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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported that the Company has moved into additional laboratory space at its existing R&D site in Heidelberg, Germany, based on a previously signed long-term lease agreement. The expansion enables the company to accommodate for currently planned team additions in its R&D department, the installation of laboratory equipment and the build-up of the final R&D infrastructure needed for planned development activities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

VERAXA is pursuing a growing portfolio of proprietary and partnered drug development programs from early, discovery stage toward early clinical development. At the heart of VERAXA’s R&D activities is the Company’s novel BiTAC strategy and its application to drive a portfolio of BiTAC-TCE and BiTAC-ADC development programs. The BiTAC therapeutic strategy is designed to unlock a new level of precision in cancer treatment by using two complementary precursors and enabling a tumor-restricted activation of the desired therapeutic effect.

"Securing the necessary space for our growing R&D organization was vital as we expand both internal drug development activities and plan ahead for an increased level of research activities within therapeutic alliances," said Torsten Bürgermeister, Chief Financial Officer of VERAXA. "We were able to avoid any disruption of our R&D operations at our existing site in the Heidelberg biopharmaceutical cluster, which continues to provide us with a rich academic research environment and offers multiple touchpoints with some of the world’s leading research organizations in medical oncology."

(Press release, Veraxa Biotech, JUN 24, 2026, View Source [SID1234668949])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 Passage Bio, Inc. (Nasdaq: PASG) ("Passage Bio") and Remix Therapeutics, Inc. ("Remix"), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, reported that they have entered into a definitive merger agreement to combine in an all-stock transaction. Upon completion of the transaction, the combined company plans to operate under the name Remix Therapeutics, Inc. and expects to trade on Nasdaq under the ticker symbol "RMTX."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In connection with the proposed merger, Remix has secured commitments for a concurrent oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $100 million from a syndicate of new investors led by Decheng Capital, with participation from Lynx1 Capital Management, Forge Life Science Partners, existing investors and other leading investment management firms.

The private placement financing is expected to close immediately prior to completion of the proposed merger. The combined company’s cash and cash equivalents balance at closing, including the proceeds from the private placement, is anticipated to fund the combined company’s operations into 2028 and provide runway through key clinical milestones, including data from the registrational Phase 2 trial of REM-422 in Adenoid Cystic Carcinoma (ACC); data from the Phase 1 trial in Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) and progression of Remix’s discovery pipeline.

"This transaction marks a transformative step for Remix as we advance our mission to reprogram RNA processing and unlock a new class of medicines with the strength of our seasoned team and support from leading biotechnology investors," said Peter Smith, Ph.D., Co-Founder and CEO of Remix. "We are exceptionally well-positioned to accelerate a pipeline of RNA-targeted small-molecule therapies led by REM-422, an orally available mRNA degrader targeting MYB, a historically undruggable transcription factor implicated across multiple cancers. With this strengthened foundation and compelling REM-422 data in hand, we are focused on rapidly translating our breakthrough science into differentiated therapies for patients who urgently need better options."

"Following a thorough evaluation of strategic alternatives, we are thrilled to have identified Remix as the ideal partner for this transaction. Remix has built a truly differentiated platform in RNA processing modulation, and REM-422’s impactful Phase 1 data in ACC and strong execution of their ongoing registrational study in this underserved disease reflect the quality of their science and team. We believe this combination delivers compelling value for Passage Bio stockholders, providing meaningful participation in a clinical-stage company with a well-defined path to pivotal data. We look forward to supporting the combined company as it advances these important medicines for patients," said Will Chou, M.D., President and CEO of Passage Bio.

About the Proposed Transaction
Under the terms of the merger agreement, as of the closing of the proposed merger, the pre-merger Passage Bio shareholders are expected to own approximately 7% of the combined company and the pre-merger Remix stockholders (inclusive of those investors participating in the financing) are expected to own approximately 93% of the combined company. The percentage of the combined company that Passage Bio shareholders will own as of the closing of the proposed merger is subject to adjustment based on the estimated amount of Passage Bio’s net cash immediately prior to the closing date. In connection with the proposed merger, a contingent value right ("CVR") will be distributed to Passage shareholders of record at the closing date. Each CVR will entitle its holder to receive a pro rata portion of certain net proceeds actually received by the combined company from milestones associated with Passage Bio’s out-licensed pediatric gene therapy pipeline assets, subject to the terms and conditions of a CVR agreement to be entered into at closing. The CVRs will not be transferable (except in limited circumstances), will not be listed on any securities exchange, and will not bear interest. There can be no assurance that any proceeds will be realized or that CVR holders will receive any payment.

The transaction has been unanimously approved by the Board of Directors of both companies and is expected to close in the fourth quarter of 2026, subject to the satisfaction of customary closing conditions, including, among others, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission (the "SEC") to register the securities to be issued in connection with the proposed merger and the satisfaction of other customary closing conditions.

The combined company plans to operate under the name Remix Therapeutics, Inc. and will be led by Dr. Smith. Remix’s Board of Directors will become directors of the combined company, chaired by Matthew Patterson. In conjunction with the transaction, Peter Colabuono of Decheng Capital will join the Board of Directors.

Latham & Watkins LLP is serving as legal counsel to Remix. Goldman Sachs & Co. LLC, Jefferies and Evercore ISI are acting as the placement agents in connection with the concurrent private placement financing. RBC Capital Markets and Canaccord Genuity are acting as Capital Markets Advisors. Cooley LLP is serving as legal counsel to the placement agents. Fenwick & West LLP is serving as legal counsel to Passage Bio. Wedbush Securities Inc. is serving as exclusive financial advisor for the transaction.

Conference Call and Webcast Information
The companies will host a conference call and webcast on June 24, 2026 at 4:30 P.M. ET. Participants are invited to listen here or by visiting the Investors & Media section of Passage Bio’s website at investors.passagebio.com.

About REM-422
REM-422 is a potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of a poison exon in the MYB mRNA transcript, leading to nonsense-mediated decay of the transcript. REM-422 is currently in Phase 1/2 clinical studies in both Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The U.S. Food and Drug Administration granted REM-422 Orphan Drug Designation for ACC and AML and Fast Track designation for ACC.

(Press release, Remix Therapeutics, JUN 24, 2026, View Source [SID1234668946])