Arvinas Announces Data Presentations from the Vepdegestrant (ARV-471) Clinical Development Program at the 2025 San Antonio Breast Cancer Symposium (SABCS)

On November 24, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that multiple abstracts on vepdegestrant (ARV-471) have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12, 2025 in San Antonio, Texas. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.* Ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.

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The presentation details are as follows:

Title: Subgroup analyses of VERITAC-2: A phase 3 trial of vepdegestrant, a PROTAC estrogen receptor (ER) degrader, versus fulvestrant in ER-positive/ human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)
Presenting Author: Erika P. Hamilton
Presentation Number: PD10-03
Presentation Type: Poster Spotlight Presentation
Session: Poster Spotlight 10: Novel Combinations with Endocrine Therapy
Date: Friday, December 12, 2025
Session Time: 7:00–8:30 AM CT
Presentation Time: 7:36–7:39 AM CT

Title: Circulating tumor DNA (ctDNA) biomarker analyses of a phase 1/2 study evaluating vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)
Presenting Author: Seth A. Wander
Presentation Number: PS2-07-24
Presentation Type: Poster Presentation
Session: Poster Session 2
Date: Wednesday, December 10, 2025
Session Time: 5:00–6:30 PM CT

Title: Real-world prevalence of ESR1 mutations (ESR1m) among patients with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) after first-line (1L) treatment with endocrine therapy (ET) and/or a cyclin dependent kinase 4/6 inhibitor (CDK4/6i)
Presenting Author: David Chandiwana
Presentation Number: PS1-11-09
Presentation Type: Poster Presentation
Session: Poster Session 1
Date: Wednesday, December 10, 2025
Session Time: 12:30–2:00 PM CT

Title: I-SPY2 Endocrine Optimization Pilot (EOP): Neoadjuvant vepdegestrant monotherapy or in combination with letrozole or abemaciclib in molecularly selected patients with stage 2/3 HR+ HER2-negative breast cancer (BC)
Presenting Author: Jo Chien
Presentation Number: PD10-02
Presentation Type: Poster Spotlight Presentation
Session: Poster Spotlight 10: Novel Combinations with Endocrine Therapy
Date: Friday, December 12, 2025
Session Time: 7:00–8:30 AM CT
Presentation Time: 7:33–7:36 AM CT

The I-SPY2 EOP trial is sponsored by Quantum Leap.

Title: A phase 1/2 trial evaluating the safety, tolerability, and efficacy of the KAT6 inhibitor, PF-07248144, in combination with vepdegestrant in patients with ER+/HER2− locally advanced or metastatic breast cancer
Presenting Author: Fengting Yan
Presentation Number: PS5-09-30
Presentation Type: Poster Presentation (Trial in Progress Poster)
Session: Poster Session 5
Date: Friday, December 12, 2025
Session Time: 12:30–2:00 PM CT

The full abstracts can be accessed via the SABCS online program.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC estrogen receptor degrader. In the VERITAC-2 Phase 3 study, vepdegestrant demonstrated statistically significant and clinically meaningful improvement in progression free survival compared to fulvestrant in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The U.S. Food and Drug Administration (FDA) is reviewing the filed New Drug Application (NDA) for vepdegestrant. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer share worldwide development costs, commercialization expenses, and profits.

*In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the commercialization and potential further development of vepdegestrant.

(Press release, Arvinas, NOV 24, 2025, View Source [SID1234660887])

AMGEN TO PRESENT AT CITI’S 2025 GLOBAL HEALTHCARE CONFERENCE

On November 24, 2025 Amgen (NASDAQ:AMGN) reported it will present at Citi’s 2025 Global Healthcare Conference at 1:45 p.m. ET on December 3, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, NOV 24, 2025, View Source [SID1234660886])

AMGEN TO PRESENT AT THE 8TH ANNUAL EVERCORE ISI HEALTHCONX CONFERENCE

On November 24, 2025 Amgen (NASDAQ:AMGN) reported it will present at the 8th annual Evercore ISI HealthCONx Conference at 10:00 a.m. ET on December 3, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, NOV 24, 2025, https://investors.amgen.com/news-releases/news-release-details/amgen-present-8th-annual-evercore-isi-healthconx-conference [SID1234660885])

J & D Pharmaceuticals LLC Receives Orphan Drug Designation for Treatment of Hepatocellular Carcinoma (HCC)

On November 23, 2025 J & D Pharmaceuticals LLC reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s investigational therapy for the treatment of Hepatocellular Carcinoma (HCC) a rare and life-threatening disorder that is estimated to occur in approximately 73,000 individuals in the United States in 2025.

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HCC is a devastating disorder that has a very poor prognosis. With FDA approved medications the amount of time extended in patient with HCC is only 2.5 months. There is a need for a safer and more effective medication for HCC.

"Receiving Orphan Drug Designation is yet another significant milestone for J & D Pharmaceuticals," said Lenard Lichtenberger, PhD, Chief Scientific of J & D Pharmaceuticals LLC. "This designation adds to the two previous orphan drug designations we received and continues to underscore the urgent need for innovative therapies for HCC patients and strengthens our commitment to developing solutions that we expect to transform the lives of those affected by this debilitating condition not just by adding years to their lives but life to those years."

The FDA’s Orphan Drug Designation program provides incentives to encourage the development of treatments for rare diseases, including tax credits for qualified clinical testing, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon regulatory approval.

J & D Pharmaceuticals plans to advance its HC program into clinical development and will continue working closely with the FDA and the HCC community to accelerate progress toward delivering a novel treatment option to patients in need.

(Press release, J & D Pharmaceuticals, NOV 23, 2025, View Source [SID1234660994])

Harbour BioMed Advances Global Strategic Collaboration with AstraZeneca to Discover and Develop Next-Generation Biotherapeutics in Oncology

On November 23, 2025 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics for immunology and oncology, reported an update and advancement of its global strategic collaboration with AstraZeneca, originally established in March 2025. The collaboration aims to discover and develop next-generation biotherapeutics, including antibody-drug conjugates (ADCs) and T cell engagers, leveraging the knowledge of both companies.

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Under the terms of the agreement, AstraZeneca will continue to nominate discovery programs to Harbour BioMed each year over the next four years, reflecting the continued progress of the partnership, and will retain the option to license these programs for further development. Harbour BioMed will be eligible to receive option and option exercise fees, development and commercial milestone payments, plus tiered royalties on future net sales on such licensed programs. The economic terms are consistent with the financial framework established in March 2025.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, said: "We are pleased to advance our collaboration with AstraZeneca to develop next-generation biotherapeutics in oncology. Harbour BioMed has collaborated with AstraZeneca on multiple programs since 2022, and over time, the two parties have established a trusted and solid partnership. With our strong capabilities enabled by our proprietary antibody platforms, we are well positioned to support AstraZeneca in developing innovative biotherapeutics that can address significant unmet medical needs and improve patient outcomes globally."

(Press release, Harbour BioMed, NOV 23, 2025, View Source [SID1234660873])