Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now engage with European regulatory agencies to prepare for the Phase III trial. Following the positive endorsement from the FDA, we expect partnering talks to intensify in the coming weeks, with the partner taking on responsibility for further clinical development.
Written by
IRLAB Therapeutics |
FDA thumbs up to mesdopetam’s Phase III plan |
Regulatory update |
Pharma and biotech |
25 March 2024 |
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Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now engage with European regulatory agencies to prepare for the Phase III trial. Following the positive endorsement from the FDA, we expect partnering talks to intensify in the coming weeks, with the partner taking on responsibility for further clinical development.
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.
We are encouraged by the FDA’s endorsement of mesdopetam’s clinical plan and see this as a key step forward for the programme in PD-LIDs (present in 25–40% of all Parkinson’s disease (PD) cases), an underserved market. Based on the latest information disclosed, the Phase III programme will recruit 200–250 patients (we had previously assumed 150–200) for a treatment duration of 12 weeks. Dosage has been confirmed at 7.5mg BID, the highest dose evaluated in the Phase IIb study, which showed the maximum efficacy (while maintaining strong safety). As previously mentioned, the primary endpoint will be improvement on UDysRS (part 1, 3 and 4 of the four-part scale), a clinically recognised measure of dyskinesia where mesdopetam showed positive efficacy in the previous study. The secondary endpoints will be based on subsections of UDysRS, the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and 24-hour patient motor diaries. As expected, the programme will include a one-year open label extension treatment period following the end of the 12 weeks double-blind treatment period.
Following this green light from the FDA, we expect partnership discussions to gather momentum in the next few weeks. IRLAB had previously indicated that it would seek a partnership to further progress mesdopetam’s clinical development and subsequent commercialisation and we therefore expect an update in the coming months (refer to our note for details). We note that IRLAB currently has a cash runway through Q324 and expect any upfront payment from a licensing deal to provided increased operational headroom.
The company’s other clinical programme, pirepemat, which aims to improve balance and reduce falls in PD patients (PD-Falls), is in a Phase IIb trial, with topline results expected in Q424 or Q125. IRLAB also has a solid preclinical pipeline, led by IRL757 for the treatment of apathy in PD (Phase I ready with clinical entry expected in Q224), IRL942 (for cognitive impairment, expected to be Phase I-ready in H124) and IRL1117 in PD (Phase I-ready in 2024), positioned as a competitor/adjuvant to market leader Levodopa.
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Research: TMT
Nano Dimension made good progress growing revenue and gross margins in FY23. The company is now focused on reducing cash burn and moving to profitability, via its Reshaping Nano initiative, and is simultaneously looking to acquire in the additive manufacturing space to consolidate its position. Nano Dimension continues to buy back shares while they trade at a discount to book value.