On February 24, 2026 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its financial results for the fourth quarter and full year 2025, and reaffirms its outlook for 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2025 was a seminal year for Day One, marked by significant achievements across every pillar of our organization. By maintaining our strong commercial execution, leveraging our expertise to extend into additional rare cancers, and steadily advancing our early-stage pipeline, we are delivering on our mission to bring new medicines to people of all ages with life-threatening diseases," said Jeremy Bender, Ph.D., chief executive officer of Day One. "The commercial momentum we’ve established for OJEMDA and the important upcoming clinical data updates across our full pipeline position us for strong growth in 2026 and beyond."

OJEMDA Commercial Performance

•
OJEMDA net product revenue of $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively
•
Full-year 2025 net product revenue represented 172% year-over-year growth, with double-digit sequential quarterly growth throughout the year
•
Fourth quarter prescription volumes increased to 1,394 and total 2025 prescriptions were 4,635, representing 181% growth versus 2024 (April launch), and demonstrating strong and growing patient demand, increasing treatment persistence and expanding prescriber adoption
•
Company reaffirmed its previously announced 2026 U.S. OJEMDA net product revenue guidance of $225 million to $250 million

Clinical and Pipeline Highlights

FIREFLY-1 Progress in 2025 and Frontline pLGG FIREFLY-2 Trial Enrollment Complete in 2026

•
Updated three-year data from the pivotal Phase 2 FIREFLY-1 trial presented at the Society for Neuro-Oncology Annual Meeting in November 2025, reinforcing the durability of response and long-term safety profile of OJEMDA in patients with relapsed or refractory pLGG
•
Long term follow-up data from FIREFLY-1 demonstrate that time to next treatment analyses better reflected clinical decision-making among FIREFLY-1 investigators versus radiographic-only tumor progression (as assessed via traditional progression free survival analyses)
•
Enrollment in the pivotal Phase 3 FIREFLY-2 trial evaluating OJEMDA in patients with frontline pLGG remains on track, with full enrollment anticipated in the first half of 2026

Pipeline Progress in 2026

•
Updated Phase 1 clinical data on Emi-Le, a B7-H4-directed ADC acquired from Mersana, expected to be available mid-2026
•
The Phase 1a clinical trial of DAY301, a PTK7-targeted ADC, is progressing through dose escalation, with initial clinical data and program update planned for the second half of 2026

2025 Financial Summary

•
Net Product Revenue: OJEMDA net product revenues were $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively
•
License Revenue: License revenues from the sale of ex-U.S. commercial rights for tovorafenib were $0.9 million and $2.8 million for the fourth quarter and full year 2025, respectively
•
R&D Expenses: Research and development expenses were $40.9 million and $148.1 million for the fourth quarter and full year 2025, respectively, as compared to $61.8 million and $227.7 million for the same periods in 2024
•
SG&A Expenses: Selling, general and administrative expenses were $34.2 million and $120.6 million for the fourth quarter and full year 2025, respectively, as compared to $29.8 million and $115.5 million for the same periods in 2024
•
Net Loss: Net loss totaled $21.3 million and $107.3 million for the fourth quarter and full year 2025, respectively, with non-cash stock-based compensation expense of $11.1 million and $44.4 million for the same periods. By comparison, net loss totaled $65.7 million and $95.5 million for the fourth quarter and full year 2024, respectively, with non-cash stock-based compensation expense of $11.0 million and $48.3 million for the same periods
•
Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $441.1 million as of December 31, 2025

Upcoming Events

•
46th Annual TD Cowen Health Care Conference
o
Management will participate in a fireside chat on Tuesday, March 3 at 9:10 a.m. Eastern Time. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website

•
2026 Leerink Partners Global Healthcare Conference
o
Management presentation on Wednesday, March 11 at 1:40 p.m. Eastern Time. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website

Conference Call

Day One will host a conference call and webcast today, February 24 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.

(Press release, Day One, FEB 24, 2026, View Source [SID1234662905])

On February 24, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported data from the phase 1 dose-escalation part of the VB-C-03 trial (N=13). The data will be further elaborated at an oral presentation by Dr. Caroline Even, Institut Gustave Roussy, Villejuif (Paris) at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO) on March 20, 2026. A full abstract is expected to be published by ICHNO before the congress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The VB-C-03 trial is investigating abi-suva in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in 1st line unresectable recurrent or metastatic oropharyngeal head and neck cancer patients (NCT06016920). Nykode is further advancing abi-suva development in 1st line head and neck cancer through the Abili-T phase 2 randomized clinical trial.

The phase 1 VB-C-03 data show that anti-tumor activity was observed with a final confirmed objective response rate (ORR) of 38.5%. The data demonstrates that abi-suva elicits rapid, strong and durable HPV16-specific T cell responses. Robust and durable T cell expansion in the circulation was also confirmed by TCR sequencing. The data also demonstrate that all tested doses of abi-suva in combination with pembrolizumab were well tolerated and showed a favorable safety profile.

Michael Engsig, Chief Executive Officer of Nykode, commented: "The objective response rate of 38.5% for the combination treatment compared to historical 19% of standard of care gives us confidence in abi-suva heading into the Abili-T trial which is investigating the same regiment in a randomized controlled setting. This is the third trial for abi-suva indicating effect across three different patient groups including both head and neck as well as cervical cancer."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. KEYTRUDA has been supplied by MSD for the VB-C-03 trial according to the clinical trial collaboration and supply agreement between Nykode and MSD.

(Press release, Nykode Therapeutics, FEB 24, 2026, View Source [SID1234662929])

On February 24, 2026 K36 Therapeutics, Inc. ("K36"), a privately held, clinical-stage biotechnology company developing novel targeted therapies for cancers with high unmet medical need, reported data from its Phase 1 clinical trial of KTX-2001 will be presented in a Trial in Progress poster at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place February 26–28, 2026, in San Francisco, California. KTX-2001 is a first-in-class, orally administered, selective NSD2 inhibitor being evaluated in patients with metastatic castration-resistant prostate cancer (mCRPC) and represents the company’s second NSD2 inhibitor to enter clinical development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The KTX-2001 Trial in Progress poster will highlight the scientific rationale, study design, patient population, and dose-escalation study of the first-in-human Phase 1 STRIKE-001 trial. Part A is designed to evaluate the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose(s) of KTX-2001 monotherapy. Part B will evaluate the safety and tolerability of KTX-2001 plus darolutamide to determine the recommended Phase 2 dose(s) for the combination. Secondary objectives include assessments of pharmacokinetics, pharmacodynamics, and preliminary clinical activity.

"We are pleased to present the STRIKE-001 study design evaluating KTX-2001, an oral, first-in-class NSD2/MMSET inhibitor, in metastatic castration-resistant prostate cancer," said Wassim Abida, MD, PhD, of Memorial Sloan Kettering Cancer Center. "Preclinical findings support the rationale for targeting NSD2 in prostate cancer, where it has been associated with lineage plasticity, resistance to androgen receptor pathway inhibitors, and progression to treatment-emergent neuroendocrine disease. STRIKE-001 is designed to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of KTX-2001 as monotherapy and in combination with darolutamide in this setting."

STRIKE-001 (NCT07103018) is a multi-center, open-label dose escalation of KTX-2001 monotherapy (Part A) and in combination with darolutamide, an oral, nonsteroidal androgen receptor inhibitor (Part B).

ASCO Genitourinary Cancers Symposium, February 26–28, 2026
Trial in Progress Poster Details:

Title: Phase 1, dose-escalation study of KTX-2001 (an NSD2 inhibitor) alone and in combination with darolutamide for metastatic castration-resistant prostate cancer
Abstract Number: TPS276
Poster Number: N12
Session Title: Trials in Progress Poster Session A: Prostate Cancer
Presentation Time: February 26, 2026, 11:30 AM-12:45 PM; 5:45 PM-6:45 PM (PST)
Location -Moscone Center (West), San Francisco
Full abstract can be found at ASCO (Free ASCO Whitepaper) GU Meeting Website: View Source

About the KTX-2001 Phase 1 Clinical Trial (STRIKE-001)
STRIKE-001 (NCT07103018) is a multi-center, open-label dose escalation evaluating KTX-2001 as a monotherapy (Part A) and in combination with darolutamide (Part B). K36 expects to enroll approximately 140 patients with mCRPC who have received prior androgen receptor inhibitors and prior chemotherapy.

KTX-2001 is a small molecule, selective inhibitor of nuclear receptor binding SET domain protein 2 (NSD2, also known as multiple myeloma [MM] SET domain-containing protein [MMSET]/Wolf-Hirschhorn syndrome candidate 1 protein [WHSC1]). KTX-2001 inhibits NSD2-mediated dimethylation of histone H3 at lysine 36 (H3K36me2), disrupting aberrant NSD2-dependent oncogenic pathways.

(Press release, K36 Therapeutics, FEB 24, 2026, View Source [SID1234662947])

On February 24, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported that company management will present at two upcoming investor conferences:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TD Cowen 46th Annual Health Care Conference on Tuesday, March 3rd at 9:50 a.m. ET in Boston, MA.
Leerink Global Healthcare Conference on Monday, March 9th at 3:40 p.m. ET in Miami, FL.

Disc management will be participating in investor meetings during the above conferences, as well as the Jefferies Biotech on the Beach Summit on March 10th and the Barclays 28th Annual Global Healthcare Conference on March 11th, both in Miami, FL.

Live webcasts of the presentations will be available through the investor relations section of the Company’s website at ir.discmedicine.com and an archived replay will be available after the event.

(Press release, Disc Medicine, FEB 24, 2026, View Source [SID1234662906])

On February 24, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that Christopher J. Schaber, Ph.D., President & Chief Executive Officer will deliver a corporate presentation at the BIO Investment & Growth Summit at 3:00 PM on Monday, March 2. The BIO Investment & Growth Summit, held March 2 to 3 at Eden Roc Miami Beach, in Miami Beach, Florida, will include innovative programs, one-on-one meetings, and company presentations. For more information please refer to the conference website at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Registered conference attendees may schedule a meeting with Soligenix via the conference scheduling platforms. If you are unable to attend the conferences and would like to schedule a meeting with management, please contact [email protected].

(Press release, Soligenix, FEB 24, 2026, View Source [SID1234662930])