Category - Developments

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

Developments

Theralase to present Phase 2 NMIBC interim data at ASCO GU cancer symposium

Interim data from Theralase Technologies’ (TSXV:TLT; OTCQB:TLTFF) Phase 2 non-muscle invasive bladder cancer (NMIBC) clinical study has been accepted by the American Society of Clinical Oncology (ASCO) Genito Urinary...

January 25, 2023

Developments

Precigen posts positive Phase 1 AdenoVerse data in RRP

Precigen (NASDAQ:PGEN) reported positive Phase 1 dose escalation and expansion cohort data as of the Jan. 12, 2023 cut-off for its investigational PRGN-2012 off-the-shelf AdenoVerse immunotherapy in patients with...

January 25, 2023

Developments

CMS sets national pricing for BioStem’s VENDAJE

The Center for Medicare Services (CMS) established national pricing for BioStem Technologies’ (OTCQB:BSEM) VENDAJE in all Medicare Administrative Contractors (MAC) regions, effective Jan. 1, 2023. VENDAJE allografts now...

January 24, 2023

Category - Developments

Subscribe