On May 6, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest") reported its most recent clinical data from its lead dual-targeting chimeric antigen receptor T-cell ("CAR-T") therapy product candidate, TPST-2003, at the International Society for Cell & Gene Therapy ("ISCT") Scientific Annual Meeting in Dublin, Ireland. Updates include the latest data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, as well as progress in Tempest’s other dual-targeting CAR-T pipeline programs.

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Earlier this year, Tempest announced positive interim data from REDEEM-1, including a 100% complete response ("CR") rate among all six efficacy then-evaluable patients according to the International Myeloma Working Group ("IMWG") uniform response criteria, as well as a favorable safety profile. Today’s clinical update more than doubles the previous dataset, achieving a 100% CR rate among all 15 CAR-T-naïve efficacy evaluable patients across two ongoing Phase 1 trials – REDEEM-1 evaluating TPST-2003 in relapsed/refractory multiple myeloma ("rrMM") (10/10 according to the IMWG uniform response criteria) and POEMS-1 evaluating TPST-2003 in POEMS syndrome (5/5 CRVEGF).

To date, a total of 44 patients have received one infusion of TPST-2003, including 24 patients in a prior Phase 1/2 investigator-initiated trial ("IIT") evaluating TPST-2003 in rrMM, 13 patients in the ongoing REDEEM-1 trial, and seven patients in the ongoing POEMS-1 trial, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy.

All 10 CAR-T-naïve patients currently evaluable for efficacy in the REDEEM-1 trial – three treated at dose level 1 (1 x 106 cells/kg), three at dose level 2 (2 x 106 cells/kg), and four at dose level 3 (3 x 106 cells/kg) – achieved a CR according to the IMWG uniform response criteria. A single patient, who had previously received a BCMA-targeting CAR-T, did not respond. Among 29 CAR-T-naïve evaluable patients with measurable disease at baseline across REDEEM-1 and the prior Phase 1/2 IIT, including 18 patients with EMD, the overall response rate ("ORR") was 100% (29/29) according to the IMWG uniform response criteria.

In the POEMS-1 trial, as of the January 31, 2026 data cutoff, all five evaluable patients had achieved a CRVEGF within two months of being administered TPST-2003. No dose-limiting toxicities were observed in any of the treated patients.

"The results that we are presenting at ISCT this week support our belief that TPST-2003 could offer a life-saving option for patients with rrMM, and, if approved, may outperform first-generation single-targeting CAR-T therapies, in particular in patients with EMD" said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "We are excited by the potential to offer patients who have relapsed from multiple prior lines of therapy a treatment that may achieve up to complete remission of their cancer."

The observed safety profile (no Grade >3 CRS or ICANS), together with the consistency of responses observed in the REDEEM-1 trial continue to support Tempest’s plan to pursue its objective of meeting with the FDA to discuss initiating a U.S. registrational study later this year.

Presentation Details

REDEEM-1, a multicenter open-label Phase 1/2a study of a BCMA/CD19 dual-targeting CAR-T therapy in patients with relapsed/refractory multiple myeloma including those with extramedullary disease. Abstract #1268. Oral Presentation, May 6, 2026 (12:00-13:00 GMT) & Poster Reception, May 7, 2026 (18:00-19:30 GMT), Immunotherapy Session. Presenter: Dr. Matt Angel.

About TPST-2003

TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma ("rrMM") through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics ("Novatim"). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia.

About REDEEM-1

REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The REDEEM-1 trial has a targeted full enrollment of 32 patients. The REDEEM-1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of eight clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), The First Affiliated Hospital of Nanchang University (Dr. Fei Li), Peking University First Hospital (Dr. Yujin Dong), Henan Cancer Hospital (Dr. Baijun Fang), Shanxi Provincial Cancer Hospital (Dr. Liping Su), The Second Xiangya Hospital of Central South University (Dr. Hongling Peng), The First Affiliated Hospital of China Medical University (Dr. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou).

About POEMS-1

POEMS-1 is a Phase 1 clinical trial (Study nos. CTR20242409/NCT06518876) evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. The POEMS-1 trial has a targeted full enrollment of 12 patients. The POEMS-1 trial is sponsored and being conducted by Tempest’s partner, Novatim, with a total of three clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), Xuanwu Hospital Capital Medical University (Dr. Wanling Sun), and West China Hospital, Sichuan University (Dr. Yu Wu).

Additional Clinical Trial Evaluating TPST-2003

A Phase 1/2 IIT (Study no. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su).

(Press release, Tempest Therapeutics, MAY 6, 2026, View Source [SID1234665201])

On May 6, 2026 Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for BIZENGRI (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. PTx submitted a supplemental Biologics License Application (sBLA) to the FDA for this indication based on data from the Phase 2 eNRGy trial. BIZENGRI previously received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for NRG1+ cholangiocarcinoma.

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"We are honored to receive this Commissioner’s National Priority Voucher, which reflects the FDA’s recognition of the profound unmet need facing patients with NRG1+ cholangiocarcinoma, an ultra-rare cancer for which no approved targeted therapy currently exists," said Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics. "Receiving this voucher highlights the urgent need for new treatment options in NRG1 fusion-positive cholangiocarcinoma. Based on the encouraging data from the eNRGy trial, including meaningful tumor responses, durable benefit and a favorable tolerability profile, we believe BIZENGRI has the potential to address a critical gap in care for these patients. We look forward to working closely with the FDA through this accelerated review process."

The FDA’s Commissioner’s National Priority Voucher pilot program, announced in June 2025, is designed to reduce drug and biologic review times from the standard 10–12 months to as little as 1–2 months for products that align with one or more U.S. national health priorities. These priorities focus on advancing innovative breakthrough therapies that introduce novel mechanisms and meaningfully improve how diseases are treated, while also addressing significant unmet medical needs where current treatment options fall short for patients. The program employs a multidisciplinary, tumor board-style review process involving the primary FDA review team and senior agency leadership. BIZENGRI, as a first-in-class bispecific antibody targeting a rare and actionable oncogenic driver with no approved targeted therapy, aligns directly with national priorities.

"For patients facing cholangiocarcinoma, innovation and timely diagnosis can make a profound difference. The FDA’s recognition of this potential treatment underscores both the unmet need in this rare biomarker-defined population and the importance of expanding access to comprehensive biomarker testing so patients can be matched to the most appropriate therapies as early as possible," said Stacie Lindsey, CEO of the Cholangiocarcinoma Foundation.

Data from the cohort of patients with NRG1+ cholangiocarcinoma in the Phase 2 eNRGy trial were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Meeting in October 2025, highlighting clinical outcomes in this rare cancer.1 "Patients with NRG1 fusion–positive cholangiocarcinoma face a significant unmet need, with limited effective treatment options available today," said Alison Schram, MD, Gynecologic Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK) and Principal Investigator of the eNRGy trial. "The FDA’s recognition through the Commissioner’s National Priority Voucher program emphasizes the urgency of advancing therapies for this population. In the eNRGy study, zenocutuzumab demonstrated clinically meaningful activity, with objective responses in more than one-third of evaluable patients and a median progression-free survival of over nine months. These data also highlight the critical role of comprehensive molecular testing, particularly RNA-based comprehensive molecular profiling, in identifying patients who may benefit from emerging targeted approaches."

About NRG1+ Cholangiocarcinoma
Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with an all-stage 5-year overall survival of less than 15%. NRG1 gene fusions occur in fewer than 1% of cholangiocarcinoma cases. NRG1 fusions are largely mutually exclusive with other actionable oncogenic drivers, leaving affected patients—many of whom are younger adults —without approved targeted therapy. Standard cytotoxic regimens carry substantial toxicity, and second-line options such as FOLFOX produce objective responses in only approximately 5% of patients.

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

About NRG1 Gene Fusions
NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS
BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions
BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis
BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.

In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.

Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction
BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity
Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC

Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma

Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.

In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

(Press release, Partner Therapeutics, MAY 6, 2026, View Source [SID1234665220])

On May 6, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported that the first clinical site in the ZIMA-101 Phase 1 trial has now been activated.

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This marks the transition of the study from clinical preparation to active trial execution of the ZIMA-101 study.

The first activated clinical site is The Christie NHS Foundation Trust in the United Kingdom, where Professor Fiona Thistlethwaite serves as Chief Investigator for the study.

ZIMA-101 is a first-in-human Phase 1 trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.

On 20 February 2026, Zelluna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) had approved the Company’s Clinical Trial Application (CTA) for ZIMA-101 in the UK.

Activation of the second clinical site, The Royal Marsden, is expected in the near term.

"This is an important milestone for Zelluna. With the first clinical site now activated, we are entering the execution phase of the ZIMA-101 study. Our focus is now on advancing clinical execution, including patient screening and progression toward first patient dosing" says CEO Namir Hassan.

Zelluna has previously communicated that initial clinical data from the ZIMA-101 study are expected to emerge from mid-2026.

(Press release, Zelluna Immunotherapy, MAY 6, 2026, View Source [SID1234665236])

On May 6, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the first quarter ended March 31, 2026.

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"The Castle Biosciences team delivered outstanding results to start 2026, delivering $83.7 million in revenue," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "I thank our team for their dedication and focus, which translates directly to our performance. Our momentum this quarter reflects our robust execution and the strength of our core revenue drivers, with both DecisionDx-Melanoma and TissueCypher achieving double digit year-over-year test volume growth, 16% and 58%, respectively. As a result of our first quarter performance and continued confidence in the business, we are raising our 2026 total revenue guidance to $345-355 million, compared to the previously provided guidance of $340-350 million.

"In addition, during the quarter we expanded the body of evidence supporting our market-leading DecisionDx-Melanoma test. Specifically, we announced new data from a prospective, multicenter, U.S. based study demonstrating that patients with a less than 5% predicted risk of sentinel lymph node positivity had an actual positivity rate of just 2.6%, reinforcing DecisionDx-Melanoma’s ability to guide sentinel lymph node biopsy decision-making in line with guideline thresholds. Our substantial body of evidence is a key driver of adoption and an important differentiator for DecisionDx-Melanoma and our innovative test portfolio more broadly, reinforcing our position of strength as we continue to execute across the business."

First Quarter Ended Mar. 31, 2026, Financial and Operational Highlights
•Revenues were $83.7 million, compared to $88.0 million in the first quarter of 2025. Affecting first quarter 2026 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.
◦Revenues for our non-dermatologic tests were $42.6 million, compared to $25.0 million during the same period in 2025.

Core revenue drivers:
•First quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 36% over the first quarter of 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,021, compared to 8,621 in the first quarter of 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 11,745, compared to 7,432 in the first quarter of 2025.

Additional tests:
◦DecisionDx-SCC test reports delivered in the quarter were 3,702, compared to 4,375 in the first quarter of 2025.
◦MyPath Melanoma test reports delivered in the quarter were 973, compared to 926 in the first quarter of 2025.
◦DecisionDx-UM test reports delivered in the quarter were 492, compared to 470 in the first quarter of 2025.

•Gross margin was 73%, and Adjusted Gross Margin was 76%, compared to 49% and 81%, respectively, for the same periods in 2025. Affecting first quarter 2025 gross margin was the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million.
•Net cash used in operations was $22.1 million, compared to net cash used in operations of $6.0 million for the same period in 2025. First quarter 2026 cash use reflects payout of employee annual cash bonuses as well as certain health care benefit payments, totaling $28.8 million, that are not expected to recur during the remainder of 2026.
•Net loss, which includes non-cash stock-based compensation expense of $9.8 million, was $14.5 million, compared to net loss of $25.8 million for the same period in 2025.
•Net loss per share, Basic and Diluted, was $0.49, compared to net loss per share, Basic and Diluted of $0.90 and Adjusted Net Loss per Share, Basic and Diluted, of $0.20, for the same period in 2025.
•Adjusted EBITDA was $(5.1) million, compared to $13.0 million for the same period in 2025.

Cash, Cash Equivalents and Marketable Investment Securities
As of Mar. 31, 2026, the Company’s cash, cash equivalents and marketable investment securities totaled $261.7 million.
2026 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $345-355 million in total revenue in 2026, compared to the previously provided guidance of between $340-350 million.
First Quarter and Recent Accomplishments and Highlights

Dermatology – Skin Cancer
•The Company presented new data at the 2026 American Academy of Dermatology Annual Meeting demonstrating that its DecisionDx-Melanoma test refines mortality risk within American Joint Committee on Cancer (AJCC) stages for patients with cutaneous melanoma (CM). The data showed that DecisionDx-Melanoma identifies clinically meaningful differences in mortality risk among patients within the same stage, which may help clinicians more confidently escalate care for higher-risk patients while avoiding unnecessary interventions in those at lower risk of poor outcomes. See the Company’s news release from March 27, 2026, for more information.
•The Company also announced new data from a prospective, multicenter study evaluating DecisionDx-Melanoma’s integrated sentinel lymph node biopsy (i31-SLNB) test result. The study data confirmed that the i31-SLNB accurately predicts SLN positivity and identifies low-risk patients who may safely consider forgoing SLNB while maintaining favorable long-term outcomes. These results expanded upon earlier publications from the same prospective, multicenter clinical study and further strengthened the growing body of evidence supporting the role of DecisionDx-Melanoma in guiding SLNB decision-making. The paper, available in Future Oncology, confirmed that DecisionDx-Melanoma’s i31-SLNB identifies patients below the 5% National Comprehensive Cancer Network (NCCN) threshold for forgoing sentinel lymph node biopsy and outperforms traditional staging

criteria and other predictive gene expression profile (GEP) tests. See the Company’s news release from March 9, 2026, for more information.
•The Company presented new data at the European Congress of Dermato-Oncology (EADO) Congress and the American College of Mohs Surgery (ACMS) Annual Meeting demonstrating that its DecisionDx-Melanoma test provides independent, personalized prognostic information beyond AJCC staging, identifying biologically high-risk patients—including those with thin and early-stage disease—and supporting more precise, risk-aligned clinical management. See the Company’s news release from April 21, 2026, for more information.
•The Company is supporting a series of initiatives across the country during May in recognition of Skin Cancer Awareness Month, including advocacy walks, community skin cancer screenings and patient education programs in collaboration with leading patient advocacy organizations. These efforts are aimed at expanding access to early detection, education and community-based resources to help prevent skin cancer and improve patient outcomes. See the Company’s news release from May 5, 2026, for more information.
Gastroenterology
•The Company announced that new data from Mayo Clinic researchers, presented at Digestive Disease Week, demonstrate that its TissueCypher test improves risk stratification and informs real-world management decisions for patients with Barrett’s esophagus, including influencing surveillance intervals in more than half of patients and enabling more personalized, risk-aligned care. See the Company’s news release from May 4, 2026, for more information.

Dermatology – Atopic Dermatitis
•The Company announced the publication of a prospective, multicenter clinical validation study in the Journal of the American Academy of Dermatology (JAAD) demonstrating that its AdvanceAD-Tx test can identify patients with moderate-to-severe atopic dermatitis who are significantly more likely to achieve greater and faster clinical responses when treated with a Janus kinase inhibitor compared to T helper type 2-targeted therapies. See the Company’s news release from February 19, 2026, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Wednesday, May 6, 2026, at 4:30 p.m. Eastern time to discuss its first quarter 2026 results and provide a corporate update.
A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 27, 2026.
There will be a brief Question & Answer session following management commentary.

(Press release, Castle Biosciences, MAY 6, 2026, View Source [SID1234665186])

On May 6, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) reported its financial results for the first quarter of 2026, along with recent company developments and provided an update on 2026 financial guidance.

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "We are off to a strong start in 2026, with BRIUMVI performance exceeding expectations and momentum continuing to build. Growth is being driven by strong underlying demand, record new patient starts, and consistent commercial execution— reinforcing our belief that we remain early in the adoption curve for BRIUMVI. Based on this performance, we are significantly increasing our full-year U.S. BRIUMVI revenue guidance to $885-900 million and continue to see the brand as having a multi-billion-dollar potential before considering the impact of a subcutaneous BRIUMVI currently under development. With multiple near-term clinical catalysts and ongoing efforts to expand the franchise, we believe BRIUMVI is well-positioned to become a leading therapy in MS and a durable, long-term growth driver for TG."

Recent Highlights & Developments

BRIUMVI (ublituximab-xiiy) Commercialization

BRIUMVI U.S. net product revenue of $194.8 million for the first quarter 2026, representing approximately 63% quarterly growth over the same period last year
BRIUMVI Data Presentations & Publications

Published two articles in medical journals:
March 2026: "Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis", published in Neurology and Therapy, highlighting data from a post hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI in people with highly active RMS.
February 2026: "Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension (OLE) Study", published in JAMA Neurology, highlighting five-year data from the OLE of the ULTIMATE I and II trials.
Pipeline

Completed patient enrollment into the randomized Phase 3 pivotal program evaluating subcutaneous BRIUMVI
Completed patient enrollment into the randomized Phase 3 pivotal program to evaluate a consolidated Day 1 and Day 15 dosing regimen for intravenous (IV) BRIUMVI in the ongoing ENHANCE trial
Continued enrollment for patients with progressive multiple sclerosis into the ongoing Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases
Financial Update

Secured an additional $500 million in non-dilutive capital from Blue Owl Capital and expanded our second share repurchase program from $100 million to $300 million, of which $200 million is remaining
Since the inception of the first share repurchase program in 2024, and as of April 30, 2026, TG has repurchased a total of $200 million of common stock at an average price of $29.28 per share, of which $100 million was completed during the first quarter of 2026
2026 Financial Guidance

Raises full year 2026 target total global revenue to approximately $925 million
Raises full year 2026 target BRIUMVI U.S. net product revenue to approximately $885 – $900 million (prior guidance of $825-$850 million)
Provides second quarter 2026 target BRIUMVI U.S. net product revenue of approximately $220 million
Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 million excluding non-cash compensation, in addition to approximately $100 million in expenses associated with the subcutaneous BRIUMVI manufacturing costs and secondary manufacturer start-up costs
2026 Development Pipeline Anticipated Milestones

Announce topline Phase 3 data for ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI mid-year 2026
Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026
Announce topline Phase 3 data for subcutaneous BRIUMVI (ublituximab) year-end 2026/first quarter 2027
Commence a potentially registration-directed trial for BRIUMVI in Myasthenia Gravis (MG)
Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS)
Financial Results for First Quarter 2026

Product Revenue, net: Product revenue, net was $201.3 million for the three months ended March 31, 2026, compared to $119.7 million for the three months ended March 31, 2025. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled $194.8 million during the three months ended March 31, 2026. Also included in product revenue, net for the three months ended March 31, 2026 is sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $6.5 million.
License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $3.6 million for the three months ended March 31, 2026 compared to approximately $1.2 million for the three months ended March 31, 2025. License, milestone, royalty and other revenue for the three months ended March 31, 2026 is predominantly comprised of $2.7 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm and $0.9 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement.
R&D Expenses: Total research and development (R&D) expense was approximately $48.4 million for the three months ended March 31, 2026, compared to $46.4 million for the three months ended March 31, 2025. The increase in R&D expense during the three months ended March 31, 2026 was primarily attributable to license and milestone expense pertaining to our license agreement with Precision BioSciences, Inc., as well as increased clinical trial related expenses and increased personnel costs during the period ended March 31, 2026. These increases were partially offset by lower manufacturing and development costs in connection with our subcutaneous ublituximab development work incurred during the period ended March 31, 2026.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately $88.2 million for the three months ended March 31, 2026, compared to $50.3 million for the three months ended March 31, 2025. The increase in selling, general and administrative costs during the three months ended March 31, 2026 was primarily due to an increase in marketing and media spend, and personnel and external costs associated with the commercialization of BRIUMVI.
Net income: Net income was $19.8 million for the three months ended March 31, 2026, compared to net income of $5.1 million for the three months ended March 31, 2025.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $572.8 million as of March 31, 2026. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2026, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan.

CONFERENCE CALL INFORMATION
The Company will host a conference call today, May 6, 2026, at 8:30 AM ET, to discuss the Company’s financial results from first quarter of 2026.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: BRIUMVI is contraindicated in patients with:

Active Hepatitis B Virus infection
A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.

(Press release, TG Therapeutics, MAY 6, 2026, View Source [SID1234665202])