On May 5, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported first quarter 2026 financial results and corporate updates.

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"We have made important progress so far in 2026, highlighted by promising data supporting further development for the zovegalisib plus atirmociclib triplet combination in frontline breast cancer," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "With initial clinical data in vascular anomalies expected at ISSVA and preparations underway for our planned Phase 3 frontline study in endocrine-sensitive patients with metastatic breast cancer, we are entering a data-rich period for zovegalisib. Additionally, RLY-8161, our NRAS-selective molecule, has entered clinical development for patients with NRAS-mutant solid tumors. We remain focused on executing across these priorities to bring differentiated therapies to patients."

Corporate Highlights

2L Breast Cancer

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U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to zovegalisib in combination with fulvestrant for PIK3CA-mutant, HR+/HER2- advanced breast cancer
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Designation supported by robust clinical data from the Phase 1/2 ReDiscover trial of 600mg twice daily (BID) fasted and 400mg BID fed regimens of zovegalisib in combination with fulvestrant
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Presented 400mg BID zovegalisib doublet data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026

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11.1-month median progression-free survival (PFS) observed in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer, consistent with previously reported data
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Efficacy in patients with kinase and non-kinase domain mutations was similar, with median PFS of 11.2 and 11.0 months, respectively
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Safety and tolerability data were consistent with previously reported 600mg BID fasted data
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Relay Tx continues to execute on the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
1L Breast Cancer

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Announced clinical data for zovegalisib plus atirmociclib triplet combination, plans for frontline breast cancer study, and clinical supply agreement with Pfizer
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Compelling efficacy and tolerability data presented for zovegalisib triplet in median third-line (3L) patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer
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44% objective response rate (ORR) reported in heavily pre-treated CDK4/6-experienced patients (median 3L) at unoptimized doses and ORR was similar across kinase and non-kinase PIK3CA mutations
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Adverse events were consistent with those previously reported by each molecule
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Phase 3 1L trial in patients with endocrine-sensitive breast cancer expected to initiate in early 2027, subject to regulatory feedback
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Pfizer has agreed to supply atirmociclib for the experimental arm and the palbociclib portion of the control arm for use in the planned study, and Relay Tx will retain full global rights for zovegalisib
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Relay Tx continues to execute the Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with zovegalisib + atirmociclib + endocrine therapy
Vascular Anomalies

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Corporate conference call planned for May 19 at 8:00am ET during the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 to announce initial clinical results for zovegalisib in vascular anomalies
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Late breaking abstract for clinical data to be presented May 20 from 4:45pm-4:49pm ET
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Pre-clinical data presentation May 22 at 11:10am ET
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Conference call details to be shared at a later date
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Continued execution of the Phase 1/2 ReInspire trial, evaluating zovegalisib in PIK3CA-driven vascular anomalies
NRAS Selective Inhibitor: RLY-8161

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Initiated Phase 1/2 clinical trial for RLY-8161, a NRAS-selective inhibitor, in patients with NRAS-mutant melanoma and other NRAS-mutant solid tumors

First Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2026, cash, cash equivalents and investments totaled $642.1 million, as compared to $554.5 million as of December 31, 2025. The increase in cash was due to $137.1 million in net proceeds from "at-the-market" offerings under our sales agreement with TD Securities (USA) LLC during the quarter. This figure does not include an additional $22.1 million in net proceeds received from "at-the-market" offerings in April. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

Revenue: Revenue was $3.0 million for the first quarter of 2026, as compared to $7.7 million for the first quarter of 2025. The revenue recognized in each period was under the company’s Exclusive License Agreement with Elevar Therapeutics, Inc.

R&D Expenses: Research and development expenses were $70.6 million for the first quarter of 2026, as compared to $73.8 million for the first quarter of 2025. The decrease was primarily due to the series of strategic choices made to streamline the research organization prior to 2026, offset by increases in costs related to the ReDiscover-2 trial.

G&A Expenses: General and administrative expenses were $11.0 million for the first quarter of 2026, as compared to $18.7 million for the first quarter of 2025. The decrease was primarily due to decreases in employee compensation costs, including stock compensation expense, and costs to obtain the Exclusive License Agreement with Elevar Therapeutics, Inc., which were expensed during the three months ended March 31, 2025.

Net Loss: Net loss was $73.3 million for the first quarter of 2026, or a net loss per share of $0.41, as compared to a net loss of $77.1 million for the first quarter of 2025, or a net loss per share of $0.46.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant-selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a Phase 1/2 study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies.

(Press release, Relay Therapeutics, MAY 5, 2026, View Source [SID1234665140])

On May 5, 2026 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported that members of the management team are scheduled to present at the following investor conferences:

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Bank of America Securities 2026 Healthcare Conference
Presentation on Tuesday, May 12 at 4:35 p.m. ET in Las Vegas, NV

2026 Stifel Virtual Targeted Oncology Forum
Virtual presentation on Wednesday, May 20 at 12:00 p.m. ET

A live and archived audio webcast of the conference call will be available from the Investors and Media section of the Company’s website at www.geron.com.

(Press release, Geron, MAY 5, 2026, View Source [SID1234665155])

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])