#NMIBC
$IBRX Premium report, now with a downloadable 50-page PDF. FDA expanded ANKTIVA to papillary-only NMIBC (Oct 14); QUILT-2.005 topline expected in November.

https://www.merlintrader.com/immunitybio-inc-nasdaq-ibrx-stock-hub/
IBRX Stock: ImmunityBio News, ANKTIVA & QUILT Data
ImmunityBio stock news: ANKTIVA expands into papillary-only NMIBC; QUILT-2.005 topline is expected in November, with sales, cash and dilution in focus.
www.merlintrader.com
October 27, 2026 at 9:59 AM
$IBRX QUILT-2.005 topline guided to November. Oct 21: database lock for 366 patients; sBLA planned for Q4 (procedural, not efficacy). Rebuilt hub with the 50-page PDF report. Not investment advice.

https://www.merlintrader.com/immunitybio-inc-nasdaq-ibrx-stock-hub/?v=snello
IBRX Stock: ImmunityBio News, ANKTIVA & QUILT Data
ImmunityBio stock news: ANKTIVA expands into papillary-only NMIBC; QUILT-2.005 topline is expected in November, with sales, cash and dilution in focus.
www.merlintrader.com
October 30, 2026 at 12:47 AM
$IBRX QUILT-2.005 topline guided to November. Oct 21: database lock for 366 patients; sBLA planned for Q4 (procedural, not efficacy). Rebuilt hub with the 50-page PDF report. Not investment advice.

https://www.merlintrader.com/immunitybio-inc-nasdaq-ibrx-stock-hub/?v=snello
IBRX Stock: ImmunityBio News, ANKTIVA & QUILT Data
ImmunityBio stock news: ANKTIVA expands into papillary-only NMIBC; QUILT-2.005 topline is expected in November, with sales, cash and dilution in focus.
www.merlintrader.com
October 30, 2026 at 12:47 AM
Summary of the results posted: phase II trial of pembrolizumab, vibostolimab in non-Muscle Invasive Bladder Cancer in 7 EU/EEA countries. Sponsor: Merck Sharp & Dohme LLC. 254 participants planned.

https://ctis.eu/trial/2022-502526-41-00
#ClinicalTrials #Oncology
Pembrolizumab (MK-3475) and pembrolizumab in combination with other investigational agents in high risk NMIBC patients unresponsive to BCG
Trial record 2022-502526-41-00 in the public EU register, on CTIS.eu
ctis.eu
October 29, 2026 at 11:39 AM
Anktiva + BCG gains FDA approval for adults with BCG-unresponsive, high-grade papillary-only NMIBC. Evidence was extrapolated from the related CIS subtype.
www.fda.gov/news-events/...
October 18, 2026 at 4:01 PM
🔍Just in: The @fda.gov accepted a new drug application seeking the approval of UGN-103 for recurrent low-grade intermediate-risk non–muscle-invasive bladder #blcsm #oncology

Read more on the target action date for approval and the UTOPIA data supporting the NDA: www.onclive.com/view/fda-acc...
FDA Accepts NDA for UGN-103 in Recurrent Low-Grade Intermediate-Risk NMIBC | OncLive
The FDA accepted an NDA for UGN-103 for recurrent low-grade intermediate-risk NMIBC, with a target action date of June 14, 2027.
www.onclive.com
October 19, 2026 at 4:13 PM
Useful context for trainees: this is part of the shift toward chemoablation in recurrent low-grade intermediate-risk NMIBC, an intravesical mitomycin gel given in clinic that aims to spare patients repeated TURBTs under anesthesia.
October 19, 2026 at 4:46 PM
Among patients with a single NMIBC tumor sized less than 3 cm, 12-month recurrence and RFS rates were significantly better after thulium laser endoscopic vs bipolar transurethral en bloc resection.

Read more: https://bit.ly/4yf3Ng9
NMIBC Recurrence at 12 Months Lower With Thulium-Laser en Bloc Resection
A trial compared perioperative and oncologic outcomes after 2 different en bloc resection techniques for a single small nonmuscle-invasive bladder tumor.
bit.ly
October 18, 2026 at 6:19 PM
ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS,
Peer-reviewed publication reports long-term outcomes from the QUILT-3.032 study supporting durable disease control and bladder preservation CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced the publication of long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology. The study evaluated ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. Highlights: 71% complete response (CR) rate in patients with BCG-unresponsive NMIBC CIS, with or without papillary disease Median duration of CR of 26.6 months, with responses extending beyond 53 months More than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months 84% cystectomy-free survival at 36 months among responders 98.2% disease-specific survival at three years No Grade 4 or Grade 5 treatment-related adverse events reported “The QUILT-3.032 study represents one of the longest follow-up data sets in BCG-unresponsive NMIBC to date, and the results continue to support the durability of ANKTIVA’s unique mechanism of action in generating sustained immune responses,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These...
www.biospace.com
October 19, 2026 at 3:34 AM
Did you miss this week's key updates in GEP-NETs, NMIBC, pancreatic cancer, and HCC? Test your knowledge with OncLive's weekly news quiz #blcsm #HCC #pancsm #oncology

www.onclive.com/view/onclive...
OncLive Weekly News Quiz (10/16/2026): Did You Miss Crucial Bladder, Neuroendocrine, Pancreatic, and Liver Cancer Updates? | OncLive
Did you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.
www.onclive.com
October 16, 2026 at 2:57 PM
🟢 #$IBRX — Regulatory Approval
FDA Expands ANKTIVA Approval to BCG-Unresponsive NMIBC Papillary-Only Tumors
FDA expanded the approved indication for ANKTIVA plus BCG to all adult patients with BCG-unresponsive NMIBC, including papillary-only tumors. First FDA a…

https://biostock.app/symbols/IBRX
October 14, 2026 at 10:07 PM
New data from the Journal of Urology found adding nogapendekin alfa to BCG leads to durable responses and cystectomy avoidance in a subset with BCG-unresponsive NMIBC with any carcinoma in situ.

Read the data here: https://bit.ly/4yVBNzm
Nogapendekin Alfa Plus BCG Has Durable Response in BCG-Unresponsive NMIBC CIS
Nogapendekin alfa, an IL-15 receptor super agonist, is FDA approved for nonmuscle-invasive bladder cancer (NMIBC) carcinoma in situ.
bit.ly
October 14, 2026 at 5:47 PM
FDA broadens Anktiva approval to papillary-only bladder cancer, giving #$IBRX a larger addressable market in BCG-unresponsive NMIBC. notreload.xyz/xy/fda-widen...
FDA Widens Anktiva Approval, Expanding IBRX Opportunity
FDA broadens Anktiva approval to papillary-only bladder cancer, giving ImmunityBio (IBRX) a larger addressable market in BCG-unresponsive NMIBC.
notreload.xyz
October 14, 2026 at 5:00 PM
NMIBC is a localized form of bladder cancer in which the tumor is constrained to the bladder lining. Learn more about prevention, screening, and treatment options for bladder cancer: buff.ly/rIi0rYd
Bladder Cancer Overview - American Association for Cancer Research (AACR)
More than 80,000 people a year in the U.S. are diagnosed with bladder cancer. Learn about the screening and treatment options.
buff.ly
October 14, 2026 at 7:55 PM
Learn about other developments in treating BCG-resistant NMIBC on the #AACRBlog: buff.ly/5jkzeJY
Bladder Cancer: Burgeoning Beyond BCG
At a recent AACR Special Conference, experts discussed emerging therapeutic options to overcome resistance to Bacillus Calmette-Guérin (BCG).
buff.ly
October 14, 2026 at 7:55 PM
Among patients with a single NMIBC tumor sized less than 3 cm, 12-month recurrence and RFS rates were significantly better after thulium laser endoscopic vs bipolar transurethral en bloc resection.

Read more: https://bit.ly/4yf3Ng9
NMIBC Recurrence at 12 Months Lower With Thulium-Laser en Bloc Resection
A trial compared perioperative and oncologic outcomes after 2 different en bloc resection techniques for a single small nonmuscle-invasive bladder tumor.
bit.ly
October 13, 2026 at 7:10 PM
📄 #IBRX 10-Q — what changed
MD&A now says: "Forward-looking statements include, but are not limited to: • our ability to successfully commercialize ANKTIVA globally in current and future approved indications (including NMIBC and NSCLC), and to obtain incremental regulatory approvals for new i
FormDelta — Insider Trading Alerts
What ImmunityBio, Inc. changed in their own words, quarter over quarter.
www.formdelta.com
October 6, 2026 at 10:12 PM
Another recent CSP paper: a mini review on liquid biopsy in non-muscle-invasive bladder cancer, covering detection, risk stratification, and surveillance.

Promising area, but there is still a clear need for standardization and prospective validation.

xiahepublishing.com/2835-3315/CS...
The Role of Liquid Biopsy in the Detection, Risk Stratification, and Surveillance of Non-muscle-invasive Bladder Cancer: A Mini Review
Non-muscle-invasive bladder cancer (NMIBC) is characterized by a high recurrence rate and a substantial long-term surveillance burden. However, current detection and surveillance strategies rely largely on invasive cystoscopy and urine cytology, which are limited by patient discomfort, suboptimal adherence, and insufficient sensitivity, particularly for low-grade disease. This mini review examines the role of liquid biopsy in the detection, risk stratification, and surveillance of NMIBC. It summarizes current evidence on circulating tumor DNA, circulating tumor cells, exosomes and extracellular vesicles, urinary tumor DNA, and DNA methylation and protein biomarkers in blood or urine. For detection, urine-based molecular assays complement cystoscopy and cytology in the noninvasive assessment of patients with suspected bladder cancer. For risk stratification, molecular detection of residual disease and longitudinal biomarker changes help identify patients at increased risk of recurrence or progression. During surveillance, urine-based assays support earlier recurrence detection and, in selected settings, help reduce the frequency of cystoscopy. Overall, liquid biopsy is a promising minimally invasive complement to conventional NMIBC management although technical standardization and prospective clinical validation are required before routine implementation.
xiahepublishing.com
October 4, 2026 at 3:01 PM
Updated phase 2 trial data suggest efficacy and durability of first-line Gem/Doce in a small cohort of patients with BCG-naïve high-risk NMIBC.
https://www.renalandurologynews.com/news/bladder-cancer-intravesical-gemcitabine-docetaxel-bcg-treatment-risk/
Intravesical Gemcitabine and Docetaxel Appears Durable for BCG-Naïve, High-Risk NMIBC
A phase 2 open label trial tested intravesical gemcitabine and docetaxel as first-line treatment in patients with high-risk BCG-naïve nonmuscle-invasive bladder cancer.
www.renalandurologynews.com
September 16, 2026 at 1:35 PM
IBCG Risk Stratification Model for Intermediate-Risk NMIBC algorithm from Dr. Ashish Kamat: myopenmedicine.com/algorithms/i...
IBCG Risk Stratification Model for Intermediate-Risk NMIBC
Intermediate-Risk Non–Muscle-Invasive Bladder Cancer (IR NMIBC) Risk Stratification Model by the International Bladder Cancer Group (IBCG).
myopenmedicine.com
September 15, 2026 at 2:29 PM
🚨 JUST IN: $TYRA
Tyra reports positive SURF302 data: 79% ORR, 57% CR at 60mg in FGFR3-altered NMIBC

#SEC #stocks #investing #TYRA
🔗 secwatch.observer
September 9, 2026 at 11:24 AM