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    ALSEN   FR0012596468

SENSORION

(ALSEN)
  Report
Real-time Euronext Paris  -  11:35:29 2023-02-01 am EST
0.3800 EUR   +4.40%
01/31Sensorion and EVEON Collaborating to Develop an Injection System for the Delivery of Gene Therapy Treatments Into the Inner Ear
CI
01/03Sensorion Announces First Patient Enrolled in Phase 2a Proof of Concept Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity
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01/03Sensorion : Inside Information / Other news releases
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Sensorion SA Announces Approval to Initiate amended Phase 2a Proof of Concept Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity in France

10/24/2022 | 01:30am EST

Sensorion SA announced that the initiation of a Proof of Concept (PoC) clinical trial of SENS-401 (Arazasetron) in patients with Cisplatin-Induced Ototoxicity (CIO) has been approved by regulatory authorities in France. Cisplatin and other platinum-based compounds are essential chemotherapeutic agents for many cancers. A serious side effect of these therapies is ototoxicity, or permanent and irreversible hearing loss, in 50-60% of adult patients and 90% of pediatric patients who survive cancer.

This indication represents a very significant unmet need for patients and is a large market with an estimated incidence of more than 500,000 patients in the United States, the European Union and Japan. Approval has been granted to conduct a Phase 2a trial with SENS-401 in CIO. Following extensive analysis of the AUDIBLE-S study data earlier in 2022, Sensorion has adapted the design of this trial to focus the prevention of hearing loss.

The exploratory, Phase 2a, multicenter, randomized, controlled, open-label study, NOTOXIS, will evaluate the efficacy of SENS-401 to prevent the ototoxicity induced by cisplatin in adult subjects with a neoplastic disease. The trial will assess several endpoints, including the rate and severity of ototoxicity, the change in the pure tone audiometry PTA (dB) and tolerance. First patient enrolment is expected by end of 2022.


ę S&P Capital IQ 2022
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2022Sensorion Wins US FDA's Orphan Drug Tag for Hearing Loss Gene Therapy
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2022Sensorion SA Announces Approval to Initiate amended Phase 2a Proof of Concept Clinical ..
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Financials
Sales 2022 5,53 M 6,04 M 6,04 M
Net income 2022 -21,4 M -23,4 M -23,4 M
Net Debt 2022 20,1 M 21,9 M 21,9 M
P/E ratio 2022 -1,35x
Yield 2022 -
Capitalization 30,4 M 33,1 M 33,1 M
EV / Sales 2022 9,11x
EV / Sales 2023 12,3x
Nbr of Employees 38
Free-Float 50,7%
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Mean consensus BUY
Number of Analysts 2
Last Close Price 0,36 €
Average target price 2,80 €
Spread / Average Target 669%
EPS Revisions
Managers and Directors
Nawal Ouzren Chief Executive Officer & Director
Scott D. Myers Chairman
GÚraldine Honnet Chief Medical Officer
Eric Forquenot de la Fortelle Independent Director
Julien Miara Independent Director
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