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SpyGlass and Agomab plan an IPO & Genmab fails a Phase 3

AuthorAuthor

Joachim Eeckhout & Eduardo Longoria
January 20, 2026

 

Good morning! The FDA had a rough year, but it still won the approvals race. According to the EMA’s Human Medicines in 2025 report, the European regulator recommended 38 novel drugs last year. That’s eight fewer than the FDA’s 46, with two US approvals slipping in during the final week of December. That gap held despite a tumultuous 2025 for the FDA, marked by leadership churn, layoffs, review delays, and the longest US government shutdown on record.

Yes, but: Both agencies approved fewer drugs than in 2024, but analysts say output has remained broadly stable. The concern is what comes next: the FDA’s staff losses and political disruption in the U.S. could compound into slower reviews in 2026.

Bottom line: Even battered, the FDA remains faster, but the regulatory climate on both sides of the Atlantic is tightening. Let’s see who wins in 2026.

Enjoy today’s read!

—Joachim E.

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SNAPSHOT

SpyGlass and Agomab plan IPOs as a biotech market rebound appears over the horizon

Take a step back from the view and you'll find more subtleties than you know.

 

The Belgian immunology company Agomab Therapeutics and the Californian eye-focused SpyGlass Pharma have filed to go public, signaling renewed optimism in the biotech IPO market.

Why it matters: These filings hint at a potential reopening of the IPO window in 2026, which could revitalize biotech funding after a prolonged market slowdown.

Backstory: Agomab, founded in 2019, is advancing two ALK5 inhibitors, including ontunisertib for fibrostenosing Crohn’s disease. The company raised $100M in Series C funding in 2023. SpyGlass is developing an implantable intraocular lens to deliver long-acting glaucoma medication. Both plan to use IPO proceeds to fund mid- to late-stage clinical trials.

Big picture: If successful, these IPOs may spark a wave of new biotech listings, echoing the strong debut of Aktis Oncology´s $318M IPO, the first biotech IPO of 2026.

Zoom in: Agomab intends to fund a global phase 2b trial of ontunisertib, targeting the 46% of Crohn’s patients with fibrostenosing complications across major global markets. Additionally, it will aim to launch a phase 2 trial for AGMB-447 in IPF. In the case of SpyGlass, the firm aims to complete phase 3 trials of its Bimatoprost Drug Pad-IOL System for glaucoma and ocular hypertension. Early data showed 36–37% intraocular pressure reduction.

What’s next: Both companies await SEC approval and market conditions before pricing their IPOs. Clinical trial milestones are expected later this year and into 2027.

SNIPPETS

What’s happening in biotech today?

🌥️ Silver linings: Genmab and AbbVie’s bispecific antibody epcoritamab failed to meet its primary endpoint of overall survival in the phase 3 EPCORE DLBCL-1 trial for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This dark cloud of failure seems to have overshadowed secondary outcomes like improved progression-free survival, higher response rates, and delayed time to next therapy. Despite this setback, both companies emphasized the secondary efficacy signals as evidence of disease control in a heavily pretreated population. Epcoritamab, already conditionally approved in the U.S. and EU, will remain under development, with two additional phase 3 combination trials expected to report results in 2026.

 🐢 Bulletproof cell therapy: AstraZeneca has acquired full global rights to the armored CAR-T cell therapy C-CAR031 through a $630 million deal with AbelZeta Pharma for the remaining rights in China, expanding on its previous ex-China ownership. C-CAR031, originally based on AstraZeneca’s discontinued CAR-T AZD5851, uses a GPC3-targeting chimeric antigen receptor enhanced by TGFβRII-based armoring technology and is being developed for hepatocellular carcinoma (HCC). A 2024 first-in-human study in China showed promising response rates, including a 75% objective response at the highest dose. The acquisition aligns with AstraZeneca’s strategy to expand its cell therapy pipeline for solid tumors with high unmet need.

 🚗 Hop in the CAR: ImmunityBio has reported ongoing complete responses lasting up to 15 months in two patients treated with its off-the-shelf CD19 CAR-NK cell therapy combined with rituximab in a phase 1 trial for Waldenstrom macroglobulinemia, a rare type of non-Hodgkin lymphoma. Both patients, who had advanced disease and had failed standard treatments, achieved complete remission after two cycles and required no further therapy. The treatment was administered in outpatient settings without chemotherapy or lymphodepletion, and no serious adverse events were reported. ImmunityBio is continuing patient enrollment and planning a follow-up trial that will add Anktiva, its IL-15 agonist, to the combination regimen.

😴 Sleep win: Nxera Pharma has announced positive top-line results from a phase 3 trial of its insomnia treatment daridorexant in South Korea, supporting a planned marketing submission in early 2026. The study, which tested a 50 mg dose in adult and elderly patients, met all primary and secondary endpoints, demonstrating significant improvements in subjective total sleep time, latency to sleep onset, and wake after sleep onset compared to placebo. Adverse event rates were comparable between treatment and placebo groups. Already marketed as Quviviq in several global regions, daridorexant may receive regulatory approval in South Korea by early 2027, addressing a large patient population.

🪓Workforce whack: Vedanta Biosciences has significantly reduced its workforce to prioritize resources for its lead program, VE303, a live bacterial consortium aimed at treating recurrent Clostridioides difficile infections. While the company did not confirm reports of a 50% layoff, it acknowledged the downsizing as necessary to maintain progress on the phase 3 trial, which is expected to complete by June 2027. Vedanta is refocusing efforts after a previous phase 2 failure in ulcerative colitis and an earlier 20% staff reduction. VE303 is supported by promising phase 2 data, and the company is seeking additional funding to sustain development.

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