Clinical Trials
Viking Therapeutics Shares Crash After Obesity Pill VK2735 Delivers 12% Weight Loss, But Side Effects and Discontinuations Raise Concerns
Viking Therapeutics; VK2735; obesity pill; weight loss; clinical trial; stock crash; side effects; adverse events; gastrointestinal; drug efficacy
High Drop-Out Rate Clouds Viking Therapeutics’ Oral Weight Loss Drug Trial Results
Viking Therapeutics; oral obesity drug; VK2735; high drop-out rate; weight loss data; clinical trial; treatment discontinuations
FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful
PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure
Battle Intensifies in the Obesity Drug Market as Novo Nordisk and Eli Lilly Vie for Dominance
obesity drugs; GLP-1; Wegovy; Zepbound; Novo Nordisk; Eli Lilly; market competition; direct-to-consumer; pharmacy benefit managers; compounders; clinical trials
Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder
Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence
Reunion Psychedelic Therapy Advances to Pivotal Trials after Postpartum Depression Success
Reunion Neuroscience; RE104; psychedelic therapy; postpartum depression (PPD); Phase II trial; Phase III trial; RECONNECT trial; clinical trial results; Montgomery-Åsberg Depression Rating Scale (MADRS); remission rates
FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years
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
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
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
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