Register Now: From Clinical to Commercial: Accelerating ADC Late-Stage Development with Technology Innovation and Integrated Platform
News|Podcasts|June 30, 2026 (Updated: June 29, 2026)

The BioPharm Brief: Priority Review, ADC Progress, and New Frontiers in Fibrosis

Listen
0:00 / 0:00

From a potential first at home treatment for thyroid eye disease to progress in lymphoma and a first in class antibody entering the clinic for kidney fibrosis, today's BioPharm Brief highlights three developments advancing biologic drug development.

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

Today's stories span ophthalmology, oncology, and nephrology, but they share a common theme. Biopharma companies continue to push biologic therapies into new indications while improving convenience for patients and expanding treatment options for diseases with significant unmet need.

We begin with Genentech, where the FDA has granted Priority Review to the supplemental Biologics License Application for Enspryng (satralizumab) for thyroid eye disease. If approved, the IL-6 receptor inhibitor would become the first and only at home subcutaneous treatment for the condition, giving patients an alternative to infusion based therapies. The application is supported by data from the global Phase III SatraGO-1 and SatraGO-2 studies, which demonstrated clinically meaningful improvements in proptosis, disease activity, and double vision. The FDA is expected to make a decision by October 15, 2026.

Next, ADC Therapeutics announced completion of patient enrollment in the Phase Ib LOTIS 7 trial evaluating Zynlonta in combination with glofitamab for patients with relapsed or refractory diffuse large B cell lymphoma. The study is assessing whether pairing an antibody drug conjugate with a CD20 bispecific antibody can improve outcomes in patients whose disease has returned or progressed after previous therapies. Initial safety and efficacy data are expected later this year.

Finally, Mediar Therapeutics has dosed the first participant in a phase I study evaluating MTX-439, a first in class monoclonal antibody targeting SMOC2 for chronic kidney disease associated fibrosis. Rather than addressing symptoms, the therapy is designed to interrupt fibrotic signaling pathways that contribute to progressive kidney damage. The study represents an early clinical milestone for a novel mechanism that could eventually have applications beyond kidney disease in other fibrotic conditions.

Whether improving patient convenience, exploring combination biologics, or advancing entirely new therapeutic targets, these stories illustrate how innovation continues to expand across the biologics pipeline.

Thanks for listening to The BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key Takeaways

  • Genentech's Priority Review could lead to the first self administered biologic treatment for thyroid eye disease.
  • ADC Therapeutics has completed enrollment in a key combination trial pairing an ADC with a bispecific antibody in relapsed lymphoma.
  • Mediar Therapeutics has entered the clinic with a first in class anti SMOC2 antibody designed to address fibrosis in chronic kidney disease.


Related to this article

The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
The BioPharm Brief: argenx Bets on Peptides, a Two-Bispecific Regimen in Prostate Cancer, and a New Take on T-Cell Engagers
argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.
The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia
FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
The BioPharm Brief: A $7 Billion Oncology Option Deal, a TL1A Pivot, and Oral Adalimumab Heads to the Clinic
Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.