Avenzo Therapeutics Granted Fast Track Designation for AVZO-103, a Potential Best-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate, for the Treatment of Patients with Urothelial Cancer Previously Treated with Enfortumab Vedotin

On November 24, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (BsADC).

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The designation was granted for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. There are no approved antibody-drug conjugates for patients previously treated with enfortumab vedotin.

"Receiving Fast Track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on enfortumab vedotin," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We believe AVZO-103 has the potential to become a promising treatment option for patients and we are committed to rapidly advancing its clinical development."

AVZO-103 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors.

About Fast Track Designation
Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
Rolling Review of a Biologic License Application or New Drug Application by the FDA

(Press release, Avenzo Therapeutics, NOV 24, 2025, View Source [SID1234660888])

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])