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Oncolytics Aligns with FDA on Planned Pivotal Anal Cancer Study

On April 27, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, reported that a Type C meeting with the U.S. Food and Drug Administration ("FDA") has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal ("SCAC").

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"We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments," said Jared Kelly, Chief Executive Officer of Oncolytics. "While a single-arm study was possible in this setting, following a productive discussion with the FDA and in consideration of recent regulatory decisions regarding similar studies, we have aligned on a randomized controlled trial designed to potentially support both accelerated approval and full approval within the same study. This approach directly addresses relevant and rigorous evidentiary standards while allowing for approval based on multiple endpoint assessments."

SCAC is a rare gastrointestinal malignancy affecting more than 10,000 patients annually in the United States. Patients whose disease progresses following first-line chemotherapy/checkpoint inhibitor treatment have no FDA-approved therapeutic options and limited National Comprehensive Cancer Network recommended treatments. In a recent study combining pelareorep with a checkpoint inhibitor in second-line and later SCAC, the combination achieved a median duration of response of 15.5 months versus 9.5 months and 12-month survival of 82% versus 45.7%, each measured against the current standard of care.1

"The post-first-line SCAC setting remains an area of significant unmet need," said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX. "Pelareorep provides a strong rationale for evaluation in this population, and the study design represents a thoughtful and appropriate approach to advancing new options for these patients."

The Company plans to incorporate FDA feedback into the final protocol, which is expected to be a single, randomized controlled trial for which accelerated approval and full approval could be applied at different points in time.

(Press release, Oncolytics Biotech, APR 27, 2026, View Source [SID1234664796])

Terns Pharmaceuticals Announces FDA Breakthrough Therapy Designation Granted to TERN-701 for Certain Patients with Chronic Myeloid Leukemia

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.

"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])

Ligand to Acquire XOMA Royalty, Further Accelerating Profit Growth and Strengthening Ligand’s Position as a Leading Biopharma Royalty Aggregator

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.

"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])

Corporate Overview

On April 27, 2026 Kazia Therapeutics presented its corporate presentation.

(Presentation, Kazia Therapeutics, APR 27, 2026, View Source [SID1234664793])

Intellia Therapeutics Announces Proposed Public Offering of Common Stock

On April 27, 2026 Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, reported that it has commenced an underwritten public offering of $150 million of shares of its common stock. Intellia also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering. All of the shares in the proposed offering are to be sold by Intellia.

Jefferies, Goldman Sachs & Co. LLC and Citigroup are acting as joint book-running managers for the proposed offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares of common stock are being offered by Intellia pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-275740) that was previously filed with the U.S. Securities and Exchange Commission (SEC) on November 24, 2023 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from: Jefferies LLC, by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Goldman Sachs & Co. LLC, by mail at Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Intellia, APR 27, 2026, View Source [SID1234664792])