Saniona provides update on ongoing review of tesofensine in Mexico
May 20 2022 - 2:45AM
Saniona provides update on ongoing review of tesofensine in Mexico
PRESS RELEASE
May 20,
2022
Saniona (OMX: SANION), a
clinical-stage biopharmaceutical
company focused on rare diseases, today announced
that the Mexican regulatory authority
Comisión Federal para la
Protección contra
Riesgos Sanitarios
(COFEPRIS) has published on Twitter
that its technical committee on
new molecules (El Comité
de Moléculas
Nuevas) was
unable to provide a favorable opinion on
tesofensine following a meeting held on May 18,
2022. The statement
on Twitter does not provide any details or
explanation for the position taken.
As part of the ongoing review process, the tesofensine
application was reviewed by a COFEPRIS technical committee on new
molecules on May 18, 2022. Saniona’s partner Productos Medix, S.A
de S.V, (Medix) has not received any official statement from
COFEPRIS yet. Therefore, Medix is not able to comment on this
statement and the possible implication for pursuing the process of
seeking approval for tesofensine in Mexico.
For more information, please contact Thomas
Feldthus, CEO, +45 22109957; thomas.feldthus@saniona.com
This information is such information as Saniona AB (publ) is
obliged to make public pursuant to the EU Market Abuse Regulation.
This information was submitted for publication, through the agency
of the contact person set out above, at 9.45 CEST on May 20,
2022.
About Saniona Saniona is a clinical-stage
biopharmaceutical company with a mission to leverage its ion
channel targeting expertise to discover, develop and deliver
innovative rare disease treatments. The company’s most advanced
product candidate, Tesomet™, has been progressed into mid-stage
clinical trials for hypothalamic obesity and Prader-Willi syndrome,
serious rare disorders characterized by severe weight gain,
disturbances of metabolic functions and uncontrollable hunger.
These clinical trials are voluntarily paused due to funding
limitations and Saniona is actively exploring partnering
opportunities. Saniona has developed a proprietary ion channel drug
discovery engine anchored by IONBASE™, a database of more than
130,000 compounds, of which more than 20,000 are Saniona’s
proprietary ion channel modulators. Through its ion channel
expertise, Saniona is advancing two wholly-owned ion channel
modulators, SAN711 and SAN903. SAN711 is in a Phase 1 clinical
trial and is positioned for the treatment of neuropathic pain
conditions, and SAN903 is in preclinical development for rare
inflammatory, fibrotic and hematological disorders. Saniona is
based in the Copenhagen area, Denmark, and is listed on Nasdaq
Stockholm Small Cap (OMX: SANION). Read more
at http://www.saniona.com.
- 20220520 Saniona press release (UK)
Saniona Ab (LSE:0RQJ)
Historical Stock Chart
From Jan 2025 to Feb 2025
Saniona Ab (LSE:0RQJ)
Historical Stock Chart
From Feb 2024 to Feb 2025
