Currency in EUR
Last close As at 25/03/2023
EUR0.68
▲ 0.03 (4.62%)
Market capitalisation
EUR34m
Research: Healthcare
Nicox has completed screening for additional patients for its Mont Blanc Phase III study of lead candidate NCX-470 for the treatment of open-angle glaucoma and ocular hypertension. Given that the primary efficacy endpoint measurements conclude at three months following a patient’s first NCX-470 dosing, the company now expects to report top line efficacy data in November 2022, earlier than its previous guidance of Q123. The Mont Blanc data release is potentially a key catalyst for the company, given NCX-470’s opportunity as a best-in-class single-agent glaucoma therapy.
Nicox |
Mont Blanc top-line data timelines pushed forward |
Clinical study timing update |
Pharma and biotech |
7 June 2022 |
Share price performance Business description
Analysts
Nicox is a research client of Edison Investment Research Limited. |
Nicox has completed screening for additional patients for its Mont Blanc Phase III study of lead candidate NCX-470 for the treatment of open-angle glaucoma and ocular hypertension. Given that the primary efficacy endpoint measurements conclude at three months following a patient’s first NCX-470 dosing, the company now expects to report top line efficacy data in November 2022, earlier than its previous guidance of Q123. The Mont Blanc data release is potentially a key catalyst for the company, given NCX-470’s opportunity as a best-in-class single-agent glaucoma therapy.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
14.4 |
(10.2) |
(0.30) |
0.0 |
N/A |
N/A |
12/21 |
8.6 |
(15.5) |
(0.32) |
0.0 |
N/A |
N/A |
12/22e |
5.3 |
(18.7) |
(0.43) |
0.0 |
N/A |
N/A |
12/23e |
7.0 |
(19.8) |
(0.44) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
We anticipate that positive Mont Blanc top line study data, demonstrating superior intraocular pressure (IOP) lowering efficacy to latanoprost, would materially de-risk future NCX-470 development and likely drive a re-rating on the stock. In the 433-patient US multicentre 28-day Dolomites Phase II trial the highest tested NCX-470 concentration (0.065%) demonstrated statistical superiority in IOP lowering to the latanoprost arm at day 28, delivering up to 1.4mmHg of additional lowering of IOP at this time point (p<0.025). The Phase III NCX-470 trials are testing a higher 0.1% drug concentration, which may provide further IOP reduction.
While Nicox’s updated timeline for a November 2022 Mont Blanc readout is an encouraging development, we are not revising our existing H226 launch timing estimate for the product, as outlined in our recent Outlook report. Commercial approval of the product will also require data from the second Phase III study, Denali. The company continues to expect to report Denali top line data after 2023, but has not yet provided formal updated guidance. However, the company expects to announce a new date for availability of the results once it obtains a more firm estimate of the overall timelines of this trial.
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Research: Healthcare
Newron Pharmaceuticals has announced positive interim results from the first 100 randomised patients completing one year of treatment (77 out of 100) in the Phase II 014/015 clinical trial (international, open label, rater-blinded study), in which evenamide is an add-on therapy to antipsychotics in moderate to severe treatment-resistant schizophrenia (TRS). The data are consistent with a gradual and sustained pattern of improvement in key efficacy measures compared with results after six weeks and six months of treatment, with the proportion of patients achieving meaningful improvements increasing over time. We view these updated results as particularly encouraging for evenamide as an effective treatment for TRS, and continued justification of Newron’s strategy to expand into this schizophrenia patient population.
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