PIZZODIGINO
Pacifico
Chissà se un giorno non capiterà anche a noi della Nicox ?
NicOx.... in attesa di.....
- Creatore Discussione DickSIM
- Data di Inizio
Chissà se un giorno non capiterà anche a noi della Nicox ?
Jazalde
Forumer storico
e sai che soddisfazione arrivare a 2 euro dopo anni di stasi sul titolo? ci hai rimesso di sicuro
PIZZODIGINO
Pacifico
A 2 € non ci rimetto, ci guadagno poco, ma almeno non ci smeno soldi.
elfrancese
Forumer storico
nos amis de kepler ne sont plus nos amis aujourd'hui !!
NCX 470 needs to improve its efficacy profile
Why this report? In October 2022, Nicox released top-line data of the Mont Blanc phase III trial evaluating NCX 470 in the treatment of open angle glaucoma and ocular hypertension. Although the study met the primary endpoint of non- inferiority vs. latanoprost (the standard of care) in lowering IOP, it failed to demonstrate a statistically significant superiority in a pre-specified secondary efficacy analysis. Thus, although these results meet the criteria for approval in the US, we believe it will be harder to convince the medical community. As the design of the Denali phase III trial is very close to the Mont Blanc trial, outcomes are likely to be similar. To create strong differentiation and generate commercial interest, Nicox plans to initiate two phase IIIb studies in H1 to assess the protective effects of NCX 470 on the retina. Key findings The Mont Blanc phase III study met its primary endpoint, fulfilling the efficacy requirements for approval in the US. However, due to the inability to reach statistical superiority of NCX 470 versus latanoprost, we expect a reduced market share. Improvement of retinal functions could increase the commercial value of NCX470. Deconstructing the forecasts We forecast a market share of 6% (vs. 15%), leading to peak sales of EUR86m (vs. EUR215m). Hence, we cut our TP from EUR7.0 to EUR2.7.
NCX 470, a promising asset needing an improved efficacy profile NCX 470 is a second-generation nitrite oxide-donating bimatoprost analogue, discovered through Nicox’s NO-donating proprietary research platform, for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Following promising phase II data demonstrating NCX 470’s excellent safety/tolerability profile and superior efficacy to latanoprost (the most widely prescribed first-line therapy for glaucoma), two phase III trials, Mont Blanc and Denali, were initiated in 2020. Top-line data of the Mont Blanc trial were presented in October 2022, however, due to several hurdles (the Covid situation in China and the US) leading to delays, top-line results of the Denali trial will not be available before 2025E. Mixed results from Mont Blanc phase III trial Initiated in the US in June 2020, the Mont Blanc phase III trial aimed to assess the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost (0.005%) in patients with open-angle glaucoma or ocular hypertension (n=691). The primary efficacy objective of demonstrating non-inferiority of NCX 470 (once day) to latanoprost 0.005% was based on time matched IOP at 8 AM and 4 PM at week 2, week 6, and month 3. The secondary efficacy objective was to demonstrate a statistical superiority to latanoprost. The Mont Blanc trial met its primary efficacy endpoint, with NCX 470 showing 8.0 to 9.7 mmHg IOP lowering from baseline vs. 7.1 to 9.4 mmHg for latanoprost (reduction in time matched IOP at 8 AM and 4 PM across the week 2, week 6 and month 3 visits). Moreover, in the pre-specified secondary efficacy analysis, NCX 470 was statistically superior (p<0.049) to latanoprost in IOP reduction from baseline at four of the six timepoints (time-matched change from baseline IOP), and numerically greater at all six timepoints. However, while the difference in IOP reduction between NCX 470 and latanoprost was up to 1.0 mmHg in favour of NCX 470, it failed to reach the overall statistical superiority (secondary endpoint).
Although the study data met the efficacy requirements for approval in the US (non-inferiority in lowering IOP compared to the standard of care, latanoprost 0.005%), the failure to demonstrate superiority at all timepoints makes it unlikely that NCX 470 will achieve best-in-class status. Denali, the second pivotal phase III trial The Denali phase III trial (n=670), which started in November 2020, is the second phase III clinical trial assessing NCX 470 in patients with glaucoma. Equally funded by Nicox and Ocumension Therapeutics, its Chinese partner, the trial is currently ongoing in the US and China.
Subject to numerous delays primarily linked to the pandemic, top-line data are now expected in 2025E but should hold no surprises. Indeed, the Mont Blanc and Denali phase III trials are very close in terms of design (population, size, primary endpoint). Thus, we do not expect the outcomes of the Denali trial to differ from Mont Blanc. Although achievement of the primary endpoint is anticipated, NCX 470 is unlikely to demonstrate superiority over latanoprost. Retinal benefits: the key to differentiation Against this backdrop, Nicox is now focusing on differentiating features that will increase the commercial value of NCX 470. Indeed, although IOP lowering is the focus when addressing glaucoma, other risk factors are involved in the eventual loss of vision. Results from exploratory nonclinical studies conducted by Nicox have already suggested a positive effect of NCX 470 on ocular perfusion and retinal functions. Indeed, NCX 470 showed a significant reversal of the deleterious effects of endothelin-1 (ET-1) on ophthalmic artery hemodynamics as well as a restoration of photoreceptor responses (in decline after ET-1 administration).
To confirm the potential protective effects on the retina, Nicox will launch two phase IIIb trials aiming to investigate: NCX 470’s ability to lower episcleral venous1 pressure and enhance outflow in the trabecular meshwork (a filter-like structure essential to regulate aqueous humor outflow), two key determinants in IOP. NCX 470’s effect on the retinal blood vessel density as evidence of its action on the retinal blood flow. Should the trials demonstrate beneficial retinal effects in patients, thus confirming nonclinical findings, this would give NCX 470 an edge over its competitors, increasing its appeal to physicians. Impact on our valuation A lower market share Following the results of the Mont Blanc study and the inability to demonstrate a statistical superiority of NCX 470 vs. latanoprost, we believe that the asset will struggle to convince physicians to prescribe this treatment and payers to reimburse it, especially if NCX 470 is sold with a premium compared with generic latanoprost
Although the improvement in retinal functions may represent an attractive added value, we have adjusted the market share downwards to account for this possible a less attractive profile, which leads us to reduce the expected peak sales. Henceforth, our valuation model forecasts a market share of 6% compared to 15% previously, corresponding to peak sales of EUR86m (vs. EUR215m). We do not change our other estimates regarding NCX 4251, Vyzulta and Zerviate. Fair value of EUR2.7 per share Our rNPV-based model yields a valuation of EUR141m, corresponding to EUR2.7 TP (vs. EUR7.0 previously).
NCX 470 needs to improve its efficacy profile
Why this report? In October 2022, Nicox released top-line data of the Mont Blanc phase III trial evaluating NCX 470 in the treatment of open angle glaucoma and ocular hypertension. Although the study met the primary endpoint of non- inferiority vs. latanoprost (the standard of care) in lowering IOP, it failed to demonstrate a statistically significant superiority in a pre-specified secondary efficacy analysis. Thus, although these results meet the criteria for approval in the US, we believe it will be harder to convince the medical community. As the design of the Denali phase III trial is very close to the Mont Blanc trial, outcomes are likely to be similar. To create strong differentiation and generate commercial interest, Nicox plans to initiate two phase IIIb studies in H1 to assess the protective effects of NCX 470 on the retina. Key findings The Mont Blanc phase III study met its primary endpoint, fulfilling the efficacy requirements for approval in the US. However, due to the inability to reach statistical superiority of NCX 470 versus latanoprost, we expect a reduced market share. Improvement of retinal functions could increase the commercial value of NCX470. Deconstructing the forecasts We forecast a market share of 6% (vs. 15%), leading to peak sales of EUR86m (vs. EUR215m). Hence, we cut our TP from EUR7.0 to EUR2.7.
NCX 470, a promising asset needing an improved efficacy profile NCX 470 is a second-generation nitrite oxide-donating bimatoprost analogue, discovered through Nicox’s NO-donating proprietary research platform, for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Following promising phase II data demonstrating NCX 470’s excellent safety/tolerability profile and superior efficacy to latanoprost (the most widely prescribed first-line therapy for glaucoma), two phase III trials, Mont Blanc and Denali, were initiated in 2020. Top-line data of the Mont Blanc trial were presented in October 2022, however, due to several hurdles (the Covid situation in China and the US) leading to delays, top-line results of the Denali trial will not be available before 2025E. Mixed results from Mont Blanc phase III trial Initiated in the US in June 2020, the Mont Blanc phase III trial aimed to assess the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost (0.005%) in patients with open-angle glaucoma or ocular hypertension (n=691). The primary efficacy objective of demonstrating non-inferiority of NCX 470 (once day) to latanoprost 0.005% was based on time matched IOP at 8 AM and 4 PM at week 2, week 6, and month 3. The secondary efficacy objective was to demonstrate a statistical superiority to latanoprost. The Mont Blanc trial met its primary efficacy endpoint, with NCX 470 showing 8.0 to 9.7 mmHg IOP lowering from baseline vs. 7.1 to 9.4 mmHg for latanoprost (reduction in time matched IOP at 8 AM and 4 PM across the week 2, week 6 and month 3 visits). Moreover, in the pre-specified secondary efficacy analysis, NCX 470 was statistically superior (p<0.049) to latanoprost in IOP reduction from baseline at four of the six timepoints (time-matched change from baseline IOP), and numerically greater at all six timepoints. However, while the difference in IOP reduction between NCX 470 and latanoprost was up to 1.0 mmHg in favour of NCX 470, it failed to reach the overall statistical superiority (secondary endpoint).
Although the study data met the efficacy requirements for approval in the US (non-inferiority in lowering IOP compared to the standard of care, latanoprost 0.005%), the failure to demonstrate superiority at all timepoints makes it unlikely that NCX 470 will achieve best-in-class status. Denali, the second pivotal phase III trial The Denali phase III trial (n=670), which started in November 2020, is the second phase III clinical trial assessing NCX 470 in patients with glaucoma. Equally funded by Nicox and Ocumension Therapeutics, its Chinese partner, the trial is currently ongoing in the US and China.
Subject to numerous delays primarily linked to the pandemic, top-line data are now expected in 2025E but should hold no surprises. Indeed, the Mont Blanc and Denali phase III trials are very close in terms of design (population, size, primary endpoint). Thus, we do not expect the outcomes of the Denali trial to differ from Mont Blanc. Although achievement of the primary endpoint is anticipated, NCX 470 is unlikely to demonstrate superiority over latanoprost. Retinal benefits: the key to differentiation Against this backdrop, Nicox is now focusing on differentiating features that will increase the commercial value of NCX 470. Indeed, although IOP lowering is the focus when addressing glaucoma, other risk factors are involved in the eventual loss of vision. Results from exploratory nonclinical studies conducted by Nicox have already suggested a positive effect of NCX 470 on ocular perfusion and retinal functions. Indeed, NCX 470 showed a significant reversal of the deleterious effects of endothelin-1 (ET-1) on ophthalmic artery hemodynamics as well as a restoration of photoreceptor responses (in decline after ET-1 administration).
To confirm the potential protective effects on the retina, Nicox will launch two phase IIIb trials aiming to investigate: NCX 470’s ability to lower episcleral venous1 pressure and enhance outflow in the trabecular meshwork (a filter-like structure essential to regulate aqueous humor outflow), two key determinants in IOP. NCX 470’s effect on the retinal blood vessel density as evidence of its action on the retinal blood flow. Should the trials demonstrate beneficial retinal effects in patients, thus confirming nonclinical findings, this would give NCX 470 an edge over its competitors, increasing its appeal to physicians. Impact on our valuation A lower market share Following the results of the Mont Blanc study and the inability to demonstrate a statistical superiority of NCX 470 vs. latanoprost, we believe that the asset will struggle to convince physicians to prescribe this treatment and payers to reimburse it, especially if NCX 470 is sold with a premium compared with generic latanoprost
Although the improvement in retinal functions may represent an attractive added value, we have adjusted the market share downwards to account for this possible a less attractive profile, which leads us to reduce the expected peak sales. Henceforth, our valuation model forecasts a market share of 6% compared to 15% previously, corresponding to peak sales of EUR86m (vs. EUR215m). We do not change our other estimates regarding NCX 4251, Vyzulta and Zerviate. Fair value of EUR2.7 per share Our rNPV-based model yields a valuation of EUR141m, corresponding to EUR2.7 TP (vs. EUR7.0 previously).
elfrancese
Forumer storico
pendant ce temps onxeo gagne 53%
350% sur 5 jours
350% sur 5 jours
viralic
Forumer storico
Penso a questo punto ( e concordo con Kepler) che nicox abbia perso per un 90% attrattiva causa del flop del 470 ( i risultati del latanoprost sui pazienti trattati mai cosi forti nella storia lunga del farmaco ancora è rimasto un mistero e quindi penso che qualcosa non abbia funzionato nelle prove visto che il 470 ha avuto una efficacia simile alla fase 2 dove era superiore di 1,4 al latanoprost e quindi un farmaco da 200 e passa milioni di fatturato potenziale). Valiamo poco in borsa ma purtroppo valiamo poco anche come pipeline.....2,70 penso sia un target più che generoso al momento.....se chiudiamo a 2 questa brutta lunga avventura che solo a tratti ha regalato qualche soddisfazione in 20 anni come azionista ( guadagnando solo grazie al trading e mai come cassettista ) sarei già contento......temo invece che a causa anche di un management guidato da una persona poco capace, senza alcun titolo precedente REALE in aziende pharma ( praticamente poco più di un impiegato) anche 2 euro a meno di miracoli sarà un miraggio.
Jazalde
Forumer storico
si ma tu dici mistero e allora la societa che fa sta zitta non indaga sum questa storia o hanno pure loro capito che dipende dal 4760 e non dal latanoprost?se tacciono significa che eì' il 470 che ha qualcosa che non va piu chiaro di cosi,
chiaro che hanno capito di aver toppato in pieno e tacciono e cercano di salvare la baracca per darsi altri stipendi ma penso che ormai il destino e' segnato,non hanno piu nulla in mano e quindi il fallimento e' segnato ora ci sara una agonia che durera per mesi fino ache dovranno chiudere e sarebbe ora visto che stanno li solo a scaldare le sedie,quello che c'e ora sara pure incapace ma lo e' da poco tempo ,invece chi c'era prima lo e' stato per tantissimi anni visti i risultati che in maggior parte sono opera sua
Jazalde
Forumer storico
finalmente ammetti il fallimento di nicox e ora dovresti sparire tu dal forum....ricordi come mi hai attaccato per anni dicendo che appena arrivava a 14 euro dovevo sparire?
mi hai offeso per anni dandomi dell'incompetente etc etc e ora se hai un minimo di dignita dovresti ammettere di essere stato un supponente e dovresti sparire tu dal forum
mi hai offeso per anni dandomi dell'incompetente etc etc e ora se hai un minimo di dignita dovresti ammettere di essere stato un supponente e dovresti sparire tu dal forum
Ultima modifica:
Jazalde
Forumer storico
parlano pure questi di keplero hanno la faccia come il.....dopo tutti i target che hanno dato e mi sembra abbiano partecipato pure agli ak sarebbero da indagare
viralic
Forumer storico
Non sparisco proprio per niente.....nicox aveva le potenzialità di arrivare all'epoca in cui l ho scritto a 14 euro.....cosi come la tua INNATE se non cannava la fase 3 sulla NASH arrivava a 50 euro .....invece quota poco più di 3 e speriamo che riesca in parte a salvare il salvabile con un altra patologia al fegato più facile da curare e che non finisca pure questa come altre che stanno chiudendo i battenti.
Riguardo al mistero del latanoprost con efficacia senza eguali mai visti prima, la tua ignoranza e supponenza di certo non inferiore alla mia....anzi, è realmente tragicomica......il 470 ha curato il glaucoma nei pazienti trattati nella stessa maniera della fase 2 e anche leggermente meglio sul punto più alto, quindi i tuoi sospetti che il 470 non funzioni sono ridicoli....il problema è la differenza con l efficacia contro latanoprost che ha deluso per colpa dell'efficacia di quest'ultimo....lo sai che te l ho spiegato mille volte e tu non l hai ancora capito?.....anche il fatto che tu scriva che il 470 sia meno efficace del latanoprost dimostra ulteriormente la tua ignoranza in materia....il 470 è stato più efficace a trattare il glaucoma nei pazienti ma non in modo cosi alto come era previsto dall'endpoint secondario con la FDA.....ha fatto 0.9 meglio del latanoprost contro 1 punto che doveva fare per raggiungere l'endpoint ( il farmaco migliore in commercio è il roklatan che ha fatto 1.58 meglio ma in COMBO....ossia una goccia di roklatan e una di latanoprost insieme)....in quel caso però l'efficacia del latanoprost nei pazienti ebbe una efficacia simile alla fase 2 del 470....ossia l 'efficacia che ha da anni quel farmaco......e ora basta spiegarti perchè tanto dici sempre le stesse cose.
continua pure a fare il leone da tastiera , tanto il livello della tua preparazione culturale si misura da come scrivi e da come ti esprimi...ma questo sarebbe anche facilmente superabile e soprattutto di poca importanza in questi forum....il problema è la scarsità realmente palese della tua intelligenza ...e questo è invece realmente fastidioso....buon proseguimento ....mi auguro tu possa emigrare in altri forum di altre azioni ciofeche e parlarne male anche se le hai comprate e mai vendute......
