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Pulse Biosciences to Present at Canaccord Genuity’s 46th Annual Growth Conference

On July 30, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation (nano-PFA or nsPFA) technology, reported plans to participate in the upcoming Canaccord Genuity 46th Annual Growth Conference in Boston, MA.

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Pulse Biosciences’ Management is scheduled to present on Tuesday, August 11, at 2:30 pm ET. A live and recorded webcast of the fireside chat will be available on the "Events Calendar and Presentations" page of the company’s investor website at View Source

(Press release, Pulse Biosciences, JUL 30, 2026, View Source [SID1234669548])

Regeneron Reports Second Quarter 2026 Financial and Operating Results

On July 30, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2026 and provided a business update.

"Regeneron delivered another quarter of strong financial performance, with double-digit top- and bottom-line growth reflecting the continued strength of our commercial portfolio and the potential of our pipeline," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Of note, global Dupixent, global Libtayo, and U.S. EYLEA HD net product sales increased by 38%, 30%, and 52%, respectively, compared to the second quarter of 2025. With approximately 50 clinical assets, we remain focused on translating our science into even more successful new medicines across a broad array of diseases."
Financial Highlights

($ in millions, except per share data) Q2 2026 Q2 2025 % Change
Total revenues $ 4,291 $ 3,676 17 %
GAAP net income $ 1,297 $ 1,392 (7 %)
GAAP net income per share – diluted $ 12.23 $ 12.81 (5 %)
Non-GAAP net income(a)
$ 1,543 $ 1,424 8 %
Non-GAAP net income per share – diluted(a)
$ 14.29 $ 12.89 11 %

"Second quarter revenues grew 17% and non-GAAP net income per share grew 11%, marking our second consecutive quarter of double-digit growth on both measures," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "By the end of the second quarter, we had fully repaid the Sanofi Development Balance, which represented the outstanding amount due to Sanofi for their funding of prior collaboration development activities. The repayment of this obligation will drive a meaningful step-up in collaboration profits beginning in the third quarter. Given our strong financial position, we continue to invest confidently in our pipeline, U.S. manufacturing, and external innovation, while returning capital to shareholders, reflected by the nearly $3.0 billion deployed in the first half of the year to share repurchases, dividends, capital expenditures, and business development."
Business Highlights
Key Pipeline Progress
Regeneron has approximately 50 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
Dupixent (dupilumab)
•In April 2026, the U.S. Food and Drug Administration (FDA) and European Commission approved Dupixent for the treatment of chronic spontaneous urticaria (CSU), expanding the eligible population to include children aged 2 to 11 years who remain symptomatic despite antihistamine treatment.
EYLEA HD (aflibercept) 8 mg
•In April 2026, the FDA approved the extension of dosing intervals for EYLEA HD up to every 20 weeks (5 months) for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes.
Otarmeni (lunsotogene parvec, formerly known as DB-OTO)
•In May 2026, the European Medicines Agency (EMA) accepted for review, under accelerated assessment, the Marketing Authorization Application (MAA) for Otarmeni for the treatment of biallelic OTOF variant-associated hearing loss.
Fianlimab (LAG-3 antibody)
•In May 2026, the Company announced results from the Phase 3 trial evaluating two dose levels of fianlimab in combination with cemiplimab as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab monotherapy.
Other Programs
•In June 2026, the Company announced that both the FDA and EMA have accepted the regulatory applications for cemdisiran (C5 RNAi therapy) to treat adult patients with gMG. The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher. A decision from the European Commission is anticipated in the second half of 2027.
•The Company announced positive results from the Phase 1/2 LINKER-AL2 trial for Lynozyfic (linvoseltamab) in adults with second-line-plus systemic amyloid light chain amyloidosis. The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)

(ASCO) 2026 Annual Meeting. The Phase 2 portion of the trial with registrational intent, part of a broad clinical development program investigating Lynozyfic, is underway.
•A Phase 3 study was initiated in peripheral artery disease (PAD) for cenvacibart (REGN7508, an antibody to Factor XI (catalytic domain)), and amrecibart (REGN9933, an antibody to Factor XI (A2 domain)), to evaluate each antibody individually compared to standard of care.
Corporate Updates
•The FDA selected the Company’s manufacturing facility in Saratoga Springs, New York, which is currently under construction, to participate in the FDA PreCheck Pilot Program. The FDA PreCheck Pilot Program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway.
•In May 2026, the Company entered into a collaboration with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon peptide platform.
•The Company announced that it had been named to the Dow Jones Best-in-Class World Index, one of the world’s most recognized benchmarks for corporate sustainability performance, for the seventh consecutive year.
Second Quarter 2026 Financial Results
Revenues
($ in millions) Q2 2026 Q2 2025 % Change
Net product sales:
EYLEA HD – U.S. $ 596 $ 393 52 %
EYLEA – U.S.
412 754 (45 %)
Total EYLEA HD and EYLEA – U.S. 1,008 1,147 (12 %)
Libtayo – U.S. 343 248 38 %
Libtayo – ROW* 146 129 13 %
Total Libtayo – Global
489 377 30 %
Praluent – U.S.
75 66 14 %
Evkeeza – U.S.
53 41 29 %
Lynozyfic – Global
17 — **
Total net product sales 1,642 1,631 1 %
Collaboration revenue:
Sanofi 2,174 1,444 51 %
Bayer 276 415 (33 %)
Other 6 2 **
Other revenue 193 184 5 %
Total revenues $ 4,291 $ 3,676 17 %

Net product sales of EYLEA HD increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.
Net product sales of EYLEA in the second quarter of 2026, compared to the second quarter of 2025, were negatively impacted by (i) lower sales volumes, driven by decreased demand, as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
Global net product sales of Libtayo increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand.
Sanofi collaboration revenue increased in the second quarter of 2026, compared to the second quarter of 2025, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $2.033 billion and $1.282 billion in the second quarter of 2026 and 2025, respectively. The change in the Company’s share of profits from the commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales. In addition, the Sanofi Development Balance was fully repaid as of the end of the second quarter of 2026 and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.
Refer to Table 4 for a summary of collaboration revenue.
Operating Expenses
GAAP % Change
Non-GAAP(a)
% Change
($ in millions)
Q2 2026 Q2 2025 Q2 2026 Q2 2025
Research and development (R&D) $ 1,632 $ 1,422 15 % $ 1,500 $ 1,283 17 %
Acquired in-process research and development (IPR&D) $ 127 $ 10 ** * * *
Selling, general, and administrative (SG&A) $ 662 $ 634 4 % $ 574 $ 542 6 %
Cost of goods sold (COGS) $ 361 $ 276 31 % $ 221 $ 222 — %
Gross margin on net product sales(b)
78% 83% 87% 86%
Cost of collaboration and contract manufacturing (COCM)(c)
$ 216 $ 255 (15 %) * * *
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful or greater than 100%

•GAAP and non-GAAP R&D expenses increased in the second quarter of 2026, compared to the second quarter of 2025, driven by the Company’s mid- and late-stage clinical pipeline.
•Acquired IPR&D expenses for the second quarter of 2026 included up-front and opt-in payments in connection with collaboration and licensing agreements.
•GAAP gross margin on net product sales decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to unabsorbed manufacturing costs as a result of the previously disclosed temporary interruption of bulk manufacturing production at the Company’s facility in Limerick, Ireland. As of the end of the second quarter of 2026, bulk manufacturing production returned to normal levels. The interruption did not impact the availability of any of the Company’s products.
Other Financial Information
GAAP other income (expense), net decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to lower net gains on marketable and other securities.
In the second quarter of 2026, the Company’s GAAP effective tax rate (ETR) was 15.1%, compared to 8.4% in the second quarter of 2025. The GAAP ETR increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to the net change in unrecognized tax benefits, as during the second quarter of 2025 the Company released liabilities associated with unrecognized tax benefits upon the settlement of an IRS audit. In the second quarter of 2026, the non-GAAP ETR was 15.5%, compared to 8.3% in the second quarter of 2025.
A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.
Capital Allocation
During the three and six months ended June 30, 2026, the Company repurchased $1.2 billion and $2.0 billion, respectively, of its common stock. As of June 30, 2026, $2.5 billion remained available for share repurchases under the Company’s share repurchase programs.
In July 2026, the Company’s board of directors declared a cash dividend of $0.94 per share on the Company’s common stock and Class A stock, payable on August 31, 2026 to shareholders of record as of August 18, 2026.
2026 Financial Guidance*
The Company’s full year 2026 financial guidance consists of the following components:
2026 Guidance
Prior
Updated
GAAP R&D $6.450–$6.680 billion $6.500–$6.635 billion
Non-GAAP R&D(a)
$5.900–$6.100 billion $5.950–$6.050 billion
GAAP SG&A
$2.860–$3.040 billion $2.830–$2.960 billion
Non-GAAP SG&A(a)
$2.500–$2.650 billion $2.500–$2.600 billion
GAAP gross margin on net product sales
77%–78% 78%–79%
Non-GAAP gross margin on net product sales(a)
83%–84% 84%–85%
GAAP COCM
$955 million–$1.035 billion
$985 million–$1.035 billion
Non-GAAP COCM(a)
$940 million–$1.020 billion $970 million–$1.020 billion
Capital expenditures
$1.100–$1.200 billion
$1.030–$1.100 billion
GAAP effective tax rate 12%–14% 13%–14%
Non-GAAP effective tax rate(a)
13%–15% 14%–15%
* The Company’s 2026 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release

(Press release, Regeneron, JUL 30, 2026, View Source [SID1234669546])

Crescent Biopharma Reports Second Quarter 2026 Financial Results and Recent Business Highlights

On July 30, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported financial results for the second quarter ended June 30, 2026 and recent business highlights.

"We have continued to demonstrate exceptional execution and are on track for multiple key clinical data readouts across our portfolio in 2027. The positive momentum in our ASCEND trial of CR-001 positions us for robust datasets from hundreds of patients globally in monotherapy and standard of care chemotherapy combinations across several tumor types. CR-001 is the first PD-1 x VEGF bispecific antibody to be evaluated in combination with sac-TMT, and we are proud to be partnering with Kelun-Biotech to realize its full potential as an immuno-oncology backbone. Our ADC pipeline also is advancing, with the CR-003 clinical trial enrolling in China and we are preparing for CR-002 to enter the clinic in a global study during the second half of this year," said Joshua Brumm, chief executive officer of Crescent. "Our recent financing extends our expected cash runway into the second half of 2028, beyond key catalysts, strengthening our balance sheet as we work to deliver transformative therapies for people living with cancer."

Recent Business Highlights & Anticipated Milestones

CR-001, PD-1 x VEGF bispecific antibody

•CR-001 is an investigational tetravalent bispecific antibody that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. Enrollment continues to progress in ASCEND, a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients.
•A trial in progress poster of the ASCEND study design was featured during the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held May 29-June 2, in Chicago.

•Under its strategic collaboration, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., ("Kelun-Biotech") exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China.

◦In May 2026, Kelun-Biotech received Investigational New Drug (IND) approval from the Center for Drug Evaluation of the National Medical Products Administration for CR-001 (SKB118) for the treatment for advanced solid tumors, and subsequently commenced a Phase 1/2 monotherapy trial in China.
◦Kelun-Biotech recently initiated a Phase 2 trial of CR-001 (SKB118) in combination with sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC, in China. It is an open-label, multi-center trial designed to evaluate the safety, tolerability and efficacy of CR-001 in combination with sac-TMT, in approximately 206 participants with locally advanced or metastatic NSCLC. Primary outcomes of the study are safety and assessment of objective response rate (ORR); secondary outcomes include evaluating progression-free survival (PFS) and overall survival (OS).
•Crescent also plans to evaluate CR-001 in combination with additional ADCs.

•Crescent anticipates reporting:

◦Proof-of-concept clinical data from the ASCEND trial of CR-001 in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts in first-line and previously treated patients in multiple solid tumor types. A backfill cohort of first-line NSCLC patients is planned as part of this readout.
◦Initial data of CR-001 in combination with various standard of care chemotherapy regimens in first-line and previously treated patients by mid-2027 (Q2/Q3) utilizing the dose expansion part of the ASCEND trial.
◦Initial data from the Phase 2 trial in China of CR-001 in combination with sac-TMT in mid-2027 (Q2/Q3).
CR-002, topoisomerase inhibitor ADC targeting PD-L1
•CR-002 is an ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation.
•Crescent is on track to submit an IND application to the U.S. Food and Drug Administration (FDA) for CR-002 in mid-2026 to support the initiation of a global Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027.
CR-003, topoisomerase inhibitor ADC targeting integrin beta-6 (ITGB6)
•CR-003 is an investigational ADC directed to ITGB6, which is overexpressed in many solid tumors with minimal expression in most normal tissues. CR-003 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker.
•A Phase 1/2 trial of CR-003 (also known as SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. A Phase 1/2 combination trial of CR-003 and CR-001 is expected to initiate in the first half of 2027, with initial data anticipated by year-end 2027. Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105) in the United States, Europe and all markets outside of Greater China.
Corporate
•In July 2026, Crescent completed a public offering of ordinary shares and pre-funded warrants with gross proceeds of $143.7 million before deducting underwriting discounts and commissions and other offering expenses.
Second Quarter 2026 Financial Results
Cash position: Cash and cash equivalents were $171.6 million as of June 30, 2026. Pro forma cash was $305.1 million as of June 30, 2026, reflecting an additional $133.5 million in net proceeds from the July 2026 public offering. Crescent expects that its existing cash and cash equivalents will fund operations into the second half of 2028.
Research and development (R&D) expenses: R&D expenses were $19.4 million and $12.1 million for the three months ended June 30, 2026 and 2025, respectively. R&D expenses increased to support the continued development of the Company’s pipeline primarily due to increased costs for chemistry, manufacturing, and controls and clinical activity as well as higher personnel-related costs.

General and administrative (G&A) expenses: G&A expenses were $8.7 million and $8.9 million for the three months ended June 30, 2026 and 2025, respectively. The decrease in G&A expenses is the result of decreased personnel costs, primarily related to share-based compensation and decreased professional service costs, offset by increased office, facilities and software costs and expenses associated with operating as a public company.
Net loss: Net loss was $24.8 million and $21.8 million, or $0.74 and $4.93 per basic and diluted share, for the three months ended June 30, 2026 and 2025, respectively.
Shares outstanding: As of June 30, 2026, Crescent had approximately 33.5 million ordinary shares and ordinary share equivalents issued and outstanding, including ordinary shares underlying pre-funded warrants and non-voting convertible preferred stock. Pro forma, Crescent had 43.5 million ordinary shares and ordinary share equivalents issued and outstanding as of June 30, 2026, which includes an additional 9.9 million ordinary shares and ordinary shares underlying pre-funded warrants issued pursuant to the July 2026 public offering.

(Press release, Crescent Biopharma, JUL 30, 2026, View Source [SID1234669545])

Veracyte Announces Second Quarter 2026 Financial Results

On July 30, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the second quarter ended June 30, 2026.

"Q2 was a milestone quarter for Veracyte as we launched two new products, Prosigna LDT and TrueMRD for MIBC, while also delivering strong double-digit revenue growth, profitability and cash generation," said Marc Stapley, Veracyte’s chief executive officer. "These launches meaningfully expand our ability to serve more patients across the cancer care continuum and, combined with the strength of our core business, position us well to deliver durable double-digit growth."

Key Financial Highlights
For the three-month period ended June 30, 2026, as compared to the same period in 2025:
•Increased total revenue by 15% to $150.3 million and testing revenue by 19% to $145.7 million, driven by Decipher growth of 20% to $91.9 million and Afirma growth of 18% to $51.2 million.
•Increased total volume by 13% to 50,967 tests and testing volume by 14% to 48,389 tests, driven by Decipher growth of 17% to approximately 29,700 tests and Afirma growth of 10% to approximately 18,600 tests.
•Recorded GAAP net income of $25.5 million, or 17.0% of revenue, and delivered adjusted EBITDA of $44.0 million, or 29.2% of revenue.
•Generated $45.8 million of cash from operations to end the quarter with $485.2 million of cash, cash equivalents, and short-term investments as of June 30, 2026.
Key Business Highlights
•Launched the Prosigna Breast Test in the U.S. for patients diagnosed with early-stage hormone-receptor positive (HR+) breast cancer.
•Launched the TrueMRD Monitoring Test for patients with muscle-invasive bladder cancer (MIBC).
•Secured Medicare coverage for the TrueMRD Monitoring Test, representing the first Medicare coverage decision for the whole-genome sequencing-based TrueMRD platform.
•Further expanded the clinical evidence of our testing portfolio, including new predictive evidence from the OPTIMA trial supporting the clinical utility of Prosigna and the ENZAMET trial expanding the Decipher clinical evidence base. Together, Decipher and Afirma were featured in nearly 60 abstracts and presentations during the quarter.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Second Quarter 2026 Financial Results

Total revenue for the second quarter of 2026 was $150.3 million, an increase of 15% compared to $130.2 million reported in the second quarter of 2025. Testing revenue was $145.7 million, an increase of 19% compared to $122.3 million in the second quarter of 2025, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $3.9 million, an increase of 7% compared to $3.6 million in the second quarter of 2025. Biopharmaceutical and other revenue was $0.8 million, an expected decrease compared to $4.3 million in the second quarter of 2025 given the restructuring and liquidation proceedings of Veracyte SAS.

Total gross margin for the second quarter of 2026 was 72%, compared to 69% in the second quarter of 2025. Non-GAAP gross margin was 75%, compared to 72% in the second quarter of 2025.

Operating expenses were $85.6 million for the second quarter of 2026 compared to $95.0 million in the second quarter of 2025. Non-GAAP operating expenses grew 16% to $70.0 million compared to $60.3 million in the second quarter of 2025.

Net income for the second quarter of 2026 was $25.5 million, an increase of $26.5 million compared to the second quarter of 2025. Diluted net earnings per common share was $0.31, an improvement of $0.32 compared to the second quarter of 2025. Non-GAAP diluted net earnings per common share was $0.54, an increase of $0.10 compared to the second quarter of 2025. Net cash provided by operating activities in the first six months of 2026 was $81.0 million, an improvement of $42.1 million compared to the same period in 2025.

Adjusted EBITDA for the second quarter of 2026 was $44.0 million, an improvement of 23% compared to the second quarter of 2025, representing 29.2% of revenue compared to 27.5% of revenue in the same period in 2025.

2026 Financial Outlook

The company is raising 2026 total revenue guidance to $590 million to $596 million, or 14% to 15% growth, from prior guidance of $582 to $592 million, or 13% to 14% growth. The company is also raising testing revenue guidance to $576 million to $582 million, or 17% to 18% growth, from prior guidance of $570 million to $580 million, excluding the contribution from recently launched tests.

The company continues to expect adjusted EBITDA margin to be greater than 26%.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA margin to expected GAAP net income margin, the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

(Press release, Veracyte, JUL 30, 2026, View Source [SID1234669541])

Replimune Announces Favorable Outcome of FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

On July 30, 2026 Replimune Group, Inc. (Nasdaq: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported the outcome of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which discussed the Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

The committee discussed two topics: (1) whether the single-arm IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response in the proposed population; and (2) the clinical meaningfulness of the response rate and duration of response reported in IGNYTE, and whether the observed responses are indicative of systemic antitumor activity attributable to RP1. The committee then voted 10 to 3, on the question: "Are the efficacy results from IGNYTE evaluable and clinically meaningful?"

"We are encouraged by today’s outcome and would like to thank the committee for its thoughtful discussion of the IGNYTE data," said Sushil Patel, Ph.D., CEO of Replimune. "We are grateful to the patients and physicians who took the time to speak today and so clearly articulate the high unmet need in advanced melanoma and importance of new treatment options such as RP1 for the community. This is an important step forward for patients with advanced melanoma who have progressed on anti-PD-1 therapy. We look forward to continuing to work with the FDA as it completes its review of the BLA ahead of the action date."

The FDA’s target action date under the Class 1 resubmission is August 2, 2026.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, JUL 30, 2026, View Source [SID1234669540])