On August 13, 2026 Curis, Inc. (Nasdaq: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported the pricing of its public offering with certain new and existing healthcare-focused institutional investors for the purchase and sale of 3,733,334 shares of common stock of the Company (or pre-funded warrants to purchase shares of common stock in lieu thereof) and warrants to purchase up to 3,733,334 shares of common stock at a combined public offering price of $1.50 per share and accompanying common warrant (or a combined public offering price of $1.49 per pre-funded warrant and accompanying common warrant) (the "Offering"). The common warrants will have an exercise price of $1.75 per share, will be exercisable immediately and will expire five years from the issuance date. The pre-funded warrants will have an exercise price of $0.01 per share and will be exercisable immediately until exercised in full.

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The gross proceeds from the Offering are expected to be approximately $5.6 million, before deducting placement agents fees and estimated Offering expenses payable by Curis. The Company intends to use the net proceeds of this Offering to fund its research and development activities and for working capital and general corporate purposes The Offering is expected to close on or about August 14, 2026, subject to market conditions and the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as the lead placement agent and Laidlaw & Company (UK) Ltd. is acting as co-placement agent in connection with the Offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-298203) filed on August 10, 2026 and declared effective by the Securities and Exchange Commission (the "SEC") on August 12, 2026. The Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus related to the offering was filed with the SEC on August 10, 2026. The final prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus relating to the offering, when available, may be obtained from: A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus to be filed with the SEC.

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

(Press release, Curis, AUG 13, 2026, View Source,-Inc-Announces-Pricing-of-5-6-Million-Public-Offering [SID1234670063])

On August 13, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the quarter ended June 30, 2026, and provided a corporate update.

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"Our second quarter marked another period of significant execution as we continued to advance multiple programs across our oncology pipeline while laying the foundation for several important near-term catalysts," said James Caruso, president and chief executive officer of Cellectar. "Most notably, we progressed our regulatory strategy for iopofosine I 131 in Waldenström macroglobulinemia, including initiation of site activation activities for our confirmatory Phase 3 trial, which is an important first step toward our accelerated approval application in the U.S., which we plan to submit in mid-2027. The compelling data we continue to generate from the Phase 2b CLOVER WaM study reinforce our belief that iopofosine has the potential to address a critical unmet need for WM patients, including those previously treated with BTK inhibitors and prior to off-label salvage therapies."

"At the same time, we continued to expand the clinical validation of our proprietary PDC platform, achieving key enrollment and dosing milestones in our CLR 125 Phase 1b trial in triple-negative breast cancer and advancing our broader radiopharmaceutical portfolio. Supported by a strengthened balance sheet and a clear operational roadmap, we are entering the second half of 2026 with strong momentum, multiple anticipated data and development milestones, and a steadfast commitment to creating long-term value for patients and stockholders."

Second Quarter 2026 and Recent Corporate Highlights

Iopofosine I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Presented data from the CLOVER WaM study of iopofosine I 131 in relapsed/refractory Waldenström macroglobulinemia (r/r WM) patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting (ASCO) (Free ASCO Whitepaper). The poster presentation highlighted efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy, which consisted of two cycles administered at 15 mCi/m2 on days 1 and 15 of each 57-day cycle. Major response rate (MRR) was the primary efficacy endpoint, while the subset analysis also assessed a modified intent-to-treat (mITT) population who were immediately post-BTKi treatment.
Efficacy from the evaluable patients (n=24) included:
100% clinical benefit rate
87.5% overall response rate (ORR)
79.2% MRR, partial response (PR) or better
Median duration of response (DOR) of 16 months
(range: 7.3-25.4 months)
20% of patients exceeded 30 months DOR
Treatment was well-tolerated with a manageable toxicity profile with cytopenias as the only Grade 3 or greater adverse event.
Advanced preparations for the Phase 3 confirmatory trial of iopofosine I 131 and began site initiation activities. Sites are expected to begin opening in the coming months with first patient to be dosed in early 2027.
The Phase 3 study will be a comparator, randomized controlled study with approximately 100 WM patients per arm; full patient enrollment is projected within 18-24 months of the first patient admitted to the study.
The New Drug Application is planned for submission in mid-2027 under the FDA’s Accelerated Approval Program. Based on the Breakthrough Therapy Designation awarded to iopofosine I 131 for r/r WM, an approximate 6-month review is anticipated.
Published results from a Phase 1 dose-escalation study of iopofosine I 131 in combination with low-dose dexamethasone in patients with heavily pretreated relapsed/refractory multiple myeloma (r/r MM) in the peer-reviewed journal, Cancer.
Among 26 efficacy-evaluable patients, iopofosine I 131 achieved disease control in 84.6% of patients and an ORR of 15.4%, including four partial responses, with evidence of enhanced clinical activity at higher administered doses and a 30% ORR among evaluable patients receiving at least 60 mCi.
Treatment was generally well tolerated, with a favorable safety profile consisting primarily of predictable and reversible hematologic toxicities, no new safety signals, and mostly low-grade non-hematologic adverse events.
Given that iopofosine I 131’s mechanism of action is not dependent on a single target or mutation, the company believes these and other data underscore its potential to address a broad range of B-cell-mediated malignancies, including WM, MM, diffuse large B-cell lymphoma and other difficult-to-treat hematologic cancers where new therapeutic options are needed.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumor
Initiated enrollment and dosing of the first patients in the Phase 1b trial evaluating CLR 125 in refractory triple negative breast cancer (TNBC).
Phospholipid Drug Conjugate (PDC) Platform
On August 18th, Cellectar management will host a virtual educational webinar highlighting its validated PDC platform. The webinar will highlight the company’s Phospholipid Drug Conjugates’ (PDCs) ability to target and gain intracellular access to most primary tumors, metastatic sites, and cancer stem cells and will underscore how this approach may enhance drug efficacy and simultaneously minimize side effects for patients.
The event will showcase how this next-generation proprietary PLE delivery platform was engineered to be conjugated (combined) with a wide variety of therapeutic molecules, such as small-molecule chemotherapeutics, radiotherapeutics, and other molecules that utilize alternative therapeutic approaches.
Details of the webinar are below:
Date: August 18th, 2026
Time: 11:30 am – 12:30 pm ET
Registration Link: HERE
Corporate
In May 2026, the company entered into a securities purchase agreement with certain institutional investors and members of executive management to issue and sell an aggregate of approximately $35 million upfront and up to $105 million milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants and milestone-based warrants. Proceeds from this financing will primarily be used to fund the Phase 3 confirmatory study of iopofosine I 131 in WM.
2026 Financial Highlights

Cash and Cash Equivalents: As of June 30, 2026, the company had cash and cash equivalents of $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects net proceeds of approximately $31.7 million from the May 2026 offering. The company believes its cash balance as of June 30, 2026, is adequate to fund its budgeted operations into the second quarter of 2027.
Research and Development Expenses: R&D expenses for the three months ended June 30, 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended June 30, 2025. The initiation of the WM confirmatory iopofosine I 131 and CLR 125 Triple Negative Breast Cancer studies drove the increase.
General and Administrative Expenses: G&A expenses for the three months ended June 30, 2026, were approximately $2.6 million, compared to approximately $3.6 million for the same period in 2025. The decrease was primarily a result of reduced commercialization efforts, professional fees, and lower personnel costs.
Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared to $5.4 million, or $3.39 per share, for the three months ended June 30, 2025.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, August 13, 2026, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the company’s website for approximately 90 days.

(Press release, Cellectar Biosciences, AUG 13, 2026, View Source [SID1234670062])

On August 13, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"This quarter reflects meaningful execution across the company as we advance aglatimagene toward a planned BLA submission in the fourth quarter of 2026 and continue to build the foundation for a potential U.S. commercial launch in localized prostate cancer," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "We believe the extended follow-up data presented at AUA, together with the publication of our pivotal phase 3 results in The Lancet Oncology, further reinforce the potential of aglatimagene to address an important unmet need for patients with intermediate- to high-risk localized prostate cancer. At the same time, the activation of the first trial site for the AURORA phase 3 clinical trial in patients with advanced NSCLC underscores the broader potential of our multimodal immunotherapy platform across solid tumors."

Dr. Tak continued, "We also made important progress in commercial readiness through our appointment of Mark Sims as Chief Commercial Officer, adding deep oncology commercialization and launch experience as we prepare for the next stage of Candel’s growth. With a strong balance sheet, we believe we are well-positioned to execute our operating plan into the first quarter of 2028, including activities intended to support a potential U.S. commercial launch of aglatimagene in 2027, if approved."

Second Quarter 2026 & Recent Highlights

•
Aglatimagene besadenovec – Prostate Cancer
•
The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, preparation of clinical study reports, and BLA modules.
•
Process validation campaign for drug substance and drug product is being executed at our contract development and manufacturing organization. The campaign is progressing well and is a critical CMC activity to enable the anticipated BLA submission in Q4 2026.
•
New clinical material has been produced and is intended to be used in the pivotal phase 3 clinical trial of aglatimagene in NSCLC.
•
The Company published results from the randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer in The Lancet Oncology. These data were initially announced in December 2024 and presented as an oral presentation at ASCO (Free ASCO Whitepaper) 2025.

•
The Company presented clinical data from extended follow-up of its phase 3 trial of aglatimagene in prostate cancer in a plenary oral presentation at the AUA 2026 Annual Meeting, held in Washington, D.C. from May 15-18, 2026.
•
Among the 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival (PCa-specific DFS) compared to placebo after a median follow-up of 58 months (data as of March 15, 2026).
•
The Company observed consistently favorable trends in both the intent to treat and intermediate-risk subgroup populations across all secondary and exploratory endpoints, including time to biochemical failure, time to metastasis, rate of metastasis, and time to salvage anti-cancer therapy (time to new treatment), when comparing the aglatimagene arm with placebo, on top of standard-of-care radiotherapy.
•
There were no new safety signals or additional toxicities observed.
For additional information, please refer to Candel’s May 15, 2026, press release.

•
The Company will present an abstract delineating extended biomarker analysis from the phase 3 clinical trial of aglatimagene in patients with localized prostate cancer at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting in Q3 2026.
•
The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to certain aspects of the study design, agreed with the FDA.
•
Aglatimagene besadenovec – Non-Small Cell Lung Cancer (NSCLC)
•
In June 2026, the Company activated the first clinical trial site of the global pivotal phase 3 clinical trial (AURORA) (NCT07660094), which will evaluate aglatimagene plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous NSCLC whose disease has progressed despite treatment with pembrolizumab and platinum-based chemotherapy.
•
The randomized, open-label AURORA trial is expected to enroll patients with metastatic stage IV non-squamous NSCLC across approximately 150 sites worldwide, randomized 1:1 to receive either two courses of aglatimagene plus valacyclovir with continued pembrolizumab or standard-of-care docetaxel chemotherapy.
•
The study’s primary endpoint is overall survival, with secondary endpoints including safety and quality-of-life assessments (NSCLC-SAQ and EORTC QLQ-30).
•
The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.
•
Linoserpaturev – Recurrent Glioblastoma (rGBM)
•
Following FDA clearance of its Investigational New Drug application for linoserpaturev in Q1 2026, the Company is advancing next-stage development planning for rGBM.
•
Enabling work is underway to support a potential randomized phase 2 dose-regimen-finding study.
•
The clinical trial is expected to inform the optimal number of linoserpaturev administrations and a recommended regimen for future development.
•
Recent Corporate Events
•
In June 2026, the Company appointed Mark Sims as Chief Commercial Officer. Mr. Sims is a seasoned oncology commercial leader with more than 25 years of experience building and advancing Global and U.S. cancer franchises. He held key leadership roles at AstraZeneca PLC, Novartis AG, and Idenix Pharmaceuticals, Inc.. Mr. Sims’ appointment strengthens the Company’s efforts toward its planned BLA submission in the fourth quarter of 2026 and potential 2027 launch of aglatimagene in localized prostate cancer.
•
In April 2026, the Company announced a commercialization agreement with EVERSANA to support the potential U.S. launch of aglatimagene in localized prostate cancer. This operating model gives Candel immediate access to leading commercial capabilities, while maintaining financial flexibility, capital efficiency, and scientific focus that has driven the Company’s progress to date.
Anticipated Milestones

•
Abstract showcasing extended biomarker data from the phase 3 clinical trial of aglatimagene in patients with localized prostate cancer to be presented as a poster at the ASTRO Annual Meeting in Q3 2026.
•
The Company expects to present potential long-term survival data from arm C of its phase 1b clinical trial of linoserpaturev in patients with recurrent high-grade glioma (rHGG) in Q4 2026.

•
Submission of a BLA for aglatimagene in prostate cancer is planned for Q4 2026.

Financial Results for the Second Quarter Ended June 30, 2026

Research and Development Expenses: Research and development expenses were $19.8 million for the second quarter of 2026 compared to $7.0 million for the second quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $1.8 million for the second quarter of 2026, as compared to a non-cash stock compensation expense of $0.4 million for the second quarter of 2025.

General and Administrative Expenses: General and administrative expenses were $6.9 million for the second quarter of 2026, compared to $4.2 million for the second quarter of 2025. The increase was primarily due to higher commercial readiness costs and an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $1.0 million for the second quarter of 2026, as compared to a non-cash stock compensation expense of $0.6 million for the second quarter of 2025.

Net Income/Loss: Net loss for the second quarter of 2026 was $38.9 million compared to net loss of $4.8 million for the second quarter of 2025 and included net other expense of $12.2 million and net other income of $6.4 million, respectively. The increase in net other expense was primarily related to the change in the fair value of the Company’s warrant liabilities.

Cash Position: Cash and cash equivalents, as of June 30, 2026, were $201.6 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of June 30, 2026, will be sufficient to fund operations into Q1 2028.

About aglatimagene besadenovec

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a varietyof tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.

About linoserpaturev

Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition1. The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA).

(Press release, Candel Therapeutics, AUG 13, 2026, View Source [SID1234670061])

On August 13, 2026 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has approved ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.1 Full approval for this indication will be contingent upon verification and description of clinical benefit in the confirmatory trial(s). ZENBEXUS is the first FDA-approved CELMoD, belonging to a new class called cereblon-modulating protein degraders for the treatment of multiple myeloma.1 Please see the Important Safety Information section below, including Boxed WARNINGS for ZENBEXUS regarding embryo-fetal toxicity and venous and arterial thromboembolism. ZENBEXUS is contraindicated in females who are pregnant.

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"Today’s approval of ZENBEXUS represents meaningful progress for patients living with multiple myeloma and underscores the power of our targeted protein degradation platform, particularly our CELMoD programs," said Cristian Massacesi, MD, chief medical officer and head of development at Bristol Myers Squibb. "As the first approved CELMoD, ZENBEXUS marks the arrival of a new treatment class and is an important milestone in our efforts to expand what is possible for patients with multiple myeloma. And we believe this is only the beginning. This approval validates years of scientific research and strengthens our confidence in the potential of this approach as we continue to advance our innovative pipeline on behalf of patients with significant unmet needs."

Approval of ZENBEXUS is based on results from the Phase 3 EXCALIBER-RRMM trial evaluating ZENBEXUS, daratumumab and hyaluronidase-fihj and dexamethasone (ZDd; n=207) compared to daratumumab, bortezomib and dexamethasone (DVd; n=213) in patients with RRMM.1 At a median follow-up of 16 months, results showed treatment with ZDd demonstrated a statistically significant improvement in one of the dual primary endpoints of minimal residual disease (MRD)-negative complete response (CR) in 41% of patients (n=85; 95% CI: 34-48) vs. 21% of patients (n=44; 95% CI: 15-27) treated with DVd (p < 0.0001).1 MRD-negativity is among the deepest measures of response in multiple myeloma and is considered predictive of improved progression-free survival (PFS).2 This FDA decision marks the first approval in relapsed or refractory multiple myeloma based on MRD-negative CR.

"The FDA approval of iberdomide marks the anticipated arrival of a new therapeutic class for relapsed or refractory multiple myeloma and has the potential to make a meaningful difference for patients," said Sagar Lonial, MD, FACP, FASCO, EXCALIBER-RRMM lead investigator and chief medical officer of the Winship Cancer Institute of Emory University. "The strong results observed with the CELMoD-based combination within a familiar triplet approach creates the potential for a new treatment foundation in multiple myeloma."

The combination of ZDd was observed to have a safety profile that is expected of the combination, with 7.8% of patients discontinuing ZDd due to adverse reactions.1 Among the key safety findings, ZDd can cause serious, life-threatening, or fatal infections and severe neutropenia.1 Neutropenia and infections in patients who received ZDd occurred at a rate of 90.2% and 78.9%, respectively, leading to few discontinuations (1% and 1.5%, respectively).1 The most common adverse reactions (≥20%) in the ZDd arm and DVd arm, respectively, were upper respiratory tract infection (54% and 52%), fatigue (36% and 33%), musculoskeletal pain (35% and 33%), pneumonia (34% and 17%), diarrhea (33% and 36%), motor dysfunction (26% and 17%), rash (26% and 15%), sleep disorder (25% and 28%), hypogammaglobulinemia (24% and 12%), COVID-19 (23% and 16%), and constipation (20% and 22%).1 Serious adverse reactions in ≥2% of patients included pneumonia (26%), upper respiratory tract infection (6.4%), second primary malignancy (5.9%), neutropenia (4.9%), febrile neutropenia (3.9%), COVID-19 (4.4%), and sepsis (2.9%).1 Fatal adverse reactions occurred in 10 patients (4.9%) who received ZENBEXUS.1 Sepsis (1.5%) was the only fatal drug reaction that occurred in more than 1 patient.1 The following fatal adverse reactions occurred in 1 patient each: listeria encephalitis, influenza, lung adenocarcinoma, cardiac arrest, large intestine perforation, metabolic acidosis, and respiratory failure.1

"The goal for every person living with multiple myeloma is not simply to live longer, but to live well," said Heather Cooper Ortner, president and chief executive officer of the International Myeloma Foundation. "That is why it is important to have access to effective therapeutic options, particularly in the community setting where the majority of myeloma care is delivered. This approval represents an important step forward by expanding treatment options for patients facing their first relapse. Every new option gives patients and their healthcare teams additional choices as treatment needs evolve, as well as renewed hope for the future."

ZENBEXUS was granted Breakthrough Therapy designation and accelerated approval based on MRD-negative CR at any time in the EXCALIBER-RRMM study.1 This review was conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries.

While ZENBEXUS is the first FDA approved CELMoD therapy, a New Drug Application for mezigdomide, an investigational CELMoD, in combination with carfilzomib and dexamethasone is also currently under review with the FDA with a Prescription Drug User Fee Act target date of May 13, 2027.

Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers, and provides support that allows for access to therapies, including ZENBEXUS.

About EXCALIBER-RRMM
EXCALIBER-RRMM (NCT04975997) is a Phase 3, multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM).2 The study included a dose optimization stage and was designed to assess dual-primary endpoints of minimal residual disease (MRD) negativity and progression-free survival (PFS), with additional secondary endpoints including overall survival (OS), overall response rate (ORR), safety and sustained MRD negativity.2 The study remains ongoing to assess the primary endpoint of PFS. Eligible participants included adults with 1 to 2 prior lines of anti-myeloma therapy and progressive disease.2 A total of 939 patients were randomized.1 The primary efficacy population for MRD negativity included the first 420 patients randomized to the ZENBEXUS (1 mg) + Dd arm (n=207) or the comparator daratumumab, bortezomib, and dexamethasone (DVd) arm (n=213).1 Treatment in both arms was administered until disease progression or unacceptable toxicity.1

This approval, the first in RRMM based on MRD-negative complete response (CR), marks the first public disclosure of MRD-negative CR data from the EXCALIBER-RRMM trial. The MRD data were first disclosed at the time of approval to preserve the integrity of the study while additional endpoints mature. The study remains ongoing, with patients continuing to be evaluated for PFS, one of the trial’s dual primary endpoints. Full data from EXCALIBER-RRMM are expected this year.

About Minimal Residual Disease (MRD)
Minimal residual disease (MRD) refers to the small number of cancer cells that may remain in a patient’s body after treatment and are undetectable using conventional diagnostic methods.3 In multiple myeloma, MRD assessment has emerged as a highly sensitive and clinically meaningful tool for evaluating treatment response.3 MRD negativity does not necessarily mean all cancer cells are gone.3

Modern MRD detection methods, such as next-generation sequencing (NGS) and next-generation flow cytometry (NGF), can identify one malignant cell among 100,000 (threshold for MRD) to 1,000,000 normal cells, offering unprecedented precision in measuring disease burden.3 MRD is increasingly being used in clinical trials as a surrogate endpoint for progression-free survival (PFS) and is gaining recognition from regulatory authorities for its role in accelerating approval timelines.2

Indication
ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM

EMBRYO-FETAL TOXICITY

ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment.

Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment.

Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS.

SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM

Increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended.

CONTRAINDICATIONS

Based on the mechanism of action and findings in animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans. ZENBEXUS is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity

Females of Reproductive Potential: Must avoid pregnancy while taking ZENBEXUS and for at least 4 weeks after completing therapy. Advise females of reproductive potential of the potential risk to a fetus and to use 2 methods of effective contraception for at least 4 weeks before beginning ZENBEXUS therapy, during therapy, during dose interruptions and for at least 4 weeks after the last dose of ZENBEXUS therapy. Refer patients who can become pregnant to a qualified provider of contraceptive methods, if needed.

Two negative pregnancy tests with a sensitivity of at least 25 mIU/mL must be obtained prior to initiating therapy. Pregnancy testing should be performed weekly during the first 4 weeks of treatment. Thereafter, testing should occur every 4 weeks in patients with regular menstrual cycles, or every 2 weeks in patients with irregular menstrual cycles.

Females of reproductive potential taking ZENBEXUS must not donate eggs during treatment and for 4 weeks after completion.

Males: ZENBEXUS may pass into human semen. Advise patients who can impregnate partners to use effective contraception during treatment and for 4 weeks following the discontinuation of ZENBEXUS therapy. Male patients taking ZENBEXUS must not donate sperm during treatment and for 4 weeks after completion.

Blood Donation: Patients must not donate blood during treatment with ZENBEXUS and for 4 weeks following discontinuation of ZENBEXUS therapy.

ZENBEXUS REMS

ZENBEXUS is available only through a restricted program called ZENBEXUS REMS, because of the risk of embryo-fetal toxicity. Prescribers must be certified with and patients must be enrolled in the ZENBEXUS REMS Program and comply with ongoing monitoring and contraception requirements. Further information about ZENBEXUS REMS, including information for pharmacies, wholesalers, and distributors, is available at www.ZENBEXUSREMS.com or by telephone at 1-888-423-5436.

Serious Venous and Arterial Thromboembolism

ZENBEXUS can cause serious and life-threatening venous thromboembolic events (DVT and PE) and arterial thromboembolic events (myocardial infarction and stroke). In the EXCALIBER-RRMM study (N=204), venous thromboembolic events occurred in 6.4% of patients treated with ZENBEXUS combined with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd) despite mandatory thromboembolism prophylaxis. The incidence of DVT was 3.4% and the incidence of PE was 1.5%.

Arterial thromboembolic events occurred in 3.4% of patients. The incidence of myocardial infarction was 2.0%, and the incidence of stroke (CVA) was 1.5%.

Monitor patients for signs and symptoms of thromboembolic events during treatment with ZENBEXUS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors. In patients who develop a thromboembolism, interrupt ZENBEXUS and initiate anticoagulant therapy according to guidelines.

Neutropenia

ZENBEXUS can cause severe neutropenia. In the EXCALIBER-RRMM study, all-grade neutropenia was reported in 90.2%, Grade 3 in 30.9%, and Grade 4 in 53.4% of patients in the IberDd arm. Febrile neutropenia occurred in 5.4% of patients.

Monitor complete blood count throughout treatment with ZENBEXUS. Interrupt, reduce dosage, or discontinue ZENBEXUS, as necessary. Initiate granulocyte colony-stimulating factor (GCSF) as appropriate per guidelines.

Infections

ZENBEXUS can cause serious infections, including life-threatening or fatal infections. Patients with active or uncontrolled infection should not start ZENBEXUS treatment until the infection is controlled. In the EXCALIBER-RRMM study, infections, including opportunistic infections, were reported in 78.9%, Grade 3 in 35.8%, Grade 4 in 3.4%, and fatal infections in 2% of patients receiving IberDd. Serious infections occurred in 40% of patients. Discontinuations due to infections occurred in 1.5% of patients.

Monitor patients for signs and symptoms of infection prior to and during treatment with ZENBEXUS and treat appropriately. Withhold or reduce the dose based on severity.

Consider prophylactic anti-infective medications according to current practice guidelines.

Second Primary Malignancies

In the EXCALIBER-RRMM study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in 6.9% of patients in the IberDd arm and 4.9% of patients in the daratumumab and hyaluronidase-fihj, bortezomib, and dexamethasone (DVd) arm.

Monitor patients for the development of SPM.

ADVERSE REACTIONS

Serious adverse reactions occurred in 58.3% of patients receiving ZENBEXUS. Serious adverse reactions in ≥2% of patients included pneumonia (26%), upper respiratory tract infection (6.4%), SPM (5.9%), neutropenia (4.9%), febrile neutropenia (3.9%), COVID-19 (4.4%), and sepsis (2.9%). Fatal adverse reactions occurred in 10 patients (4.9%) who received ZENBEXUS. Sepsis (1.5%) was the only fatal drug reaction that occurred in more than 1 patient. The following fatal adverse reactions occurred in 1 patient each: listeria encephalitis, influenza, lung adenocarcinoma, cardiac arrest, large intestine perforation, metabolic acidosis, and respiratory failure.

The most common adverse reactions (≥20%) in the IberDd arm and DVd arm, respectively, were upper respiratory tract infection (54% and 52%), fatigue (36% and 33%), musculoskeletal pain (35% and 33%), pneumonia (34% and 17%), diarrhea (33% and 36%), motor dysfunction (26% and 17%), rash (26% and 15%), sleep disorder (25% and 28%), hypogammaglobulinemia (24% and 12%), COVID-19 (23% and 16%), and constipation (20% and 22%).

The most common Grade 3 to 4 laboratory abnormalities (≥30%) in the IberDd arm and DVd arm, respectively, were neutropenia (77% and 11%), leukopenia (69% and 18%), and lymphopenia (62% and 51%).

DRUG INTERACTIONS

Effects of Other Drugs on ZENBEXUS

Strong or Moderate CYP3A Inhibitors: Coadministration of ZENBEXUS with strong or moderate CYP3A inhibitors should be avoided. If a strong or moderate CYP3A inhibitor must be used in combination with ZENBEXUS, reduce the ZENBEXUS dose. Concomitant use with strong or moderate CYP3A inhibitors may increase the risk of adverse reactions.

Strong or Moderate CYP3A Inducers: Coadministration of ZENBEXUS with strong or moderate CYP3A inducers should be avoided. Concomitant use with a strong or moderate CYP3A inducer may decrease the efficacy of ZENBEXUS.

SPECIFIC POPULATIONS

Pregnancy (See the BOXED WARNINGS)

There is a pregnancy exposure registry that monitors outcomes in patients exposed to ZENBEXUS during pregnancy. See the ZENBEXUS REMS WARNINGS AND PRECAUTIONS section.

Lactation

Advise women not to breastfeed during treatment with ZENBEXUS. Refer to the Prescribing Information for daratumumab hyaluronidase-fihj or dexamethasone for additional information.

Females and Males of Reproductive Potential

ZENBEXUS can cause fetal harm when administered during pregnancy.

Pregnancy Testing, Females of Reproductive Potential, and Males: See the Embryo-Fetal Toxicity WARNINGS AND PRECAUTIONS section.

Geriatric Use

In patients treated with IberDd, the incidence of serious adverse reactions was 53%, 56%, and 74% in adult patients younger than 65 years of age, 65 years of age to younger than 75 years of age, and 75 years of age and older, respectively.

Renal Impairment

Reduce the ZENBEXUS dose in patients with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 not on dialysis. If dose modification is needed due to adverse events, reduce the ZENBEXUS dose to 1 mg every other day on Days 1 to 21 of a 28-day cycle.

Please see full Prescribing Information for ZENBEXUS including Boxed WARNINGS.

About Targeted Protein Degradation and CELMoD
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered difficult to address. BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including cereblon E3 ligase modulators (CELMoDs), ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb here.

About Ongoing Trials
ZENBEXUS is also being evaluated in the EXCALIBER Maintenance study.

(Press release, Bristol-Myers Squibb, AUG 13, 2026, View Source;FDA-Grants-Accelerated-Approval-to-Bristol-Myers-Squibbs-First-CELMoD-Therapy-ZENBEXUS-in-Combination-with-Daratumumab-and-Hyaluronidase-fihj-and-Dexamethasone-ZDd-for-Patients-with-Multiple-Myeloma-as-Early-as-First-Relapse/default.aspx [SID1234670060])

On August 13, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel payload targeting RNA splicing, reported financial results for the second quarter ending June 30, 2026 and provided an update on the continued advancement of its lead ADC candidate, AKTX-101, towards Phase 1 clinical trials.

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"Akari entered the second half of 2026 with increasing momentum across the business and a clear focus on advancing AKTX-101 towards the clinic," said Abizer Gaslightwala, Chief Executive Officer of Akari Therapeutics. "We are executing the IND-enabling work required to support our planned Phase 1 trial in mid-2027, while continuing to generate data that strengthen the scientific rationale for AKTX-101 and further differentiate our novel PH1 spliceosome-modulating payload."

Mr. Gaslightwala continued, "The compelling data presented at ASCO (Free ASCO Whitepaper) demonstrated synergistic anti-tumor activity when our PH1 payload was combined with an approved KRAS inhibitor in KRAS-mutated pancreatic cancer models, adding to a growing body of preclinical evidence supporting PH1’s differentiated mechanism and potential utility across difficult-to-treat cancers. At the same time, our collaboration with Whitehawk expands the opportunity for PH1 into dual-payload ADCs and provides another avenue to explore the potential advantages of combining PH1’s unique mechanism with established ADC payload technologies. Importantly, receipt of approximately $8 million of financing during the quarter, led by long-term strategic investors, strengthened our balance sheet and enhances our ability to continue executing against these development priorities."

Second Quarter 2026 Highlights

Strengthened the balance sheet through private placement with $5.5 million in gross proceeds, and warrant exercises worth $3.1 million in gross proceeds for a total of approximately $8.6 million in gross proceeds from financing in the quarter, resulting in approximately $8.0 million of net proceeds to the Company.
Continued advancing AKTX-101 through IND-enabling activities by progressing manufacturing and development work to enable the Phase 1 clinical trial. The Company remains focused on initiating AKTX-101 for clinical development in mid-2027.
Expanded the Company’s strategic position in novel ADC payloads through a research collaboration on dual ADC payloads with Whitehawk Therapeutics to evaluate Akari’s proprietary PH1 spliceosome modulating payload platform in combination with Whitehawk’s topoisomerase I payload platform. The collaboration is designed to investigate the potential of combining complementary ADC payload technologies to synergize and enhance anti-tumor activity. This collaboration further demonstrates the unique potential of the PH1 payload and continued strong interest in ADC payload innovation across biotech/pharma.
Presented breakthrough preclinical data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating synergistic anti-tumor activity of the Company’s PH1 spliceosome modulating payload combined with an approved KRAS inhibitor in KRAS-mutated pancreatic cancer models. These data support the potential of using ADCs with the PH1 payload as a way to attack KRAS mutant tumors, still one of the greatest unmet needs.
Expanded the Company’s intellectual property portfolio through newly issued international patents for its proprietary PH1 spliceosome modulating payload technology, further strengthening long-term protection of the platform and supporting future ADC pipeline expansion.
Second Quarter 2026 Financial Results

Research and development expenses were $2.1 million for the second quarter of 2026, compared with $0.7 million for the second quarter of 2025. The increase primarily reflects expanded development and manufacturing activities supporting the advancement of AKTX-101 through critical IND enabling activities.

General and administrative expenses were $2.5 million for the second quarter of 2026, comparable with $2.5 million for the same period in 2025.

Net loss for the second quarter of 2026 was $4.8 million, compared with $1.9 million for the second quarter of 2025.

Cash totaled $7.7 million as of June 30, 2026, compared with $5.2 million as of December 31, 2025.

(Press release, Akari Therapeutics, AUG 13, 2026, View Source [SID1234670059])