On November 25, 2025 Novartis reported it will present data from over 70 abstracts, including investigator-initiated trials at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium (SABCS). Featured among these latest advances in hematology and oncology are 11 oral presentations, with the Phase III VAYHIT2 trial for ianalumab in immune thrombocytopenia (ITP) accepted as a late-breaker abstract.

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"For decades, Novartis has redefined the future of hematology and oncology, and we’re building on that foundation with compelling new data presented at ASH (Free ASH Whitepaper) and SABCS," said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. "These data underscore how we seek to set new standards for transformative care, with the aim of turning cutting-edge innovation into meaningful impact for patients."

Key highlights of data accepted by ASH (Free ASH Whitepaper) include:

Abstract Title Abstract Number/ Presentation Details
Ianalumab (VAY736)
Primary results from VAYHIT2, a randomized, double-blind, Phase 3 trial of ianalumab plus eltrombopag versus placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatment Abstract #LBA-2
Oral Presentation
December 9, 7:45 – 8:00 am ET
Secondary analysis results from VAYHIT3, a Phase 2 study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapy Abstract #844
Oral Presentation
December 8, 3:30 – 3:45 pm ET
Scemblix (asciminib)
Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysis Abstract #1997
Poster Presentation
December 6, 5:30 – 7:30 pm ET
Improved long-term tolerability with asciminib (ASC) vs investigator-selected (IS) tyrosine kinase inhibitors (TKIs) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Week 96 exploratory analysis of the phase 3 ASC4FIRST trial Abstract #5549
Poster Presentation
December 8, 6:00 – 8:00 pm ET
Asciminib (ASC) in chronic myeloid leukemia in chronic Phase (CML-CP): Efficacy and safety results of the Phase 2 ASC2ESCALATE trial in the cohort of patients (pts) with 1 prior tyrosine kinase inhibitor (TKI) Abstract #906
Oral Presentation
December 8, 4:00 – 4:15 pm ET
A comparison of real-world outcomes of asciminib versus ATP-competitive tyrosine kinase inhibitors as second-line treatment in patients with chronic myeloid leukemia in chronic phase Abstract #724
Oral Presentation
December 7, 5:15 – 5:30 pm ET
Pelabresib (DAK539)
Durable efficacy and long-term safety with pelabresib plus ruxolitinib in JAK Inhibitor–Naive myelofibrosis: 96-week Results from the Phase III MANIFEST-2 study Abstract #910
Oral Presentation
December 8, 3:30 – 3:45pm ET
Rapcabtagene autoleucel (YTB323)
Rapcabtagene autoleucel (YTB323) for patients with first line high-risk large B-cell lymphoma: phase II interim results Abstract #670
Oral Presentation
December 7, 5:15 – 5:30 pm ET
Fabhalta (iptacopan)
Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin increases in patients with paroxysmal nocturnal hemoglobinuria with baseline hemoglobin levels 10 to <12 g/dL on anti-C5 therapy: Subgroup analysis of the APPULSE-PNH Phase 3b trial Abstract #4981
Poster Presentation
December 8, 6:00 – 8:00 pm ET
Long-term safety and efficacy of iptacopan in patients with paroxysmal nocturnal hemoglobinuria: 4- and 5-year follow-up of patients from phase 2 studies who entered the roll-over extension program Abstract #3198
Poster Presentation
December 7, 6:00 – 8:00 pm ET
The 2-year efficacy and safety of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria with a history of aplastic anemia on concomitant immunosuppressive therapy who entered the roll-over extension program Abstract #4978
Poster Presentation
December 8, 6:00 – 8:00 pm ET

Key highlights of data accepted by SABCS include:

Kisqali (ribociclib)
Pooled analysis of patients (pts) treated with 1st-line (1L) ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) studies: long-term progression-free survival (PFS) Abstract # PD5-10
Poster Spotlight Presentation
December 11, 8:09 – 8:12 am CST
Five-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC) Abstract # PS3-09-08
Poster Presentation
December 11, 12:30 – 2:00 pm CST
Progression-free survival (PFS) and overall survival (OS) results from the phase 3 MONALEESA-3 trial of postmenopausal patients with hormone receptor–positive (HR+)/HER2-negative (HER2−) advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL): A subgroup analysis of patients with invasive lobular carcinoma (ILC) Abstract # PS1-10-27
Poster Presentation
December 10, 12:30 – 2:00 pm CST
Ribociclib drug-drug interaction and concomitant medication management in early and advanced breast cancer patients Abstract # PS3-09-15
Poster Presentation
December 11, 12:30 – 2:00 pm CST
Real-world patient (pt) and caregiver experiences with breast cancer (BC) risk of recurrence (ROR) in the US: Results of an Online Survey and Social Media Analysis Abstract # PS1-04-17
Poster Presentation
December 10, 12:30 – 2:00 pm CST
Repower: a real-world noninterventional study of outcomes and experiences in patients with hormone receptor-positive (HR+)/human epidermal growth fact receptor 2-negative (HER2−) early breast cancer (EBC) treated with an adjuvant cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) plus endocrine therapy (ET) Abstract # PS3-08-27
Poster Presentation
December 11, 12:30 – 2:00 pm CST

(Press release, Novartis, NOV 25, 2025, View Source [SID1234660913])

On November 25, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, reported that members of its management team will participate in fireside chats at the following healthcare investor conferences:

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Piper Sandler Healthcare Conference, New York, NY: Fireside Chat on Tuesday, December 2 at 10:30 am EST
EvercoreISI HealthCONx Conference, Miami, FL: Fireside Chat on Wednesday, December 3 at 3:00 pm EST

To access the live webcast of BridgeBio’s presentations, please visit the "Events and Presentations" page within the Investors section of the BridgeBio website at View Source A replay of the webcasts will be available on the BridgeBio website for 90 days following the event.

(Press release, BridgeBio, NOV 25, 2025, View Source [SID1234660946])

On November 25, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported that it will present at the following investor conferences:

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8th Annual Evercore Healthcare Conference 2025
December 2, 2025
8:20 AM EST

Citi’s 2025 Global Healthcare Conference
December 3, 2025
3:15 PM EST

53rd Annual Nasdaq Investor Conference
December 9, 2025
9:30 AM GMT

A live webcast of the presentations can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

(Press release, Bio-Techne, NOV 25, 2025, View Source [SID1234660931])

On November 25, 2025 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) reported the U.S. Food and Drug Administration (FDA) approved an updated label for UNLOXCYT (cosibelimab-ipdl) for the treatment of adults with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The updated label now incorporates long-term follow-up data from the pivotal CK-301-101 trial, a multicenter, multicohort, open-label study of 109 patients (31 with laCSCC; 78 with mCSCC), which showed patients receiving UNLOXCYT experienced durable clinical responses.

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At least 50% of patients in the trial achieved the primary endpoint of objective response. In addition, 14% of mCSCC patients and 32% of laCSCC patients achieved stable disease. At the time of the follow-up analysis, the median duration of response had not been reached in either group. Many clinical trial participants achieved a rapid response; median time to response was 1.9 months (range: 1.6-16.9) and 3.6 months (range: 1.7-10.1) in mCSCC and laCSCC, respectively.

In the CK-301-101 pivotal trial, the most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. 53 patients (24%) in this study experienced imARs (any grade), with a low incidence of high-grade events. Two patients (0.9%) experienced high-grade imARs; both were Grade 3 dermatologic imARs. There were no treatment-related deaths.

UNLOXCYT restores the adaptive immune response, enabling T cells to recognize cancer cells by inhibiting the binding of PD-L1 with PD-1 on T cells and B7.1 on antigen-presenting cells. UNLOXCYT also engages the innate immune system through an active fragment crystallizable (Fc) domain that binds to natural killer (NK) cells to induce antibody-dependent cell-mediated cytotoxicity (ADCC). UNLOXCYT also spares PD-L2, which may help preserve immune tolerance in non-tumor tissues, such as lung and liver, potentially limiting off-target effects and imARs.

"The longer-term results confirm that UNLOXCYT represents an advancement in the available treatment options for people living with aCSCC," said Richard Ascroft, CEO, Sun Pharma North America. "As a company committed to addressing the unmet needs of the patient communities we support, these pivotal data highlight that more patients responded and maintained their responses to UNLOXCYT for longer than observed in the primary analysis. The updated label reinforces UNLOXCYT as an evolution in checkpoint inhibition."

UNLOXCYT was initially approved by the FDA in 2024. This updated label approval further underscores Sun Pharma’s commitment to advancing data-driven innovation and expanding differentiated immunotherapy treatment options within its growing cutaneous oncology portfolio. With this updated label, Sun Pharma intends to commercially launch UNLOXCYT in early 2026.

"While there have been advances in aCSCC treatment, there still remains a significant unmet need for therapies that provide durable, long-term efficacy with acceptable tolerability. This is especially important in this aging population who are dealing with significant comorbidities," said Emily Ruiz, MD, MPH, Associate Professor of Dermatology, Harvard Medical School, Academic Director of the Micrographic Surgery Center at Brigham and Women’s Hospital, co-founder of Skin Cancer Champions, and primary author on the long-term analysis publication. "For many aCSCC patients who are over the age of 65 and dealing with comorbidities, UNLOXCYT provides an important, new treatment option that balances both efficacy and tolerability."

Key Clinical Data From Updated Analysis (CK-301-101 Study):

Efficacy Endpoints

mCSCC

n=78

laCSCC

n=31

Objective Response Rate (ORR)

ORR, n (%)

(95% CI)

39 (50)

(38, 62)

17 (55)

(36, 73)

Complete response, n (%)

10 (13)

8 (26)

Partial response, n (%)

29 (37)

9 (29)

Duration of Response (DOR)a

Number of responders

n=39

n=17

Median DOR in monthsb (range)

NR (1.4+, 45.3+)

NR (8.3, 31.3+)

Responders with observed DOR ≥ 6 months, n (%)c

33 (85)

17 (100)

Responders with observed DOR ≥ 12 months, n (%)c

26 (67)

15 (88)

CI: confidence interval; NR: not reached; +: Denotes ongoing at last assessment.
a Median follow up time: mCSCC: 29.3 months; laCSCC: 24.1 months.
b Based on Kaplan-Meier estimate.
c The numerator includes the number of patients whose observed DOR reached at least the specified times of 6 or 12 months. Patients who did not have the opportunity to reach the specified timepoint were included in the denominator only.

Incidence of CSCC
CSCC is the second most common type of skin cancer in the United States, with approximately 1 million people diagnosed annually. While most cases are localized tumors amenable to curative resection, each year in the United States approximately 40,000 cases progress to an advanced stage and approximately 15,000 people die of this disease. These patients with advanced-stage disease face limited treatment options and remain a population with a high unmet need.

"This label update reinforces the importance of therapeutic diversity in advanced CSCC," said Dr. David Miller, Co-Director, NMSC Multi-Disciplinary Clinic, Mass General Brigham Cancer Institute. "Having access to a treatment option that works in a different way than other checkpoint inhibitors can only benefit patients who are fighting this disease and demand an efficacious treatment with acceptable tolerability."

Following the FDA’s approval of the UNLOXCYT label, Sun Pharma will continue to focus on ensuring all appropriate patients have access to UNLOXCYT while engaging with pathway and guideline groups, such as the National Comprehensive Cancer Network (NCCN),1 to consider this important treatment option for future updates.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims responsibility for their application or use in any way.

Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Squamous Cell Skin Cancer V.1.2026. © National Comprehensive Cancer Center, Inc. 2025. All rights reserved. Accessed November 6, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

About Cutaneous Squamous Cell Carcinoma
Important risk factors for CSCC include chronic ultraviolet exposure and immunosuppressive conditions. In addition to being life-threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear.

About UNLOXCYT (cosibelimab-ipdl)
UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT was recently named a finalist for the 2025 Prix Galien USA Bridges Award, recognizing it as one of the year’s most significant biomedical advancements.

Please see the INDICATIONS and IMPORTANT SAFETY INFORMATION below.

INDICATIONS AND USAGE

UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

It is not known if UNLOXCYT is safe and effective in children

The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.

IMPORTANT SAFETY INFORMATION

WARNING AND PRECAUTIONS

Immune-mediated Adverse Reactions: Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis and renal dysfunction, and solid organ transplant rejection. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. While such adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies.

Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue UNLOXCYT based on the severity of reaction.

Infusion-Related Reactions: Infusion-related reactions were reported in 11% (24/223) of patients, including Grade 2 in 5.8% (13/223) of patients receiving UNLOXCYT. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue UNLOXCYT based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins.

Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic Hematopoietic Stem Cell Transplantation (HSCT) before or after being treated with a PD-1/PDL1 blocking antibody. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity/Females and Males of Reproductive Potential: UNLOXCYT can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential prior to initiating UNLOXCYT. Females should use effective contraception during treatment with UNLOXCYT and for 4 months after the last dose. Advise female patients not to breastfeed during treatment with UNLOXCYT and for 4 months after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.

To report side effects of UNLOXCYT to FDA: visit www.fda.gov/medwatch or call 1-800-FDA-1088. Report SUSPECTED ADVERSE REACTIONS or any side effects or ADEs (adverse drug events) to our Drug Safety Department at 1-800-406-7984 or [email protected] (preferred) with as much information as available.

(Press release, Sun Pharma, NOV 25, 2025, https://www.prnewswire.com/news-releases/fda-approves-label-update-for-unloxcyt-cosibelimab-ipdl-based-on-longer-term-data-that-demonstrated-improved-clinical-outcomes-in-advanced-cutaneous-squamous-cell-carcinoma-acscc-302626366.html [SID1234660947])

On November 25, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that C4T management will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference taking place from December 2 – 4, 2025 in Coral Gables, Florida.

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Fireside Chat Details:
Event: 8th Annual Evercore Healthcare Conference
Date/Time: Wednesday, December 3rd, 2025 at 3:25 pm ET

A live webcast will be available on the Investors section of the company’s website at www.c4therapeutics.com. An archived replay of the webcast will be available for approximately 90 days following the live event.

(Press release, C4 Therapeutics, NOV 25, 2025, View Source [SID1234660932])