On May 8, 2026 Galapagos reported the company officially changed its name to Lakefront Biotherapeutics NV.

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Founded in 1999 as a joint venture between Crucell and Tibotec under the leadership of founder and former CEO Onno van de Stolpe, Galapagos grew from a small Belgian-Dutch biotech startup into an internationally recognized life sciences company listed on both Euronext and Nasdaq. Over the years, the company became known for its strong research platform, landmark collaboration with Gilead Sciences, and the launch of rheumatoid arthritis drug Jyseleca.

In recent years, however, the company has undergone a profound strategic transformation. Under its second CEO Paul Stoffels, who joined in 2022, Galapagos expanded into oncology and next-generation cell therapy through the acquisitions of CellPoint and AboundBio. The company later divested its Jyseleca business to focus on innovative therapeutics in immunology and oncology.

Following a broad strategic review and evolving market conditions, the company gradually shifted away from its cell therapy ambitions and toward a new model centered on transformational business development and targeted investments in novel therapeutics.

The new name, Lakefront Biotherapeutics, reflects that repositioning. According to the company, the rebranding signals "a forward-looking identity grounded in clarity, discipline, and ambition," while emphasizing its focus on building a portfolio of breakthrough opportunities for patients and creating long-term stakeholder value.

The transition closes an important era in European biotech history, while opening a new phase for one of BeNelux’ best-known life sciences companies.

(Press release, Galapagos, MAY 8, 2026, View Source [SID1234670288])

On May 8, 2026 Oncolys BioPharma reported Non-consolidated Financial Results for the Three Months Ended March 31, 2026.

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(Press release, Oncolys BioPharma, MAY 8, 2026, View Source [SID1234669195])

On May 8, 2026 Ono reported consolidated Financial Results for the Fiscal Year Ended March 31, 2026.

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(Filing, 3 mnth, MAR 31, Ono, 2026, MAY 8, 2026, View Source [SID1234669152])

On May 8, 2026 Azalea Therapeutics, Inc., a biotechnology company redefining precision genomic medicines in vivo, reported that first-in-primate data from its proprietary in vivo CAR T cell platform have been accepted as a late-breaking abstract for oral presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting, taking place May 11 – 15, 2026 in Boston, Massachusetts.

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The late-breaking abstract, titled "A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration," describes the first in vivo generation of genomic site-specific engineered TRAC-CAR T cells in non-human primates. Azalea’s platform is designed to generate CAR T cells directly inside the body through a dual-vector approach that combines CD3-targeted enveloped delivery vehicles (EDVs) delivering transient Cas9 complexes with a T cell-tropic AAV (AAV-T) carrying a promoterless CAR gene flanked by TRAC homology arms. This approach enables precise insertion of the CAR gene at the TRAC locus, placing CAR expression under control of the endogenous T cell promoter.

In the study, six rhesus macaques received a single intravenous administration of EDV and AAV-T vectors at different dose levels without prior lymphodepletion. The study assessed in vivo TRAC-CAR T cell generation, TRAC-CAR-mediated B cell depletion in peripheral blood, lymph nodes and bone marrow, and safety parameters.

"These first-in-primate data represent a major milestone for Azalea and for the broader field of in vivo cell engineering," said Jenny Hamilton, Ph.D., co-founder, president and chief executive officer of Azalea Therapeutics. "In immune-competent non-human primates, a single intravenous administration of our dual-vector platform generated TRAC-CAR T cells in vivo and achieved complete target B cell depletion across peripheral blood, lymph nodes and bone marrow without lymphodepletion. We believe that achieving precise insertion at a defined genomic locus will be foundational to the safety, durability and physiologic regulation of future in vivo cell therapies. We believe these findings provide important translational support for our approach and the potential to make powerful cell therapies more accessible by eliminating the need for individualized ex vivo manufacturing."

First-in-Primate In Vivo TRAC-CAR T Cell Engineering

In the study, animals demonstrated in vivo generation of TRAC-CAR T cells, with TRAC-CAR T cells peaking as high as 41% of all peripheral T cells on Day 11. All six animals demonstrated deep B cell aplasia of greater than 90% in peripheral blood by Day 10.

The study also demonstrated potent target B cell clearance beyond peripheral blood. In lymph nodes and bone marrow, B cells were deeply depleted by greater than 90% in five of six animals at the highest dose level within two weeks following treatment.

Treatment was generally well tolerated, with no deaths, no neurotoxicity and a favorable safety profile. Molecular analyses confirmed no off-target CAR expression or integration in non-T cells in the blood.

"To our knowledge, this is the first demonstration of site-specific gene integration in T cells in a non-human primate in vivo. This study demonstrates that Azalea’s platform can achieve cell-selective delivery, genomic locus-specific CAR insertion and robust pharmacodynamic activity in a clinically relevant non-human primate model," said Connor Tsuchida, Ph.D., scientific co-founder, vice president of research and development at Azalea Therapeutics and presenting author of the abstract. "The combination of TRAC-targeted integration, endogenous promoter-driven CAR expression and activity across multiple tissue compartments supports continued advancement of this genome editing-based in vivo CAR T platform toward clinical translation."

Azalea will present these data at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting.

Abstract Title: A first-in-primate demonstration of in vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration
Presenting Author: Connor A. Tsuchida, Ph.D., Azalea Therapeutics
Session: Oral Abstract Sessions – Late-breaking abstracts
Date/Time: Friday, May 15, 2026, 8:00 am – 9:45 am ET
Location: Westin Seaport Commonwealth Ballroom ABC (Concourse Level)

(Press release, Azalea Therapeutics, MAY 8, 2026, View Source [SID1234665405])

On May 8, 2026 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its financial and operating results for the first quarter ended March 31, 2026, and provided a business update.

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Recent Progress and Upcoming Catalysts:

TTI-109 (Healthy Volunteer Study): Study ongoing with topline data anticipated in June 2026. The Company plans to announce the clinical development strategy based on these results.
TTI-101 (HCC – REVERT LIVER CANCER study): Phase 1b/2 trial remains on track to report topline results in 2H 2026.
TTI-101 (IPF – REVERT IPF study additional analyses): Phase 2 trial showed that TTI-101 was associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo. Treatment with TTI-101 was also associated with a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine.

Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We are approaching a key inflection point with topline data from our next-generation STAT3 inhibitor, TTI-109, expected in June. These results are expected to inform our future clinical development strategy."

"TTI-109 is designed to build on the preclinical and clinical activity observed with TTI-101 while potentially offering improved tolerability through its prodrug profile and enabling broader development across inflammatory and proliferative diseases driven by STAT3."

"In parallel, we remain on track to report topline data from our ongoing Phase 2 REVERT LIVER CANCER trial in the second half of this year. Prior interim findings demonstrated clinically meaningful activity across treatment settings, and we look forward to evaluating the full dataset."

"We continue to make significant progress advancing both programs, providing line of sight to two near-term value inflection points," Dr. Alibhai concluded.

Key Upcoming Milestones:

June 2026: TTI-109 Phase 1 healthy volunteer topline data and clinical development strategy
2H 2026: TTI-101 Phase 1b/2 HCC topline data

First Quarter 2026 Financial Results

Research and development expenses for the three months ended March 31, 2026, were $4.9 million as compared to $3.1 million for the comparable period in 2025. The increase was primarily driven by higher TTI-109 developmental costs, partly offset by declining clinical costs associated with TTI-101.

General and administrative expenses were $2.1 million for the three months ended March 31, 2026, as compared to $1.2 million for the three months ended March 31, 2025. The increase was primarily driven by higher personnel costs, including stock-based compensation, and professional fees, including costs associated with being a publicly traded company.

Net loss for the three months ended March 31, 2026, was $6.8 million, as compared to a net loss of $9.6 million for the comparable period in 2025.

Basic and diluted net loss per share attributable to common shareholders for the three months ended March 31, 2026, were a net loss of $(0.73), compared to a net loss of $(3.72) for the comparable period in 2025.

Cash, cash equivalents and short-term investments as of March 31, 2026, were $25.0 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026.

(Press release, Tvardi Therapeutics, MAY 8, 2026, View Source [SID1234665402])