Last close As at 05/08/2026
USD3.15
▲ −0.09 (−2.78%)
Market capitalisation
USD226m
Research: Healthcare
Although the topline results of PALM 007 (studying SIGA’s tecovirimat in the treatment of mpox) did not meet the statistical significance for the full population (primary endpoint), we are encouraged by the clinically meaningful benefit reported over placebo in early-treated patients and in those with severe disease. The data highlight an opportunity to establish an effective regime for these key populations, given the lack of effective treatment options and the overall importance of early treatment in infectious diseases. PALM 007 was not a registrational study, and SIGA’s priorities in mpox are the four remaining ongoing studies targeting this indication, which may potentially support a mpox label in the US. Currently, tecovirimat is approved for mpox treatment in the EU and UK.
Written by
SIGA Technologies |
PALM 007 data warrant a closer look in mpox |
Clinical update |
Pharma and biotech |
19 August 2024 |
Share price performance
Business description
Analysts
SIGA Technologies is a research client of Edison Investment Research Limited |
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Although the topline results of PALM 007 (studying SIGA’s tecovirimat in the treatment of mpox) did not meet the statistical significance for the full population (primary endpoint), we are encouraged by the clinically meaningful benefit reported over placebo in early-treated patients and in those with severe disease. The data highlight an opportunity to establish an effective regime for these key populations, given the lack of effective treatment options and the overall importance of early treatment in infectious diseases. PALM 007 was not a registrational study, and SIGA’s priorities in mpox are the four remaining ongoing studies targeting this indication, which may potentially support a mpox label in the US. Currently, tecovirimat is approved for mpox treatment in the EU and UK.
Year end |
Revenue |
EBITDA* |
PBT* |
EPS* |
P/E |
Yield |
12/22 |
110.8 |
43.2 |
43.7 |
0.46 |
18.9 |
5.2 |
12/23 |
139.9 |
84.2 |
87.8 |
0.95 |
9.1 |
6.9 |
12/24e |
160.5 |
86.2 |
92.5 |
1.01 |
8.6 |
8.0 |
12/25e |
186.9 |
109.8 |
115.4 |
1.25 |
6.9 |
8.6 |
Note: *EBITDA, PBT and EPS (basic) are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
PALM 007 was a randomized, placebo-controlled, double-blind study assessing the safety and efficacy of oral tecovirimat in mpox sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), as part of an initiative to address the 2022 mpox outbreak in the Democratic Republic of the Congo (DRC). The trial was designed for humanitarian considerations and had certain restrictions for enrollment (varying stages of disease, age and health, hospitalization for duration of study, among other factors). Patients were randomized 1:1 to receive either tecovirimat or placebo and the primary efficacy measure was time to lesion resolution.
The topline results was altogether not surprising as many participants had started treatment over a week after becoming ill and all patients were hospitalized for the duration of their treatment. However, the meaningful improvements (vs placebo) reported in patients receiving tecovirimat where their symptoms began up to seven days prior to randomization, and in those with severe disease (≥100 lesions) are a positive development. The data also reaffirmed tecovirimat’s strong safety profile. SIGA and NIAID are now pursuing a detailed analysis of the results.
There are four ongoing studies for tecovirimat in mpox, which may support SIGA’s objective to obtain a mpox label; they are: STOMP (US and other countries); UNITY (Switzerland, Brazil, Argentina); Platinum-CAN (Canada); and EPOXI (EU). We highlight that PALM 007 was not a registrational study forming part of a US FDA IND application, due to key differences in design. Notably, the four studies have not yet enrolled children and include more immunocompromised patients (ie those with HIV). Currently, tecovirimat is approved for mpox treatment in the EU and UK.
Mpox is an ongoing medical challenge, with the WHO having declared the recent outbreak in the DRC and a growing number of African countries a public health emergency of international concern (August 2024). While the PALM 007 results were mixed, we continue to see upside opportunity for SIGA, provided the data from the STOMP, UNITY, Platinum-CAN and EPOXI trials are supportive. For a detailed discussion of SIGA’s current position, please see our prior update note.
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Research: TMT
Dentsu’s H124 figures show sequential quarterly improvements, with the group posting organic growth of 0.2% in Q2. Encouragingly, this is in part ascribed to improved pitch win rates in all four reporting regions, underpinning growth projections through H224 and into FY25, despite the persistent difficult macroeconomic backdrop. The One dentsu initiative is driving collaborative efforts across group capabilities and geographies and we expect this to be at the heart of the new medium-term strategy, to be unveiled in H2. In the meantime, the Business transformation (BX) offering is proving effective in Japan and is now to be rolled out more widely. The shares continue to be valued well below peers and we would expect this discount to narrow with improving operational performance.