to more than 100,000 units per year.
Orthocell delivers busy half-year, advancing development and commercialisation of key pipeline products
The company is focused on regenerating mobility for patients by developing innovative products for the repair of a variety of bone and soft tissue injuries.
Emyria grows novel MDMA-analogue library with University of Western Australia partnership
“We are currently working with Professor Iain McGregor, an expert in characterising the effects of novel psychoactive substances, as well as A/Prof Matt Piggott and Prof Mat Martin-Iverson, to select animal screening and evaluation programs
Orthocell’s December quarter highlights the progress it is making in regenerating mobility
“This is exciting research that opens up potential for novel treatments addressing significant unmet medical needs and we will explore these development options alongside our nerve repair applications."
Emyria readies for phase one CBD capsule trials in Q1, 2022
“Following our recent successful animal studies — comparing our formulation to Epidyolex — we also believe EMD-RX5 has the potential to become a registered treatment for multiple indications,” says MD.
Emyria enhances growth strategy with appointment of Sixty Two Capital as corporate advisor
“Sixty Two Capital has a track record of supporting high growth client companies over the long-term,” says MD.
Emyria and Cydelic agree to develop a biometric monitoring platform for psychedelic-assisted therapy programs
“Psychedelic-assisted therapy is showing tremendous promise for patients suffering the most debilitating mental health challenges," managing director Dr Michael Winlo said.
Orthocell’s SmrtGraft™ tendon repair treatment flexes its muscles in new shoulder study
Ultimately, the new data supports the breadth of Orthocell’s cornerstone CelGro™ platform, with positive results recorded across nerve, tendon and bone repair studies.
Emyria’s ultra-pure CBD capsule outperforms TGA-approved CBD treatment in pre-clinical animal trial
“These animal study results suggest Emyria has developed a novel, high performing and cost-effective CBD capsule that can meet the strict registration requirements for product quality and purity with both the TGA in Australia and the FDA in
Orthocell releases clinical data confirming OrthoATI™ efficacy in treating chronic shoulder tendon injuries, shares up
The orthopaedic cell therapy company is in its strongest position yet to launch into the lucrative US market, worth an estimated US$4-5 billion.
Emyria receives positive results for first batch of MDMA-analogues screened for neuroreceptor activity
In addition, the first patent family has been filed, supported by the initial screening data, with further IP generation underway.
ASX recovers some losses as travel stocks crash
The UN’s tourism body has said the tourism sector’s recovery would be “fragile” and “slow”, but the pandemic would cost the global tourism sector $US2 trillion in lost revenue in 2021.
Emyria’s new board appointee puts it one step closer to FDA registration
“Emyria is uniquely placed to accelerate treatment development as one of only a few companies operating a network of clinical services, curating proprietary Real-World Evidence and developing novel treatments,” Dr Karen Smith said.
Mixed movements on the ASX today .. and the small cap risers
"The near-term rise in inflation is accentuated by higher oil prices, rising transport costs and the impact of supply shortfalls," the RBZA says.
Emyria boosts finances with $1.16 million R&D tax incentive refund
The R&D Tax Incentive is an Australian Government program under which eligible companies can receive cash rebates of up to 43.5% of eligible expenditure on R&D activities.
Travel stocks drag ASX down, but could they be in for a revival as international borders re-open?
“We are starting to see more and more Victorians booking a much-deserved international getaway, and as borders open up to international visitors we’re expecting to see them visit Melbourne in large numbers, which will give local tourism and
Emyria receives $5 million from one of Australia’s largest private investment groups
“Tattarang shares our long-term vision to accelerate the development and registration of medicines that can transform the lives of millions of people around the world living with conditions for which current therapies are either ineffective
Orthocell shoulders out the competition with Ortho-ATI® rotator cuff tendon study
“This is an important development milestone for OrthoATI® and the company and I am delighted to have reached this pivotal stage of the study,” says MD.
Emyria passes MDMA analogue development milestone with Eurofins to lead extensive compound screening program
“We are pleased to be working with global leader Eurofins to screen our first batch of novel MDMA-analogues after successfully completing purity and stability testing at UWA,” says MD.
Orthocell is ready to make waves in the regenerative medicine space: Pitt Street Research
Orthocell’s CelGro platform forms the basis of a specialised collagen ‘rope’ that could help reconstruct the anterior cruciate ligament, a strong band of tissue linking the thigh and shin bones that can rupture during athletic activity.
Emyria gains access to world-class data platform under Palantir Foundry Builders Program
The data-backed clinical drug development and care delivery company will leverage the platform to develop its real world evidence asset and accelerate its drug development programs.
The TGA could reschedule MDMA and psilocybin — what that means for ASX-listers
A rescheduling decision could help introduce psychedelics to the psychiatrist’s office — and they’ve got off-the-charts potential to treat mental health conditions.
Emyria buoyed by TGA-commissioned Independent Expert Report on MDMA and psilocybin
The Therapeutic Goods Administration released an Independent Expert Panel Report reviewing the therapeutic potential of MDMA and psilocybin ahead of the Advisory Committee of Medicines Scheduling at the November 3, 2021 meeting, which may d
Emyria makes strides in MDMA analogue screening program with preliminary analysis
As it embarks on the novel MDMA program, the drug development and care delivery company has completed preliminary analysis over half of its MDMA analogue library, developed in conjunction with the University of Western Australia.
Emyria expands psychiatry advisory team with new appointment
“I’m pleased to support Emyria’s unique model of care delivery, evidence generation and treatment development, which is well-placed to evaluate how best to deliver these treatments consistently and safely,” says new appointment.
Orthocell explores new application for CelGro® platform in ACL reconstruction
The regenerative medicine company could be on the verge of developing the first off-the-shelf biological device used to treat ACL injuries, a market linked to a growing health economic burden.
Orthocell secures new patents for CelGro® suture-less repair of soft tissue
The company’s pre-clinical studies have shown at a microscopic level that CelGro® produces superior nerve repair and return of muscle function in severed peripheral nerves when compared to the traditional (direct suture) repair method.
Emyria highlights promising in vivo and in vitro results from early UWA MDMA-analogue studies for Parkinson’s disease
The results highlight the potential of uniquely designed MDMA-analogues to elicit different neurological effects, which may lead to new treatments for psychiatric and neurological disorders such as PD.
Orthocell passes Ortho-ATI® milestone on completing 12-month follow-up of last patient in rotator cuff tendon study
“This is an important development milestone for Ortho-ATI and the company, representing the first randomised controlled trial for a tendon cell therapy to be completed for this indication globally,” says MD.
Orthocell tables 41% boost in product sales revenue over FY21
The regenerative medicine company focused on advancing its CelGro® and Ortho-ATI® pipelines during FY21, ending the period with more than $16 million in the bank.
Emyria’s Calvert agreement is a step forward to human trials
“This preclinical work will help strengthen Emyria’s intellectual property relating to our synthetic cannabinoid platform. Importantly, this work will help guide the novel formulation, delivery, and dosing strategies of our platform as we p
ASX back up, but where to next?
The week has been highlighted by company reporting, however, one event stood out: the BHP/Woodside merger. The companies announced late on Tuesday that they had entered into an agreement to merge their respective oil and gas portfolios with
Emyria appoints expert neuropharmacologist for MDMA-analogue development program
The company recently secured exclusive rights to a library of more than 100 novel MDMA analogues from the University of Western Australia, creating a unique drug discovery pipeline for Emyria.
ASX 200 rises on the back of health and tech as ASX small caps enjoy a good day out
China’s resolve to reduce the impact of the steel industry on the environment is having ramifications for Australia’s mining stocks and iron ore prices. Iron ore was down 1.5% to US$162.96 a tonne overnight and is likely to continue its dec
Emyria signs pure CBD agreement with US-based Altasciences to help fast track registration
Emyria is on track to deliver one of the first successfully registered, over-the-counter CBD medicines in Australia and has already completed much of the preliminary registration work.
Emyria enters exclusive agreement with UWA to develop drug discovery pipeline of novel psychedelic therapies
Emyria has secured exclusive rights to a library of more than 100 novel MDMA analogues from the University of Western Australia creating a unique drug-discovery pipeline.
Orthocell’s breakthrough tissue engineering study with CelGro® to create functional lymphatic tissue published in PNAS
The findings represent a substantial advance in the ex vivo fabrication of implantable lymphatic grafts and their use in novel surgical treatments for patients suffering from lymphedema.
Emyria makes "great progress" across treatment, care and digital health portfolios in June quarter
Emyria advanced its cannabinoid-based drug registration programs and launched an MDMA-assisted therapy trial for people with post-traumatic stress disorder during the June quarter.
Orthocell sets stage for commercialisation progress with CelGro®, Striate+ and Ortho-ATI® after busy June quarter
The ASX-lister tabled data from a key CelGro® nerve regeneration trial and worked towards getting its Striate+ product to the US market over the June quarter, with data from a rotator cuff trial using the Ortho-ATI® product anticipated this
Orthocell appoints exclusive distributor in Australia for dental technology
The company believes SMT is the ideal partner for the Australian market, with its established relationships with oral surgeons and a successful track record driving market entry of high-quality products.
Emyria appoints principal investigator to lead MDMA trial for Post-Traumatic Stress Disorder
The company believes the new principal investigators’ clinical experience in psychedelic-assisted therapies will help develop its evidence-based and scalable clinical services for patients with major mental health concerns.
Orthocell unveils positive CelGro® nerve regeneration results in quadriplegic patients
Twelve months on from Orthocell’s CelGro® nerve regeneration trial, a data readout has indicated more than three-quarters of all nerve repairs conducted during the clinical study resulted in functional recovery.
Orthocell locks in patents in China and New Zealand for CelGro® soft tissue sutureless repair
The patents cover the method of using CelGro® to repair a defect in soft tissue, such as tendons, ligaments and nerves, avoiding the use of damaging sutures.
Emyria files patents and advances cannabinoid-based IBS treatment EMD-004 toward registration
Patents were filed after signal analysis of Emyria’s clinical data, one of the largest trials-grade clinical registries for medicinal cannabis, and extensive review of the global literature and patent landscape.
Emyria has project data validated with care model reducing opioid use and opening new opportunities
The data show that on average opioid consumption reduces after commencing care at Emerald Clinics from a previous 12 month steady-state of opioid use.
Orthocell higher on securing further Asian patent protection for CelGro® collagen rope
China and Hong Kong have granted patents to the product, which is used to augment ligament repair surgeries.
Emyria gains TGA approval for Openly medical grade, smartphone enabled, cardiovascular monitoring software
A Class IIa classification applies to software that is intended to provide information used to make decisions with diagnostic or therapeutic purposes.
Emyria has news pending regarding regulatory registration of Openly remote health monitoring application
The company has been granted a trading halt by the ASX pending an announcement and securities will remain halted until Thursday, May 13 or when the announcement is released to the market.
Emyria and partner Mind Medicine Australia launch psychedelic-assisted therapy program targeting PTSD
EMDMA-001 has been modelled on a major Phase III clinical trial developed by the Multidisciplinary Association for Psychedelic Studies (MAPS).
Orthocell’s strong cash balance allows company to progress key regulatory approvals and commercialisation strategy
Orthocell is well-positioned to establish CelGro® as the best-in-class membrane for bone and soft tissue repair and to realise multiple commercial partnering opportunities.
Emyria to focus on initiating and completing pivotal clinical trials for EMD-003 program and advancing EMD-004 program
EMD-003 is being developed to reduce anxiety, depression and stress symptoms while the company is also advancing EMD-004 targeting irritable bowel syndrome.
Orthocell’s CelGro® study results open up new US market access strategy
The breakthrough results position CelGro® as the potential market leader in nerve regeneration and restoration of voluntary muscle control in patients with tetraplegia or paralysed upper limbs with a strategic evaluation of medical device U
Emyria secures $5 million placement to advance drug registration activity and expand treatment pipeline
The company is now well placed to achieve current milestones for its registration plans for EMD-003 targeting mental health concerns and EMD-004 for irritable bowel syndrome (IBS) which is under development.
Emyria Ltd and Cann Group collaborate to seek accelerated registration of unique, low-dose, CBD-only capsule with TGA
Under the agreement, Emyria’s EMD-003 drug development program will use Cann Group’s proprietary Gelpell microsphere technology, to seek a Schedule 3 registration for treating unmet needs in mental health.
Emyria's strong financial and operational outlook supports growth plans for 2021
In 2021, the company is focused on delivering and completing the required pivotal clinical trials required to successfully register EMD-003 and further expanding its clinical services nationally to meet demand.
Orthocell’s CelGro® Dental granted inclusion on Australian Prostheses List
The prostheses list defines the minimum value of benefit private insurers pay for CelGro® Dental used in approved dental bone and soft tissue repair procedures.
Emyria opens second clinic in Perth to meet record patient appointments and ahead of EMD-003 registration trials
The expansion comes off the back of record patient appointments in January 2021 and a recently announced expansion in Victoria.
Emyria in strong financial position to deliver on drug registration priorities
Buoyed by its financial and operational strength, the company is focused on advancing the development and commercialisation of its treatments for mental health conditions and IBS.
Emyria appoints global pharmaceutical expert to chair Strategic Advisory Board
The appointment of highly acclaimed and experienced Dr Karen Smith boosts the company’s global clinical trial and regulatory approval expertise to accelerate drug registration initiatives.