Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Japan’s MHLW approves Aurinia’s LUPKYNIS (voclosporin) for lupus nephritis

Aurinia Pharmaceuticals (NASDAQ:AUPH), has announced that Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved voclosporin, a second-generation calcineurin inhibitor (CNI), in combination with...

September 25, 2024

Developments

Acurx reports CDI antibiotic research results in collaboration with LUMC

Acurx Pharmaceuticals (NASDAQ:ACXP), announced results from its research, in collaboration with Leiden University Medical Center (LUMC), for its lead oral antibiotic candidate, ibezapolstat, to treat patients with C...

September 24, 2024

Developments

Zevra receives FDA approval for Miplyffa to treat NPC

Zevra Therapeutics (NASDAQ:ZVRA), has announced FDA approval for its Miplyffa oral capsules, used in combination with miglustat, for the treatment of Niemann-Pick disease C (NPC) in adult and pediatric patients aged two...

September 23, 2024

Developments

MIEC grants Aethlon full ethics approval for Hemopurifier cancer trial in India

Aethlon Medical (NASDAQ:AEMD), has announced that the Medanta Institutional Ethics Committee (MIEC) has granted full ethics approval for a safety, feasibility, and dose finding study of its Hemopurifier in cancer...

September 19, 2024

Developments

Senseonics and Ascensia receive FDA approval for world’s first CGM with 365-day sensor

Senseonics Holdings (NYSE:SENS) and closely-held Ascensia Diabetes Care herald a significant breakthrough in diabetes technology and management, announcing FDA approval of Eversense 365, the world’s first one-year...

September 18, 2024

Developments

PharmaJet and Scancell forge alliance to develop and commercialize needle-free DNA vaccine for advanced melanoma

Closely-held PharmaJet has announced a strategic partnership with Scancell Holdings (AIM:SCLP) to supply its Stratis Intramuscular (IM) Needle-free Injection System for delivery of Scancell’s advanced melanoma DNA...

September 17, 2024

Developments

Ripple and AbbVie launch strategic partnership to leverage eye care expertise and drug delivery innovation for next-gen glaucoma therapies

Closely-held Ripple Therapeutics has entered into a collaboration and option-to-lease agreement with AbbeVie (NYSE:ABBV) to develop RTC-620, a next generation, fully biodegradable, sustained-release drug delivery...

September 17, 2024

Developments

Profound’s PRO-Talk Live! 2024 spotlights the future of prostate disease care with TULSA-PRO

Profound Medical (NASDAQ:PROF; TSX:PRN) hosted its second PRO-Talk Live! educational event, by physicians for physicians, in Las Vegas this past weekend. The event featured a prestigious panel of experts, innovators...

September 16, 2024

Developments

Inspira secures additional U.S. patent approval for blood oxygenation system

Inspira Technologies (NASDAQ:IINN) has announced the approval of a second U.S. patent for VORTEX, its orbiting blood oxygenation delivery system designed to oxygenate blood without the use of fibre membranes, bringing...

September 16, 2024

Developments

Evaxion reports positive one-year Phase 2 data on personalized cancer vaccine

Evaxion Biotech (NASDAQ:EVAX) has announced positive one-year data from its Phase 2 trial of the AI-designed personalized cancer vaccine, EVX-01, a potential treatment for melanoma. The data, from a one-year interim...

September 16, 2024

Developments

Cidara’s workforce restructuring enables focus on clinical development

Cidara Therapeutics (NASDAQ:CDTX) has announced a planned workforce reduction, impacting approximately 30% of the company’s employees, enabling the company to reduce capital needs and concentrate on the clinical...

September 13, 2024

Developments

Tenon prepares to launch new joint fixation device with 30% reduction in implant width

Tenon Medical (NASDAQ:TNON) announced the limited alpha launch of its new Catamaran SE SI Joint Fusion System in early Q4. The company aims to gather initial user feedback from a select group of physicians to support a...

September 13, 2024

Developments

Aura announces positive Phase 2 EOS results evaluating bel-sar for CM

Aura Biosciences (NASDAQ:AURA) has announced positive Phase 2 end-of-study (EOS) results evaluating the safety, tolerability, and efficacy of bel-sar (AU-011) for the first-line treatment of early-stage choroidal...

September 12, 2024

Developments

Vor Bio reports data validating shielded transplants and early evidence of patient benefit

Vor Bio (NASDAQ:NOR) announced new data from its ongoing Phase 1/2 study of VBP101 in relapsed/refractory AML patients, demonstrating reliable engraftment, shielding from Mylotarg toxicity, a broadened therapeutic...

September 6, 2024

Developments

Ocuphire doses first participants in Phase 3 presbyopia study

Ocuphire Pharma (NASDAQ:OCUP) has initiated its VEGA-3 Phase 3 trial, evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia, with its first dose. Topline results are expected in the first half of 2025...

September 6, 2024

Developments

NIH awards TransCode with $2 million grant for lead therapeutic

TransCode Therapeutics (NASDAQ:RNAZ) announced that the National Institutes of Health (NIH) has awarded the company a $2 million Direct to Phase II Small Business Innovation Research grant to support the clinical...

September 5, 2024

Developments

Aurinia reports first participant dosed milestone for potential therapy in autoimmune diseases

Aurinia Pharmaceuticals (NASDAQ:AUPH) has announced that the first participant has been dosed in its Phase 1a study of AUR200, a differentiated, best-in-class potential therapy for autoimmune diseases targeting B-cell...

September 5, 2024

Developments

Valneva and Pfizer announce positive Phase 2 data for Lyme disease booster candidate

Valneva SE (NASDAQ:VALN) and Pfizer (NYSE:PFE) have announced positive Phase II immunogenicity and safety data from a second booster dose of the VLA15 Lyme disease vaccine candidate, administered one year after the...

September 3, 2024

Developments

Praxis reports positive topline results from study of relutrigine in developmental epilepsies

Praxis Precision Medicines (NASDAQ:PRAX) has announced positive topline results from its EMBOLD Phase II proof of concept study evaluating relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathy...

September 3, 2024

Developments

Nuvectis receives FDA orphan drug designation for NXP800 targeting cancer

The FDA granted orphan drug designation (ODD) to Nuvectis Pharma’s (NASDAQ:NVCT) oral GCN2 activator, NXP800, for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. The ODD could...

August 30, 2024

Developments

Ventyx announces CFO departure and launches search for successor

Ventyx Biosciences (NASDAQ:VTYX) announced the departure of Martin Auster, M.D., as CFO, effective August 30, 2024, and has initiated a search for his successor. The company’s SVP of finance, Ron Gonzales, CPA, MBA, has...

August 30, 2024

Developments

Medigene secures patents advancing TCR-guided therapies

Medigene AG (FSE:MDG1) has announced that patents have been granted for its proprietary JOVI and iM-TCR technologies, enhancing the company’s End-to-End (E2E) platform of TCR-guided therapies for the treatment of cancer...

August 29, 2024

Japan’s MHLW approves Aurinia’s LUPKYNIS (voclosporin) for lupus nephritis

Acurx reports CDI antibiotic research results in collaboration with LUMC

Zevra receives FDA approval for Miplyffa to treat NPC

MIEC grants Aethlon full ethics approval for Hemopurifier cancer trial in India

Senseonics and Ascensia receive FDA approval for world’s first CGM with 365-day sensor

PharmaJet and Scancell forge alliance to develop and commercialize needle-free DNA vaccine for advanced melanoma

Ripple and AbbVie launch strategic partnership to leverage eye care expertise and drug delivery innovation for next-gen glaucoma therapies

Profound’s PRO-Talk Live! 2024 spotlights the future of prostate disease care with TULSA-PRO

Inspira secures additional U.S. patent approval for blood oxygenation system

Evaxion reports positive one-year Phase 2 data on personalized cancer vaccine

Cidara’s workforce restructuring enables focus on clinical development

Tenon prepares to launch new joint fixation device with 30% reduction in implant width

Aura announces positive Phase 2 EOS results evaluating bel-sar for CM

Vor Bio reports data validating shielded transplants and early evidence of patient benefit

Ocuphire doses first participants in Phase 3 presbyopia study

NIH awards TransCode with $2 million grant for lead therapeutic

Aurinia reports first participant dosed milestone for potential therapy in autoimmune diseases

Valneva and Pfizer announce positive Phase 2 data for Lyme disease booster candidate

Praxis reports positive topline results from study of relutrigine in developmental epilepsies

Nuvectis receives FDA orphan drug designation for NXP800 targeting cancer

Ventyx announces CFO departure and launches search for successor

Medigene secures patents advancing TCR-guided therapies

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