Last close As at 05/08/2026
CHF12.26
▲ 0.44 (3.72%)
Market capitalisation
CHF256m
Research: Healthcare
Newron Pharmaceuticals has shared positive top-line data for its evenamide programme from its potentially pivotal Phase II/III trial (study 008A) in patients with poorly managed schizophrenia on current antipsychotic therapy, but not considered treatment-resistant. The trial met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) score from baseline, and the key secondary endpoint of improvement on the Clinical Global Impression of Severity (CGI-S) scale. Statistical significance was met in both, consolidating the already strong results from the Phase II trial (study 014/015) in treatment-resistant schizophrenia (TRS). Management plans to follow this up with a potentially pivotal Phase III study in TRS (study 017), which, subject to final agreement by potential partners and regulatory bodies, could commence within 2024.
Written by
Newron Pharmaceuticals |
Evenamide notches up another win (study 008A) |
Clinical update |
Pharma and biotech |
1 May 2024 |
Share price performance
Business description
Analysts
Newron Pharmaceuticals is a research client of Edison Investment Research Limited |
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Newron Pharmaceuticals has shared positive top-line data for its evenamide programme from its potentially pivotal Phase II/III trial (study 008A) in patients with poorly managed schizophrenia on current antipsychotic therapy, but not considered treatment-resistant. The trial met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) score from baseline, and the key secondary endpoint of improvement on the Clinical Global Impression of Severity (CGI-S) scale. Statistical significance was met in both, consolidating the already strong results from the Phase II trial (study 014/015) in treatment-resistant schizophrenia (TRS). Management plans to follow this up with a potentially pivotal Phase III study in TRS (study 017), which, subject to final agreement by potential partners and regulatory bodies, could commence within 2024.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
6.09 |
(16.99) |
(0.95) |
0.0 |
N/A |
N/A |
12/23 |
9.06 |
(16.00) |
(0.90) |
0.0 |
N/A |
N/A |
12/24e |
24.33 |
(2.6) |
(0.14) |
0.0 |
N/A |
N/A |
12/25e |
27.06 |
(0.8) |
(0.04) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Study 008A was a randomised, double-blind, placebo-controlled, potentially pivotal Phase II/III trial across 45 centres in 11 countries in Europe, Asia and Latin America. The study was designed to assess the safety, tolerability and efficacy of evenamide following a four-week 30mg twice-daily (bid) treatment regimen (n=291). The target population was patients with poorly managed schizophrenia already receiving antipsychotics, but who are not classed as having TRS. 280 of 291 patients completed the study, with only three discontinuing due to adverse events (two of whom were in the evenamide treatment arm).
Encouragingly, the top-line results confirmed the safety and tolerability profile of evenamide, which was similar to placebo (adverse events – 25.0% for evenamide vs 25.8% for placebo). Management noted that no new or specific concerns were raised in the study that were inconsistent with prior data. In terms of the primary efficacy measure, evenamide treatment was associated with a statistically significant (p-value 0.006) reduction in PANSS total score of 10.2 points, compared to 7.6 points with placebo at day 29. The key secondary endpoint was also met with statistical significance (p-value 0.037), with the CGI-S data showing a least square mean difference of 0.16 between evenamide and placebo. Collectively, we believe the results are highly encouraging, supporting Newron’s approach to managing this condition through the glutamatergic inhibition mechanism.
While we await further details on the study data (expected in the next few weeks), as well as Newron’s development/commercial plans, we maintain our valuation of CHF219.1m; our assumptions may be reassessed as new information becomes available. We expect partnering discussions to gather steam, and anticipate progress here to define the plan and expected timeline for the Phase III 017 study initiation. Based on our projections, we expect the company to be funded into 2025, sufficient for it to finalise a partnering deal for evenamide, in our opinion.
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Research: Metals & Mining
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