On July 29, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage biotechnology company, reported that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA (nogapendekin alfa inbakicept) across two indications. The authorization covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC. With this action, the UAE becomes the fifth regulatory jurisdiction to authorize ANKTIVA, expanding its global footprint to 34 countries. The UAE has taken the lead in the broadest approval of ANKTIVA to date. The NMIBC authorization is the first anywhere in the world to span carcinoma in situ (CIS) and papillary disease, including patients with papillary-only tumors in the absence of CIS.

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World’s First Approval Spanning the Full Spectrum of BCG-Unresponsive Disease in NMIBC

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and BCG-unresponsive NMIBC with papillary tumors. Eligible patients therefore include those with CIS alone, CIS accompanied by papillary tumors, and papillary disease alone without CIS.

BCG-unresponsive NMIBC carries a high risk of progression and, historically, radical cystectomy has been the standard option for patients who fail BCG. An approval that spans CIS and papillary disease addresses a defined unmet need across the disease spectrum by offering an alternative immunotherapy option.

"For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007, we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy. This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.

Authorization in Checkpoint-Refractory Metastatic Non-Small Cell Lung Cancer

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alterations should have disease progression on approved therapy for those alterations, before receiving ANKTIVA in combination with immune checkpoint inhibitors. In this indication, ANKTIVA is administered as a fixed 1 mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy.

Checkpoint inhibitor resistance represents a defined unmet need in metastatic NSCLC, with limited options and poor survival after progression. By activating the natural killer and memory T cells that checkpoint inhibitors alone do not reach, ANKTIVA is designed to restore anti-tumor immunity in this setting.

Clinical Evidence Supporting the Approvals

NMIBC Indication: The NMIBC authorization is supported by QUILT-3.032, the multicenter registrational trial of ANKTIVA plus BCG in BCG-unresponsive NMIBC (ClinicalTrials.gov NCT03022825).

Papillary Disease Alone (QUILT-3.032, Cohort B): In the papillary-only cohort (papillary disease without CIS; N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months as shown in the table below.

In the QUILT-3.032 program, most treatment-related adverse events were Grade 1 or 2; Grade 3 treatment-related adverse events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported.

NSCLC Indication: The NSCLC authorization is supported by QUILT-3.055 (ClinicalTrials.gov NCT03228667), a Phase 2 study of ANKTIVA in combination with a checkpoint inhibitor in patients with advanced NSCLC whose disease had progressed on prior checkpoint inhibitor therapy (N=79). Median overall survival was 14.6 months (95% CI: 12.0, 19.5). Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0). The table below summarizes these findings.

In QUILT-3.055, the most common NAI-related adverse drug reactions were injection site reaction (86%), chills (46%), fatigue (32%), pyrexia (28%), nausea (16%), injection site erythema and injection site pruritus (15% each), injection site pain (14%), influenza like illness (13%), decreased appetite (10%).

Regulatory Details

The EDE issued Marketing Authorization approval for both presentations with first registration in July 2026 and validity through July 2031. ANKTIVA 0.4 mg (solution for intravesical instillation), indicated for BCG-unresponsive NMIBC, is registered under No. 78609-45860-260486. ANKTIVA 1.2 mg (solution for subcutaneous injection), indicated for metastatic NSCLC, is registered under No. 78609-1572-260487. ImmunityBio, Inc. is the Marketing Authorization Holder, with Modern Pharmaceutical Company serving as the local agent in the United Arab Emirates. The UAE is the fifth regulatory jurisdiction to authorize ANKTIVA, following the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the European Union, and expands the global footprint of ANKTIVA to more than 30 countries.

"With this authorization, the global regulatory footprint for ANKTIVA now includes 34 countries. Securing approvals across two distinct indications, bladder cancer and lung cancer, on the strength of the same data packages we submitted to the FDA, positions us to broaden access across the Gulf region through our partnership with Modern Pharmaceutical Company, in markets where the need for new treatment options is significant," said Richard Adcock, President and Chief Executive Officer of ImmunityBio.

Sources

Chamie K, et al. IL-15 Superagonist NAI (N-803) plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. NEJM Evidence. 2023;2(1). (CIS cohort complete response rate.)
QUILT-3.032 updated analyses, including the papillary-only (Ta/T1) cohort and extended duration-of-response follow-up, as presented at AUA 2025 and disclosed by ImmunityBio, Inc.
QUILT-3.055 Phase 2 overall survival results in checkpoint-refractory advanced NSCLC, as disclosed by ImmunityBio, Inc. (ClinicalTrials.gov NCT03228667).
gov Identifiers NCT03022825 (QUILT-3.032) and NCT03228667 (QUILT-3.055).
Emirates Drug Establishment, Product Marketing Authorization Approval certificates and approved Summaries of Product Characteristics, Registration Nos. 78609-45860-260486 (NMIBC) and 78609-1572-260487 (NSCLC), first registration 24 July 2026.
Immunotherapy Agent Workshop, July 12, 2007 NCI, View Source
Cancer Immune Evasion Through Loss of MHC Class I Antigen Presentation. Karthik Dhatchinamoorthy, et. al. View Source
About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JUL 29, 2026, View Source [SID1234669490])

On July 29, 2026 AbCellera (Nasdaq: ABCL) reported a collaboration with Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) to research, develop, manufacture, and commercialize multispecific T-cell engagers (TCEs) for autoimmune diseases and other conditions.

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"We are excited to collaborate with Vertex, a recognized leader in innovation, to accelerate the development of new, transformative therapies," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "We continue to see our TCE platform as a source for advancing impactful programs into the clinic, both internally and through strategic partnerships."

"Vertex is committed to transforming the treatment landscape for people with serious diseases," said Mark Bunnage, D.Phil., EVP and Chief Scientific Officer at Vertex. "AbCellera’s T-cell engager platform offers sophisticated capabilities for discovering and engineering multispecific antibodies and we look forward to working with AbCellera’s team to explore the potential of this technology to develop innovative therapies for patients in need."

Under the terms of the agreement, AbCellera will leverage its proprietary TCE platform to lead discovery and early development activities. Vertex will fund all research and development costs and will have the right to develop and commercialize therapeutic multispecific antibodies resulting from the collaboration. AbCellera will receive $28 million in total upfront payments and is eligible to receive preclinical, development, regulatory, and commercial milestone payments, along with tiered royalties on net sales. In addition, AbCellera and Vertex may mutually agree to have AbCellera perform cell line development, process development, and clinical manufacturing through Phase 1 for any program under the collaboration.

About AbCellera’s T-Cell Engager Platform

AbCellera’s T-cell engager platform is a fully integrated capability, from discovery to clinical manufacturing, for developing multispecific TCEs in many therapeutic areas, including oncology and autoimmune conditions. The platform includes novel and proprietary panels of CD3-binding antibodies, costimulatory targeting arms, multispecific protein engineering technology, novel formats, and a suite of high-throughput functional assays.

(Press release, AbCellera, JUL 29, 2026, View Source [SID1234669508])

On July 29, 2026 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof), in an underwritten public offering. INOVIO intends to grant the underwriter a 30-day option to purchase additional shares of its common stock and/or accompanying warrants in an amount up to 15% of the shares of its common stock and/or accompanying warrants offered in the public offering under the same terms and conditions. All of the securities in the proposed offering will be sold by INOVIO. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Piper Sandler is acting as sole manager for the offering.

A shelf registration statement relating to the shares of common stock and accompanying warrants offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on July 2, 2026 and declared effective by the SEC on July 10, 2026. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Inovio, JUL 29, 2026, View Source [SID1234669491])

On July 29, 2026 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS T-cell therapy, in patients with relapsed or refractory ("R/R") B-cell non-Hodgkin’s lymphoma ("NHL"). The new site, Baylor Research Institute d/b/a Baylor Scott & White Research Institute in Dallas, Texas, has begun screening and enrolling patients.

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"Partnering with Baylor Scott & White Research Institute, a nationally recognized medical institution, represents a key step forward in broadening the reach of our STARLIGHT-1 trial," said Cheng Liu, CEO of Estrella Immunopharma. "The expansion of our clinical footprint will help accelerate development and increase patient access to EB103, while we remain focused on our mission to deliver safer, more effective treatments for patients with advanced NHL."

The ongoing expansion phase of the Phase I/II clinical trial for EB103 is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the recommended Phase II dose ("RP2D") in subjects (≥ 18 years of age) who have R/R B-cell NHL. Data from this expansion cohort will be used to determine the pivotal trial strategy for EB103. As of the date of this press release, active clinical sites for the trial are UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. (Eureka), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, such as EB103, allows it to be activated and regulated upon engagement with cancer targets through a cellular mechanism that more closely resembles that of an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Immunopharma, JUL 29, 2026, View Source [SID1234669509])

On July 29, 2026 Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2026.

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Second Quarter 2026 Highlights

•Second quarter revenues of $418.8 million increased 0.8% on a reported basis and 0.7% on an organic basis compared to the prior year.

•Second quarter GAAP earnings per diluted share of $0.06, compared to $(6.31) in the prior year.

•Adjusted earnings per diluted share of $0.56, compared to $0.45 in the prior year.

•The Company is updating its reported revenue guidance range to $1.654 billion to $1.695 billion to reflect the impact of a stronger U.S. dollar on foreign exchange rates.

•The Company is reaffirming its 2026 full-year organic revenue growth guidance of 0.8% to 3.3% and adjusted earnings per share guidance of $2.40 to $2.50.

•The Company initiated production at its Braintree manufacturing facility and remains on track for the planned fourth-quarter relaunch of SurgiMend.

"Our second-quarter performance reflects meaningful progress on our most important priorities. We are improving supply reliability, advancing quality, and returning products to market with discipline. The Braintree facility is now producing and ramping to support the planned SurgiMend relaunch later this year," said Stuart Essig, Chairman and CEO of Integra LifeSciences.

"At the same time, we are seeing the benefits of a more aligned commercial organization while we continue to reduce our balance sheet leverage. Supported by our broad portfolio, attractive markets, and focused leadership team, we are strengthening our operating foundation and enhancing our ability to deliver sustainable long-term shareholder value."
Second Quarter 2026 Consolidated Performance
Total reported revenues of $418.8 million increased 0.8% on a reported basis and 0.7% on an organic basis compared to the prior year.
The Company reported GAAP gross margin of 52.5%, compared to 50.4% in the second quarter of 2025. Adjusted gross margin was 61.3%, compared to 60.7% in the prior year.
Adjusted EBITDA for the second quarter of 2026 was $78.4 million, or 18.7% of revenue, compared to $71.2 million, or 17.1% of revenue, in the prior year.
The Company reported GAAP net income of $4.5 million, or $0.06 per diluted share, in the second quarter of 2026, compared to GAAP net loss of $(484.1) million, or $(6.31) per diluted share, in the prior year.

Adjusted net income for the second quarter of 2026 was $43.7 million, or $0.56 per diluted share, compared to $34.4 million, or $0.45 per diluted share, in the prior year.

Second Quarter 2026 Segment Performance
Specialty Surgery (~70% of Revenues)
Total revenues were $309.3 million, representing reported growth of 1.7% and an organic growth of 1.6% compared to the second quarter of 2025.

•Sales in Neuro increased 1.9% on an organic basis primarily driven by growth in Certas Plus, Bactiseal and CUSA.
•Sales in Instruments grew 3.2% on an organic basis.
•ENT sales declined (1.9%) as MicroFrance ENT instrument growth was offset by declines in other products.

Tissue Reconstruction (~30% of Revenues)

Total revenues were $109.5 million, representing reported and organic declines of (1.9)% and (2.0)% respectively compared to the second quarter of 2025. Key drivers for the quarter include:

•Mid-single digit decline in wound reconstruction, driven by strong growth in DuraSorb and the relaunch of PriMatrix, offset by declines in MicroMatrix and Integra Skin. Integra Skin faced a prior year comparison that included the clearance of back orders in the second quarter of 2025.
•Sales in private label grew 4.7%.

Balance Sheet, Cash Flow and Capital Allocation
The Company generated cash flow from operations of $22.8 million in the quarter. Net debt at the end of the quarter was $1.6 billion, and the consolidated total leverage ratio was 4.1x.

As of the end of the quarter, the Company had total liquidity of approximately $496 million, including $274.1 million in cash plus short-term investments and the remainder available under its revolving credit facility.
2026 Revenue and Adjusted Earnings Per Share Guidance

For the third quarter of 2026, the Company expects reported revenues in the range of $410 million to $425 million, representing reported growth of 2.0% to 5.7% and organic growth of 1.9% to 5.7%. The Company expects adjusted EPS in the range of $0.53 to $0.61 per share.

The Company is updating its reported revenue outlook from a range of $1.662 billion to $1.702 billion to a range of $1.654 billion to $1.695 billion to reflect the impact of a stronger U.S. dollar on foreign exchange rates. For the full year 2026, the Company is reaffirming its organic revenue growth guidance of 0.8% to 3.3% and adjusted earnings per share guidance of $2.40 to $2.50. The adjusted EPS outlook reflects updated tariff assumptions, a higher interest rate environment, and potential debt refinancing actions.

The Company’s organic sales growth guidance for the third quarter and full year excludes the impact of acquisitions, divestitures, and foreign currency.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, July 29, 2026, to discuss second quarter 2026 financial results and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.

A live webcast will be available on the Investors section of the Company’s website at investor.integralife.com. For those planning to participate on the call, register here to receive dial-in details and an individual pin. While not required, it is recommended to join 10 minutes prior to the event’s start. A webcast replay of the conference call will be available on the Investors section of the company’s website following the call.

(Press release, Integra LifeSciences, JUL 29, 2026, View Source [SID1234669492])