Last close As at 05/08/2026
EUR2.92
▲ −0.01 (−0.41%)
Market capitalisation
EUR248m
Research: Healthcare
Oryzon Genomics has confirmed the FDA’s alignment with its proposed Phase III programme for vafidemstat in borderline personality disorder (BPD). Notably, the FDA acknowledged agitation and aggression (A/A) as a therapeutic indication and, as such, the State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger may be used as a primary endpoint for Phase III (PORTICO-2). We note that vafidemstat showed statistically significant benefit by this measure in the prior Phase IIb PORTICO trial. We view the news as encouraging and believe there is a sizeable opportunity for Oryzon to develop an effective treatment for BPD, for which there are currently no approved drugs. Next steps are to submit a full trial protocol for PORTICO-2 to the FDA (expected within Q125), before a potential trial launch from H225, contingent on regulatory clearance and providing that there are no other delays.
Oryzon Genomics |
FDA aligns on Phase III BPD plans |
Regulatory update |
Pharma and biotech |
2 October 2024 |
Share price performance
Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
|||||||||||||||||||||||||||||||||
Oryzon Genomics has confirmed the FDA’s alignment with its proposed Phase III programme for vafidemstat in borderline personality disorder (BPD). Notably, the FDA acknowledged agitation and aggression (A/A) as a therapeutic indication and, as such, the State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger may be used as a primary endpoint for Phase III (PORTICO-2). We note that vafidemstat showed statistically significant benefit by this measure in the prior Phase IIb PORTICO trial. We view the news as encouraging and believe there is a sizeable opportunity for Oryzon to develop an effective treatment for BPD, for which there are currently no approved drugs. Next steps are to submit a full trial protocol for PORTICO-2 to the FDA (expected within Q125), before a potential trial launch from H225, contingent on regulatory clearance and providing that there are no other delays.
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
15.7 |
(6.3) |
(0.07) |
0.0 |
N/A |
N/A |
12/23 |
14.2 |
(6.1) |
(0.06) |
0.0 |
N/A |
N/A |
12/24e |
8.6 |
(4.9) |
(0.05) |
0.0 |
N/A |
N/A |
12/25e |
31.6 |
15.5 |
0.28 |
0.0 |
6.5 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Following its end-of-Phase II meeting with the FDA, Oryzon has announced the receipt of positive feedback. The FDA confirmed that STAXI-2 Trait Anger may be used as the primary endpoint for Phase III, and secondary endpoints will involve patient-rated and clinician-rated scales, such as the Clinical Global Impression – Severity A/A (CGI-S A/A) subscale and Borderline Evaluation of Severity over Time (BEST) scale, both of which were used in the prior Phase IIb PORTICO trial, as well as the CGI-S full scale (not used in PORTICO). It was noted that the FDA will require further information to demonstrate that STAXI-2 Trait Anger constitutes a clinically meaningful endpoint, alongside similar research to justify the choice of secondary endpoints. Management is planning to conduct a qualitative research study on a subset of the PORTICO-2 patients to provide validation of the proposed endpoints. The study protocol will be submitted to the FDA for review and feedback prior to initiating PORTICO-2. Psychometric properties and performance of the endpoints will also be shared with the FDA prior to the initiation of the Phase III trial.
It is estimated that the Phase III PORTICO-2 trial will recruit c 350 participants, who will be randomised (1:1) to receive vafidemstat or a control, across an 18-week treatment duration. Subject to the FDA accepting the protocol, PORTICO2 will be one of two registrational trials required before filing for approval. We believe a key goal of the Phase III programme will be to build on the positive results from the prior Phase IIb PORTICO trial, which provided a robust foundation, in our view. As a reminder, this trial confirmed the safety of vafidemstat and, in terms of efficacy, the candidate was favoured over placebo in all measures. Notably, the secondary endpoints were met with statistical significance. The STAXI-2 Trait Anger data showed a 58.6% relative reduction in A/A with vafidemstat compared to placebo at weeks 8–12 (p=0.0071), with p values at weeks 10 and 12 of p=0.006 and p=0.016, and relative reductions of 92.1% and 57.1%, respectively. For a more detailed discussion of the final PORTICO data, please read our prior update note.
|
|
Research: Consumer
Topps Tiles (TPT) finished FY24 well on a relative basis by outperforming the still weak domestic repair, maintenance and improvement market. Its Q424 trading update indicates reassuring ‘stable’ trends in Topps Tiles stores versus the immediately prior quarter and continued growth from the rest of the portfolio. As a result, Q424’s yearly growth rate was slightly better than the rest of the year. The stability in Topps Tiles store sales is important as the company has weak comparatives through the whole of FY24, and macroeconomic indicators point to recovery. Topps has also announced it is working with the Competition and Markets Authority, which intends to review the company’s acquisition of certain assets of CTD Tiles under merger control, after receiving an initial information request.