Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

Developments

Hepion Pharmaceuticals receives non-dilutive funding

Hepion Pharmaceuticals (NASDAQ:HEPA) received $2.9-million in net proceeds from the sale of tax benefits under the company’s participation in the New Jersey Economic Development Authority (NJEDA) net operating loss...

January 9, 2023

Developments

Hepion to present Phase 2a rencofilstat multiomics data at NASH-TAG 2023

Hepion Pharmaceuticals (NASDAQ:HEPA) will present an abstract highlighting its lead drug candidate, rencofilstat, at the NASH-TAG 2023 Conference in Park City, Utah on Jan. 7. The presentation is entitled, “Rencofilstat...

January 6, 2023

Developments

liberDi receives FDA clearance for digital home dialysis system

liberDi, a portfolio company of The Trendlines Group (OTCQX:TRNLY), received regulatory clearance from the FDA for its Digital Dialysis Clinic, which allows patients to perform dialysis at home or at the workplace, by...

January 4, 2023

Developments

Aravive completes enrolment in Phase 3 ovarian cancer trial

Aravive (NASDAQ:ARAV) achieved full enrollment in a global registrational Phase 3 trial of batiraxcept plus paclitaxel for platinum-resistant ovarian cancer (PROC). The Phase 3 AXLerate-OC trial is evaluating efficacy...

January 4, 2023

Developments

Kiora completes enrollment in persistent corneal epithelial defects trial

Kiora Pharmaceuticals (NASDAQ:KPRX) completed enrollment in its clinical study evaluating KIO-201 in patients with persistent corneal epithelial defects (PCED), a rare ocular condition characterized by non-healing...

January 3, 2023

Developments

Profound Medical CEO adds to holdings, again

According to a filing with SEDI, Profound Medical (NASDAQ:PROF; TSX:PRN) chairman and CEO, Arun Menawat, acquired 13,000 shares of the company at a price of $7.81 (U.S.) each on the open market to hold 425,296 shares...

December 21, 2022

Developments

Zymeworks posts positive pivotal topline data in BTC

Zymeworks (NASDAQ ZYME) reported positive topline results from the pivotal Phase 2b HERIZON-BTC-01 open-label, single-arm clinical trial investigating zanidatamab, a HER2-targeted bispecific antibody, as monotherapy in...

December 19, 2022

Developments

Avidity posts first-ever data targeting delivery of RNA to muscle

Avidity Biosciences (NASDAQ:RNA) reported positive AOC 1001 data from the preliminary assessment of the Phase 1/2 MARINA trial, demonstrating the first-ever successful targeted delivery of RNA into muscle, a...

December 14, 2022

Developments

PharmaJet partner gets fast track for cancer vaccine

PharmaJet partner, Immunomic Therapeutics, received FDA fast track designation for a clinical study of its plasmid DNA vaccine, ITI-3000, in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin...

December 13, 2022

Developments

MAIA Biotechnology expands Phase 2 THIO-101 trial to Europe

Regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, have approved implementation of MAIA Biotechnology’s (NASDAQ:MAIA) THIO-101, the company’s Phase 2 clinical trial evaluating its lead...

December 13, 2022

Developments

Indaptus initiates Phase 1 trial of Decoy20 in advanced solid tumors

Indaptus Therapeutics (NASDAQ:INDP) initiated INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound, Decoy20, in patients with...

December 13, 2022

Developments

UT Southwestern performs 100th procedure with Profound’s TULSA-PRO

UT Southwestern in Dallas, one of the nation’s premier academic medical centers, performed its 100th procedure with Profound Medical’s (NASDAQ:PROF; TSX:PRN) TULSA-PRO, an innovative MRI-guided minimally invasive...

December 9, 2022

Developments

Context posts encouraging preliminary Phase 2 data in breast cancer

Context Therapeutics (NASDAQ:CNTX) reported preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s orally administered progesterone receptor (PR) antagonist, in...

December 8, 2022

Developments

Rani posts positive repeat-dose results with RaniPill in osteoporosis

Rani Therapeutics (NASDAQ:RANI) reported topline results from the repeat-dose Part 2 of a Phase 1 study of RT-102, the RaniPill GO capsule containing a proprietary formulation of human parathyroid hormone being...

December 7, 2022

Developments

IntelGenx, UPEI collaborate on VetaFilm platform in dogs and cats

IntelGenx (TSX:IGX; OTCQB:IGXT) and the University of Prince Edward Island are collaborating on a research project to assess palatability, owner-perceived acceptability, and ease of administration of IntelGenx’s...

December 7, 2022

Developments

FDA fast tracks Vistagen’s PH10 for major depressive disorder

The FDA granted Vistagen (NASDAQ:VTGN) fast track designation for development of PH10, an investigational nasal sprays, for the treatment of major depressive disorder (MDD). The FDA decision aligns with “our belief in...

December 6, 2022

Subscribe