Clinical Trials – Page 8

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

2 months ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

CytomX Continues Phase I ADC Study After Patient Death

2 months ago talkbio0Tagged ADC, Clinical Trials, Colorectal Carcinoma, CX-2051, CytomX, Kidney Failure, Acute, Patient Death, Phase I, Safety, therapeutic autologous dendritic cells, United States Food and Drug Administration

CytomX; CX-2051; Phase I; ADC; colorectal cancer; patient death; acute kidney injury; clinical trial; safety; FDA; trial continuation

Vaxart Seeks Clarity After BARDA Suspends Funding for Oral COVID-19 Vaccine Project Again

3 months ago talkbio0Tagged ATI, BARDA, CHARGE Syndrome, Clinical Trials, COVID19 (disease), Oral cavity, Project NextGen, stop work, Vaccines, Vaxart

Vaxart; BARDA; vaccine funding; stop work order; oral COVID-19 vaccine; Project NextGen; clinical trial; HHS; ATI

IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025

3 months ago talkbio0Tagged biotech, Blackfoot language, Clinical Trials, Cylembio, Drops - Drug Form, etimupepimut, Hazard Ratio, Io satellite, Keytruda, melanoma, Overall Survival, P-Value, pembrolizumab, Phase 3, Progression-Free Survival, United States Food and Drug Administration

Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop

Strand Therapeutics Raises $153M Series B to Advance mRNA Tumor Drugs

3 months ago talkbio0Tagged Big Pharma investors, biotech financing, Clinical Trials, Genomic Orientation, interleukin-12, mRNA cancer, Series B funding, Solid Neoplasm, STX-001

Strand Therapeutics; Series B funding; mRNA cancer therapy; STX-001; IL-12; solid tumors; Big Pharma investors; clinical trial results; biotech financing

Terns to Stop Funding Metabolic Disease Trials Beyond 2025; Seeks Partners for Assets

3 months ago talkbio0Tagged agonists, Clinical Trials, Glucagon-Like Peptide 1, Metabolic Diseases, Myeloid Leukemia, Chronic, Oncology Focus, Partnering, Pipeline Strategy, TERN-601, TERN-701, Terns

Terns Pharmaceuticals; metabolic disease; clinical trials; pipeline strategy; partnering; oncology focus; TERN-601; TERN-701; GLP-1 agonists; CML

Pfizer’s Embattled Obesity Program Loses Another GLP-1 Drug Due to Data and Competition Issues

3 months ago talkbio0Tagged Agonist, Clinical Trials, competition, Danuglipron, Drug Development, Glucagon-Like Peptide 1, Injury of liver, lotiglipron, Obesity, PF-06954522, Pfizer

Pfizer; obesity; GLP-1 agonist; clinical trial; liver injury; danuglipron; lotiglipron; PF-06954522; obesity drug development; competition

Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy

3 months ago talkbio0Tagged Clinical Trials, Drug Approval, Heterogeneity, IGYNTE, melanoma, Oncolytic Immunotherapy, Rejection, Replimune, RETINITIS PIGMENTOSA 1, scientist protest, United States Food and Drug Administration

Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity

Praxis touts ‘best-in-disease’ epilepsy data, but shares dip

3 months ago talkbio0Tagged anti-seizure medication, Clinical Research, Clinical Trials, Epilepsy, focal onset seizures, Market, Praxis Precision Medicines, Radiant heater, Seizures, vormatrigine

Praxis Precision Medicines; epilepsy; vormatrigine; RADIANT study; focal onset seizures; Phase 2 trial; seizure reduction; clinical trial; anti-seizure medication; stock market

Spine BioPharma’s Phase 3 Back Pain Drug Fails to Meet Primary Endpoint, Attributes Miss to High Sham Response

3 months ago talkbio0Tagged Chronic low back pain, Clinical Trials, Intervertebral Disc Degeneration, primary endpoint, Response process, salicylhydroxamic acid, SB-01, Spine BioPharma

Spine BioPharma; Phase 3 trial; chronic low back pain; degenerative disc disease; SB-01; primary endpoint; sham response; clinical trial results