Category - Developments

Developments

IntelGenx in research collaboration with renowned neurologist for Montelukast VersaFilm in PD

IntelGenx (TSX:IGX; OTCQB:IGXT) announced a research collaboration with Per Svenningsson, M.D., Ph.D., of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled...

February 9, 2023

Developments

NeuroSense cleared in Germany to enroll patients in Phase 2b ALS trial

Germany’s Federal Institute for Drugs and Medical Devices approved NeuroSense Therapeutics’ (NASDAQ:NRSN) clinical trial application to enroll patients in PARADIGM, a Phase 2b study of its lead combination drug...

February 8, 2023

Developments

Annovis Bio to expand Phase 3 PD study of buntanetap to EU

Annovis Bio (NYSE:ANVS) received approval to open 48 clinical trial sits in five European Union countries for its ongoing Phase 3 study of buntanetap for the treatment of Parkinson’s disease (PD). The company is...

February 8, 2023

Developments

SynaptixBio gets FDA rare pediatric disease nod for TUBB4a leukodystrophy

Dr. Dan Williams, CEO and Co-founder The FDA granted a rare pediatric disease (RPD) designation to closely-held SynaptixBio of the UK to develop the first treatment for TUBB4A leukodystrophy, a rare genetic and...

February 7, 2023

Developments

Tonix starts Phase 2 intranasal oxytocin study in chronic migraine

Tonix Pharmaceuticals (NASDAQ:TNXP) enrolled the first participant in the Phase 2 PREVENTION study of TNX-1900 (intranasal potentiated oxytocin) for the prevention of chronic migraine headache. The double-blind, placebo...

February 6, 2023

Developments

Theralase to present Phase 2 NMIBC interim data at AUA meeting

The American Urology Association has accepted for a moderated poster presentation at its annual meeting Theralase Technologies’ (TSXV:TLT; OTCQB:TLTFF) interim data from its Phase 2 Bacillus Calmette Guerin unresponsive...

February 2, 2023

Developments

Miromatrix to respond to FDA clinical hold on miroliverELAP in second half

Miromatrix Medical (NASDAQ:MIRO) has evaluated a clinical hold on its investigational miroliverELAP transplantable organ and plans to submit its response to the FDA in the second half of 2023 and initiate a first-in...

February 1, 2023

Developments

Roth Capital acquires MKM Partners

Roth Capital Partners completed its acquisition of MKM Partners on Jan. 31, and the combined organization will conduct business as ROTH MKM. This is the first acquisition ROTH has made in its 30-plus years of business...

February 1, 2023

Developments

First Wave to initiate Phase 2 trial of enhanced adrulipase formulation

First Wave BioPharma (NASDAQ:FWBI) plans to initiate a Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in...

January 31, 2023

Developments

Reneo receives FDA fast track for of long-chain fatty acid oxidation disorder

The FDA granted Reneo Pharmaceuticals’ (NASDAQ:RPHM) mavodelpar (REN001) fast track designation for long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, one of the predominant genotypes in patients with long...

January 31, 2023

Category - Developments

IntelGenx in research collaboration with renowned neurologist for Montelukast VersaFilm in PD

NeuroSense cleared in Germany to enroll patients in Phase 2b ALS trial

Annovis Bio to expand Phase 3 PD study of buntanetap to EU

SynaptixBio gets FDA rare pediatric disease nod for TUBB4a leukodystrophy

Tonix starts Phase 2 intranasal oxytocin study in chronic migraine

Theralase to present Phase 2 NMIBC interim data at AUA meeting

Miromatrix to respond to FDA clinical hold on miroliverELAP in second half

Roth Capital acquires MKM Partners

First Wave to initiate Phase 2 trial of enhanced adrulipase formulation

Reneo receives FDA fast track for of long-chain fatty acid oxidation disorder

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