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Research: Healthcare
Mendus has announced that the FDA has granted Fast Track designation to its lead cancer vaccine, vididencel, as a potential maintenance therapy in acute myeloid leukaemia (AML). This regulatory decision was based on interim results from the ADVANCE II trial (reported in December 2022), which showed encouraging survival data to support vididencel as a monotherapy in AML maintenance, as well as a desirable safety profile. Benefits of Fast Track designation include more frequent interactions with the FDA for an expedited approval process and a ‘rolling review’ for its market application. We believe that Fast Track designation represents a key milestone, enabling a potentially accelerated route to market, provided clinical results continue to be positive. Updated data (relapse free survival and overall survival) from the ADVANCE II trial are expected in Q424. Mendus is also preparing for an additional Phase II combination trial with Onureg, which is on track to commence by end-2023.
Written by
Mendus |
Vididencel secures Fast Track designation in AML |
Regulatory update |
Pharma and biotech |
8 September 2023 |
Share price performance
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Analysts
Mendus is a research client of Edison Investment Research Limited |
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Mendus has announced that the FDA has granted Fast Track designation to its lead cancer vaccine, vididencel, as a potential maintenance therapy in acute myeloid leukaemia (AML). This regulatory decision was based on interim results from the ADVANCE II trial (reported in December 2022), which showed encouraging survival data to support vididencel as a monotherapy in AML maintenance, as well as a desirable safety profile. Benefits of Fast Track designation include more frequent interactions with the FDA for an expedited approval process and a ‘rolling review’ for its market application. We believe that Fast Track designation represents a key milestone, enabling a potentially accelerated route to market, provided clinical results continue to be positive. Updated data (relapse free survival and overall survival) from the ADVANCE II trial are expected in Q424. Mendus is also preparing for an additional Phase II combination trial with Onureg, which is on track to commence by end-2023.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(133.4) |
(0.73) |
0.0 |
N/A |
N/A |
12/22 |
3.4 |
(138.8) |
(0.70) |
0.0 |
N/A |
N/A |
12/23e |
0.3 |
(96.1) |
(0.18) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(124.2) |
(0.14) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As a reminder, vididencel is an off-the-shelf, non-patient-specific, cell-based cancer vaccine being developed as a potential maintenance therapy for AML and ovarian cancer. The ADVANCE II trial (n=20) is currently in the long-term follow-up stage and involves patients who have responded to previous therapy and achieved complete remission, but still harbour measurable residual disease. The interim data from this study were encouraging, demonstrating a potentially competitive profile versus Onureg (oral azacitidine), the current standard of care and the only approved drug for AML maintenance. As a result, we view the company’s previously disclosed plans to prioritise a combination study favourably, and believe that exploring possible synergies between the two treatments could maximise the potential of vididencel. Further details can be accessed in our prior update note.
Mendus’s announcement that it has secured Fast Track designation marks a key step for the clinical development of vididencel, in our view, as the company continues to progress its lead asset on both the clinical front and regulatory front. To further corroborate this programme, we note that the cancer vaccine has already been assigned Orphan Drug designation from the FDA for AML in the US and Europe. Furthermore, the company was also recently granted an Advanced Therapy Medicinal Product certificate from the EMA, based on a review of manufacturing quality and non-clinical data for vididencel. In June 2023, Mendus announced a strategic alliance with NorthX Biologics, a leading Swedish manufacturing organisation for cell and gene therapies, to establish large-scale manufacturing capabilities. We believe the agreement should ensure smooth progress from pivotal-stage clinical development through to commercialisation, provided vididencel obtains regulatory approval.
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