Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Aravive to present positive updated data at ASCO GU cancer symposium

Aravive (NASDAQ:ARAV) will present updated results from its ongoing Phase 1b/2 trial of batiraxcept in clear cell renal cell carcinoma (ccRCC) at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary (GU)...

February 14, 2023

Developments

Cognition completes enrollment in Phase 2 SEQUEL study in AD

Cognition Therapeutics (NASDAQ:CGTX) completed enrollment in the randomized, double-blind Phase 2 SEQUEL study of its CT1812 in 16 adults with mild-to-moderate Alzheimer’s disease. The study was designed to assess...

February 9, 2023

Developments

Abbott to acquire Cardiovascular Systems for $890-million

Abbott (NYSE:ABT) agreed to acquire Cardiovascular Systems, Inc. (NASDAQ:CSII) for $20 a share or approximately $890-million. Cardiovascular Systems is a leader in devices for atherectomy, a minimally invasive treatment...

February 9, 2023

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

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

Developments

IntelGenx, ARWAN Pharma in supply agreement for RIZAPORT in MENA countries

IntelGenx (TSX:IGX; OTCQB:IGXT) entered into an exclusive supply agreement for its RIZAPORT product with ARWAN Pharmaceuticals Industries Lebanon for various countries in the Middle East and North Africa, known as the...

January 23, 2023

Developments

Jazz, Zymeworks post positive Phase 2 survival in metastatic gastroesophageal adenocarcinoma

Jazz Pharmaceuticals (NASDAQ:JAZZ) and Zymeworks (NASDAQ:ZYME) reported the first overall survival (OS) data from a Phase 2 trial examining zanidatamab, an investigational HER2-targeted bispecific antibody, in...

January 19, 2023

Developments

Hepion posts positive preclinical results in multiple myeloma expanding rencofilstat’s anti-cancer potential

Hepion Pharmaceuticals (NASDAQ:HEPA) announced positive results of preclinical studies examining rencofilstat as a potential therapeutic for multiple myeloma (MM). Rencofilstat exerted anti-cancer activity across a...

January 18, 2023

Developments

FDA grants Avidity fast tract for facioscapulohumeral muscular dystrophy

The FDA granted Avidity Biosciences (NASDAQ:RNA) fast track designation to the company’s AOC 1020 drug candidate for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary...

January 18, 2023

Developments

Oramed oral insulin flunks Phase 3 Type 2 diabetes trial

Oramed Pharmaceuticals’ (NASDAQ, TASE ORMP) oral insulin drug candidate, ORMD-0801, did not meet its primary endpoint in a Phase 3 clinical trial in patients with Type 2 diabetes (T2D) at 26 weeks. The multi-center ORA...

January 12, 2023

Developments

Hepion presents preclinical study of anti-cancer activity of rencofilstat

Hepion Pharmaceuticals’ (NASDAQ:HEPA) research collaborator presented new findings from a preclinical study on the company’s lead drug candidate, rencofilstat, a potent inhibitor of cyclophilins, at the 2023 State of...

January 11, 2023

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