On November 5, 2025 Evotec reported Interim results for first nine months 2025.

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(Presentation, Evotec, NOV 5, 2025, View Source [SID1234661701])

On November 5, 2025 Genmab A/S (Nasdaq: GMAB) reported that its Chief Executive Officer Jan Van de Winkel and Chief Financial Officer Anthony Pagano will participate in a fireside chat at the Jefferies Global Healthcare Conference in London at 12:00 PM GMT (7:00 AM EST) on November 19, 2025. A webcast of the fireside chat will be available on Genmab’s website at View Source

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(Press release, Genmab, NOV 5, 2025, View Source [SID1234659462])

On November 5, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the third quarter ended September 30, 2025, and highlighted recent corporate progress.

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"Our focus remains on patients – those living with skeletal dysplasia and bladder cancer who need improved, precise options of care," said Todd Harris, Ph.D., CEO of TYRA. "Enrollment continues to progress across our BEACH301 and SURF302 Phase 2 studies, reflecting strong engagement from the clinical and patient communities. We are also expanding the Phase 2 development of dabogratinib into low-grade upper tract urothelial carcinoma, where FGFR3 alterations occur in approximately 85% of LG-UTUC cases, further reinforcing our commitment to addressing FGFR3-driven disorders."

Dr. Harris continued, "We believe 2026 will be a pivotal year for TYRA. We expect to report interim Phase 2 results that could validate dabogratinib’s broad potential across achondroplasia, IR-NMIBC and LG-UTUC."

Third Quarter 2025 and Recent Corporate Highlights

Dabogratinib (formerly TYRA-300)

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Dabogratinib is an oral investigational FGFR3-selective inhibitor being developed for the treatment of pediatric achondroplasia (ACH), low-grade intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and LG-UTUC. TYRA previously reported interim clinical proof-of-concept results in metastatic urothelial cancer (mUC) – dabogratinib demonstrated encouraging anti-tumor activity and was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities.
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Enrolling Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating dabogratinib in children ages 3 to 10 with achondroplasia with open growth plates. The study is enrolling a safety sentinel cohort of at least 3 participants per dose level in children ages 5 to 10. The Company remains on track to report interim results from the safety sentinel cohort in 2H 2026.
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Enrolling Phase 2 NMIBC Study – SURF302. SURF302 is a Phase 2 open-label clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade IR NMIBC. The Company remains on track to report initial three-month complete response data in 1H 2026.
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Expanded Development into LG-UTUC – SURF303. TYRA advanced dabogratinib into LG-UTUC, where FGFR3 alterations occur in approximately 85% of cases. An Investigational New Drug application (IND) was cleared by the US Food and Drug Administration (FDA) to enable a Phase 2 study of dabogratinib in LG-UTUC patients (SURF303), which is expected to be initiated in 2026.
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Phase 1/2 mUC Study – SURF301. Dabogratinib continues to be evaluated in Part B of SURF301 at potentially therapeutic once-daily doses in support of determining an optimal dose for mUC.

TYRA-430

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Advanced Phase 1 HCC Study – SURF431. TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The SURF431 study continues to enroll and dose adults with hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations. We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies.

TYRA-200

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Advanced Phase 1 ICC Study – SURF201. TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study continues to enroll and dose adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma (ICC) and other advanced solid tumors with activating FGFR2 gene alterations.

SNÅP Platform and Pipeline

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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.

Third Quarter 2025 Financial Results

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Cash, Cash Equivalents and Short-Term Investments. As of September 30, 2025, TYRA had cash, cash equivalents and marketable securities of $274.9 million. TYRA’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027.
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Research and Development (R&D) Expenses. R&D expenses for the three months ended September 30, 2025 were $25.5 million compared to $22.7 million for the same period in 2024. The increase was primarily associated with start-up and enrollment activities for BEACH301, SURF302 and SURF431.
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General and Administrative (G&A) Expenses. G&A expenses for the three months ended September 30, 2025 were $7.5 million compared to $5.9 million for the same period in 2024. The increase was primarily driven by higher personnel-related costs, including non-cash stock-based compensation.
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Net Loss. Third quarter net loss was $29.9 million compared to $24.0 million for the same period in 2024.

Upcoming Clinical Milestones:

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BEACH301: initial results from safety sentinel cohort – 2H 2026
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SURF302: initial three-month complete response data – 1H 2026
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SURF303: initiate Phase 2 study – 2026

About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of skeletal dysplasia and cancer that has demonstrated interim clinical proof-of-concept results in mUC. The current planned clinical development for dabogratinib includes Phase 2 clinical trials for pediatric achondroplasia (BEACH301), intermediate risk (IR) non-muscle invasive bladder cancer (SURF302), low-grade upper tract urothelial carcinoma (SURF303) and potentially future mUC clinical trials. The FDA has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to dabogratinib for the treatment of achondroplasia.

BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating dabogratinib in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. The study is now enrolling a safety sentinel cohort of at least 3 participants per dose level in children ages 5 to 10.

SURF302 is a Phase 2, open-label, clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade IR NMIBC. Participants will be randomized initially to treatment with dabogratinib at 50 mg once-daily (QD) (Cohort 1) or treatment with dabogratinib at 60 mg QD (Cohort 2). The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, median duration of response, recurrence free survival, progression free survival, safety and tolerability.

SURF303 will be a Phase 2, open-label, clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered LG-UTUC. This study has not yet begun enrolling patients.

About TYRA-430

TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 clinical study (SURF431) is a multicenter, open-label, first-in-human study of TYRA-430 and is currently enrolling and dosing adults with advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations.

About TYRA-200

TYRA-200 is an oral, investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The Phase 1 clinical study of TYRA-200, SURF201, is a multi-center, open label study designed to evaluate the maximum tolerated dose and the recommended Phase 2 dose of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling and dosing adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, NOV 5, 2025, View Source [SID1234659478])

On November 5, 2025 Leukogene Therapeutics Inc. (LTI), a biopharmaceutical company developing next-generation immunotherapies for hematologic and other malignancies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s lead product candidate, M2T-CD33 (LTI-214), for the treatment of Acute Myeloid Leukemia (AML).

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This designation underscores the significant unmet medical need for AML patients and recognizes the therapeutic potential of LTI-214 as a novel and differentiated approach for this aggressive blood cancer. The designation may provide LTI with a range of development incentives, including eligibility for tax credits on qualified clinical trial costs, waiver of certain FDA fees, and U.S. market exclusivity upon approval.

"We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation," said Dr. Sandeep Gupta, CEO of Leukogene. "AML remains one of the most challenging hematologic cancers, and outcomes for relapsed or refractory patients remain poor. The LTI-214 program embodies our commitment to advancing new immunotherapy approaches that are both potent and safer for patients. This designation represents an important step toward our goal of transforming the treatment paradigm for AML."

Nathan Dolloff, PhD, Founder and CSO of Leukogene stated, "This is an important step forward for Leukogene and the company’s Major Histocompatibility Complex Class II (MHCII) engager technology. The M2T platform is a completely new approach to cancer immunotherapy and the endorsement from FDA is a testament to its high impact potential."

(Press release, Leukogene Therapeutics, NOV 5, 2025, View Source [SID1234659495])

On November 5, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the third quarter of 2025 and recent business highlights.

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"The high unmet need in lower-risk MDS is well known, and RYTELO is a therapy with a novel mechanism of action and the potential to significantly impact the treatment paradigm. There is work ahead of us to fully maximize the value of this therapy and ensure RYTELO reaches more patients," said Harout Semerjian, President and Chief Executive Officer of Geron. "Geron is positioned, with our realigned leadership team, to strengthen commercial execution, increase both physician and patient awareness, and drive RYTELO sales in the U.S. We look forward to presenting meaningful data at ASH (Free ASH Whitepaper), enhancing our partnerships with the MDS community and conducting the interim analysis for the IMpactMF trial. Our actions are focused on creating value for our patients and shareholders."

Recent Business Highlights

RYTELO

Achieved net product revenue of $47.2 million in the third quarter of 2025.
Demand was down 3% quarter-over-quarter, with opportunities to elevate brand awareness and clinical value communications.
Number of ordering accounts is now approximately 1,150, an increase of approximately 150 quarter-over-quarter.
Increased RYTELO presence at major hematology forums, such as the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting.
Announced that two abstracts highlighting data from the IMerge clinical trial in lower-risk MDS were accepted for presentation at the ASH (Free ASH Whitepaper) 2025 Annual Meeting, including one oral presentation on the potential correlation between imetelstat clinical response rates and treatment-emergent cytopenias.
Clinical Pipeline

Completed enrollment of 320 patients in the IMpactMF Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis in September 2025.
Expect IMpactMF interim analysis readout for overall survival in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis in the second half of 2028 (when approximately 50% of patient events have occurred).
Announced three abstracts were accepted at the ASH (Free ASH Whitepaper) 2025 Annual Meeting highlighting clinical data from Geron’s IMbark and IMproveMF clinical trials and the investigator-sponsored IMpress clinical trial.
Corporate Updates

Announced the appointment of Ahmed ElNawawi ("Nawawi") as Executive Vice President, Chief Commercial Officer to advance the company’s strategic priorities, including driving growth, maximizing the potential of RYTELO, and strengthening the foundation for potential future portfolio expansion.
Appointed three additional executives with expertise across technical operations, investor relations and corporate affairs, and portfolio management, further strengthening the company’s commercial, operational and development capabilities.
Third Quarter 2025 Financial Results

Cash and Marketable Securities

As of September 30, 2025, Geron had approximately $421.5 million in cash, cash equivalents, restricted cash and marketable securities, compared to $502.9 million as of December 31, 2024.

Net Loss

For the three months ended September 30, 2025, the Company reported a net loss of $18.4 million, or $0.03 per share, compared to $26.4 million, or $0.04 per share, for the three months ended September 30, 2024.

Revenues

Total product revenue, net for the three months ended September 30, 2025, was $47.2 million, compared to $28.2 million for the three months ended September 30, 2024.

Total revenues for the three months ended September 30, 2025 was $47.2 million, compared to $28.3 million for the three months ended September 30, 2024. Total revenues include license fees and royalties in addition to product revenue, net.

Costs and Operating Expenses

Total costs and operating expenses for the three months ended September 30, 2025 were $61.1 million, compared to $56.5 million for the three months ended September 30, 2024.

Cost of goods sold was approximately $1.0 million for the three months ended September 30, 2025, compared to $456,000 for the three months ended September 30, 2024, which consisted of costs to manufacture and distribute RYTELO.

Research and development expenses for the three months ended September 30, 2025 were $21.1 million, compared to $20.2 million for the same period in 2024. The increase in research and development expenses for the three months ended September 30, 2025, compared to the same period in 2024, was primarily due to increased chemistry, manufacturing, and controls (CMC) and personnel-related expenses. Geron expects research and development expenses to increase in the remaining quarter of 2025 over 2024 levels, primarily due to ongoing investments to support the Company’s CMC strategy.

Selling, general and administrative expenses for the three months ended September 30, 2025 were $39.0 million, compared to $35.9 million for the same period in 2024. The increase in selling, general and administrative expenses was primarily due to an increase in sales and marketing full-time employees and additional investment in marketing programs.

2025 Financial Guidance

For fiscal year 2025, the Company expects total operating expenses will be between $250 million and $260 million, compared to previously announced guidance of approximately $270 million to $285 million. Total operating expenses include non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

Based on current operating plans and assumptions, the Company believes that its existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Wednesday, November 5, 2025, to discuss business updates and third quarter 2025 financial results.

A live webcast of the conference call and accompanying presentation will be available on the "Investors & Media" page of the Company’s website at www.geron.com. A replay of the webcast will be archived and available on the Company’s website.

(Press release, Geron, NOV 5, 2025, View Source [SID1234659463])