On June 29, 2026 Nuvectis Pharma, Inc. (Nasdaq: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology, reported the pricing of its previously announced underwritten public offering of 5,000,000 shares of its common stock at a price of $20.00 per share, with expected gross proceeds to Nuvectis of $100 million. Nuvectis has also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about July 1, 2026, subject to satisfaction of customary closing conditions.

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Cantor is acting as sole book runner for the offering. H.C. Wainwright & Co., Laidlaw & Company (UK) Ltd., Lucid Capital Markets, Maxim Group LLC, Roth Capital Partners and Titan Partners, a division of American Capital Partners are acting as co-managers for the offering.

Nuvectis intends to use the net proceeds from the offering to continue to advance the development programs of NXP100, NXP200, and NXP900 or any future product candidate, hiring of additional personnel, capital expenditures, costs of operating as a public company and other general corporate purposes.

The shares of common stock described above are being offered by Nuvectis pursuant to its shelf registration statement on Form S-3 (File No. 333-293459) filed with the U.S. Securities and Exchange Commission ("SEC") on February 13, 2026 and declared effective by the SEC on February 20, 2026. The preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to these shares of common stock may also be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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, Nuvectis Pharma, JUN 29, 2026, View Source [SID1234669003])

On June 29, 2026 Samsung Bioepis Co., Ltd. reported that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), have met their primary endpoints.

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"We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development," said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis. "We are on track to complete both Phase 1 and Phase 3 studies within this year. Leveraging our robust quality management system, we remain committed to advancing our biosimilar portfolio to broaden access to life-saving biologic medicines for patients with unmet needs."

Pembrolizumab is a humanized monoclonal antibody that acts as an immune checkpoint inhibitor by targeting and blocking the programmed cell death protein 1 (PD-1) receptor on T cells. It is used to treat various types of cancer, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell cancer (HNSCC).2

The randomized, double-blind, three-arm, parallel group, multicenter Phase 1 clinical trial demonstrated pharmacokinetic (PK) bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. The study assessed PK, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA NSCLC following complete resection and adjuvant platinum-based chemotherapy.3 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks up to 51 weeks, and blood samples were collected. The preliminary PK evaluation indicates that the drug exposure, measured by the Area Under the Curve (AUC), has met the predefined equivalence criteria.

The randomized, double-blind, parallel group, multicenter Phase 3 clinical trial demonstrated equivalent objective response rate (ORR) at Week 24. The study assessed efficacy, safety, PK, and immunogenicity of SB27 and Keytruda in patients with metastatic non-squamous NSCLC, followed by chemotherapy.4 555 participants were randomized to receive SB27 or Keytruda followed by pemetrexed and carboplatin5 every 3 weeks up to 48 weeks. The 90% confidence interval (CI) for the ORR ratio between SB27 and Keytruda at Week 24 was 0.737 to 1.071, which completely fell within the pre-defined equivalence margin of 0.712 to 1.405, thereby demonstrating equivalence. Safety, PK and immunogenicity profiles of SB27 were also comparable with those of Keytruda.

(Press release, Samsung Bioepis, JUN 29, 2026, View Source [SID1234669002])

On June 29, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and Aveta Biomics, Inc., a clinical-stage immuno-oncology company advancing first-in-class oral immunotherapies for solid tumors, reported a strategic partnership supporting AVTA 30-01, Aveta’s global Phase 3 registrational clinical trial evaluating APG-157 in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) (NCT07667296).

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APG-157 is Aveta’s first-in-class oral immunotherapy intended to expand the benefits of immunotherapy to both immune-cold and immune-hot tumors in patients with LA-HNSCC. APG-157 has received FDA Fast Track and Orphan Drug Designations for this indication.

AVTA 30-01 builds upon previously reported Phase 2 clinical data of APG-157 monotherapy in demonstrating favorable safety, evidence of tumor-control, deep molecular responses, and encouraging event-free survival outcomes. The trial will incorporate serial Signatera testing to assess molecular residual disease (MRD) and treatment response throughout therapy and follow-up. Circulating tumor DNA (ctDNA) has emerged as one of the most promising approaches for detecting MRD and identifying recurrence earlier than conventional imaging alone.

Approximately 826 patients are expected to be enrolled across North America, Europe, Asia-Pacific, and Australia. The study includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms, and Signatera will be a secondary endpoint. The trial is expected to begin enrollment in 2H’26.

Global annual incidence of head and neck cancer is approximately 950,000,1 and disease recurrence remains a major cause of mortality despite advances in surgery, radiation therapy, and immunotherapy.

"Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment," said Parag Mehta, Ph.D., founder and chief executive officer of Aveta Biomics. "We believe APG-157 has the potential to transform treatment by activating anti-tumor immunity in both immune-cold and immune-hot tumors. Incorporating serial Signatera testing into AVTA 30-01 will allow us to further validate the ctDNA findings observed in Phase 2 while generating molecular response data that will advance the understanding of treatment benefits for patients and strengthen the regulatory submission."

This study adds to the evidence Natera continues to generate in head and neck cancer. The company recently announced a successful readout of the prospective Phase 2 SINERGY trial, supporting Signatera MRD-guided treatment in this histology.

"Growing evidence continues to demonstrate the value of Signatera MRD detection in head and neck cancer," said Eric Matthews, general manager, biopharma, Natera. "We’re pleased to partner with Aveta on AVTA 30-01 to demonstrate how Signatera has the potential to advance the field and improve care for patients."

(Press release, Aveta Biomics, JUN 29, 2026, View Source [SID1234669001])

On June 29, 2026 Excalipoint Therapeutics, a clinical-stage biotechnology company advancing novel T-cell engager (TCE) therapies for solid tumors and autoimmune disorders, reported a clinical collaboration with Roche to explore the combination of Excalipoint’s lead product candidate EXP011 (CTM012), a tri-specific T-cell engager targeting DLL3, CD3, and 4-1BB and Roche’s atezolizumab in patients with DLL3-expressing solid tumors.

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Roche will supply atezolizumab for use in the planned clinical studies. The clinical studies under the collaboration are designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of EXP011 combined with atezolizumab in small cell lung cancer (SCLC), with potential extension into other tumor types such as neuroendocrine tumors (NET).

"We are pleased to partner with Roche to explore the combination potential of EXP011 and atezolizumab for patients with SCLC and other hard-to-treat solid tumors." said Lei Fang, Ph.D., Co-Founder, Chairman and Chief Executive Officer, Excalipoint Therapeutics. "This collaboration enables us to evaluate a differentiated immuno-oncology combination strategy to address the limitations of current treatment regimens and deliver better clinical benefits for patients."

"This clinical collaboration with Roche will further crystallize the clinical value of EXP011 in solid tumors and accelerate the global development of this highly differentiated asset," said Jielun Zhu, Co-Founder, CFO & CBO, Excalipoint Therapeutics. "This partnership is also a strong endorsement of the potential of EXP011 in overcoming treatment barriers of existing therapies to drive more durable response and improve patient outcomes."

EXP011 is Excalipoint’s lead tri-specific T-cell engager from its proprietary co-stimulatory EXCOPIA Platform (formerly known as TOPABody) designed to selectively target DLL3, a tumor-specific antigen highly expressed in SCLC and neuroendocrine tumors, while engaging CD3 and 4-1BB to achieve potent, controlled and synergistic T-cell activation and anti-tumor activity.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

(Press release, Excalipoint Therapeutics, JUN 29, 2026, View Source [SID1234669000])

On June 29, 2026 Nuvation Bio (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has validated the Marketing Authorisation Application (MAA) submitted by its partner Eisai Co, Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The application was submitted through the International Recognition Procedure, which takes into account approvals from trusted regulatory partners and supports expedited access to medicines in the U.K. The application will now be evaluated by the MHRA to decide whether to approve or reject the application.

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In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Taletrectinib is an oral treatment for patients living with advanced ROS1+ NSCLC (marketed as IBTROZI in the U.S. and Japan). In March 2026, the European Medicines Agency validated the MAA for taletrectinib. Additional filings are planned for Canada and other regions included in Eisai’s licensed territories.

Within the U.K., there are around 50,200 new lung cancer cases every year. Around 80 to 85% of all lung cancers are NSCLC, of which approximately 2% of patients harbor the ROS1+ mutation.

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were originally published in the Journal of Clinical Oncology in April 2025, and updated data reflecting longer patient follow-up were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, further building the efficacy and safety profile observed to date. Updated results from the TRUST-I study were also simultaneously published in April 2026 in the Journal of Clinical Oncology.

"We are pleased to see taletrectinib advance into the regulatory review process in the U.K. following the recent progress with the EMA," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "Having seen the meaningful impact taletrectinib has already brought to patients in the U.S., China and Japan, we are excited about this important step in expanding access to this medicine. This validation brings us closer to delivering taletrectinib to patients in the U.K. and reinforces our commitment to making it available to patients around the world."

In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.

* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About Taletrectinib
Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

About the International Recognition Procedure (IRP) in the United Kingdom
IRP is a regulatory pathway established by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) that allows the agency to take into account the expertise and decision-making of trusted international reference regulators, such as the European Medicines Agency (EMA) and FDA.

Under IRP, MHRA conducts a targeted assessment based on existing regulatory evaluations, with the aim of supporting patients in the U.K. with expedited access to safe and effective medicines.

(Press release, Nuvation Bio, JUN 29, 2026, View Source [SID1234668999])