Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

BioLineRx enters license agreement with Ayrmid for APHEXDA

BioLineRx (NASDAQ:BLRX; TASE:BLRX) and Ayrmid, the parent company of Gamida Cell, announced they have entered into a licensing agreement for motixafortide, commercially marketed in the U.S. as BioLineRx’s APHEXDA. The...

November 22, 2024

Developments

Rallybio launches Phase II trial of RLYB212 for FNAIT in pregnancy

Rallybio (NASDAQ:RLYB) announced the commencement of an open-label Phase II trial of RLYB212 in pregnant women at high-risk of HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). FNAIT is...

November 22, 2024

Developments

Perimeter’s B-Series OCT with ImgAssist AI demonstrates super-superiority compared to standard-of-care in breast cancer surgery pivotal clinical trial

Perimeter Medical Imaging AI (TSX-V:PINK) (OTC:PYNKF) announced positive topline results from the pivotal study designed to support its planned FDA PMA submission for approval to market its next-generation Perimeter B...

November 20, 2024

Developments

Neurizon reports positive results from preclinical study of NUZ-001 in ALS

Neurizon Therapeutics (ASX: NUZ & NUZOA) announced positive results from a preclinical study of its lead candidate, NUZ-001, in amyotrophic lateral sclerosis (ALS). The company states that NUZ-001 reduces the...

November 19, 2024

Developments

Adverum announces positive 52-week LUNA results and four-year OPTIC data

Adverum Biotechnologies (NASDAQ:ADVM) announced topline 52-week results from its LUNA Phase 2 trial, new four-year long-term follow-up data from its OPTIC study, and key design elements for its pivotal program. Both the...

November 18, 2024

Developments

Therma Bright to spin off consumer product portfolio creating new company

Therma Bright (TSXV:THRM; QTCQB:TBRIF) announced plans to spin off its consumer product portfolio into a separate publicly traded company during the first half of 2025. The spin-off transaction will be subject to...

November 18, 2024

Developments

AC Immune announces positive interim results from study of ACI-7104.056 in Parkinson’s

AC Immune (NASDAQ:ACIU) announced positive interim safety and immunogenicity data from its Phase 2 VacSYn clinical trial, evaluating ACI-7104.056 as a treatment for patients with early Parkinson’s disease. The company...

November 15, 2024

Developments

Moleculin amends protocol for Phase 3 trial of Annamycin for AML

Moleculin Biotech (NASDAQ:MBRX) announced it has amended the protocol with the FDA for its Phase 3 pivotal MIRACLE trial, evaluating Annamycin in combination with Cytarabine for treating patients with acute myeloid...

November 14, 2024

Developments

BioRestorative Therapies preliminary BRTX-100 Phase 2 data for cLDD bolsters confidence in trial hitting primary and secondary endpoints

BioRestorative Therapies (NASDAQ:BRTX) announced new preliminary 26–52 week blinded data from the first 10 patients with chronic lumbar disc disease (cLDD) enrolled in the ongoing Phase 2 clinical trial of BRTX-100...

November 13, 2024

Developments

Lipella’s liposomal delivery platform granted patent by USPTO

Lipella Pharmaceuticals (NASDAQ:LIPO) announced that the U.S. Patent and Trademark Office (USPTO), has issued a patent for its proprietary liposomal delivery platform today. Lipella reports that the patent protects its...

November 12, 2024

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

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

Developments

USPTO issues NOA for Starton’s STAR-LLD continuous delivery system

Closely-held Starton Therapeutics has announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance (NOA) for its U.S. patent application covering the company’s continuous delivery...

October 31, 2024

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