DATE – Talk Bio

Immunofoco Presents Phase I/IIa Data of IMC002 at ASCO GI 2026, Highlighting Durable Complete Response and 66.7% ORR in Advanced GC/GEJ

22 hours ago talkbio0Tagged ASCO GI 2026, CAR-T, Claudin-18 Isoform A2, IMC002, Immunofoco, In complete remission, Malignant neoplasm of stomach, ORR

Immunofoco; IMC002; ASCO GI 2026; CAR-T; CLDN18.2; gastric cancer; complete response; ORR

Aktis Oncology’s 25% IPO jump lifts optimism for a biotech IPO rebound in 2026

4 days ago talkbio0Tagged Aktis, AKTS, Biotech IPOs, bounce, Capital Markets, CD276 gene, Eli Lilly backing, IPO, NECTIN4 gene, Neoplasms, Radiopharmaceuticals, Window (physical object)

Aktis Oncology IPO; AKTS; 2026 biotech IPOs; IPO bounce; radiopharmaceuticals; Eli Lilly backing; biotech capital markets; Nectin-4; B7-H3; IPO window 2026

MoonLake revives FDA push; biotech trio to debut in Hong Kong

4 days ago talkbio0Tagged * * Investor Day, Asia, Biological Factors, Blackfoot language, Capital, Hidradenitis Suppurativa, Hong Kong, HS drug approval pathway, immunotherapeutics, License Application, Market, MIRA trial, MoonLake, sonelokimab, Type B meeting, United States Food and Drug Administration, VELA-1 trial, VELA-2 trial

MoonLake Immunotherapeutics; Sonelokimab; Hidradenitis Suppurativa; FDA Type B meeting; Biologics License Application; BLA H2 2026; VELA-1 trial; VELA-2 trial; MIRA trial; HS drug approval pathway; investor day February 23 2026; Hong Kong biotech IPOs; Hong Kong listing; Asia biotech capital markets

2025 FDA staff cuts and their impact on new drug review timelines

5 days ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

5 days ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

5 days ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

5 days ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions