On June 16, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of pulmonary neuroendocrine carcinomas (NECs).

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The designation follows a positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP), recognizing both the seriousness of neuroendocrine carcinomas and the need for new treatment options. Small cell lung cancer (SCLC) is the most significant pulmonary NEC, accounting for around 15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year (an estimated 375,000 new cases annually), and is one of the most aggressive and lethal solid tumors. 1,2

In granting the designation, the COMP noted that preliminary clinical data in patients with relapsed or refractory extensive-stage SCLC suggest zoci may offer a more favorable effect than currently authorized therapies, including durable responses, a finding the Committee characterized as a clinically relevant advantage.

The U.S. FDA previously granted Fast Track designation (FTD) and ODD to zoci for SCLC. The FDA also recently granted FTD to zoci for extrapulmonary NECs (epNECs).

"This important designation from the EMA supports zoci’s potential to become a first-in-class therapy for pulmonary neuroendocrine carcinomas," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "This milestone is another demonstration of Zai Lab’s commitment to address critical unmet needs for patients with limited treatment options."

The EMA’s ODD provides important regulatory and development incentives, including potential market exclusivity following approval, reduced development fees, and enhanced development efficiency, which may help streamline clinical development.

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci targets Delta-like ligand 3 (DLL3), a validated therapeutic target that is overexpressed in many neuroendocrine carcinomas, such as small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNECs), and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across second- and third-line SCLC, first-line SCLC, and epNECs by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential role as a new standard of care in previously treated extensive stage SCLC, as well as a backbone DLL3-targeting antibody-drug conjugate (ADC) in first line combination regimens, including those that reduce the burdens of chemotherapy, such as check point inhibitors and T-cell engagers.

(Press release, Zai Laboratory, JUN 16, 2026, View Source [SID1234668766])

On June 16, 2026 CEL-SCI Corporation (NYSE American: CVM) reported its dual-track strategy to bring Multikine (Leukocyte Interleukin, Injection)* to patients with newly diagnosed locally advanced head and neck cancer through parallel regulatory initiatives in the U.S. and Saudi Arabia.

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The Company plans to commence its Confirmatory Registration Study of Multikine this summer while simultaneously advancing regulatory and commercialization activities in Saudi Arabia through its strategic partnership with Saudi Amarox.

"Following extensive clinical development and close engagement with regulators, we are excited to begin our final Confirmatory Registration Study, aiming to extend lives and improve the quality of life for head and neck cancer patients," said Geert Kersten, Chief Executive Officer of CEL-SCI. "We are also looking forward to participating in next week’s signing ceremony at BIO with Amarox, our Saudi partner, as we advance a second pathway to bring Multikine to patients."

U.S. Registration Pathway

CEL-SCI’s Confirmatory Registration Study will enroll 212 newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low PD-L1 tumor expression and no lymph node involvement—the patient population that demonstrated the greatest benefit in the Company’s completed Phase 3 study.

In that study, patients treated with Multikine before surgery and standard of care therapy achieved a 73% five-year overall survival rate compared to 45% for patients receiving standard of care alone. The confirmatory study is designed to show, among other things, significant improvement in overall survival and support potential registration of Multikine in the United States.

Saudi Market Entry Pathway

CEL-SCI has a strategic partnership with Amarox to support regulatory approval, commercialization and distribution of Multikine in Saudi Arabia. Under the agreement, Amarox is leading local regulatory activities and will be the exclusive distributor of Multikine in the Kingdom upon approval.

The partnership provides a 50%/50% revenue share for Multikine sales in Saudi Arabia upon receipt of Breakthrough Medicine Designation. Amarox is ranked #1 for Saudi-FDA (SFDA) applications for critical and unavailable medicine for 3 consecutive years. CEL-SCI retains ownership of all Multikine intellectual property, manufacturing know-how and global rights. The agreement also includes the option for Amarox to distribute Multikine throughout the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.

CEL-SCI and Amarox will conduct a formal signing ceremony during the BIO International Convention in San Diego on June 22, 2026 to highlight their collaboration and commitment to advancing Multikine in the region.

Addressing a Significant Unmet Need

Head and neck cancer is the 6th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need. The target population of the U.S. Confirmatory Registration Study represents approximately 100,000 newly diagnosed head and neck cancer patients annually. Based on CEL-SCI’s completed Phase 3 study of 928 patients, approximately 70% of head and neck cancer patients are estimated to have low or zero PD-L1 tumor expression, a population for whom currently available checkpoint inhibitors may offer only limited benefit with no definitive overall survival benefit.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

(Press release, Cel-Sci, JUN 16, 2026, View Source [SID1234668765])

On June 16, 2026 Assertio Holdings, Inc. (Nasdaq: ASRT) ("Assertio" or the "Company") reported the successful completion of its previously announced merger (the "Merger") with Zydus Lifesciences Ltd. ("Zydus Lifesciences") pursuant to the terms of the Agreement and Plan of Merger, dated as of May 13, 2026 (the "Merger Agreement"), between, among others, the Company, Zydus Worldwide DMCC, a limited liability company incorporated under the laws of the United Arab Emirates and a wholly-owned subsidiary of Zydus Lifesciences ("Zydus") and Zara Merger Sub Inc., a Delaware corporation and wholly owned subsidiary of Zydus and Zydus Lifesciences ("Purchaser"). Assertio will continue to operate as a wholly-owned subsidiary of Zydus Lifesciences. Effective today, Assertio common stock has been delisted from the Nasdaq Stock Exchange. Assertio stockholders are receiving $23.50 per share in cash in connection with the acquisition.

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Assertio also reported that it has delivered a notice to holders of its 6.50% Convertible Senior Notes due 2027 (the "Notes"), pursuant to the Indenture, dated as of August 25, 2022, between the Company and U.S. Bank Trust Company, National Association, as Trustee (as supplemented from time to time, the "Indenture"), notifying holders of the Notes that, as a result of the consummation of the Merger, pursuant to the terms of the Merger Agreement, a "Fundamental Change," a "Make-Whole Fundamental Change" and a "Merger Event," each as defined in the Indenture, occurred effective as of June 16, 2026 (the "Effective Date").

As a result of the Fundamental Change, holders of the Notes have the right (the "Fundamental Change Repurchase Right") to require the Company to repurchase for cash (i) all of such holder’s Notes or (ii) any portion of the principal amount thereof that is equal to $1,000 or an integral multiple of $1,000, in each case, on July 17, 2026 (the "Fundamental Change Repurchase Date"), at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest thereon, if any, to, but excluding, the Fundamental Change Repurchase Date (the "Fundamental Change Repurchase Price"). Holders may exercise their Fundamental Change Repurchase Right by delivering their Notes for repurchase by book-entry transfer, in compliance with The Depository Trust Company ("DTC") procedures in connection with tendering beneficial interests in a global note for repurchase, at any time on or before 5:00 p.m., New York City time, on July 16, 2026.

Notwithstanding the Fundamental Change Repurchase Right, the Notes are convertible, at the option of the Holder, at any time until 5:00 p.m., New York City time, on July 16, 2026 (the "Conversion Period"). Pursuant to the terms of the Indenture, in connection with the consummation of the Merger and the occurrence of a Merger Event, the Company and the Trustee entered into a First Supplemental Indenture to the Indenture, providing that, following the Effective Date, the consideration due upon conversion of each $1,000 principal amount of Notes shall be solely an amount of cash equal to the Conversion Rate (as defined in the Indenture) multiplied by the merger consideration of $23.50 per share of the Company’s outstanding common stock. The Conversion Rate in effect immediately prior to the Merger Event, taking into account all adjustments, was 16.2799 shares of common stock per $1,000 principal amount of Notes, reflecting a Conversion Price of approximately $61.46 (after giving effect to the 1-for-15 reverse stock split effective December 26, 2025). As a result, holders will be entitled to receive approximately $382.58 in cash per $1,000 principal amount of Notes validly surrendered for conversion. The Company shall satisfy the Conversion Obligation (as defined in the Indenture) by paying cash to converting holders on the second business day immediately following the relevant Conversion Date (as defined in the Indenture). Holders may convert their Notes by delivering the appropriate instruction form pursuant to DTC’s book-entry conversion program and transferring such Notes to U.S. Bank Trust Company, National Association, as conversion agent, through the transmittal procedures of DTC, prior to the end of the Conversion Period. Holders may not convert any Notes with respect to which they have delivered a Fundamental Change Repurchase Notice (as defined in the Indenture) unless such Holder first withdraws such notice in accordance with the terms of the Indenture.

The trustee, paying agent and conversion agent for the Notes is:

U.S. Bank West Side Flats Operations Center
Mail Station – EP-MN-WS2N
60 Livingston Avenue
St Paul, MN 55107
Attn: Conversion Processing – Assertio Holdings

None of the Company, Zydus or any of their respective affiliates, or any of its or their respective boards of directors, employees, advisors or representatives, or U.S. Bank Trust Company, National Association, in its role as trustee, paying agent and conversion agent, is making any representation or recommendation to any holder as to whether or not to surrender or convert such holder’s Notes.

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

(Press release, Assertio Holdings, JUN 16, 2026, View Source [SID1234668764])

On June 16, 2026 Cizzle Bio, Inc., a Texas-based biotechnology company advancing biomarker blood tests for early detection of lung and gastric cancers, reported the laboratory validation of its proprietary CIZ1B biomarker blood test for early lung cancer at OmniHealth Diagnostics, a CLIA-certified, COLA-accredited clinical laboratory based in Dallas and a member of the Katharos Health family of laboratories. With laboratory validation complete, Cizzle Bio is now finalizing launch readiness activities in preparation for the test’s near-term availability to U.S. healthcare providers.

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The CIZ1B biomarker test is a novel, ELISA-based immunoassay that detects a protein variant associated with early-stage lung cancer using less than a tablespoon of blood. Designed to complement low-dose CT (LDCT) screening and other standard diagnostic approaches, the test can help clinicians assess cancer risk, clarify indeterminate findings and support clinical decision-making.

Because CIZ1B is offered as a laboratory-developed test (LDT), each CLIA-certified laboratory that performs the assay must complete its own validation process to verify analytical performance and ensure compliance with rigorous quality standards. Completion of the validation process at OmniHealth Diagnostics confirms the test’s readiness for use within a U.S. clinical laboratory environment and establishes a foundation for broader access as Cizzle Bio expands validation efforts with additional CLIA-certified laboratory partners.

Prior studies of the assay reported 95% sensitivity for stage I lung cancer detection and a 96% negative predictive value (NPV), supporting its potential role as an adjunctive tool for early detection.

"The laboratory validation of CIZ1B marks an important milestone in our mission to expand access to innovative tools for early cancer detection," said Bill Behnke, founder and chief executive officer of Cizzle Bio. "Lung cancer outcomes are closely tied to how early the disease is detected. By advancing a blood-based biomarker test, we aim to close critical gaps in early detection and help patients and their healthcare providers make more informed decisions about next steps in care."

Lung cancer remains the leading cause of cancer-related deaths in the United States and worldwide, with more than 229,000 new cases expected to be diagnosed in the United States in 2026, according to the American Cancer Society. Because symptoms often do not appear until the disease has advanced, lung cancer is frequently diagnosed at later stages, when five-year survival rates can fall to approximately 10%. By contrast, five-year survival rates approach 65% when lung cancer is detected early, according to the American Lung Association.

While approximately 14.2 million Americans are eligible for annual lung cancer screening under current U.S. Preventive Services Task Force guidelines, screening uptake remains low, and LDCT can produce false positives that lead to unnecessary follow-up procedures. The CIZ1B biomarker test may enhance risk stratification and reduce diagnostic uncertainty.

"We are committed to bringing high-quality diagnostic solutions into clinical practice," said Steve Kamalic, chief executive officer of OmniHealth Diagnostics. "Guided by a dedication to quality, scientific rigor, and clinical excellence, we are proud to partner with Cizzle Bio to help expand access to a promising new biomarker tool that may support earlier identification of lung cancer."

Built on more than three decades of research led by Professor Dawn Coverley, Ph.D., at the University of York, CIZ1B is being further evaluated in clinical studies with leading NCI-designated cancer centers, including Moffitt Cancer Center.

(Press release, Cizzle Bio, JUN 16, 2026, View Source [SID1234668763])

On June 16, 2026 Niowave, Inc., a leading manufacturer of medical radioisotopes, and Ratio Therapeutics Inc. (Ratio), a clinical-stage pharmaceutical company developing radiopharmaceuticals for cancer treatment, reported a supply agreement for Actinium-225.

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Under this agreement, Niowave will supply cGMP Actinium-225 to support Ratio’s development of targeted radiotherapeutics. The supply agreement provides Ratio with further reliable sourcing of Actinium-225 to support ongoing clinical trial activities and future program advancement.

Actinium-225 is a highly sought after alpha-emitting radioisotope with significant potential in targeted cancer therapies. When attached to targeting molecules, Actinium-225 delivers potent alpha radiation directly to cancer cells while minimizing damage to surrounding healthy tissue. As demand for targeted alpha therapies continues to grow, establishing a reliable domestic supply of Actinium-225 remains essential to clinical development and future commercialization.

"Niowave is the leading partner for companies with radiopharmaceutical programs that require a reliable, scalable supply of Actinium-225, and we are pleased to be working with Ratio," said Matt Burba, President and Chief Commercial Officer of Niowave. "Our agreement demonstrates the growing importance of medical radioisotopes, especially Actinium-225, and their potential to bring new hope to patients."

"Niowave’s expertise and growing production capabilities make them an important partner as we continue advancing our radiopharmaceutical pipeline," said John Babich, Ph.D., Chief Scientific Officer of Ratio Therapeutics. "This agreement supports our efforts to secure the Actinium-225 supply needed for ongoing clinical development while reinforcing our broader strategy of building the infrastructure and partnerships necessary to bring targeted alpha therapies to patients."

(Press release, Ratio Therapeutics, JUN 16, 2026, View Source [SID1234668762])