Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload

On July 20, 2026 Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, to be held October 23-27 in Madrid, Spain.

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The new Phase 1 data planned for ESMO (Free ESMO Whitepaper) will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven’s R&D Day on May 27, 2026. The new data will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27 2026, showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. This included a heavily pretreated patient with FGFR3-TACC3 fusion–positive metastatic urothelial cancer who had progressed on four prior lines of therapy, including Padcev (a nectin-4-directed ADC), pembrolizumab, and two FGFR-targeting small molecules. This patient has tolerated BHV-1530 with no FGFR-related toxicity. The data has shown a favorable safety profile, with no dose-limiting toxicities and no FGFR inhibitor–class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors.

Clinical Supply Agreement with Regeneron for BHV-1530 and Cemiplimab

Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors based upon the emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and immune therapy. BHV-1530’s TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition.

This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven’s oncology pipeline. Of note, early clinical data from the BHV-1510 program demonstrate a signal consistent with this thesis, as responses have been observed in multiple patients with prior anti–PD-(L)1 therapy.

About BHV-1530

BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers, and is a first in clinic FGFR3-directed ADC incorporating Biohaven’s proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors. BHV-1530 is being studied in an ongoing Phase 1 dose-escalation trial in unselected patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have failed standard-of-care therapy, as well as other tumor types harboring FGFR3 genomic alterations. Biohaven plans to initiate combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the recently announced combination with cemiplimab (Libtayo), in the second half of 2026.

(Press release, Biohaven Pharmaceutical, JUL 20, 2026, View Source [SID1234669323])

Halozyme Announces Global Collaboration and License Agreement with Incyte to Support the Development of Subcutaneous Formulations of INCA033989 Using its ENHANZE® Technology

On July 20, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported that it has entered into a global collaboration and license agreement with Incyte (Nasdaq: INCY) to evaluate additional subcutaneous formulations of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms (MPNs), utilizing Halozyme’s proprietary ENHANZE drug delivery technology. The collaboration will focus on the potential for ENHANZE to strengthen the subcutaneous formulation currently in development for INCA033989, with the goal of enabling more convenient delivery and dosing regimens that may improve the treatment experience.

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Under the terms of the agreement, Halozyme will receive an upfront payment from Incyte and is eligible to receive additional payments upon achievement of agreed upon milestones. In addition, Halozyme is eligible to receive royalties on net sales of commercialized medicines using ENHANZE. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE.

"This collaboration with Incyte underscores the continued momentum and broad applicability of our ENHANZE technology across high-value therapeutic areas," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "Incyte brings a strong portfolio and deep expertise in hematology, and we look forward to working together to enable the development of more convenient subcutaneous treatment options for patients. This agreement builds on Halozyme’s established track record of successful collaborations with leading biopharmaceutical companies and further diversifies our portfolio of partnered programs across multiple therapeutic areas."

(Press release, Halozyme, JUL 20, 2026, View Source [SID1234669321])

ORIC® Pharmaceuticals Announces Three Presentations at the European Society for Medical Oncology (ESMO) Congress 2026

On July 20, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing and commercializing treatments that address mechanisms of therapeutic resistance, reported three poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

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Poster presentation details:

Title: Enozertinib (ORIC-114), a Brain Penetrant, Highly Selective EGFR Inhibitor, in Treatment-Naive Metastatic NSCLC with EGFR Atypical Mutations
Presentation Number: 2627P
Session Date & Time: Monday, October 26, 2026; 12:00 – 12:45 p.m. CET
Session Title: Metastatic NSCLC

Title: Rinzimetostat, an Allosteric PRC2 Inhibitor Combined With Darolutamide: A Global Phase 3 Study in mCRPC Patients Previously Treated With Abiraterone Acetate (Himalayas-1)
Presentation Number: 2303TiP
Session Date & Time: Friday, October 23, 2026; 3:15 – 4:00 p.m. CEST
Session Title: Metastatic Prostate Cancer

Title: Rinzimetostat, a Next-Generation PRC2 Inhibitor, Enhances Luminal Fate and AR Signaling While Restricting Lineage Plasticity in Preclinical Models and Demonstrates Mechanistic
Proof-of-Concept in Samples From Patients with mCRPC
Presentation Number: 1128eP
Session Title: Developmental Therapeutics

Full abstracts will be available for public viewing via the ESMO (Free ESMO Whitepaper) Congress website on October 19, 2026.

(Press release, ORIC Pharmaceuticals, JUL 20, 2026, View Source [SID1234669320])

VERAXA Biotech Announces Regulatory Progress with its BiTAC®-TCE
Development Plan

On July 20, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA), an emerging leader in designing novel cancer therapies, reported that it has received Scientific Advice from the German regulatory authority, the Paul-Ehrlich-Institute (PEI), regarding the underlying biology and proposed non-clinical development plan for its most-advanced development program based on its proprietary BiTAC-TCE technology.

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In the PEI’s Scientific Advice procedure, drug developers can consult with regulatory experts on how to best evaluate their new drug candidates with a key focus on safety and tolerability. The advice was given in a meeting in which VERAXA presented the scientific rationale for the BiTAC-TCE mechanism together with its proposed safety assessments and pharmacokinetics strategy. The supportive feedback indicates that the authorities understand the biological concept behind the dual-targeting, conditionally active BiTAC-TCE format, which provides an initial derisking of the development path and greater clarity as the Company advances its BiTAC-TCE program.

"Scientific Advice on the first therapeutic candidate based on a novel platform is an important early validation, and the feedback we received is encouraging," said Christoph Erkel, Ph.D., Vice President, Research & Development of VERAXA. "It indicates that the regulatory authorities understand the biological rationale behind our BiTAC-TCE technology approach and gives us greater clarity on the development path we have proposed. For our new modality, such early alignment is crucial to make sure that we progress as efficiently as possible towards the clinics."

Initial data from VERAXA’s most advanced BiTAC-TCE program were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, in April. In those studies, VERAXA’s BiTAC-TCE candidate performed as intended in vitro and in vivo, attacking cancer cells displaying both target molecules while sparing cells expressing only one of the two targets. The data demonstrated a superior safety profile with matching efficacy compared with a more traditional TCE, pointing to the possibility of a meaningfully improved therapeutic index. The related posters are available on the VERAXA website at www.veraxa.com.

(Press release, Veraxa Biotech, JUL 20, 2026, View Source [SID1234669319])

Tempus to Acquire Personalis, More Tightly Integrating Molecular Residual Disease (MRD) into Its AI-Enabled Precision Oncology Platform

On July 20, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that it has entered into a definitive agreement to be acquired by Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care. The acquisition will expand Tempus capabilities in minimal residual disease (MRD) and enhance its ability to support patients from diagnosis and treatment selection, to recurrence and monitoring.

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Under the terms of the agreement, Personalis shareholders will receive consideration of $16.25 per share of common stock, representing a total enterprise value of $1.5 billion, net

of Tempus’ existing ownership interest.

The complementary acquisition builds on the companies’ existing partnership, established in November 2023, through which Tempus invested in Personalis and commercializes the company’s NeXT Personal MRD test. It brings together Tempus’ multimodal data platform, AI capabilities and precision oncology portfolio with Personalis’ industry-leading tumor-informed MRD technology to expand access to longitudinal monitoring, create new opportunities to advance biomarker discovery and enhance personalized cancer care.

"MRD is a large and rapidly growing market with the potential to truly transform how cancer patients are monitored, helping clinicians make faster and more informed decisions when cancer recurs," said Eric Lefkofsky, CEO of Tempus. "Through our existing collaboration with Personalis, we have already demonstrated the strength of combining highly sensitive MRD technology with our commercial infrastructure. With clinical adoption and reimbursement momentum building, we are collectively well positioned to capture this opportunity, which makes this acquisition particularly exciting."

With approximately 2.1 million new cancer diagnoses expected in the U.S. this year1 and more people living longer after a cancer diagnosis, the need for long-term monitoring is critical and continues to grow. Personalis’ ultrasensitive MRD tests are uniquely positioned to support this essential need. NeXT Personal has industry-leading sensitivity for detecting small traces of circulating tumor DNA, enabling tracking of cancer treatment response, detection of residual cancer and early detection of recurrence. With Medicare coverage in three indications and additional coverage anticipated, Personalis continues to demonstrate leadership in monitoring treatment response and cancer recurrence.

"We believe this transaction represents an exciting next chapter for Personalis," said Chris Hall, CEO of Personalis. "Combining with Tempus gives us the scale, complementary capabilities and resources to accelerate innovation and deliver even greater value to patients, clinicians and biopharma partners. After conducting an exhaustive process, we are confident Tempus’ offer provides the most value to our shareholders and the fastest path to bringing Personalis’ industry-leading tests to patients suffering from cancer."

Transaction Terms

Under the terms of the agreement Tempus will acquire all outstanding shares of Personalis not already owned by Tempus at a price of $16.25 per common share, representing a 6% premium to Friday’s closing price and a 28% premium to unaffected 30-day VWAP. Consideration will be structured as a 100% stock transaction with Tempus having the option to elect payment in cash at Tempus’ discretion, capped at 50% of the consideration paid. Personalis shareholders will receive a floating exchange ratio of Tempus AI common stock for each share of Personalis common stock they own at closing, subject to a maximum exchange ratio of 0.3356, which shall be finalized closer to the closing of the transaction. Cash consideration will be financed with cash on hand and borrowings under the Company’s then existing credit facilities.

The closing is expected in late 2026 or early 2027, and is subject to Personalis’ shareholder approval, as well as receipt of applicable regulatory approvals and other customary closing conditions. The transaction was approved by both companies’ board of directors.

Personalis delivered preliminary revenue in Q2 of $22.4 million. In the quarter, they delivered 10,384 clinical tests, representing a 33% increase in test volumes quarter over quarter.

(Press release, Personalis, JUL 20, 2026, View Source [SID1234669317])