SynAct Pharma — Post-hoc analysis strengthens Phase III case

SynAct Pharma (STO: SYNACT)

Last close As at 04/09/2026

SEK17.50

0.06 (0.34%)

Market capitalisation

SEK934m

More on this equity

Research: Healthcare

SynAct Pharma — Post-hoc analysis strengthens Phase III case

SynAct Pharma has reported further analysis of the Phase IIb ADVANCE study (testing resomelagon in rheumatoid arthritis), providing a clearer explanation for the unexpectedly strong placebo response. Management estimates that around 20% of patients entered the study during a temporary inflammatory flare, with this subgroup accounting for much of the variability observed in the placebo arm. Excluding these patients, the 40mg resomelagon achieved an ACR20 response of 79% versus 55% for placebo (p<0.05), alongside greater separation in ACR50 and DAS28 improvements. We believe the analysis strengthens the overall interpretation of ADVANCE and should provide useful support for upcoming regulatory discussions. Importantly, we believe that these findings offer a practical framework for the Phase III design, where tighter selection of patients with stable baseline inflammatory activity should be as important as demonstrating deeper and more durable responses over the proposed 26-week treatment period.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

Pharma and biotech

Clinical data update

7 September 2026

Price SEK17.50
Market cap SEK984m

SEK9.30/US$

Net cash/(debt) at 30 June 2026

SEK14.2m

Shares in issue

56.2m
Free float 56.5%
Code SYNACT
Primary exchange OMX
Secondary exchange N/A
Price Performance

Business description

SynAct Pharma is a clinical-stage biotechnology company focused on the development of treatments to resolve, rather than inhibit, ongoing inflammatory processes in acute and chronic diseases.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

SynAct Pharma is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Year end Revenue (SEKm) PBT (SEKm) EPS (SEK) DPS (SEK) P/E (x) Yield (%)
12/24 0.0 (90.8) (2.08) 0.00 N/A N/A
12/25 0.0 (119.0) (2.17) 0.00 N/A N/A
12/26e 0.0 (101.4) (1.68) 0.00 N/A N/A
12/27e 0.0 (63.3) (0.98) 0.00 N/A N/A

Management highlighted that one in five patients in ADVANCE had active inflammatory flare-ups, with this subgroup accounting for the majority of variance in placebo response. Excluding these, the ACR20 delta widened to 24pp versus 15.6pp in the original ADVANCE dataset. More importantly, on the primary DAS28-CRP endpoint, placebo-adjusted separation improved to 0.5 points from 0.19 points. This suggests that a single elevated inflammatory measurement such as hsCRP may not adequately identify stable inflammatory disease, with baseline stability potentially as important as the absolute CRP threshold. This aligns with prior rheumatoid arthritis (RA) research which noted that selecting patients during periods of temporarily high disease activity can result in material regression to the mean, supporting multiple assessments to establish a more representative baseline.

We believe this provides a strong framework for SynAct to design the Phase III study, which it expects to submit (alongside the supporting toxicology programme) to the FDA in Q426 ahead of a Type C meeting, with feedback expected by late 2026/early 2027. This could include repeated pre-randomisation assessments to confirm stable inflammatory activity. The proposed 26-week treatment period also appears informed by ADVANCE, where responses continued to deepen beyond week eight. The latest analysis showed ACR50 of 38% versus 30% in the new subset, which, while improved from the near-flat separation in the original analysis, was not statistically significant. Extending treatment beyond the 12-week Phase IIb window should therefore provide a more robust test of whether the strong ACR20 signal translates into greater differentiation on ACR50 and ACR70.

We view the Type C meeting as a key step in defining the next phase for resomelagon in RA, with regulatory endorsement of Phase III the most meaningful valuation catalyst. Other upcoming catalysts include the first Brazilian dengue commercial agreement and RESOVIR-2 Part 1 data, followed by full RESOVIR-2 and RESPIRE readouts.

General disclaimer and copyright

This report has been commissioned by SynAct Pharma and prepared and issued by Edison, in consideration of a fee payable by SynAct Pharma. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright 2026 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or sol icitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

More on SynAct Pharma

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Consumer

Bally’s Intralot — Encouraging UK strength, outlook moderated

Bally’s Intralot’s H126 results show encouraging underlying momentum in International Interactive, particularly in the UK where growth accelerated despite the increase in remote gaming duty at the start of Q226. Management has mitigated a substantial part of the tax headwind with revenue growth and cost actions, although the anticipated benefit from industry consolidation is taking longer to emerge. Intralot’s legacy business was softer, reflecting weaker US lottery activity and pressure in Turkey, where the company continues to outperform, following changes to the remuneration mechanism. Management introduced a lower range for FY26e adjusted EBITDA that takes into account H126’s performance, changes in forex and confidence in a better H226 performance.

Continue Reading
Cookie Policy Overview
Edison Group

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping us understand which section of the website you find more interesting and useful. See our Cookie Policy for more information.

Strictly necessary and functional

These cookies are used to deliver our website and content. Strictly necessary cookies relate to our hosting environment, and functional cookies are used to facilitate social logins, social sharing and rich-media content embeds.

Advertising

Advertising Cookies collect information about your browsing habits such as the pages you visit and links you follow. These audience insights are used to make our website more relevant.

Performance

Performance Cookies collect anonymous information designed to help us improve the site and respond to the needs of our audiences. We use this information to make our site faster, more relevant and improve the navigation for all users.