Last close As at 05/08/2026
AUD0.04
▲ −0.01 (−11.11%)
Market capitalisation
AUD5m
Research: Healthcare
Argent BioPharma is a clinical-stage specialty biopharma company developing therapeutics targeting areas of unmet need. Currently focused on CNS conditions and immunology, Argent has a broad pipeline of assets, led by CannEpil (drug-resistant epilepsy), CimetrA (acute lung disease) and CogniCann (CNS disorders). The first two are available under special access schemes in markets such as the UK, US and EU, generating early revenue streams as well as real-world evidence, which should aid regulatory outcomes. Argent has a strong internal IP position with two EU-GMP R&D and manufacturing sites (in Malta and Slovenia) supporting in-house drug development. These could potentially be monetised via contract manufacturing services. We expect the most significant upcoming catalysts to be the investigational new drug (IND) filings with the FDA for CannEpil and CimetrA, expected by end 2025 according to management.
Argent BioPharma |
An innovative approach to drug development
|
Pharma and biotech |
QuickView
5 September 2024 |
Share price graph
Share details
Business description
Bull
Bear
Analysts
Argent BioPharma is a research client of Edison Investment Research Limited |
|||||||||||||||||||||||
Argent BioPharma is a clinical-stage specialty biopharma company developing therapeutics targeting areas of unmet need. Currently focused on CNS conditions and immunology, Argent has a broad pipeline of assets, led by CannEpil (drug-resistant epilepsy), CimetrA (acute lung disease) and CogniCann (CNS disorders). The first two are available under special access schemes in markets such as the UK, US and EU, generating early revenue streams as well as real-world evidence, which should aid regulatory outcomes. Argent has a strong internal IP position with two EU-GMP R&D and manufacturing sites (in Malta and Slovenia) supporting in-house drug development. These could potentially be monetised via contract manufacturing services. We expect the most significant upcoming catalysts to be the investigational new drug (IND) filings with the FDA for CannEpil and CimetrA, expected by end 2025 according to management.
A differentiated portfolio and business strategy…
Argent’s pipeline, developed fully in-house, targets a broad range of indications, all underserved areas but with significant commercial potential. Leading the pack are CannEpil, targeting drug-resistant/refractory epilepsy (market expected to be worth $6bn by 2034), currently available in the UK and covered by insurance in Ireland, and CimetrA, a drug in research for acute lung injury and acute respiratory distress syndrome, currently available in the US as an over-the-counter unlicensed drug. CogniCann targets symptoms related to Alzheimer’s, while the preclinical pipeline is focused on diverse areas such brain cancer and wound management. Argent’s strategic rationale of offering its drugs under special access schemes holds merit in our opinion, not only providing an early revenue stream but also de-risking the development process, given the real-time safety and efficacy data generated.
…backed by in-house capabilities
The company’s R&D efforts are supported by its two EU-GMP facilities, in Slovenia and Malta (with capacity to manufacture over 20k units/day), which management believes will be able to support the clinical and commercial requirements of its pipeline. We also see monetisation opportunities from offering contract manufacturing services as the company scales internal operations.
Next up: US IND filings
We expect Argent’s medium-term focus to be on progressing its pipeline while continuing to implement its early access programmes across the EU, the UK and the US. We view the most significant upcoming catalysts to be the IND filings with the FDA for CannEpil and CimetrA, expected by end 2025 according to management.
|
Historical financials
Source: Company filings |
|
||||||||||||
|
||||||||||||
Research: Healthcare
Cereno Scientific’s lead asset CS1 has been granted the Orphan Medicinal Product Designation (OMPD) from the European Commission as a potential treatment for pulmonary arterial hypertension (PAH). The OMPD provides 10 years of market exclusivity, assuming CS1 receives EU regulatory approval, in addition to fee waivers during the development process. Further, this regulatory designation complements the FDA Orphan Drug Designation (ODD) granted in 2020, bolstering the value proposition of the candidate. We expect this news will be viewed positively as investors await the Phase II CS1 trial’s topline results in PAH, expected in September 2024.