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Research: Healthcare
Pharnext has announced it has completed patient enrolment in the pivotal Phase III PREMIER trial evaluating PXT3003 in patients with Charcot-Marie-Tooth disease type 1A (CMT1A) meeting its previously announced timeline of Q222. This follows the recently presented positive data from the long-term open-label PLEO-CMT-FU study, which continued to show a sustained benefit for patients after five years of treatment and which has a strong read-across for the PREMIER trial, in our view. Recruitment completion also means that the 15-month study stays on track for a Q423 readout. Success here would make PXT3003, which has orphan drug designation in the United States and Europe, the first drug to be approved for this condition. Pharnext’s share price climbed as high as 62% on the news before settling down to close with a modest gain.
Pharnext |
PREMIER trial completes patient recruitment |
Clinical development update |
Pharma & biotech |
31 May 2022 |
Share price performance
Business description
Analysts
Pharnext is a research client of Edison Investment Research Limited |
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Pharnext has announced it has completed patient enrolment in the pivotal Phase III PREMIER trial evaluating PXT3003 in patients with Charcot-Marie-Tooth disease type 1A (CMT1A) meeting its previously announced timeline of Q222. This follows the recently presented positive data from the long-term open-label PLEO-CMT-FU study, which continued to show a sustained benefit for patients after five years of treatment and which has a strong read-across for the PREMIER trial, in our view. Recruitment completion also means that the 15-month study stays on track for a Q423 readout. Success here would make PXT3003, which has orphan drug designation in the United States and Europe, the first drug to be approved for this condition. Pharnext’s share price climbed as high as 62% on the news before settling down to close with a modest gain.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
2.8 |
(21.4) |
(117.33) |
0.00 |
N/A |
N/A |
12/21 |
3.6 |
(30.6) |
(100.67) |
0.00 |
N/A |
N/A |
12/22e |
3.9 |
(30.8) |
(23.43) |
0.00 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Pharnext’s announcement confirms that 387 patients have been recruited (versus the target of 350) in the pivotal PREMIER study, evaluating the effectiveness and safety of PXT3003 in mild-to-moderate CMT1A patients, a genetic peripheral nerve disorder that causes progressive muscle weakness. As a reminder, the PREMIER trial is a randomised, double-blinded, placebo-controlled study undertaken across 52 centres globally. The primary endpoint is improvement on the 12-point Overall Neuropathy Limitations Scale (ONLS), which measures functional motor disability. The 15-month study is expected to conclude in Q423.
CMT1A is the most common type of CMT and Pharnext estimates that the disease afflicts over 150,000 people in the United States and Europe (1.5 million people worldwide), with the most severe cases (c 5% of patients) requiring wheelchairs. There are currently no approved therapies, with treatment restricted to supportive care such as orthotics, leg braces, physical and occupational therapy, followed by surgery on disease progression. If clinical development is successful, PXT3003 would be the first therapy approved for the indication and will have seven years and 10 years of market exclusivity courtesy of its orphan drug designation in the United States and Europe.
The market has reacted positively to the news, with the share price rising as high as 62% at its peak. While the news was widely anticipated, the market reaction can be explained if seen in conjunction with the recently announced data from the long-term open-label PLEO-CMT-FU study, which continued to show sustained benefit for patients after five years of total trial time. We expect this to potentially have a positive read-across for the PREMIER trial as well.
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Research: TMT
CI Games confirmed Q122 net revenues of PLN12.9m, a 36% rise y-o-y (Q121: PLN9.5m), with adjusted EBITDA of PLN6.5m (Q121: PLN6.3m), a 51% margin, down from 66% in Q121 (FY21: 59%). However, with reduced levels of amortisation, PBT was up 45% to PLN5.0m (Q121: PLN3.5m), with EPS rising 38% to PLN0.02. Cash at period end stood at PLN34.6m, with net cash of PLN29.7m, net of lease liabilities. Since quarter-end, in Q222, CI Games has announced an ongoing tender offer to buy out the 22% minority in United Label. The group has also secured a PLN29m credit facility to support working capital, provide additional development flexibility and support the buyout of the United Label minorities. Despite falling sector multiples, CI Games has held up well, but based on our estimate, still trades on an FY23 EV/EBITDA multiple of only 2.3x.