Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Oruka initiates dosing of first patient in Phase 1 trial of ORKA-001

Oruka Therapeutics (NASDAQ:ORKA) has announced the initiation of dosing of in its Phase 1 clinical trial of ORKA-001, a subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors...

December 20, 2024

Developments

FDA approval of Mesoblast’s RYONCIL bodes well for other cell therapy companies like BioRestorative Therapies and Cell Technologies

Mesoblast (ASX:MSB; NASDAQ:MESO) is rallying today after the company announced yesterday after market close that the FDA approved RYONCIL (remestemcel-L), an allogeneic (donor) bone marrow-derived mesenchymal stromal...

December 19, 2024

Developments

Silo initiates PK and tolerability study for non-opioid extended-release pain therapeutic

Silo Pharma (NASDAQ:SILO) has announced the initiation of a preclinical pharmacokinetic (PK) and tolerability study, in partnership with AmplifyBio, to assess Silo’s dissolvable, ketamine-based injectable implant, SP-26...

December 18, 2024

Developments

Larimar reports positive initial data from OLE study of nomlabofusp in FA

Larimar Therapeutics (NASDAQ:LRMR) has announced positive initial results from its ongoing open-label extension (OLE) study evaluating daily subcutaneous injections of 25 mg of nomlabofusp, either self-administered or...

December 16, 2024

Developments

MindMed announces first patient dosed in Phase 3 study of LSD in GAD

MindMed (NASDAQ:MNMD) has announced that the first patient has been dosed in its Phase 3 Voyage study of MM120, an orally disintegrating tablet (ODT) and pharmaceutically optimized form of LSD, in generalized anxiety...

December 16, 2024

Developments

Fractyl reveals promising preclinical data for pancreatic gene therapy program

Fractyl Health (NASDAQ:GUTS) has announced that it will present new data from its RJVA-001 Rejuva Smart GLP-1 pancreatic gene therapy program for the treatment of obesity and type 2 diabetes (T2D) at the 22nd World...

December 12, 2024

Developments

Candel achieves primary endpoint in Phase 3 trial evaluating CAN-2409 in prostate cancer

Candel Therapeutics (NASDAQ:CADL) has announced results from its multicenter Phase 3 trial evaluating CAN-2409 viral immunotherapy in patients with localized prostate cancer. The study achieved its primary endpoint...

December 11, 2024

Developments

PharmaJet spotlights Nature publication on Stratis IM System benefits

Closely held PharmaJet has announced that the peer-reviewed journal Nature has published findings from a U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Phase 1 trial, demonstrating that the...

December 10, 2024

Developments

Akoya and NeraCare enter agreement to develop and commercialize Immunoprint test for melanoma

Akoya Biosciences (NASDAQ:AKYA) announced that it has entered into an exclusive global licencing agreement with NeraCare to develop and commercialize NeraCare’s Immunoprint test for guiding early-stage melanoma...

December 10, 2024

Developments

IN8bio reports sustained PFS in INB-100 trial for HSCT patients

IN8bio (NASDAQ:INAB) shared updated data showcasing continued progression-free survival (PFS) from its Phase 1 trial of INB-100 in older patients with hematologic malignancies undergoing haploidentical stem cell...

December 10, 2024

Developments

Profound Medical gains media attention for its incision- and radiation-free TULSA treatment for prostate cancer and/or BPH

Profound Medical’s (NASDAQ:PROF; TSX:PRN) CEO, Arun Menawat, recently sat down with Fierce Biotech to discuss how TULSA-PRO is revolutionizing prostate disease treatment. In the interview, Dr. Menawat noted...

December 9, 2024

Developments

China’s NMPA Approves EOM’s Coronary Imaging System Based on Conavi Medical’s IP

Conavi Medical (TSXV:CNVI) has announced that its exclusive licensing partner in China, East Ocean Medical (Hong Kong) Company Limited (EOM), has received approval by the China National Medical Products Administration...

December 9, 2024

Developments

Immunovia announces positive results and strong accuracy of next-gen test for PDAC

Immunovia (STO:IMMNOV) has announced the completion of its CLARITI study, demonstrating positive outcomes and strong accuracy in the clinical validation of its next-generation test for the early detection of pancreatic...

December 9, 2024

Developments

BioNxt achieves milestones for BNT23001 in MS

BioNxt Solutions (CSE:BNXT; OTC PINK:BNXTF; FSE:BXT) has announced that key milestones have been achieved in the development of BNT23001 for the treatment of multiple sclerosis (MS). BNT23001 is BioNxt’s proprietary...

December 9, 2024

Developments

Innate to receive up to $7.9 million from IFLI to advance IPH6501 in FL

Innate Pharma (Euronext Paris:IPH; NASDAQ:IPHA) and the Institute for Follicular Lymphoma (IFLI) have announced a collaboration agreement to clinically evaluate the potential of Innate’s IPH6501 in follicular lymphoma...

December 6, 2024

Developments

FDA grants clearance for Nanox.ARC expanding application to pulmonary and general use

Nanox Imaging (NASDAQ:NNOX) has announced that its Nanox.ARC stationary X-ray system has received 510(k) clearance from the FDA, allowing general use including the human musculoskeletal system, pulmonary, intra...

December 6, 2024

Developments

FDA grants RMAT for combination of Affimed’s acimtamig and Artiva’s AlloNK

Affimed (NASDAQ:AFMD) announced that the FDA has granted regenerative medicine advanced therapy (RMAT) designation to its combination therapy involving Affimed’s innate cell engager (ICE) acimtamig, and Artiva...

December 5, 2024

Developments

Nkarta receives IND clearance for IST in MG; launches enrollment of Ntrust-2 trial

Nkarta (NASDQ:NKTX) announced the clearance of an investigational new drug clearance (IND) application for its investigator-sponsored trial (IST) evaluating NKX019 in patients with myasthenia gravis (MG), alongside the...

December 5, 2024

Developments

Cartesian reports promising results from Phase 2b trial of Descartes-08 in MG

Cartesian Therapeutics (NASDAQ:RNAC) announced updated efficacy and safety data from its Phase 2b trial of Descartes-08 in myasthenia gravis (MG), showing deep, durable responses without the need for chemotherapy. The...

December 4, 2024

Developments

Medicus enters agreement with Swanielle to expand Phase 2 trial in APAC

Medicus Pharma (NASDAQ:MDCX) (TSXV:MDCX) announced a collaborative agreement with Swanielle to explore the expansion of its SKNJCT-003 Phase 2 clinical study for the treatment of basal cell carcinoma in the Asia-Pacific...

December 2, 2024

Developments

FDA accepts Revelation’s IND for Gemini in CKD

Revelation Biosciences (NASDAQ:REVB) announced that the FDA has accepted its investigational new drug (IND) application for Gemini in chronic kidney disease (CKD). The company notes that the milestone enables the launch...

December 2, 2024

Developments

Elite launches generic hydrocodone and acetaminophen tables for pain management

Elite Pharmaceuticals (OTCQB:ELTP) announced it has launched a generic version of Norco tablets, a combination of hydrocodone bitartrate and acetaminophen for pain management. The generic hydrocodone bitartrate and...

December 2, 2024

Oruka initiates dosing of first patient in Phase 1 trial of ORKA-001

FDA approval of Mesoblast’s RYONCIL bodes well for other cell therapy companies like BioRestorative Therapies and Cell Technologies

Silo initiates PK and tolerability study for non-opioid extended-release pain therapeutic

Larimar reports positive initial data from OLE study of nomlabofusp in FA

MindMed announces first patient dosed in Phase 3 study of LSD in GAD

Fractyl reveals promising preclinical data for pancreatic gene therapy program

Candel achieves primary endpoint in Phase 3 trial evaluating CAN-2409 in prostate cancer

PharmaJet spotlights Nature publication on Stratis IM System benefits

Akoya and NeraCare enter agreement to develop and commercialize Immunoprint test for melanoma

IN8bio reports sustained PFS in INB-100 trial for HSCT patients

Profound Medical gains media attention for its incision- and radiation-free TULSA treatment for prostate cancer and/or BPH

China’s NMPA Approves EOM’s Coronary Imaging System Based on Conavi Medical’s IP

Immunovia announces positive results and strong accuracy of next-gen test for PDAC

BioNxt achieves milestones for BNT23001 in MS

Innate to receive up to $7.9 million from IFLI to advance IPH6501 in FL

FDA grants clearance for Nanox.ARC expanding application to pulmonary and general use

FDA grants RMAT for combination of Affimed’s acimtamig and Artiva’s AlloNK

Nkarta receives IND clearance for IST in MG; launches enrollment of Ntrust-2 trial

Cartesian reports promising results from Phase 2b trial of Descartes-08 in MG

Medicus enters agreement with Swanielle to expand Phase 2 trial in APAC

FDA accepts Revelation’s IND for Gemini in CKD

Elite launches generic hydrocodone and acetaminophen tables for pain management

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