Life Sciences News | BioTuesdays by Kilmer Lucas IR

Developments

FDA grants ODD to Mustang’s MB-108 for malignant glioma

Mustang Bio (NASDAQ:MBIO) announced that the FDA has granted orphan drug designation (ODD) to MB-108, an HSV-1 oncolytic virus and a component of MB-109, for the treatment of malignant glioma. MB-109 combines MB-101, a...

November 8, 2024

Developments

USPTO grants second patent for Eton’s ET-400

Eton Pharmaceuticals (NASDAQ:ETON) announced that the U.S. Patent and Trademark Office (USPTO) has granted the company a patent for its proprietary liquid hydrocortisone, ET-400. The patent, which expires in 2043...

November 7, 2024

Developments

Alterity underscores published data on role of iron in neurodegenerative diseases

Alterity Therapeutics (ASX:ATH, NASDAQ:ATHE) has highlighted a peer-reviewed article published in Metallomics, emphasizing the significance of iron and iron-targeting agents, such as the company’s ATH434, in treating...

November 6, 2024

Developments

BioRestorative to unveil key Phase 2 findings on BRTX-100 for cLDD at ORS PSRS International Spine Research Symposium

BioRestorative Therapies (NASDAQ: BRTX) has announced that new preliminary 26- to 52-week blinded data from the Phase 2 clinical trial of BRTX-100 in patients with chronic lumbar disc disease (cLDD) will be presented at...

November 6, 2024

Developments

ZyVersa highlights published data supporting potential of IC 100 for obesity care

ZyVersa Therapeutics (NASDAQ:ZVSA) has highlighted data from a peer-reviewed International Journal of Nanomedicine article demonstrating inflammasome inhibition’s potential to protect pancreatic islet beta cells and...

November 5, 2024

Developments

Transgene and ProBioGen partner to advance cancer vaccine development

Transgene (Euronext Paris:TNG) announced a licensing agreement with closely-held CDMO, ProBioGen, for the AGE1.CR.pIX suspension cell line. The companies seek to add value by partnering to combine ProBioGen’s specific...

November 5, 2024

Developments

Essa terminates Phase 2 study of Masofaniten combined with Enzalutamide in mCRPC

Essa Pharma (NASDAQ:EPIX) has announced its decision to terminate the Phase 2 clinical trial evaluating masofaniten in combination with enzalutamide using a 2:1 randomization versus enzalutamide single agent in patients...

November 4, 2024

Developments

FDA grants Type C meeting with Kazia on next steps for Paxalisib in GBM

Kazia Therapeutics (NASDAQ:KZIA) has announced that the FDA has granted a Type C meeting scheduled for December 2024 to discuss potential pathways for the registration of the company’s blood-brain barrier-penetrant...

November 4, 2024

Developments

OSE announces positive Phase 2 results of Lusvertikimab for UC

OSE Immunotherapeutics (ISIN:FR0012127173; Mnemo:OSE) has announced positive results from the induction period its Phase 2 study of Lusvertikimab (OSE-127), demonstrating strong efficacy and a favorable safety profile...

November 4, 2024

Executive Moves

Lifecore appoints Thomas Guldager as VP operations, names Jackie Klecker as EVP quality

Lifecore Biomedical (NASDAQ:LFCR) has announced the appointments of Thomas Guldager as vice president of operations and Jackie Klecker as executive vice president of quality development services. Mr. Guldager brings...

November 4, 2024

Developments

Profound’s 2025 TULSA CMS reimbursement level leapfrogs all other prostate disease modalities

Profound Medical (NASDAQ:PROF; TSX:PRN) announced that the U.S. Centers for Medicare and Medicaid Services has issued its final rule establishing, for the first time, a Category 1 CPT code for the Transurethral...

November 4, 2024

Developments

FDA approves launch of clinical study for Envoy’s breakthrough implanted hearing device

Envoy Medical (NASDAQ:COCH) has announced that the FDA has approved its Investigational Device Exemption application for the pivotal study of its Acclaim fully implanted cochlear implant. The company asserts that the...

November 1, 2024

FDA grants ODD to Mustang’s MB-108 for malignant glioma

USPTO grants second patent for Eton’s ET-400

Alterity underscores published data on role of iron in neurodegenerative diseases

BioRestorative to unveil key Phase 2 findings on BRTX-100 for cLDD at ORS PSRS International Spine Research Symposium

ZyVersa highlights published data supporting potential of IC 100 for obesity care

Transgene and ProBioGen partner to advance cancer vaccine development

Essa terminates Phase 2 study of Masofaniten combined with Enzalutamide in mCRPC

FDA grants Type C meeting with Kazia on next steps for Paxalisib in GBM

OSE announces positive Phase 2 results of Lusvertikimab for UC

Lifecore appoints Thomas Guldager as VP operations, names Jackie Klecker as EVP quality

Profound’s 2025 TULSA CMS reimbursement level leapfrogs all other prostate disease modalities

FDA approves launch of clinical study for Envoy’s breakthrough implanted hearing device

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