Last close As at 06/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB has submitted a request for an end-of-Phase II meeting (EoP2) with the FDA for its lead asset, mesdopetam, to chart the Phase III roadmap for the drug. According to FDA guidelines, the agency intends to respond to such requests within 14 days and schedule a meeting within 70 calendar days from the receipt of the request. We see the EoP2 meeting as an important inflection point for IRLAB to continue clinical development of mesdopetam after securing full ownership rights from Ipsen in August 2023. Management met a key efficacy secondary endpoint and the drug has shown dose-dependent anti-dyskinetic and anti-Parkinsonian effects, which support continued development, in our view. Our valuation currently assumes a 40% probability of success for mesdopetam in levodopa-induced dyskinesias (PD-LIDs) and we plan to revisit our assumptions following the results from the FDA meeting.
Written by
IRLAB Therapeutics |
Mesdopetam’s clinical roadmap laid out |
Regulatory update |
Pharma and biotech |
19 December 2023 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB has submitted a request for an end-of-Phase II meeting (EoP2) with the FDA for its lead asset, mesdopetam, to chart the Phase III roadmap for the drug. According to FDA guidelines, the agency intends to respond to such requests within 14 days and schedule a meeting within 70 calendar days from the receipt of the request. We see the EoP2 meeting as an important inflection point for IRLAB to continue clinical development of mesdopetam after securing full ownership rights from Ipsen in August 2023. Management met a key efficacy secondary endpoint and the drug has shown dose-dependent anti-dyskinetic and anti-Parkinsonian effects, which support continued development, in our view. Our valuation currently assumes a 40% probability of success for mesdopetam in levodopa-induced dyskinesias (PD-LIDs) and we plan to revisit our assumptions following the results from the FDA meeting.
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.
Mesdopetam is a dopamine D3-receptor antagonist being developed for the treatment of levodopa-induced dyskinesias (PD-LIDs). The asset was previously out-licensed to Ipsen – with preclinical studies and Phase I, Ib, IIa and IIb trials completed as part of this collaboration – but the rights were taken back to IRLAB. The company’s Phase IIb PD-LIDs study did not meet its primary endpoint (change in daily hours of good ON time compared to placebo) but successfully met a key secondary efficacy endpoint. A detailed presentation of trial data by IRLAB in August 2023 following the securing of mesdopetam rights showed dose-dependent anti-dyskinetic (as measured by the Unified Dyskinesia Rating Scale) and anti-Parkinsonian effects from the drug (along with a good safety and tolerability profile), which the company asserts supports continued clinical development. The review also guided for a 7.5mg bid dose for the Phase III trial.
IRLAB has since collaborated with two US-based advisory groups, Clintrex (a clinical and regulatory strategy advisor) and ProPharma Group (a regulatory consulting organisation) to develop the strategy for the Phase III program and prepare a briefing book based on the detailed data from the prior studies, for submission to the FDA. As part of the EoP2 meeting, the FDA is likely to assess the Phase III plan, study protocols and review of the safety profile and effectiveness of the drug based on the submitted data. The FDA may also provide guidance on the requirement for additional data to support a future market application, if clinical endpoints are met.
We believe that this upcoming meeting with the FDA could be a major inflection point for the company as this discussion will inform the next steps for the clinical development of mesdopetam. We currently assume a 40% probability of success for the drug in PD-LIDs but plan to reassess our assumptions following the results from the FDA meeting.
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Research: TMT
Filtronic’s £4.5m contract with a UK defence supplier is its largest for more than five years and indicative of its improving momentum in the traditional defence market, on top of the exciting progress in the space sector. As the bulk of revenues from the deal will be spread across FY25 and FY26, we are not changing our estimates but believe they look increasingly well underpinned. The company’s rating is now starting to factor in an acceleration in growth and margin expansion. With continuing strong execution, we believe that it is more than capable of delivering this – demand for high-end radio frequency (RF) is growing and Filtronic has rare capabilities in the field, while incremental revenue growth should drop strongly through to margins.