On June 24, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported data at the T-cell Engager Therapeutic Summit in San Diego, California. The Company presented data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment ("TME"). The poster is available here.

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"The data presented at today’s summit shows the advances we have made with the RedTail platform and our progress in addressing a central challenge in immuno-oncology: how to deliver tumor-specific T-cell engagers effectively in solid tumors" said Calidi Chief Executive Officer Eric Poma, PhD. "The data highlights the ability of the RedTail platform to functionally overexpress complex biologics including cytokines and T-cell engagers, and profoundly alter the tumor microenvironment to allow for T-cell-mediated tumor cell destruction."

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist ("IL-15 SA"), a known CD8⁺ T-cell, NK cell, and gamma delta (γδ) T-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the T-Cell Therapeutic Engager meeting showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail is designed to overcome these historical limitations.

The Company is developing CLD-501, a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

Calidi Biotherapeutics continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, JUN 24, 2026, View Source [SID1234668947])

On June 24, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the European Commission has granted Marketing Authorization for PADCEVTM (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the European Union (EU). The approval establishes the first and only approved perioperative (neoadjuvant and adjuvant) treatment option for this patient population in the EU.

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The approval is based on results from the Phase 3 EV-303 clinical trial (KEYNOTE-905), in which perioperative enfortumab vedotin plus pembrolizumab significantly improved Event-Free Survival (EFS) and Overall Survival (OS) compared with surgery alone in patients with MIBC who were ineligible for or declined cisplatin-containing chemotherapy.1 The combination reduced the risk of tumor recurrence, progression, or death by 60% (Hazard Ratio (HR) 0.40, 95% CI, 0.28-0.57; p<0.0001)1 and reduced the risk of death by 50% (HR 0.50, 95% CI: 0.33-0.74; p=0.0002).1

The safety profile was consistent with the known profiles of the individual medicines, and no new safety signals were observed. The most common (≥30%) adverse events related to treatment with the combination were pruritus (itching), alopecia, diarrhea, fatigue, and anemia.1

Results from the trial were recently published in The New England Journal of Medicine.1

Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas
"For patients with muscle-invasive bladder cancer who are unable to receive cisplatin-based chemotherapy, perioperative treatment options have historically been limited. This approval establishes the first approved perioperative treatment option for these patients in Europe and represents an important advance for patients facing this disease. We remain committed to improving outcomes for people living with bladder cancer through continued innovation across different stages of the disease."

Christof Vulsteke, M.D., Ph.D., Head of Integrated Cancer Center Ghent (IKG, Belgium) and Clinical Trial Unit Oncology Ghent and EV-303 Principal Investigator
"Despite surgery with curative intent, many patients with muscle-invasive bladder cancer experience disease recurrence. The EV-303 results demonstrated clinically meaningful improvements in both event-free and overall survival, supporting perioperative enfortumab vedotin plus pembrolizumab as an important new treatment option for cisplatin-ineligible patients in Europe."

Alex Filicevas, Executive Director, World Bladder Cancer Patient Coalition
"For patients living with muscle-invasive bladder cancer, the possibility of the cancer returning after surgery can be a source of significant uncertainty and concern for them and their families. But patients who are unable to receive cisplatin-based chemotherapy have historically faced limited treatment options beyond surgery. This approval represents important progress for the bladder cancer community and a significant advance for patients affected by this disease."

Bladder cancer remains a significant health burden across Europe, with nearly 200,000 people diagnosed each year.2 MIBC accounts for up to 30% of all bladder cancer cases.3 Up to half of patients with MIBC are ineligible to receive cisplatin-containing chemotherapy. Until now, there have been no approved perioperative treatment options for these patients, despite a substantial risk of disease recurrence following surgery.4

Enfortumab vedotin plus pembrolizumab is already approved in Europe as a first-line treatment for patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.5 This approval expands the use of the combination into earlier-stage, resectable MIBC for patients who are ineligible for cisplatin-containing chemotherapy, extending its use from advanced disease into a curative-intent treatment setting.

Astellas is working closely with regulatory authorities and health technology assessment bodies across the European Union to support patient access following the approval.

Astellas has already reflected the impact of the EC approval in its financial forecast for the current fiscal year ending March 31, 2027.

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.6 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).6

Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved in the United States as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the European Union, the combination is approved for the treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

About the EV-303/KEYNOTE-905 Trial
The EV-303 trial (also known as KEYNOTE-905) is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab or neoadjuvant and adjuvant pembrolizumab versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant pembrolizumab (arm A), surgery alone (arm B) or neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab (arm C). Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on imaging, blinded independent central review (BICR), and/or biopsy or death due to any cause. Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B.

For more information on the global EV-303 trial, go to clinicaltrials.gov.

(Press release, Astellas, JUN 24, 2026, View Source [SID1234670179])

On June 24, 2026 Antares Therapeutics, Inc. ("Antares"), a biotechnology company developing first-in-class precision medicines for cancer and other serious diseases, reported a strategic collaboration with Novartis to discover, develop and commercialize small molecule therapies against promising but historically undruggable oncology targets. The agreement underscores the productivity and breadth of Antares’ discovery capabilities, which have repeatedly delivered development candidates against targets long considered intractable.

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Under the terms of the agreement, Antares will receive a $105 million upfront payment and is eligible to receive up to $1.8 billion in additional payments across programs, inclusive of option exercise, development, regulatory, and commercial milestones, as well as tiered royalties on global net sales up to the low double-digit range. Antares will lead all research and apply its proprietary discovery engine to a limited number of historically undruggable targets until option exercise. In parallel, Antares will continue to advance its wholly owned and partnered portfolio of precision medicines for cancer and other serious diseases.

"From the outset, our goal has been to build a discovery engine that systematically unlocks high-value, challenging targets and delivers first-in-class precision medicines," said Adam Friedman, M.D., Ph.D., Chief Executive Officer of Antares. "This collaboration lets us scale that engine alongside Novartis’ world-class development capabilities and global reach, so we can translate our science into transformative therapies for patients faster than either of us could alone. It builds on the work of a team that has consistently produced highly selective medicines against some of the hardest targets in drug discovery."

The collaboration pairs Antares’ covalent drug discovery expertise – proprietary screening libraries, chemical proteomics capabilities, structure-driven computational chemistry and a machine-learning suite purpose-built for compelling first-in-class targets – with Novartis’ world-class R&D and global resources.

"Novartis is committed to advancing innovative approaches to cancer drug discovery and expanding the boundaries of what’s possible in oncology treatment," said Fiona Marshall, President of Biomedical Research at Novartis. "Many of the most compelling targets today in oncology have historically been considered undruggable. We believe this collaboration has the potential to unlock a new wave of targeted therapies and bring meaningful advances to patients."

(Press release, Antares Therapeutics, JUN 24, 2026, View Source [SID1234668933])

On June 24, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported that the Company will participate in a fireside chat at the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference on Tuesday, June 30, 2026 at 11:30 a.m. Eastern Time.

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A webcast of the fireside chat will be available on the "Events and Presentations" section of the Company’s website at ir.tscan.com. An archived replay of the webcast will be available on the Company’s website for 90 days following the event.

(Press release, TScan Therapeutics, JUN 24, 2026, View Source [SID1234668948])

On June 24, 2026 GSK plc (LSE/NYSE: GSK) reported that Harmony Row Acquisition Co. ("Purchaser"), a direct wholly-owned subsidiary of ‎GlaxoSmithKline LLC ("GSK LLC"), which is an ‎indirect wholly-owned subsidiary of GSK, has commenced a tender offer to purchase all of the issued and outstanding shares of Class A Common Stock, par value $0.0001 per share (the "Class A Shares"), and Class B Common Stock, par value $0.0001 per share (the "Class B Shares" and, together with the Class A Shares, the "Shares") of Nuvalent, Inc. ("Nuvalent") (NASDAQ: NUVL), for $124.00 per Share, net to the seller in cash, without interest, subject to any applicable withholding taxes, and upon ‎the terms and subject to the conditions set forth in the Offer to Purchase, dated June 24, 2026, and the accompanying Letter of Transmittal ‎‎(together, and with other related materials, as they may be amended or supplemented from time to time, the "Offer").

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The Offer is being made pursuant to an Agreement and Plan of Merger, dated as of June 9, 2026, by and among Nuvalent, GSK LLC, Purchaser and solely for purposes of Section 9.14 therein, GSK. As soon as practicable following consummation of the Offer and subject to the satisfaction or waiver of certain conditions, Purchaser will merge with and into Nuvalent (the "Merger") and the separate existence of Purchaser will cease and Nuvalent will continue as the surviving corporation and as a direct wholly-owned subsidiary of GSK LLC. The Merger will be governed by Section 251(h) of the General Corporation Law of the State of Delaware, as amended (the "DGCL"), which does not require a vote or action by written consent of Nuvalent’s stockholders. ‎

Nuvalent’s Board of Directors (the "Nuvalent Board") has published a Solicitation/Recommendation Statement on Schedule 14D-9 (the "Schedule 14D-9") filed with the Securities and Exchange Commission (the "SEC"), which includes, among other things, the recommendation of the Nuvalent Board that Nuvalent’s stockholders accept the Offer and tender their Shares to Purchaser pursuant to the Offer.

The Offer and withdrawal rights will expire at one minute following 11:59 p.m., ‎Eastern Time, on July 14, 2026, unless the Offer is ‎extended or earlier terminated (such date, or any subsequent date to which the ‎expiration of the Offer is extended, the "Expiration Date"). ‎Any extension, delay, termination or amendment of the Offer will be followed as promptly as practicable by a ‎public announcement thereof, and such announcement, in the case of an extension, will be made no later than 9:00 a.m., Eastern Time, on the next business day after the previously scheduled Expiration Date. Purchaser is not providing for guaranteed delivery procedures.

Purchaser’s obligation to pay for ‎Shares validly tendered (and not validly withdrawn) pursuant to the Offer is subject to certain conditions, including, among others, (a) the Minimum Tender Condition (as defined below); and (b) the expiration or termination of the waiting period (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The "Minimum Tender Condition" means that there shall have been validly tendered in the Offer and "received" by the "depositary" (as such terms are defined in Section 251(h) of the DGCL), and not validly withdrawn prior to the Expiration Date that number of Class A Shares that, together with the number of Class A Shares, if any, then owned beneficially by GSK LLC and Purchaser (together with their wholly-owned subsidiaries), represents at least a majority of the Class A Shares outstanding as of the consummation of the Offer. ‎The Offer is not subject to a financing condition.

The documentation relating to the Offer (including the Offer to Purchase, the Letter of Transmittal and Schedule 14D-9) can be accessed at the following link: www.readourmaterials.com/gsk2026/. The Offer to Purchase, the related Letter of Transmittal and the Schedule 14D-9 (which contains the recommendation of the Nuvalent Board and ‎the reasons therefor) contain important information. Nuvalent’s stockholders should carefully read all documents in ‎their entirety before any decision is made with respect to the Offer. ‎

Questions or requests for assistance may be directed to Innisfree M&A Incorporated (the "Information Agent") at ‎the address and telephone numbers set forth below. Requests for copies of the Offer to Purchase, the related Letter ‎of Transmittal and other tender offer materials may be directed to the Information Agent or to brokers, dealers, ‎commercial banks or trust companies. Such copies will be furnished promptly at Purchaser’s expense.

(Press release, GlaxoSmithKline, JUN 24, 2026, View Source [SID1234668934])