On April 28, 2026 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported the presentation of new preclinical data from its ATR-01 program at the 2026 Annual Meeting of the American Society of Gene & Cell Therapy ("ASGCT 2026").

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The poster highlights Azitra’s engineered live biotherapeutic candidate ATR01-616, which is designed to treat ichthyosis vulgaris (IV) by delivering recombinant human filaggrin directly into the skin using a modified Staphylococcus epidermidis strain. IV is a common genetic skin disorder caused by filaggrin deficiency, leading to impaired skin barrier function and increased trans-epidermal water loss (TEWL).

The data being presented at ASGCT (Free ASGCT Whitepaper) 2026 highlight ATR01-616’s mechanism of action and translational potential, including its ability to elicit robust secretion of a recombinant human filaggrin domain, with peak production observed 6–8 hours following application. In an ex vivo pig skin model, ATR01-616 significantly reduced transepidermal water loss across all dose levels (p < 0.001), with levels returning near baseline within 20 hours. In parallel, studies in reconstructed human epidermis showed restoration of key structural features such as increased filaggrin levels and co-localization with keratin proteins, supporting functional integration into the skin barrier.

"These data provide compelling validation of our ATR-01 program and its potential to address the underlying cause of ichthyosis vulgaris," said Francisco Salva, Chief Executive Officer of Azitra. "By using the skin’s natural bacteria to deliver functional filaggrin domains deeper into the epidermis, we are advancing a differentiated approach designed to restore skin barrier function and target the protein to where it is needed to address this genetically driven disease. The findings presented at ASGCT (Free ASGCT Whitepaper) build on our previously reported positive preclinical data for ATR-01 and further support the program’s advancement toward IND-enabling studies and a first-in-human clinical trial in patients with ichthyosis vulgaris."

ATR01-616 is a topical formulation containing a genetically engineered S. epidermidis strain designed as an auxotroph for controlled growth and optimized to secrete therapeutic filaggrin fragments. This approach enables localized, sustained delivery of protein therapeutics directly to affected skin, potentially overcoming limitations of existing treatments that do not address underlying disease biology and positioning ATR-01 as a novel, microbiome-based modality within dermatology.

Poster Details

Title: An Engineered Human Filaggrin Secreting Staphylococcus epidermidis Strain for the Topical Treatment of Ichthyosis Vulgaris
Presenter: Roger Léger, Ph.D., Vice President of Chemistry, Formulation and Development, Azitra, Inc.
Abstract Number: 2691
Session: Gene Addition: Non-Viral Vectors
Meeting: ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting

(Press release, Azitra, APR 28, 2026, View Source [SID1234664850])

On April 27, 2026 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) and XOMA Royalty Corporation ("XOMA Royalty") (Nasdaq: XOMA), both biotechnology royalty aggregators, reported that the companies have entered into a definitive agreement under which Ligand will acquire XOMA Royalty for $39.00 per share of common stock in cash, for a total equity value of approximately $739 million. XOMA Royalty stockholders are expected to separately receive one non-transferable Contingent Value Right ("CVR") per share entitling the holder to receive a portion of 75% of the net proceeds that may result from certain pending litigation at XOMA Royalty. The cash purchase price at close represents an approximately 14% premium to XOMA Royalty’s 30 trading day volume weighted average price as of April 24, 2026, the last trading day prior to announcement of the transaction.

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"The acquisition of XOMA Royalty presents a compelling opportunity for us to strengthen and diversify our portfolio across all stages of clinical development and accelerate our long-term profitable growth. This acquisition will add seven marketed products and nearly double our portfolio of Phase 2 and 3 assets, which we believe will create significant value for our stockholders, all through a single transaction," said Todd Davis, CEO of Ligand. "The XOMA Royalty team has built a robust portfolio of complementary biopharmaceutical assets, and this acquisition will enable us to further grow and diversify in areas such as ophthalmology, oncology, CNS and rare diseases. With XOMA Royalty, we believe we will now be in an even stronger position to leverage our expertise and capital base to support broader patient access and advance late-stage clinical programs in a way that enhances patient outcomes and improves lives.

With this agreement, Ligand adds over 120 commercial, clinical, and preclinical stage assets to its broad and growing royalty portfolio highlighted by Roche’s VABYSMO (faricimab-svoa), Day One Pharmaceuticals’ OJEMDA (tovorafenib), Zevra Therapeutics’ MIPLYFFA (arimoclomol), and 14 programs in late-stage development, highlighted by Takeda’s mezagitamab and certain assets from Takeda’s externalized asset portfolio, including osavampator, volixibat and OHB-607. The addition of the XOMA Royalty portfolio is expected to increase Ligand’s long-term growth profile.

"After evaluating a broad range of strategic and financing alternatives, we believe combining our diverse portfolio with a company that shares our commitment to helping the biopharmaceutical industry thrive represents the most compelling outcome for XOMA Royalty’s stockholders," said Owen Hughes, CEO of XOMA Royalty. "The structure delivers to our stockholders both the intrinsic value of XOMA’s portfolio today and the optionality associated with our ongoing litigation with Janssen Biotech (now Johnson & Johnson Innovative Medicine) via the CVR. Since 2023, we significantly scaled our portfolio with the addition of multiple assets and two platform technologies, enabling numerous upcoming regulatory and clinical catalysts beginning in 2026 and continuing over the next several years. We believe coupling Ligand’s business development capabilities, portfolio management expertise plus the inherent financial synergies from this transaction position the combined company to maximize long-term value across the combined portfolio."

Transaction Terms

Under the terms of the merger agreement, Ligand will acquire all the outstanding shares of common stock of XOMA Royalty for $39.00 per share in cash. The cash consideration for the transaction is expected to be funded with Ligand’s existing cash on hand and borrowings under Ligand’s existing credit facility. XOMA Royalty’s Series X Convertible Preferred Stock is expected to be converted into shares of common stock at its stated fixed price prior to closing, whereas the outstanding shares of Series A Preferred Stock and Series B Preferred Stock are expected to be redeemed. XOMA Royalty stockholders also will receive one CVR per share. The CVRs are intended to provide XOMA Royalty stockholders with the opportunity to receive certain net proceeds, if any are recovered, from certain ongoing litigation with regard to XOMA Royalty’s dispute with Janssen Biotech regarding the commercialization of TREMFYA.

Timing and Approvals

The transaction has been unanimously approved by the Ligand and XOMA Royalty Boards of Directors. Entities affiliated with BVF Partners, which own approximately 21% of the outstanding shares of XOMA Royalty common stock and approximately 44% assuming the conversion of their Series X Convertible Preferred Stock, have agreed to convert such shares into shares of XOMA Royalty common stock prior to closing and have entered into a voting agreement in support of the transaction. In addition, XOMA Royalty’s directors and officers have also entered into voting agreements in support of the transaction. The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions, approval by XOMA Royalty stockholders and the receipt of certain regulatory approvals.

Financial Guidance Update

The transaction is expected to close in the third quarter of 2026 and to be immediately accretive to Ligand earnings per share. Ligand is increasing its 2026 revenue guidance to be in the range of $270 million to $310 million (previously $245 million to $285 million) and is raising adjusted earnings per diluted share1 guidance to $8.50 to $9.50 (previously $8.00 to $9.00). Royalties are now expected to range from $225 million to $250 million (previously $200 million to $225 million). Guidance for sales of Captisol ($35 million to $40 million) and contract revenue ($10 million to $20 million) are unchanged. In addition, Ligand expects the transaction to be accretive by $1.50 per share to adjusted EPS in 2027.2

Investor Call

Ligand will host a conference call and webcast today beginning at 8:00 a.m. Eastern time (5:00 a.m. Pacific time) to discuss today’s announcement. To participate via telephone, please dial (800) 715-9871 (North America toll-free number) using the conference ID 8692804. International participants outside of Canada may use the toll number (646) 307-1963 and use the same conference ID. To participate via live or replay webcast, a link is available at www.ligand.com.

Advisors

Stifel is serving as lead financial advisor and Citi is serving as financial advisor, Paul Hastings LLP is serving as legal advisor and Collected Strategies is serving as strategic communications advisor to Ligand. Leerink Partners is serving as lead financial advisor and H.C. Wainwright & Co. is serving as financial advisor, and Gibson, Dunn & Crutcher LLP is serving as legal advisor to XOMA Royalty.

(Press release, Ligand, APR 27, 2026, View Source [SID1234664794])

On April 27, 2026 Siren Biotechnology reported the publication of its first peer-reviewed manuscript in Molecular Therapy Oncology, alongside upcoming presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting.

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The publication reports preclinical data supporting Siren’s Universal AAV Immuno-Gene Therapy platform and its application to high-grade glioma, a setting with significant unmet need and limited therapeutic options.

Publication Highlights Platform Potential and Translational Depth

The study demonstrates that localized delivery of AAV-encoded cytokines enables sustained intratumoral expression and drives robust anti-tumor activity across multiple preclinical models of high-grade glioma, including human organoids and orthotopic in vivo systems.

Across these studies, treatment was associated with tumor regression and prolonged survival, alongside evidence of tumor-localized immune activation and transcriptional reprogramming.

The study includes extensive in vivo validation across multiple orthogonal glioma models, representing one of the most comprehensive preclinical datasets reported to date for AAV-based approaches in oncology.

The publication also establishes a foundation for the continued clinical development of Siren’s platform in high-grade glioma.

"This paper represents the most complete view to date of how our platform performs across systems that matter for translation," said Nicole K. Paulk, PhD, Founder and CEO of Siren Biotechnology. "We were deliberate about building a dataset that goes beyond a single model or readout, and instead shows reproducible consistency across orthogonal approaches. That level of rigor is important as we continue advancing into the clinic."

Access the full open-access manuscript here.

Upcoming ASGCT (Free ASGCT Whitepaper) 2026 Presentations

Siren Biotechnology will present new data spanning preclinical and CMC advances at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting in Boston, MA.

MRI-Guided Convection-Enhanced Delivery of an AAV-hIFNβ Vector Achieves Targeted Brain Retention and Durable Transgene Expression in a Large-Animal Model

Wednesday, May 13, 2026, 5:00 – 6:30 pm EST, Poster Hall, Abstract #2241

End-to-End Device Compatibility and In-Use Stability Assessment of an AAV Gene Therapy Delivered by Convection-Enhanced Delivery

Friday, May 15, 2026, 8:15 – 8:30 am EST, MCEC Room 162AB

"Together, these presentations extend the platform story into delivery, manufacturability, and real-world use considerations," added Dr. Paulk. "We’re excited to share data that we believe helps define what effective AAV-based therapies in oncology can look like."

This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, gene therapy research, and clinical trials (Grant number: TRAN1-15325).

(Press release, Siren Biotechnology, APR 27, 2026, View Source [SID1234664826])

On April 27, 2026 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Ph+ CML in the chronic phase without the T315I mutation previously treated with two or more TKIs.

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"There remains an urgent need for CML treatments that offer improved efficacy, safety, and tolerability over current therapies," said Scott Harris, chief development and operations officer at Terns. "This designation from the FDA supports the significant potential of TERN-701 to be a best-in-disease therapy for CML patients and offer substantial improvement based on the faster, deeper responses compared to prior TKIs and encouraging safety and tolerability profile observed to date."

"This Breakthrough Therapy Designation, along with the recent agreement for Merck to acquire Terns, has the potential to accelerate efforts to advance TERN-701 to a pivotal trial and to patients," said Amy Burroughs, chief executive officer of Terns. "This is an exciting time for everyone involved in the TERN-701 program. We are grateful to the investigators, patients and community advocates whose dedication and support have made these advancements possible."

Breakthrough Therapy Designation (BTD) is intended to expedite the development and review of potential new medicines designed to treat serious conditions or address significant unmet medical needs. Based on FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates potential for substantial improvement over available medicines.

TERN-701 BTD is based on data from the ongoing Phase 1/2 CARDINAL clinical trial of TERN-701 in patients with CML previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed at week 24. Importantly, this includes responses in patients with high baseline disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations.

(Press release, Terns Pharmaceuticals, APR 27, 2026, View Source [SID1234664795])

On April 27, 2026 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that it has received positive feedback from the U.S. Food and Drug Administration (FDA) following a constructive in person Type C meeting regarding the planned Phase 2b clinical trial of its lead candidate, amsulostat, for the treatment of patients with myelofibrosis (MF) who have had an inadequate response to standard of care.

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Following a review of amsulostat’s development to date, the FDA supported the proposed Phase 2b study design and provided guidance on the detail of the study and overall development pathway for amsulostat. This feedback represents a major milestone for the company, enabling progression into late-stage clinical development and creating opportunity for further engagement with potential commercial partners.

The Phase 2b study will be a double blind, placebo-controlled study of amsulostat added to standard of care (JAK inhibition) for patients who have had an inadequate response. The primary endpoint will be achievement of 50% reduction in total symptom score (TSS50) after 9 months of treatment. Subject to final protocol review, the number of patients to be studied is expected to be approximately 100.

Syntara Chief Executive Officer Gary Phillips said: "We are delighted to have received a positive FDA review of the trial protocol for the planned Phase 2b study. Amsulostat has a differentiated and competitive safety and efficacy profile, with strong potential as a breakthrough therapy for MF patients with an inadequate response to standard of care. We are also advancing amsulostat’s development into myelodysplastic syndrome (MDS), where two clinical studies are currently ongoing.

With additional clinical milestones expected over the next 12 months, including top-line data from the Phase 2 study of SNT-4728 for isolated REM sleep behaviour disorder (iRBD), a prodromal feature of Parkinson’s disease, and results from a placebo-controlled study of SNT-9465, a topical pan-LOX inhibitor for hypertrophic scarring; 2026 is shaping up to be a landmark year for Syntara."

(Press release, Syntara, APR 27, 2026, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/2cc7439a-7a49-d9c3-e873-9f0527792fed/Positive_FDA_feedback_for_Amsulostat_P2b_trial.pdf [SID1234664812])