Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
The recent scientific paper in Neurotherapeutics discusses the encouraging preclinical studies focused on the characterisation of the neurophysiological brain state in Parkinson’s disease psychosis (PD-Psychosis), a target indication of IRLAB’s lead asset, mesdopetam. While IRLAB’s clinical programme for this candidate in PD-Psychosis is currently on hold (Phase II-ready at present), the antipsychotic efficacy demonstrated in this preclinical research seems to support the case for further clinical development. The primary indication for mesdopetam is levodopa-induced dyskinesias (PD-LIDs), for which IRLAB recently completed an end-of-Phase II (EoP2) meeting with the US FDA to discuss a potential Phase III programme. Formal meeting feedback is expected imminently, potentially representing the next material catalyst for the company.
Written by
IRLAB Therapeutics |
Mesdopetam’s potential highlighted in PD-psychosis |
Company update |
Pharma and biotech |
20 March 2024 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||||
The recent scientific paper in Neurotherapeutics discusses the encouraging preclinical studies focused on the characterisation of the neurophysiological brain state in Parkinson’s disease psychosis (PD-Psychosis), a target indication of IRLAB’s lead asset, mesdopetam. While IRLAB’s clinical programme for this candidate in PD-Psychosis is currently on hold (Phase II-ready at present), the antipsychotic efficacy demonstrated in this preclinical research seems to support the case for further clinical development. The primary indication for mesdopetam is levodopa-induced dyskinesias (PD-LIDs), for which IRLAB recently completed an end-of-Phase II (EoP2) meeting with the US FDA to discuss a potential Phase III programme. Formal meeting feedback is expected imminently, potentially representing the next material catalyst for the company.
Year end |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
61.3 |
(113.1) |
(2.18) |
0.0 |
N/A |
N/A |
12/23 |
5.7 |
(177.8) |
(3.43) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(191.3) |
(3.69) |
0.0 |
N/A |
N/A |
12/25e |
0.0 |
(189.7) |
(3.66) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
IRLAB has announced the publication of a scientific paper in Neurotherapeutics, an established, peer-reviewed journal; the paper discusses a series of preclinical studies focused on the characterisation of the neurophysiological brain state in an advanced preclinical rodent model of PD-Psychosis. This is a condition characterised by hallucinations and delusions, and is prevalent in 20–40% of Parkinson’s disease (PD) patients. The research included IRLAB’s lead asset, mesdopetam (a dopamine D3 receptor antagonist), alongside clozapine and pimavanserin, which are used to alleviate PD-Psychosis, as well as an experimental D3 receptor antagonist (SB277011-A). Encouragingly, mesdopetam demonstrated antipsychotic efficacy, having reversed features of psychosis in the rodent model, while also corroborating the mechanism of D3 receptor antagonism, supporting mesdopetam’s potential application as a novel treatment option for the condition. Should IRLAB choose to reinitiate its programme in PD-Psychosis, we believe that the data presented in this scientific paper, alongside the desirable safety and tolerability profile observed in other clinical studies to date, should provide a supportive development pathway.
In the near term, we believe IRLAB’s next significant catalyst for investor attention will be the FDA’s formal feedback from the EoP2 meeting, which should provide a line of sight on the further development of mesdopetam for PD-LIDs. According to management, the meeting was held in a constructive and engaging spirit, and discussions during the meeting suggested alignment between the company and the regulatory authority on the design of a Phase III programme. An update from management is anticipated imminently regarding more details on the formal feedback. The company reported on 22 February that it had completed its EoP2 meeting with the FDA and it expects to receive the agency’s formal feedback in the form of official meeting minutes within 30 days of the meeting date.
|
|
Research: Healthcare
Newron Pharmaceuticals has reported results for FY23, an active period for its lead asset, evenamide, being developed for treatment-resistant schizophrenia (TRS) and poorly managed schizophrenia (non-TRS). Strong 12-month data were shared in January 2024 from the Phase II trial (study 014/015) in TRS patients, and management is gearing up to launch a potentially pivotal Phase III trial. We expect the next major catalyst to be results of the Phase III trial (study 008A) in non-TRS patients, now anticipated in April. Improved liquidity following the recent equity raise and renegotiated debt repayment terms with the EIB provides headroom into 2025, by which time we anticipate a licensing deal for evenamide. We have revised our estimates, segregating evenamide’s potential across TRS and non-TRS populations, and refined some of our assumptions. Our valuation increases to CHF219.1m or CHF12.3/share (CHF7.7/share previously).