Functional Concept – Page 10

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

5 months ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment

Lilly Posts Encouraging Early-Stage Weight Loss Data on Amylin Candidate

5 months ago talkbio0Tagged Amylin Candidate, aspects of adverse effects, Clinical Data, early-stage trial, Eli, Eli Lilly, Eloralintide, Obesity, Weight Loss

Eli Lilly; eloralintide; amylin candidate; weight loss; early-stage trial; obesity drug; clinical data; side effects

Novo Nordisk Strikes Major Deal with Deep Apple Therapeutics for Oral Cardiometabolic Medicines

5 months ago talkbio0Tagged biotech partnership, cardiometabolic diseases, Collaboration, Deep Apple, G-Protein-Coupled Receptors, Nordisk, Obesity, Oral Medicine, R&D, small molecule therapeutics, Target

Novo Nordisk; Deep Apple Therapeutics; cardiometabolic diseases; oral medicines; obesity; small molecule therapeutics; GPCR target; R&D collaboration; biotech partnership

FDA Reinstates Generic Drug Policy Group After April Firings

5 months ago talkbio0Tagged Administrative action, Departure - action, development aspects, drug price, Generic Drugs, layoffs, Office, Policy, reinstatement, Transection (procedure), United States Food and Drug Administration

FDA; generic drugs; policy office; Division of Policy Development; reinstatement; layoffs; drug prices; administrative leave

FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns

5 months ago talkbio0Tagged Biktarvy, CD4 + T-cell, Clinical Trials, Gilead Sciences, GS-1720, GS-4182, HIV, Lenacapavir, Lymphocyte Count measurement, safety signal, Study on Hold, United States Food and Drug Administration

FDA; Gilead Sciences; HIV; clinical hold; GS-1720; GS-4182; clinical trials; safety signal; CD4+ T-cell; lymphocyte count; Biktarvy; lenacapavir

Odyssey Therapeutics Abandons IPO Plans in Latest Sign of Tough Environment for Biotech Listings

5 months ago talkbio0Tagged Autoimmune, IPO, Market, Odyssey, seconds, turbulence, Withdraw (activity)

Odyssey Therapeutics; IPO; biotech; withdrawal; SEC; market turbulence; autoimmune

Regenxbio Reports Consistent One-Year Benefit for DMD Gene Therapy RGX-202

5 months ago talkbio0Tagged AFFINITY DUCHENNE trial, Biological Markers, Clinical Trials, Functional, gene therapy, Muscular Dystrophy, Duchenne, Phase III, Regenxbio, SLC6A8 Inhibitor RGX-202

Regenxbio; DMD; Duchenne muscular dystrophy; RGX-202; gene therapy; AFFINITY DUCHENNE trial; clinical trial; microdystrophin; biomarker; phase I/II; functional data

Regeneron Licenses Hansoh’s GLP-1/GIP Obesity Drug to Compete with Zepbound

5 months ago talkbio0Tagged Biopharma, eli lilly, GLP-1/GIP receptor agonist, Hansoh Pharmaceuticals, HS-20094, Licensing Deal, Obesity, Regeneron, Zepbound

Regeneron; Hansoh Pharmaceuticals; HS-20094; GLP-1/GIP receptor agonist; obesity drug; Zepbound; Eli Lilly; obesity treatment; licensing deal; biopharma

Merck Advances Middle Dose of ROR1 ADC in Relapsed/Refractory DLBCL After Safety Review

5 months ago talkbio0Tagged Adverse event, Clinical Trials, Diffuse Large B-Cell Lymphoma, Merck, middle dose, Relapsing course, ROR1 protein, human, Safety, therapeutic autologous dendritic cells, Unresponsive to Treatment, vedotin, waveLINE-003, Zilovertamab

Merck; ROR1; ADC; zilovertamab vedotin; middle dose; 1.75 mg/kg; relapsed DLBCL; refractory DLBCL; WaveLINE-003; safety; adverse events; clinical trial; ASCO 2025

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

5 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay