Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

Developments

HOOKIPA doses first patient in Phase 2 trial of eseba-vec for head and neck cancer

HOOKIPA Pharma (NASDAQ:HOOK) has announced that the first patient has been dosed in an investigator-initiated trial (IIT) of eseba-vec as adjunct therapy for patients with minimal residual disease-positive, HPV-driven...

October 30, 2024

Developments

CalciMedica announces late-breaking positive data from Phase 2b CARPO trial

CalciMedica (NASDAQ:CALC) has announced late-breaking positive data from its Phase 2b CARPO trial of Auxora in acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The results are to...

October 30, 2024

Developments

FDA grants RMAT designation to Allogene’s ALLO-316 for patients with RCC

Allogene Therapeutics (NASDAQ:ALLO) has announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its ALLO-316 for treating adult patients with CD70-positive advanced or metastatic...

October 29, 2024

Developments

Shuttle doses first patient in Phase 2 trial of Ropidoxuridine for glioblastoma

Shuttle Pharmaceuticals (NASDAQ:SHPH) has announced the successful dosing of the first three patients in its Phase 2 clinical trial of Ropidoxuridine, aimed at treating glioblastoma. Ropidoxuridine, Shuttle’s lead...

October 29, 2024

Developments

PolTREG initiates Phase 2 trial of PTG-007 targeting functional cure for children at risk of T1D

PolTREG (WSE:PTG) has launched a Phase 2 clinical trial of PTG-007, a polyclonal autologous Treg cellular therapy, in children with presymptomatic Type-1 diabetes (T1D), following approval from the European Medicines...

October 24, 2024

Developments

Olema reports compelling preclinical data on OP-3136’s anti-tumor activity

Olema Oncology (NASDAQ:OLMA) has announced results from three preclinical studies demonstrating the robust anti-tumor activity of OP-3136 as a single agent and in combination with palazestrant. The results will be...

October 23, 2024

Developments

DSMB approves second phase of Ocugen’s GARDian trial for Stargardt disease

Ocugen (NASDAQ:OCGN) has announced that the Data and Safety Monitoring Board (DSMB) has approved enrollment for the second phase of its Phase 1/2 clinical trial of OCU410ST GARDian for Stargardt disease. The GARDian...

October 22, 2024

Developments

SIGA signs licencing agreement with Vanderbilt U for mAbs portfolio

SIGA Technologies (NASDAQ:SIGA) announced that it has entered into an agreement with Vanderbilt University to license to a portfolio of preclinical, fully human monoclonal antibodies (mAbs), which have the potential...

October 22, 2024

Developments

MOBILion reveals next-gen high-res mass spec approach poised to disrupt industry

Closely-held MOBILion Systems has announced a novel, next-generation high-resolution mass spectrometry approach for complex sample analysis, delivering unprecedented speed, sensitivity, specificity, and quantitative...

October 21, 2024

Developments

Zymeworks announces first patient dosed in Phase 1 trial of ZW171 in cancer

Zymeworks (NASDAQ:ZYME) has announced that the first patient has been dosed in its global first-in-human Phase 1 clinical study to evaluate the safety and tolerability of ZW171 for the treatment of ovarian cancer, non...

October 21, 2024

Developments

IJS publishes PolyPid’s Phase 3 results of D-PLEX for preventing SSIs in colorectal surgery

PolyPid (NASDAQ:PYPD) has announced the publication of a study in the International Journal of Surgery (IJS), showcasing the full data set from its Phase 3 SHIELD I trial of D-PLEX, focused on preventing surgical site...

October 21, 2024

Developments

Lexicon signs exclusive licencing agreement with Viatris for sotagliflozin outside U.S. and Europe

Lexicon Pharmaceuticals (NASDAQ:LXRX) has announced that Viatris (NASDAQ:VTRS) obtained an exclusive license from Lexicon to commercialize sotagliflozin across all indications outside the U.S. and Europe, in exchange...

October 17, 2024

Developments

Celularity expands portfolio acquiring Rebound from Sequence

Celularity (NASDAQ:CELU) has announced its acquisition of Rebound from Sequence LifeScience, expanding its commercial portfolio of placental-derived advanced biomaterial products. Rebound is a full thickness placental...

October 17, 2024

Developments

Corbus reports enrollment completion of dose escalation stage of Phase 1 trial

Corbus Pharmaceuticals (NASDAQ:CRBP) has announced the completion of enrollment for the dose-escalation portion of its bridging Phase 1 clinical trial of CRB-701 (SYS6002) in patients with advanced solid tumors...

October 16, 2024

Developments

EC grants orphan medicinal product designation of Theriva’s VCN-01 for retinoblastoma

Theriva Biologics (NYSE American:TOVX) has announced that the European Commission (EC) has adopted the European Medicines Agency’s (EMA) recommendation to grant orphan medicinal product designation to its lead...

October 16, 2024

Developments

Ripple and Glaukos ink evaluation and licensing agreements

Closely-held Ripple Therapeutics has announced evaluation and licensing agreements with Glaukos Corporation (NYSE:GKOS), enabling Glaukos to leverage Ripple’s proprietary technology platform to create sustained release...

October 15, 2024

Developments

Aurinia presents new real-world data reinforcing LUPKYNIS in LN at ASN Kidney Week 2024

Aurinia Pharmaceuticals (NASDAQ:AUPH) has announced plans to present new data reinforcing the clinical significance of LUPKYNIS in the treatment of lupus nephritis (LN) at the American Society of Nephrology (ASN) Kidney...

October 11, 2024

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