On May 5, 2026 Applied Cells reported a collaboration with SHENTEK to integrate fast QC release solution with Applied Cells’ GoFast CAR-T manufacturing workflow on the MARS platforms.

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GoFast CAR-T is Applied Cells’ advanced rapid CAR-T manufacturing workflow designed to support closed-fluidic CAR-T production in less than 72 hours. Built on the MARS platforms, the workflow simplifies key steps including immunomagnetic T cell isolation, activation and transduction, wash, concentration, and media exchange in a streamlined process. GoFast workflow is designed to help cell therapy teams reduce complexity, accelerate manufacturing timelines, and support more scalable and cost-effective CAR-T production.

Through this collaboration, Applied Cells and SHENTEK will work together to launch Hubble, a qPCR platform with fast QC capabilities that supports same-day QC release testing of cell therapy products.

Hubble provides a hands-free approach by combining nucleic acid extraction and real-time PCR into a fully integrated, automated single-use cartridge solution. This system is designed to deliver results from sample-to-result in less than 3 hours, and offers walk-away operation. The platform features integrated internal controls, 21 CFR Part 11 compliance, and broad detection coverage for more than 180 species of Mycoplasma, Spiroplasma, and Acholeplasma currently, with sterility, VCN, and RCL capabilities planned for the near future.

"Fast, reliable QC is essential to making rapid CAR-T manufacturing more accessible," said Yuchen Zhou, CEO of Applied Cells. "By collaborating with SHENTEK, we are providing the cell therapy industry a more complete, even faster, and further lower-cost solution. Together, we aim to help cell therapies move closer to affordability, and scalable production."

This collaboration is part of Applied Cells’ broader mission to enable low cost, fast, simple, and scalable cell therapy manufacturing for global users. By pairing the MARS GoFast workflow with Hubble, Applied Cells and SHENTEK aim to accelerate patient access of life-saving CAR-T cell therapies around the world.

Applied Cells and SHENTEK will showcase the GoFast CAR-T workflow and Hubble Fast QC capabilities together at ASGCT (Free ASGCT Whitepaper) 2026. Attendees can visit Poster #2398 for GoFast CAR-T, Poster #1197 for Hubble Fast QC, and Booth #932 to learn more about the collaboration and early access opportunities.

(Press release, Applied Cells, MAY 5, 2026, View Source [SID1234665104])

On May 5, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2026 (1Q26).

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"Our first-quarter results reflect disciplined execution across the business, delivering 19% year-over-year growth alongside key pipeline advancements and positioning the company for an outstanding 2026," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "Demand for Xywav remained strong, our rare oncology launches with Modeyso and Zepzelca in 1LM ES-SCLC gained significant momentum, and Epidiolex continued to provide consistent growth. Looking ahead, we are excited about the potential launch of zanidatamab in 1L GEA later this year, as we progress our pipeline and business development efforts to bring more life-changing therapies to patients and fuel durable long-term growth."

Key First Quarter 2026 Highlights

•Total revenues in 1Q26 grew to $1.1 billion (+19% year-over-year (YoY))
•Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $4.43 / $6.34 with $408 million in cash from operations.
•Practice-changing Phase 3 HERIZON-GEA-01 results, presented as a late-breaker at ASCO (Free ASCO Whitepaper) GI, support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L advanced gastroesophageal adenocarcinoma (GEA); additional benefit from tislelizumab irrespective of PD-L1 status.
•Supplemental Biologics License Application (sBLA) accepted by FDA under Real-Time Oncology Review (RTOR) program with potential approval and launch in 1L HER2+ GEA on or before PDUFA date.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 18% to $408 million in 1Q26, compared to 1Q25.
•Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.

•Strong new patient growth, with approximately 425 net patient adds in 1Q26. There were approximately 16,600 active patients exiting the quarter, comprised of approximately 11,075 narcolepsy patients and approximately 5,525 idiopathic hypersomnia (IH) patients.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 15% YoY to $250 million in 1Q26, driven by continued strong demand.
•Announced agreement with Nippon Zoki to commercialize Epidyolex in Japan, following completion of ongoing clinical trials and potential regulatory approval.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales in biliary tract cancer (BTC) were $13 million in 1Q26.
•In April 2026, FDA accepted the zanidatamab sBLA in GEA for a Priority Review, with a PDUFA date of August 25, 2026.
•Submitted HERIZON-GEA-01 data for potential National Comprehensive Cancer Network (NCCN) guideline inclusion.
•HERIZON-GEA-01 data accepted for publication by a top-tier medical journal.
•The second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen is expected in mid-2026.
•Multiple registrational trials of zanidatamab are underway, including in metastatic breast cancer (mBC), supporting a broad development program designed to maximize patient impact and long-term shareholder value.

Modeyso (dordaviprone):
•Modeyso net product sales were $41 million in 1Q26 with ~500 patients having received Modeyso from product launch in August 2025 through the end of the first quarter.
•The company completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $200 million (50% to Jazz).
•Phase 3 ACTION trial remains on track with top-line readout expected late 2026 / early 2027.

Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 60% YoY to $101 million in 1Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1LM ES-SCLC setting, partially offset by a decline in second line use.
•The company expects second line use to decline throughout the year.
Financial Highlights
Three Months Ended
March 31,
(In millions, except per share amounts) 2026 2025
Total revenues $ 1,068.9 $ 897.8
GAAP net income (loss) $ 293.1 $ (92.5)
Non-GAAP adjusted net income $ 419.5 $ 105.2
GAAP earnings (loss) per share $ 4.43 $ (1.52)
Non-GAAP adjusted earnings per share $ 6.34 $ 1.68

The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172 million related to Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146 million (net of tax of $26 million), or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

(Press release, Jazz Pharmaceuticals, MAY 5, 2026, View Source [SID1234665121])

On May 5, 2026 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported its financial results for the quarter ended March 31, 2026 and reaffirmed its financial guidance for 2026.

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"This is an important year for Ultragenyx with two BLAs under review and our Angelman Phase 3 readout coming soon. We have the opportunity to meaningfully accelerate our consistent commercial revenue growth over the last few years as we prepare for two potential gene therapy approvals and launches in two urgent diseases without any approved therapies," said Emil D. Kakkis, M.D., Ph.D., chief executive officer and president of Ultragenyx. "The latest long-term GTX-102 Phase 1/2 data further support the potential of the program, as it heads toward Phase 3 results later this year."

First Quarter 2026 Revenue Highlights and 2026 Revenue Guidance

Total revenue in the first quarter of 2026 was $136 million. The company reaffirms its full year 2026 total revenue guidance of $730 million to $760 million, which excludes revenue from potential new product launches.
Crysvita revenue in the first quarter of 2026 was $93 million, consistent with expected seasonality in the U.S. and Canada and ordering patterns in Brazil. The company reaffirms its full year 2026 Crysvita revenue guidance of $500 million to $520 million.
Dojolvi revenue in the first quarter 2026 was $18 million. The company reaffirms its full year 2026 Dojolvi revenue guidance of $100 million to $110 million.
Evkeeza revenue in the first quarter 2026 was $18 million, driven by increased demand from new country launches and early access.
Mepsevii revenue in the first quarter 2026 was $7 million.
Recent Clinical Milestones and 2026 Catalysts

GTX-102 (apazunersen) antisense oligonucleotide (ASO) for the treatment of Angelman syndrome (AS): As of a March 2026 Phase 1/2 data cut-off date, a total of 74 patients had been treated with GTX-102, with 66 patients continuing in the long-term extension (LTE) study. Phase 1/2 patients have been on continuous treatment for an average of more than three years, with some patients now in their fifth year, generally receiving the 14 mg quarterly maintenance dose. Patients have continued to show positive improvements across multiple domains and continued to gain ground developmentally. GTX-102 has maintained a consistent safety profile, sustained over multiple years of chronic treatment, while demonstrating no new cases of transient lower extremity weakness nor any other recurring drug-related serious adverse events. These updated efficacy and safety data are planned to be presented at a future scientific meeting.

The Phase 3 Aspire study, in patients with a full maternal UBE3A gene deletion, enrolled 129 patients, randomized 1:1 to GTX-102 or sham. Data from this study are expected in the second half of 2026.

Enrollment in the open-label Phase 2/3 Aurora study, evaluating GTX-102 in other genotypes and ages, began enrollment in October 2025 and is expected to complete enrollment in the second half of 2026.
DTX401 (pariglasgene brecaparvovec) AAV8 gene therapy for the treatment of glycogen storage disease type Ia (GSDIa): In February 2026, the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) seeking approval of DTX401 as a treatment for GSDIa, granted the BLA Priority Review, and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 23, 2026. The FDA also recently informed the company that an Advisory Committee meeting is not anticipated at this time.

UX111 (rebisufligene etisparvovec) AAV9 gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA): In April 2026, the FDA accepted for review the resubmitted BLA seeking accelerated approval for UX111 as a treatment for MPS IIIA. The resubmitted BLA included substantial longer-term data that were presented in February at the WORLDSymposium 2026 and included up to eight years of follow-up. These data demonstrated further clinical improvement relative to the decline observed in natural history studies, and showed a durable treatment effect across clinical evaluations and multiple biomarkers, while maintaining an acceptable safety profile. In February 2025, the FDA granted the BLA Priority Review and, in April 2026, assigned a PDUFA action date of September 19, 2026.

DTX301 (avalotcagene ontaparvovec) AAV8 gene therapy for the treatment of Ornithine Transcarbamylase, or OTC, deficiency: As announced in March 2026, at Week 36 in the randomized, double-blind placebo-controlled period of the Phase 3 study, DTX301 patients (n=18) demonstrated a statistically significant and clinically meaningful 18% (p=0.018) reduction in 24-hour plasma ammonia (AUC0-24) into the normal range compared to placebo (n=19). Eight of nine patients with abnormal ammonia AUC0-24 at baseline also reached normal ammonia levels rapidly, which were generally maintained during this treatment period. At Week 24, patient global impression scale (PGIC) for overall OTC symptoms (n=15) showed 71% of DTX301 patients were much improved (equivalent to +3), compared to 0% of placebo patients. DTX301 was well tolerated with an acceptable safety profile.

Per the protocol, the study is continuing to its second primary endpoint, which evaluates reduction in treatment burden, including use of ammonia scavengers and dietary management, across both the treatment and placebo-crossover groups following treatment with DTX301 through 64 weeks of follow-up. Data are expected in the first half of 2027.
UX701 (rivunatpagene miziparvovec) AAV9 gene therapy for the treatment of Wilson disease: Enrollment is complete for the fourth cohort in the ongoing, dose-finding stage of the pivotal Cyprus2+ study. Data from this stage are expected in 2026.

UX016 novel prodrug for sialic acid used as a substrate replacement therapy for the treatment of GNE myopathy: The FDA cleared the Investigational New Drug (IND) application for UX016 and an externally funded Phase 1/2 study is expected to begin in the second half of 2026.
Summary of First Quarter 2026 Financial Results

Selected Financial Data (dollars in millions, except per share amounts), (unaudited)
Three Months Ended March 31,
2026 2025
Total revenues $ 136 $ 139
Operating expenses:
Cost of sales 30 29
Research and development 187 166
Selling, general and administrative 88 87
Total operating expenses 305 282
Net loss $ (185 ) $ (151 )
Net loss per share, basic and diluted $ (1.84 ) $ (1.57 )

Operating Expenses

Total operating expenses for the first quarter 2026 were $305 million, including $30 million of non-cash stock-based compensation and $30 million of expense related to the restructuring announced last quarter. The company reaffirms its full year 2026 and 2027 guidance for combined R&D and SG&A operating expenses: compared to 2025, combined R&D and SG&A expenses in 2026 are expected to be flat to down low-single digits, and combined R&D and SG&A expenses in 2027 are expected to decrease by at least 15%.

Net Loss

Net loss for the first quarter 2026 was $185 million, or $1.84 per share basic and diluted, compared with a net loss for the first quarter 2025 of $151 million, or $1.57 per share basic and diluted.

Cash Balance and Net Cash Used in Operations

Cash, cash equivalents, and marketable securities were $534 million as of March 31, 2026. For the three months ended March 31, 2026, net cash used in operations was $197 million and includes the payment of annual bonuses and $38 million of payments related to UX143 manufacturing activities.

Conference Call and Webcast Information

Ultragenyx will host a conference call today, Tuesday, May 5, 2026, at 2 p.m. PT/5 p.m. ET to discuss the first quarter financial results and provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source The replay of the call will be available for three months.

(Press release, Ultragenyx Pharmaceutical, MAY 5, 2026, View Source [SID1234665141])

On May 5, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported that Arthur Kuan, Chairman & Chief Executive Officer, and Ambaw Bellete, President & Chief Operating Officer, will participate in fireside chat presentations at the Bank of America Health Care Conference and the RBC Capital Markets Global Healthcare Conference this month. The details of the upcoming events are as follows:

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Bank of America Health Care Conference 2026
Date: Tuesday, May 12, 2026
Presentation Time: 10:40 AM – 11:10 AM PT
Location: Las Vegas, NV

RBC Capital Markets Global Healthcare Conference
Date: Wednesday, May 20, 2026
Presentation Time: 2:35 PM – 3:00 PM ET
Location: New York, NY

Interested parties may access the live audio webcast for the conferences from the Investor Relations section of the company’s website at www.cgoncology.com. The webcast replays will be available shortly after the conclusion of the live presentations and archived for approximately 90 days.

(Press release, CG Oncology, MAY 5, 2026, View Source [SID1234665156])

On May 5, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, reported financial results for the first quarter ended March 31, 2026 and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.

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"Arcus is entering a new era, with a clear path for casdatifan to be both first and best in the first-line setting, and a portfolio of wholly owned molecules for inflammation and immunology that provide a new strategic optionality as they move into and through development," said Terry Rosen, Ph.D., chief executive officer of Arcus. "Our highest priority is to establish casdatifan as a foundational standard of care in kidney cancer so that patients have the opportunity to benefit from casdatifan-based regimens across lines of treatment."

Arcus is focused on completing enrollment for PEAK-1 and initiating a Phase 3 study in the 1L setting, where casdatifan has the potential to become the first HIF-2a inhibitor-based, TKI-free option, by year-end 2026.
Casdatifan (HIF-2a inhibitor)

Casdatifan Development Program:

Arcus’s development strategy is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. The company is aggressively executing on a holistic strategy to embed casdatifan into the treatment paradigm, including in combination with the most commonly used regimen in the 1L setting, anti-PD-1 plus anti-CTLA-4. Arcus is now enrolling a cohort in the Phase 1/1b ARC-20 study to generate the dataset that will support the initiation of the corresponding Phase 3 study at year-end 2026. Arcus’s choice of combination partners has been designed to complement this casdatifan-IO regimen, which has the opportunity to be the first and only such HIF-2a inhibitor-based TKI-sparing 1L therapy, with consecutive treatments with casdatifan-containing regimens in first-, second-, and third-line-plus settings. In this context, Arcus will also begin to evaluate casdatifan plus TKI-containing regimens in 1L and late-line settings, the latter in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients.
•IO-experienced ccRCC: Enrollment in PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC, is accelerating, and Arcus is on track to complete enrollment by year-end 2026.
•1L ccRCC: Arcus has been focused on the evaluation of casdatifan-based TKI-free regimens, which have demonstrated a consistently low rate of primary progression across all cohorts and settings evaluated to date.

▪Most notably, casdatifan plus zimberelimab (anti-PD-1) showed a primary progression rate of 7% (2 of 30 patients), comparing quite favorably to published rates observed with anti-PD-1 monotherapy or ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) in the 1L setting. This ARC-20 cohort is fully enrolled.
▪A cohort evaluating casdatifan plus zimberelimab and ipilimumab in ARC-20 is currently enrolling with the purpose of supporting Arcus’s first Phase 3 study in the 1L setting.
Planned Data Readouts:
Arcus expects to have multiple data readouts for casdatifan in 2026:
•More mature overall response rate data and initial progression-free survival data for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting will be presented at an investor event or at a medical conference. All patients will have had at least 12 months of follow-up.
•Initial data from the ARC-20 cohorts evaluating casdatifan in early-line settings, including the cohort evaluating casdatifan plus zimberelimab in 1L ccRCC.
•Updated data from ARC-20 late-line monotherapy cohorts including overall survival (OS) data.
Quemliclustat (small-molecule CD73 inhibitor)
•Enrollment was completed for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in 1L metastatic pancreatic ductal adenocarcinoma, in September 2025. Results from this study are expected in the first half of 2027.
Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)

Status Update:
•In April 2026, Arcus announced the discontinuation of the Phase 3 STAR-121 study evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a 1L treatment for metastatic non-small cell lung cancer (NSCLC), based on the recommendation from the Independent Data Monitoring Committee following its review of data from a pre-planned futility analysis. At the futility analysis, the domvanalimab-based combination did not improve OS relative to that observed with pembrolizumab plus chemotherapy. STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued.
◦STAR-121 also evaluated zimberelimab plus chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to OS as compared to pembrolizumab plus chemotherapy.
Emerging I&I Portfolio
•AB102, a highly selective, oral MRGPRX2 antagonist and potential best-in-class treatment for atopic dermatitis and chronic spontaneous urticaria, is expected to enter the clinic in the third quarter of 2026.
◦In May, Arcus will present the preclinical profile for AB102 in an oral presentation at the Society for Investigative Dermatology Annual Meeting, highlighting its ability to fully block MRGPRX2-dependent degranulation and transcriptional activation in LAD2 and primary skin mast cells and its inhibition of all common human MRGPRX2 variants.
◦Clinical development will begin with a first-in-human healthy volunteer study followed by a proof-of-concept study, with potential for proof-of-concept data in early 2027.
•Arcus has selected a development candidate for an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, and expects it to enter the clinic in early 2027.
◦The molecule is designed to selectively block TNFR1 signaling. It is believed that this could lead to better safety and efficacy than those of approved anti-TNF antibodies that block both TNFR1 and

TNFR2 signaling, the latter of which can paradoxically lead to an inflammatory response in some patients.
•Arcus has also selected an orally active small-molecule antagonist of CCR6 as a development candidate for potential treatment of psoriasis and expects it to enter the clinic in the first half of 2027.
Financial Results for First Quarter 2026:
•Cash, Cash Equivalents and Marketable Securities were $876 million as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Based on our existing business plan, we believe that our cash, cash equivalents and marketable securities will be sufficient to fund our planned level of operations until at least the second half of 2028. We also expect to end 2026 with approximately $600 million in cash.
•Revenues were $17 million for the first quarter 2026, compared to $28 million for the same period in 2025. The decrease in revenue was primarily driven by lower development services revenue from the Gilead collaboration. Revenues reflect the recognition of payments previously received from our collaboration partners as we satisfy underlying performance obligations over time, and fluctuate each period based on our estimated progress toward completing those obligations rather than on the timing of cash receipts. Arcus expects to recognize GAAP revenue of between $50 million and $65 million for the full year 2026.

•Research and Development (R&D) Expenses were flat for the first quarter 2026, with (i) late-stage development programs increasing due to our investment in casdatifan and our Phase 3 PRISM-1 study for quemliclustat, partially offset by the wind-down of studies related to domvanalimab, (ii) early-stage development activities decreasing primarily due to the absence of prior-year Phase 2 study costs for domvanalimab, and (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us. Non-cash stock-based compensation expense was $9 million for the first quarter 2026, compared to $8 million for the same period in 2025. For the first quarters 2026 and 2025, Arcus recognized gross reimbursements of $19 million and $38 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
We expect R&D expenses to decline in the near term relative to what we have incurred as we wind down studies for domvanalimab. Streamlining initiatives we have undertaken across our R&D operations in connection with this wind-down, together with efficiencies we are pursuing across our programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by our increased investment in the development of casdatifan and advancement of our small-molecule inflammation and immunology programs.
•General and Administrative (G&A) Expenses were $29 million for the first quarter 2026, compared to $28 million for the same period in 2025. The increase was primarily due to an increase in non-cash stock-based compensation, which was primarily attributable to a separation agreement with an officer. Non-cash stock-based compensation expense was $10 million for the first quarter 2026, compared to $8 million for the same period in 2025.
•Net Loss was $128 million for the first quarter 2026, compared to $112 million for the same period in 2025.

Conference Call Information:
Arcus will host a conference call and webcast today, May 5, 2026, at 1:30 PM PT/4:30 PM ET to discuss its first-quarter 2026 financial results and pipeline updates. To access the call, please dial +1 (585) 542-9983 (local) or +1 (833) 461-5787 (toll-free), using Meeting ID: 304747896. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

(Press release, Arcus Biosciences, MAY 5, 2026, View Source [SID1234665105])