Core Insights - Genmab A/S announced promising results from the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S), showing a confirmed objective response rate (ORR) of 55.6% in heavily pre-treated ovarian cancer patients [2][4][8] - The study highlights the potential of Rina-S as a treatment option for patients with platinum-resistant ovarian cancer (PROC), a group with historically poor prognosis [3][6] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [13][14] - The company is headquartered in Copenhagen, Denmark, and has a global presence across North America, Europe, and Asia Pacific [14] Study Details - The RAINFOL-01 trial is an open-label, multicenter Phase 1/2 study evaluating the safety and efficacy of Rina-S in solid tumors expressing folate receptor-alpha (FRα) [7] - The B1 cohort specifically targets advanced ovarian cancer, with patients receiving either 100 mg/m or 120 mg/m doses of Rina-S [4][9] Clinical Results - In the B1 cohort, Rina-S at 120 mg/m resulted in a confirmed ORR of 55.6% and a disease control rate (DCR) of 88.9% [4][8] - The median duration of response (mDOR) was not reached, indicating sustained efficacy [4][8] - Common treatment-emergent adverse events included anemia, nausea, and fatigue, but no new safety signals were observed [5][6] Future Directions - Rina-S 120 mg/m has been selected for further evaluation in ongoing Phase 3 trials (RAINFOL-02) for PROC patients [4][11] - The FDA granted Fast Track designation to Rina-S for treating FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer [11]

Core Viewpoint - Genmab A/S's shares declined following Johnson & Johnson's decision to withdraw from the partnership to develop and commercialize GEN3014, a next-generation CD38 HexaBody aimed at treating multiple myeloma [2]. Group 1: Company Developments - Johnson & Johnson opted out of the deal with Genmab for the development of GEN3014, which is significant for Genmab's pipeline in oncology [2]. - The withdrawal from the partnership is expected to impact Genmab's stock performance negatively, as indicated by the recent decline in share prices [2]. Group 2: Market Context - The decision by Johnson & Johnson reflects broader trends in the biotech industry, where partnerships are crucial for the development and commercialization of new therapies [2].

Company Announcement - Genmab A/S held its Annual General Meeting on March 12, 2025, where the Board of Directors was constituted, appointing Ms. Deirdre P. Connelly as Chair and Ms. Pernille Erenbjerg as Deputy Chair [1] - The Board decided to grant 13,926 restricted stock units to members of the Board and employees, along with 4,214 warrants to employees [1] Restricted Stock Units - Each restricted stock unit is awarded cost-free and provides a conditional right to receive one share of Genmab A/S, with a fair value of DKK 1,372.50 per unit [2] - The restricted stock units will vest three years after the grant date, subject to specific vesting conditions [3] Warrants - Each warrant is awarded cost-free, with an exercise price of DKK 1,372.50, allowing the owner to subscribe for one share [4] - The fair value of each warrant is calculated at DKK 421.30, and they will vest three years after the grant date, expiring at the seventh anniversary of the grant date [5] Company Overview - Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics, with a vision to transform the lives of people with cancer and serious diseases by 2030 [6] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia Pacific [7]

Core Points - Genmab A/S held its Annual General Meeting on March 12, 2025, where the Annual Report for 2024 was approved and the Board of Directors received discharge [2][5] - The company's profit for the year was DKK 7,844 million, which will be carried forward to retained earnings [3][5] - Six members of the Board of Directors were re-elected for a one-year term, and Deloitte was re-elected as the company's auditor [3][5][6] Financial Decisions - The 2024 Compensation Report was approved [3][5] - Proposals from the Board of Directors included amendments to the Remuneration Policy, remuneration for 2025, reduction of share capital by DKK 2,076,853 through cancellation of treasury shares, authorization to acquire treasury shares, and issuance of warrants [5][6] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics to improve patient lives [4][7] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab aims to transform the lives of patients with cancer and other serious diseases by 2030 [4][7]

Company Announcement Johnson & Johnson has decided that it will not exercise its option to receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38 Genmab will not pursue further clinical development of HexaBody-CD38Data validates clinical potential of the HexaBody platform Genmab to host a conference call today at 5:00 PM CET / 4:00 PM GMT / 12:00 PM EDT COPENHAGEN, Denmark; March 10, 2025 – Genmab A/S (NASDAQ:GMAB) announced today that Johnson & Johnson (J&J) has decided that it ...

Core Viewpoint - Johnson & Johnson (J&J) has opted not to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38, leading Genmab to halt further clinical development of the drug despite promising initial clinical data [1][2][8]. Group 1: Clinical Data and Development - Initial clinical data for HexaBody-CD38 showed robust efficacy, with an overall response rate (ORR) of 55% in the intravenous arm compared to 52% in the subcutaneous daratumumab arm [4]. - The Phase 2 expansion study assessed the objective response rate as the primary endpoint, comparing HexaBody-CD38 with daratumumab in patients with relapsed or refractory multiple myeloma [3][9]. - Treatment emergent adverse events (TEAEs) above 20% in the HexaBody-CD38 arm included neutropenia, infusion-related reactions, anemia, and thrombocytopenia, with no new safety findings in the daratumumab arm [5]. Group 2: Future Focus and Pipeline - Genmab remains confident in its existing pipeline, which includes EPKINLY (epcoritamab) and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab, both in Phase 3 development [2]. - The company intends to maintain a disciplined investment strategy focused on its promising late-stage proprietary clinical pipeline to ensure future growth [2]. Group 3: Financial Guidance and Communication - The decision by J&J does not impact Genmab's financial guidance for 2025 [6]. - Genmab will host a conference call to discuss the event, providing an opportunity for stakeholders to gain further insights [7].

Company Announcement COPENHAGEN, Denmark; February 28, 2025 – Genmab A/S (Nasdaq: GMAB) - In accordance with Article 19 of Regulation No. 596/2014 on Market Abuse and Implementing Regulation 2016/523, this document discloses the data of the transactions made in Genmab A/S (Nasdaq: GMAB) by managerial employees and their closely associated persons. The company’s managerial employees and their closely associated persons have given Genmab A/S power of attorney on their behalf to publish trading in Genmab share ...

Core Points - Genmab A/S announced the granting of 614,676 restricted stock units and 517,191 warrants to management and employees [1] - The fair value of each restricted stock unit is DKK 1,608.50, while the exercise price for each warrant is also DKK 1,608.50 [1][3] - The restricted stock units will vest after three years, and the warrants will vest three years after the grant date, expiring at the seventh anniversary [2][4] Restricted Stock Units - Each restricted stock unit provides a conditional right to receive one share of Genmab A/S of nominally DKK 1 [1] - Vesting of restricted stock units for executive management is subject to performance criteria [1] - The fair value of each restricted stock unit is based on the closing market price on the date of grant [1] Warrants - Each warrant entitles the owner to subscribe for one share of nominally DKK 1, subject to payment of the exercise price [3] - The fair value of each warrant, calculated using the Black-Scholes formula, is DKK 501.65 [3] - The new warrants are granted under the terms set out in the warrant program adopted by the Board of Directors [4] Company Overview - Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics [5] - The company has a proprietary pipeline that includes bispecific T-cell engagers and next-generation immune checkpoint modulators [5] - Genmab aims to transform the lives of people with cancer and other serious diseases with its antibody medicines by 2030 [5]

Core Viewpoint - Genmab A/S has received approval from the Japan Ministry of Health, Labour and Welfare for EPKINLY (epcoritamab) to treat patients with relapsed or refractory follicular lymphoma (FL) who have undergone two or more prior lines of therapy, marking it as the first and only T-cell engaging bispecific antibody administered subcutaneously approved in Japan for this indication [2][8][11]. Group 1: Product Approval and Indications - EPKINLY is now approved for both relapsed or refractory follicular lymphoma and relapsed or refractory large B-cell lymphomas in Japan after two or more prior lines of therapy [2][8]. - The approval is based on results from the global Phase 1/2 EPCORE NHL-1 and the Japanese Phase 1/2 EPCORE NHL-3 clinical trials, which demonstrated strong efficacy and safety profiles [4][8]. Group 2: Clinical Trial Results - In the EPCORE NHL-1 trial, among 128 evaluable patients with R/R FL, the overall response rate (ORR) was 82% and the complete response (CR) rate was 62.5% [5]. - The Japanese trial (EPCORE NHL-3) showed an ORR of 95.2% and a CR rate of 76.2% among 21 evaluable patients, with 88.9% achieving minimal residual disease (MRD) negativity [9]. Group 3: Safety and Adverse Events - In the EPCORE NHL-1 trial, 93% of patients experienced treatment-emergent adverse events (TEAEs), with the most common being cytokine release syndrome (CRS) at 66.4% [6]. - In the EPCORE NHL-3 trial, 90.5% of patients reported TEAEs, with CRS occurring in 90.5% and injection site reactions in 71.4% [10]. Group 4: Company Commitment and Future Development - Genmab is committed to making EPKINLY available to patients and is pursuing additional international regulatory approvals for the investigational R/R FL indication and R/R DLBCL indication [11][15]. - The company continues to evaluate epcoritamab in various clinical trials across different hematologic malignancies, including ongoing Phase 3 trials [16][17].

I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up to Growth Stock Forum.Genmab ( GMAB ) reported strong Q4 2024 results last week and provided 2025 revenue guida ...