Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics has scheduled an end-of-Phase II (EoP2) meeting (on 20 February 2024) with the US FDA for the mesdopetam programme. This marks an important milestone for IRLAB as it will evaluate the clinical data generated to date and aim to reach a conclusion for the design of the planned Phase III programme. The meeting should also outline a clear path to a possible new drug application (NDA), including if any other information is required to support an NDA submission. Management will announce the outcome of the EoP2 meeting within Q124 as feedback from the regulatory authority is provided up to 30 days afterwards.
Written by
IRLAB Therapeutics |
End-of-Phase II FDA meeting set |
Regulatory update |
Pharma and biotech |
3 January 2024 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB Therapeutics has scheduled an end-of-Phase II (EoP2) meeting (on 20 February 2024) with the US FDA for the mesdopetam programme. This marks an important milestone for IRLAB as it will evaluate the clinical data generated to date and aim to reach a conclusion for the design of the planned Phase III programme. The meeting should also outline a clear path to a possible new drug application (NDA), including if any other information is required to support an NDA submission. Management will announce the outcome of the EoP2 meeting within Q124 as feedback from the regulatory authority is provided up to 30 days afterwards.
Year end |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
207.9 |
91.1 |
1.76 |
0.0 |
3.8 |
N/A |
12/22 |
61.3 |
(113.1) |
(2.18) |
0.0 |
N/A |
N/A |
12/23e |
7.2 |
(184.0) |
(3.55) |
0.0 |
N/A |
N/A |
12/24e |
0.2 |
(202.5) |
(3.90) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As per the announcement, the FDA has set an EoP2 meeting date of 20 February 2024, with the outcome expected to be shared up to 30 days after the meeting. The dates are in line with the guided timelines for this process, as the request was submitted in December 2023. IRLAB has worked in collaboration with two US-based advisory groups, Clintrex (a clinical and regulatory strategy advisor) and ProPharma Group (a regulatory consulting organisation), to prepare the briefing book for the FDA and to develop the strategy for the planned Phase III programme. Given the technical expertise of these groups and with the supportive clinical data obtained for mesdopetam to date, we believe IRLAB is well prepared for the EoP2 meeting and we note that management is confident the project is Phase III-ready. We anticipate that the outcome of the meeting, expected within Q124, could mark a significant catalyst for investor attention.
As a reminder, mesdopetam is a D3 antagonist in clinical development for the treatment of levodopa-induced dyskinesias in Parkinson’s disease patients (PD-LIDs). In January 2023, IRLAB announced top-line data from the Phase IIb trial (n=156). The results showed that the study did not meet its primary endpoint (change in daily hours of ‘ON-time’ without troublesome dyskinesia, as assessed with patient diaries). However, the results demonstrated that mesdopetam has a comparable safety and tolerability profile to placebo, and significant anti-dyskinetic effects as measured by the UDysRS. We highlight that UDysRS measurements formed the basis of Adamas’ Gocovri approval, the only FDA-approved treatment for PD-LIDs, highlighting the clinical relevance of the scale. Further, we note that Gocovri is associated with a multitude of side effects (eg hallucinations, peripheral edema, falls, suicidality and depression), potentially giving mesdopetam a competitive edge. In August 2023, IRLAB also shared a detailed analysis of the Phase IIb data, confirming that mesdopetam demonstrates dose-dependent anti-dyskinetic and anti-parkinsonian effects.
We currently assume a 40% probability of success for the mesdopetam in PD-LIDs but plan to reassess our assumptions following the results from the FDA meeting.
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Research: Healthcare
Sareum Holdings’ co-development partner CRT Pioneer Fund (CPF) has signed a new licensing agreement with an unnamed US-based private biopharma company for SRA737, its Phase II stage CHK1 inhibitor targeting the DDR network for the treatment of solid tumours. Deal terms include an upfront payment of $0.5m, additional fees of up to $1m in cash and 500,000 shares of the partner and potential milestone payments of up to $289m (comparable to the $290m allocated under its revised deal with Sierra Oncology in 2020, that has since been terminated). CPF will also be entitled to tiered high single-digit royalties on net sales. Sareum remains a passive partner in the programme with a 27.5% economic stake in SRA737, translating to $137.5k in upfront and a proportionate share of future payments. Given Sareum’s focus on progressing its lead clinical candidate SDC-1801 (Phase Ia trials ongoing), we expect any additional funds to be deployed in the asset’s development. We expect full safety data from the Phase Ia trial (expected H1 CY24) to be the next catalyst for the company.