Formulation Development
Verrica Pharmaceuticals Announces FDA Acceptance of its IND Application for Potential First-in-Class Oncolytic Peptide-Based Immunotherapy for the Treatment of Basal Cell Carcinoma
Verrica Pharmaceuticals Inc. recently announced the US FDA has accepted its Investigational New Drug Application (IND) for LTX-315, a potential first-in-class oncolytic peptide, for the…
Molecular Templates Announces Fast Track Designation Granted by FDA for MT-6402
Molecular Templates, Inc. recently announced the US FSA has granted Fast Track Designation for MT-6402 for the treatment of patients with advanced non-small cell lung…
First Subject Dosed in Biosplice Therapeutics Phase 1b Clinical Trial in Oncology
Biosplice Therapeutics, Inc. recently announced the dosing of the first subject in a Phase 1b, open-label, multi-center, dose-escalation, dose expansion clinical trial of cirtuvivint in…
OWP Pharmaceuticals Announces IND Authorization for the First-Ever Oral Liquid Formulation of Atomoxetine Hydrochloride for the Treatment of ADHD
OWP Pharmaceuticals, Inc. recently announced it has received IND authorization from the FDA for the first-ever oral suspension of atomoxetine hydrochloride. Offering an important delivery…
Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop & Co-Commercialize Brain-Penetrant Progranulin Replacement Therapy
Denali Therapeutics Inc. recently announced its strategic partner Takeda Pharmaceutical Company Limited has exercised an option, pursuant to an existing collaboration agreement between the two…
Arranta Bio Announces Completion of Sale of Florida Site & Progress on $150-Million Investment Plan to Expand Development & Commercial Manufacturing Services
Arranta Bio recently announced the completion of the sale of its process development and GMP clinical manufacturing site in Gainesville, FL, to Inceptor Bio and the transfer of client programs and key….
Alzheimer’s Disease Preventative Nasal Vaccine to be Tested at Boston's Brigham & Women’s Hospital
Boston's Brigham and Women’s Hospital recently announced it would test a nasal vaccine for Alzheimer’s disease. The move, the hospital said in a press release, represents the culmination of…
SOTIO Expands Its Antibody-Drug Conjugate Pipeline With Exclusive Collaboration & License Agreement With LegoChem Biosciences
SOTIO Biotech recently announced an exclusive, target-specific license and option agreement with LegoChem Biosciences Inc in which SOTIO will obtain rights to deploy LCB’s ADC technology for up to….
Vaxart Announces Publication of Complete Data From Preclinical COVID-19 Oral Vaccine Hamster Challenge Study
Vaxart, Inc. recently announced the Journal of Infectious Diseases has published complete data from Vaxart’s preclinical Hamster Challenge Study. The study shows Vaxart’s COVID-19 oral…
Moderna Announces Positive Data From Phase 2 Study of mRNA VEGF-A Therapeutic in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Moderna, Inc. recently announced positive data from the AstraZeneca-led Phase 2 (EPICCURE) study evaluating the use of an mRNA therapeutic that encodes for vascular endothelial…
Kala Pharmaceuticals Acquires Combangio, Expanding its Pipeline With a Clinical-Stage Novel Biologic for the Treatment of Persistent Corneal Epithelial Defect (PCED) & Other Rare Ocular Surface Diseases
Kala Pharmaceuticals, Inc. recently announced it has acquired Combangio, Inc., a private, clinical-stage company developing regenerative biotherapies for severe ocular surface diseases…..
Inozyme Pharma Announces Dosing of First Patient in First-in-Human Clinical Trial of INZ-701 in Patients With ENPP1 Deficiency
Inozyme Pharma, Inc. recently announced the first patient has been dosed in its first-in-human Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1…
CymaBay Therapeutics Long-Term Open Label Study Finds Treatment With Seladelpar for 2 Years Improves Key Liver Biomarkers in Patients With PBC
CymaBay Therapeutics, Inc. recently announced that results of analyses from two clinical studies of seladelpar were delivered during The Liver Meeting Digital Experience 2021 (TLMdX)…
Emergex Announces Approval to initiate Phase 1 Clinical Trial of Its Next-Generation COVID-19 Vaccine Candidate
Emergex Vaccines Holding Limited recently announced it has received the necessary regulatory approvals to initiate a Phase 1 clinical trial to evaluate the safety and…
Harpoon Therapeutics Presents Data on its TriTAC-XR Platform
Harpoon Therapeutics, Inc. recently presented a poster with preclinical data on its TriTAC-XR T cell engager platform at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Washington, DC…..
Vaccitech’s VTP-300 Was Well-Tolerated & Induced T cells Against All Targeted HBV Antigens in Both Healthy Volunteers & Patients With Chronic HBV Infection in Interim Analyses
Vaccitech plc recently announced results from ongoing Phase 1 and Phase 1b/2a clinical trials of VTP-300, an immunotherapy candidate in development for the treatment of…
Oculis Announces Patient Dosing in its First Phase 3 Study for Investigational Topical Eye Drop Treatment for Diabetic Macular Edema
Oculis S.A. recently announced the first patients have been dosed in its Phase 3 DIAMOND trial evaluating the efficacy and safety of OCS-01 in Diabetic…
Intensity Therapeutics Reports Use of INT230-6 Alone or in Combination With Ipilimumab Shows Evidence of Direct Tumor Necrosis & Promising Overall Survival Results in Adult Subjects With Metastatic Sarcomas
Intensity Therapeutics, Inc. recently announced that data from its open-label Phase 1/2 study of novel lead asset, INT230-6, as a monotherapy or in combination with ipilimumab in…
Oncorus Announces Exclusive Licensing Agreement With Gaeta Therapeutics for Use of Locally Delivered Interleukin-12 Via Oncolytic Viral Expression in Combination With Immune Checkpoint Inhibitors
Oncorus, Inc. recently announced it has signed an exclusive licensing agreement with Gaeta Therapeutics Ltd., related to the use of locally delivered Interleukin-12 (IL-12) via…
Exavir Therapeutics Announces Preclinical Data Demonstrating Complete Elimination of HIV From Human Cells With LNP-Delivered Tat-Targeted CRISPR-Cas9
Exavir Therapeutics recently announced the publication of preclinical data for XVIR-TAT, Exavir’s proprietary gene editing program in early preclinical development as a potential cure for…
