New Research Demonstrates the Advantages of an Insourced Dialysis Service Line for Acute-Care Facilities Using Outset Medical’s Tablo® Hemodialysis System




New Research Demonstrates the Advantages of an Insourced Dialysis Service Line for Acute-Care Facilities Using Outset Medical’s Tablo® Hemodialysis System

Data from over 1 Million Tablo Treatments Among the Findings Presented at the American Society of Nephrology’s Kidney Week 2025

SAN JOSE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced new research findings from over 1 million Tablo hemodialysis treatments across approximately 750 facilities, and 5-year results from the insourcing of dialysis at a large hospital in Florida.

The findings will be presented at the American Society of Nephrology’s Kidney Week 2025 in Houston, which runs November 5-8. The annual event to showcase the latest advancements in kidney care is attended by more than 12,000 professionals from around the world.

Among the highlights:

• AdventHealth will present data from the conversion of their Ocala, Florida site to an insourced dialysis service line with Tablo. These results over 5 years showed a 94% reduction in serious cardiac or respiratory events, a sustained reduction in central-line blood stream infections, a very high nurse retention rate with greater than 95% dialysis staff satisfaction, and a strong return on investment in the first 2 years of operation.
• Data from 1 million Tablo treatments across more than 600 facilities support the clinical effectiveness of insourced dialysis in achieving rigorous treatment goals, including up to 24-hour treatments that generally involve the most critical patients. 
• Data from 10,000 treatments prescribed for more than 23 hours and up to 24 hours, performed at approximately 150 hospitals, showed over 99% achievement of treatment goals with minimal interruptions and rapid resolution of treatment alarms.

“We believe these findings provide additional support for an insourced dialysis service line to elevate the standard of care at hospitals serving patients with compromised renal function,” said Michael Aragon, MD, Chief Medical Officer of Outset Medical. “Outset’s growing base of clinical, financial and operational evidence demonstrates that the advantages of insourcing for acute-care facilities can range from hard clinical benefits to significant cost savings and improved patient outcomes.”

The studies can be read in their entirety on the clinical evidence page of the Outset Medical website. Attendees are invited to visit the Outset booth (#709) during the ASN meeting for more information.

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include statements regarding Outset’s beliefs, projections and expectations concerning, among other things, the potential impact and implications of the research results discussed in this press release. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, which could cause actual results and other events to differ materially from those expressed or implied in such statements. These risks and uncertainties include risks described in the Risk Factors section of Outset’s public filings with the U.S. Securities and Exchange Commission, including its latest annual and quarterly reports. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Outset disclaims any obligation to update these forward-looking statements.

Indications for use
The Tablo^® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration. This device is not indicated for continuous renal replacement therapy (CRRT) and is cleared for use for up to 24 hours. The dialysate generated by this device is not sterile and should not be used for intravenous (IV) infusion.

About Outset Medical, Inc.
Outset is a medical technology company transforming the dialysis experience across the continuum of care with a first-of-its-kind technology. The Tablo^® Hemodialysis System, FDA-cleared for use from hospital to home, is trusted by more than 1,000 U.S. healthcare facilities and has enabled millions of treatments delivered by thousands of nurses. Designed to reduce the cost and complexity of dialysis, Tablo combines water purification and on-demand dialysate production into a single, integrated system that connects seamlessly with Electronic Medical Record systems and a proprietary data analytics platform. This enterprise solution empowers providers to develop an in-house dialysis program where they are in control – enabling better operational, clinical, and financial outcomes. Outset is redefining what’s possible in kidney care through innovation, scale, and a relentless commitment to improving the lives of patients and the professionals who care for them. For more information, visit www.outsetmedical.com. Tablo is a registered trademark of Outset Medical, Inc.

Contact
Jim Mazzola
jmazzola@outsetmedical.com

Sutro Biopharma to Host Virtual Research & Development Day on November 12, 2025




Sutro Biopharma to Host Virtual Research & Development Day on November 12, 2025

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that it will host a virtual Research & Development Day, highlighting the details of its platform innovation and next-generation ADC pipeline.

The live webcast will be held on Wednesday, November 12, 2025, starting at 7:00AM PT / 10:00AM ET.

Webcast Information:
To access the live audio webcast, please go to https://ir.sutrobio.com/news-events/ir-calendar. An archived replay of the webcast will be available on the Company’s website following the event.

About Sutro Biopharma  
Sutro Biopharma, Inc. is advancing a next-generation antibody-drug conjugate (ADC) platform designed to deliver single- and dual-payload ADCs that enable meaningful breakthroughs for patients with cancer. By fully optimizing the antibody, linker, and payload, Sutro’s cell-free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. With unique capabilities in dual-payload ADCs, Sutro aims to overcome treatment resistance and redefine what’s possible in cancer therapy. The Company’s pipeline of single- and dual-payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies.

For more information, follow Sutro on social media @Sutrobio or visit www.sutrobio.com.

Investor Contact
Emily White
Sutro Biopharma
(650) 823-7681
ewhite@sutrobio.com

Media Contact
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

BioStem Technologies Provides Comments on CMS CY 2026 Final Medicare Reimbursement Rule Changes for Skin Substitutes




BioStem Technologies Provides Comments on CMS CY 2026 Final Medicare Reimbursement Rule Changes for Skin Substitutes

POMPANO BEACH, Fla., Nov. 05, 2025 (GLOBE NEWSWIRE) — BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company specializing in placental-derived biologics for advanced wound care, today commented on the Centers for Medicare & Medicaid Services’ (“CMS”) Calendar Year 2026 Physician Fee Schedule (PFS) final rule, which reforms Medicare reimbursement for skin substitutes.

“CMS’s final rule represents a decisive step toward a more transparent, predictable, and sustainable reimbursement system,” said Jason Matuszewski, Chief Executive Officer and Chairman of BioStem. “For years, we have supported thoughtful reform in this category to ensure patients receive clinically proven, high-quality products while curbing the misuse and inefficiencies that have burdened the healthcare system. While the reimbursement level is lower than we initially advocated, this framework lays the foundation for a healthier, evidence-driven market.”

The new reimbursement model follows a period of rapid growth in national spending on skin substitutes and reflects CMS’s intent to restore market balance and reward clinical performance rather than pricing variability. BioStem noted that its BioREtain^®-processed placental allografts align precisely with these goals, as recently evidenced in its published Level 1 randomized controlled trial demonstrating superior patient outcomes compared to standard of care. This study was submitted to CMS to support coverage decisions and underscores BioStem’s commitment to scientific validation and responsible innovation.

In addition to its clinical advantages, BioStem emphasized that the BioREtain manufacturing process delivers structurally efficient economics. The Company’s proprietary processing methods and vertically integrated manufacturing allow for materially lower cost of goods sold (COGS) and scalable production. As a result, BioStem expects product margins to remain robust under the new CMS reimbursement model.

“We believe BioStem is exceptionally well-positioned to thrive in this environment,” added Matuszewski. “Our combination of clinically validated products, advanced GMP-compliant manufacturing, and efficient cost structure enables us to compete effectively even as the industry transitions to standardized reimbursement. We anticipate that CMS’s reforms will accelerate provider adoption of technology like BioREtain that delivers proven outcomes and economic value.”

BioStem continues to collaborate with clinical partners, policymakers, and advocacy organizations to ensure the evolving reimbursement framework supports innovation, fiscal responsibility, and optimal patient care.

About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain^® processing method. BioREtain^® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established in compliance with current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, and VENDAJE OPTIC^®. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and Linkedin.

Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign up for the Company’s email distribution list HERE, and follow us on X and LinkedIn.

Contact BioStem Technologies, Inc.:
Website: www.biostemtechnologies.com
E-Mail: info@biostemtech.com
X: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342

Investor Relations:
Philip Trip Taylor, Gilmartin Group
E-Mail: ir@biostemtech.com

electroCore Announces Third Quarter 2025 Financial Results




electroCore Announces Third Quarter 2025 Financial Results

Net sales of $8.7 million increased 33% vs. Q3 2024; YTD net sales of $22.8 million increased 26% vs. first nine months of 2024

Cash, cash equivalents, restricted cash, and marketable securities (“Total Cash”) of $13.2 million as of September 30, 2025

 Company to host a conference call and webcast today, November 5, 2025, at 4:30 p.m. EDT

ROCKAWAY, N.J., Nov. 05, 2025 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR) (“electroCore” or the “Company”), a bioelectronic technology company, today announced financial results for the three and nine months ended September 30, 2025.

Recent Highlights

• Record revenue for Q3 2025 of $8.7 million, a 33% increase over Q3’2024
• Year-to-date revenue of $22.8 million, a 26% increase compared to the first nine months of 2024
• Total Cash of $13.2 million as of September 30, 2025
• Increased FY 2025 revenue guidance

“Prescription sales continued to accelerate in this quarter driven by sales within the department of Veteran Affairs (“VA”) market. gammaCore and Quell Fibromyalgia each showed strong growth in the VA with gammaCore sales increasing 16% over the same period in 2024 and Quell contributing $530,000 in VA revenues and $595,000 of total product sales in the quarter,” commented Dan Goldberger, CEO of electroCore. “With Truvaga revenue also hitting a record high of $1.7 million in the quarter, we are increasing our revenue guidance to $31.5 million to $32.5 million for the full year 2025.”

Third Quarter 2025 Financial Results and Select Guidance

For the three months ended September 30, 2025, electroCore’s net sales totaled $8.7 million compared to $6.6 million in the same period of 2024, a 33% year-over-year increase. The $2.1 million increase was driven primarily by higher sales of prescription devices and growth in the Company’s non-prescription general wellness Truvaga^TM products. As of September 30, 2025, 195 VA facilities have purchased prescription gammaCore products up from 166 a year ago.

Gross profit in the three months ended September 30, 2025 was $7.5 million, or 86% gross margin, as compared to $5.5 million, or 84% gross margin for the three months ended September 30, 2024.

Research and development expense in the third quarter of 2025 was $0.7 million, as compared to $0.5 million in the third quarter of 2024. This increase was primarily due to increased development costs associated with our next generation mobile application.

Selling, general and administrative expense was $9.7 million for the three months ended September 30, 2025, an increase of $2.1 million as compared to $7.6 million for the previous year period. This increase was primarily due to greater investment in selling and marketing costs, consistent with the Company’s increase in sales. For the remainder of 2025, the Company plans on continuing to make targeted investments in sales and marketing to support its commercial efforts.

Total operating expenses in the three months ended September 30, 2025, were approximately $10.4 million as compared to $8.1 million in the three months ended September 30, 2024.

Total other expense was $0.5 million for the three months ended September 30, 2025, which consisted primarily of $0.4 million of acquisition-related costs in connection with a change in estimated liability (the “CVR Liability”) payable to pre-closing shareholders of NeuroMetrix, Inc. (“NURO”), pursuant to a contingent value rights agreement, and interest expense on the convertible debt financing with Avenue Venture Opportunities Fund II, L.P. (“Avenue”), as compared to total other income of $0.2 million for the three months ended September 30, 2024, which consisted mainly of interest income.

Net loss in the third quarter of 2025 was $3.4 million, or a loss of $0.40 per share, as compared to $2.5 million net loss, or a loss of $0.31 per share, in the third quarter of 2024. The increase in net loss is primarily attributable to an increase in other expense (income) related to the CVR Liability, and interest expense on the convertible debt financing with Avenue. Net loss per share includes a loss of $0.05 per share and $0.02 per share attributed to the CVR Liability and interest expense, respectively.

Adjusted EBITDA net loss in the third quarter of 2025 was $2.0 million as compared to adjusted EBITDA net loss of $2.1 million in the third quarter of 2024.

The Company defines adjusted EBITDA net loss as GAAP net loss, adjusting to exclude non-operating gains/losses, depreciation and amortization, stock-compensation expense, inventory reserve charges, accounts receivable reserve charges, non-recurring recruiting fees, severance and other related charges, legal fees associated with stockholders’ litigation and the intellectual property litigation, benefit from income taxes, and non-recurring transaction charges associated with the acquisition of NURO and other business development activities, or other one-time charges. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss is provided in the financial statement table below.

Total Cash at September 30, 2025, totaled approximately $13.2 million, as compared to approximately $12.2 million as of December 31, 2024.

Full Year 2025 and Select 2026 Outlook

For the full year of 2025, the Company is increasing its revenue guidance to $31.5 – $32.5 million and adjusting its net cash usage estimate for the fourth quarter of 2025 to be between approximately $2.0 and $2.5 million. The Company expects to reach $12.0 million in quarterly revenue and achieve its first quarter of positive adjusted EBITDA in the second half of 2026.

Webcast and Conference Call Information

electroCore’s management team will host a conference call today, November 5, 2025, beginning at 4:30 PM EDT. Investors must register at the following link to receive login credentials and be able to ask questions on the call: Q3 2025 Financial Results Weblink.

Attendees who prefer to participate in “Listen Only” mode may dial in as follows:
Dial-In: (646) 931-3860
Webinar ID: 822 9598 1338
Passcode: 454695

An archived webcast of the event will be available on the “Investors” section of the company’s website at: www.electrocore.com.

About electroCore, Inc.

electroCore, Inc. and its subsidiaries (“electroCore” or the “Company”) is a bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. The Company’s two leading prescription products to treat chronic pain syndromes through non-invasive neuromodulation technology are gammaCore non-invasive vagus nerve stimulation, or nVNS, and the Quell^® Fibromyalgia. Additionally, the Company commercializes its handheld and personal use Truvaga and TAC-STIM nVNS products utilizing bioelectronic technologies to promote general wellness and human performance.

For more information, visit www.electrocore.com.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about, electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; business prospects around its prescription gammaCore product, general wellness Truvaga and TAC-STIM products, Quell products, and other potential new products and markets, revenue, net cash usage and positive adjusted EBITDA guidance for the fourth quarter and full year 2025 and the second half of 2026, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” and other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore, TAC-STIM, and Truvaga, Quell, electroCore’s results of operations and financial performance, inflation and currency fluctuations, and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall economic and market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

Contact:

ECOR Investor Relations
(973) 302-9253
investors@electrocore.com

(Unaudited) Use of Non-GAAP Financial Measure

The Company is presenting adjusted EBITDA net loss because it believes this measure is a useful indicator of its operating performance. Management uses this non-GAAP measure principally as a measure of the Company’s core operating performance and believes that this measure is useful to investors because it is frequently used by the financial community, investors, and other interested parties to evaluate companies in the Company’s industry. The Company also believes that this measure is useful to its management and investors as a measure of comparative operating performance from period to period. Additionally, the Company believes its use of non-GAAP adjusted EBITDA net loss from operations facilitates management’s internal comparisons to historical operating results by factoring out potential differences caused by gains and charges not related to its regular, ongoing business, including, without limitation, non-cash charges and certain large and unpredictable charges such as restructuring expenses.

The Company defines adjusted EBITDA net loss as GAAP net loss, adjusting to exclude non-operating gains/losses, depreciation and amortization, stock-compensation expense, inventory reserve charges, accounts receivable reserve charges, non-recurring recruiting fees, severance and other related charges, legal fees associated with stockholders’ litigation and the intellectual litigation, benefit from income taxes, and non-recurring transaction charges associated with the acquisition of NURO and other business development activities, or other one-time charges. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss is provided in the financial statement table below.

The Company’s use of a non-GAAP measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of its results as reported under GAAP. Some of these limitations are: (i) the non-GAAP measure does not reflect interest or tax payments that may represent a reduction in cash available; (ii) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and the non-GAAP measure does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; (iii) the non-GAAP measure does not reflect the potentially dilutive impact of equity-based compensation; and (iv) the non-GAAP measure does not reflect changes in, or cash requirements for working capital needs; other companies, including companies in electroCore’s industry, may calculate adjusted EBITDA net loss differently, effectively reducing its usefulness as a comparative measure.

Because of these and other limitations, you should consider the non-GAAP measure together with other GAAP-based financial performance measures, including various cash flow metrics, net loss, and other GAAP results. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the preceding financial statements table of this press release. 

PacBio Announces Third Quarter 2025 Financial Results




PacBio Announces Third Quarter 2025 Financial Results

MENLO PARK, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — PacBio (NASDAQ: PACB) today announced financial results for the quarter ended September 30, 2025.

Third quarter results:

Gross margin, operating expenses, net loss, and net loss per share are reported on a GAAP and non-GAAP basis. The non-GAAP measures are described below and reconciled to the corresponding GAAP measures at the end of this release.

GAAP gross profit for the third quarter of 2025 was $15.9 million compared to $10.0 million for the third quarter of 2024. Non-GAAP gross profit for the third quarter of 2025 was $16.2 million compared to $13.0 million for the third quarter of 2024 and a non-GAAP gross margin of 42% in the third quarter of 2025 compared to 33% for the third quarter of 2024.

GAAP operating expenses totaled $54.8 million for the third quarter of 2025, compared to $74.1 million for the third quarter of 2024. Non-GAAP operating expenses totaled $53.9 million for the third quarter of 2025, compared to $62.4 million for the third quarter of 2024. GAAP and non-GAAP operating expenses for the third quarter of 2025 and the third quarter of 2024 included non-cash share-based compensation of $10.1 million and $17.0 million, respectively.

GAAP net loss for the third quarter of 2025 was $38.0 million, compared to $60.7 million for the third quarter of 2024. Non-GAAP net loss for the third quarter of 2025 was $36.8 million, compared to $46.0 million for the third quarter of 2024.

GAAP net loss per share for the third quarter of 2025 was $0.13, compared to $0.22 for the third quarter of 2024. Non-GAAP net loss per share for the third quarter of 2025 was $0.12, compared to $0.17 for the third quarter of 2024.

Updates since PacBio’s last earnings release

• Unveiled new SPRQ-Nx sequencing chemistry and consumables, expected to reduce sequencing costs by up to 40% and enable high-accuracy long-read genomes for under $300 per genome at scale.
• Sequel® II CNDx system received Class III Medical Device Registration approval in China through our long-standing partner, Berry Genomics.
• Launched expanded PureTarget portfolio of long-read HiFi assays covering difficult-to-sequence genes in carrier screening, supporting throughput for up to ~100,000 samples per Revio system per year.
• First major study demonstrating the clinical research power of HiFi genomes was published by the HiFi Solves EMEA Consortium; PacBio HiFi sequencing combined with Paraphase, a dedicated haplotype-based variant caller, uncovered all known clinically relevant variants present in the study population.
• Revio system selected for National Institute on Aging’s Long Life Family Study to sequence up to 7,800 whole genomes and epigenomes.
• HiFi sequencing selected for the Korean Pangenome Reference Project, targeting to sequence more than 1,000 genomes to support development of precision diagnostics and therapies.

“While revenue came in slightly below our expectations this quarter, we achieved another all-time record for consumable revenue, expanded gross margins and continued to reduce our operating expenses,” said Christian Henry, President and Chief Executive Officer. “We also reached an important milestone on our technology roadmap with the introduction of SPRQ-Nx chemistry, which we believe will help dramatically lower the cost of human genome sequencing and make our technology economically competitive with many short read sequencing platforms. These achievements underscore our focus on disciplined growth and our commitment to making PacBio’s highly accurate long-read sequencing more accessible worldwide.”

Quarterly Conference Call Information

Management will host a quarterly conference call today at 4:30 p.m. Eastern Time to review financial results for the third quarter ended September 30, 2025. Investors can access the call by dialing 1-888-349-0136 (or 1-412-317-0459 for international callers) and requesting to join the “PacBio Q3 Earnings Call”. The call will be webcast live and available for replay at PacBio’s website at https://investor.pacificbiosciences.com.

About PacBio

PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our products and technologies, which include our HiFi long-read sequencing, address solutions across a broad set of research applications including human germline sequencing, plant and animal sciences, infectious disease and microbiology, oncology, and other emerging applications. For more information, please visit www.pacb.com and follow @PacBio.

PacBio products are provided for Research Use Only. Not for use in diagnostic procedures.

Statement regarding use of non‐GAAP financial measures

PacBio reports non‐GAAP results for basic net income and loss per share, net income, net loss, gross margins, gross profit (loss) and operating expenses in addition to, and not as a substitute for, or because it believes that such information is superior to, financial measures calculated in accordance with GAAP. PacBio believes that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. In addition, other companies may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of PacBio’s non-GAAP financial measures as tools for comparison.

PacBio’s financial measures under GAAP include substantial charges that are listed in the itemized reconciliations between GAAP and non‐GAAP financial measures included in this press release. PacBio excludes recurring charges from its non-GAAP financial statements, including amortization of intangible assets and changes in fair value of contingent consideration, and further excludes infrequent and limited charges including impairment charges, restructuring related expenses for discrete restructuring events and benefits from income taxes.

Management has excluded the effects of these items in non‐GAAP measures to assist investors in analyzing and assessing past and future operating performance. In addition, management uses non-GAAP measures to compare PacBio’s performance relative to forecasts and strategic plans and to benchmark its performance externally against competitors.

PacBio encourages investors to carefully consider its results under GAAP, as well as its supplemental non‐GAAP information and the reconciliation between these presentations, to more fully understand its business. A reconciliation of PacBio’s non-GAAP financial measures to their most directly comparable financial measure stated in accordance with GAAP has been provided in the financial statement tables included in this press release. PacBio is unable to reconcile future-looking non-GAAP guidance included in this press release without unreasonable effort because certain items that impact this measure are out of PacBio’s control and/or cannot be reasonably predicted at this time.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are forward-looking statements, including, but not limited to, statements relating to PacBio’s initiatives as well as the expected financial impact and timing of these plans and initiatives; PacBio’s financial guidance and expectations for future periods; new and continued reception of PacBio’s products and their expansion into new or existing markets; developments affecting our industry and the markets in which we compete, including the impact of new products and technologies and tariffs; anticipated future customer use and costs of our products and consumables; and the availability, uses, accuracy, coverage, advantages, quality or performance of, or benefits or expected benefits of using, PacBio products or technologies. Reported results and orders for any instrument system should not be considered an indication of future performance. You should not place undue reliance on forward-looking statements because they are subject to assumptions, risks, and uncertainties and could cause actual outcomes and results to differ materially from currently anticipated results, including, but not limited to, challenges inherent in developing, manufacturing, launching, marketing and selling new products, and achieving anticipated new sales; potential cancellation of existing instrument orders; assumptions, risks and uncertainties related to the ability to attract new customers and retain and grow sales from existing customers; risks related to PacBio’s ability to successfully execute and realize the benefits of acquisitions; the impact of new, increased or enhanced tariffs and export restrictions; rapidly changing technologies and extensive competition in genomic sequencing; unanticipated increases in costs or expenses; interruptions or delays in the supply of components or materials for, or manufacturing of, PacBio products and products under development; potential product performance and quality issues and potential delays in development timelines; the possible loss of key employees, customers, or suppliers; customers and prospective customers curtailing or suspending activities using PacBio’s products; third-party claims alleging infringement of patents and proprietary rights or seeking to invalidate PacBio’s patents or proprietary rights; risks associated with international operations; and other risks associated with general macroeconomic conditions and geopolitical instability. Additional factors that could materially affect actual results can be found in PacBio’s most recent filings with the Securities and Exchange Commission, including PacBio’s most recent reports on Forms 8-K, 10-K, and 10-Q, and include those listed under the caption “Risk Factors.” These forward-looking statements are based on current expectations and speak only as of the date hereof; except as required by law, PacBio disclaims any obligation to revise or update these forward-looking statements to reflect events or circumstances in the future, even if new information becomes available.

The unaudited condensed consolidated financial statements that follow should be read in conjunction with the notes set forth in PacBio’s Quarterly Report on Form 10-Q when filed with the Securities and Exchange Commission.

Contacts

Investors:
Jim Gibson
ir@pacb.com

Media:
pr@pacb.com

⁽¹⁾  Balances include restructuring costs. Refer to the Reconciliation of Non-GAAP Financial Measures table below for additional information on such costs and related amounts.

⁽²⁾  Change in fair value of contingent consideration for the three months ended September 30, 2024 was due to fair value adjustments of a milestone payment payable upon the achievement of a milestone event.

⁽¹⁾  Balances include restructuring costs. Refer to the Reconciliation of Non-GAAP Financial Measures table below for additional information on such costs and related amounts.

⁽²⁾  In-process research and development (“IPR&D”) impairment charge during the nine months ended September 30, 2025 was driven primarily by macroeconomic factors and restructuring initiatives, including the focus on long-read innovation, resulting in changes to the timing and amounts of cash flows. Goodwill impairment charge during the nine months ended September 30, 2024 was related to a sustained decrease in the Company’s share price, among other factors.

⁽³⁾  Balance for the nine months ended September 30, 2025 includes accelerated amortization of acquired intangible assets related to restructuring initiatives. Refer to the Reconciliation of Non-GAAP Financial Measures table below for additional information on such costs and related amounts.

⁽⁴⁾  Change in fair value of contingent consideration during the nine months ended September 30, 2025 and the three and nine months ended September 30, 2024 was due to fair value adjustments of milestone payments payable upon the achievement of the respective milestone event.

⁽¹⁾  Change in fair value of contingent consideration during the nine months ended September 30, 2025 and the three and nine months ended September 30, 2024 was due to fair value adjustments of milestone payments payable upon the achievement of the respective milestone event.

⁽²⁾  Goodwill impairment charge during the nine months ended September 30, 2024 was related to a sustained decrease in the Company’s share price, among other factors.

⁽³⁾  A deferred income tax benefit during the nine months ended September 30, 2025 is primarily related to the change in the deferred tax liability balance resulting from the accelerated amortization of acquired intangible assets and impairment of IPR&D.

⁽⁴⁾  Restructuring costs related to the 2025 plan during the three months ended June 30, 2025 and September 30, 2025 and the nine months ended September 30, 2025 consist primarily of costs included in cost of revenue related to excess inventory and purchase commitment losses, as well as costs included in operating expenses related to employee separation, accelerated depreciation, IPR&D impairment, and accelerated amortization of acquired intangibles.

Restructuring costs related to the 2024 plan during the three and nine months ended September 30, 2024 consist primarily of employee separation costs, accelerated amortization and depreciation for right-of-use assets, leasehold improvements, and furniture and fixtures relating to the abandonment of the San Diego office, including charges for excess inventory due to a decrease in internal demand relating to the expense reduction initiatives.

Revolution Medicines Reports Third Quarter 2025 Financial Results and Update on Corporate Progress




Revolution Medicines Reports Third Quarter 2025 Financial Results and Update on Corporate Progress

• Company is winding down global enrollment for the RASolute 302 clinical trial studying daraxonrasib in patients with previously treated PDAC and remains on track for data readout in 2026
• Company has initiated RASolute 304, a Phase 3 clinical trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and remains on track to initiate RASolute 303 for patients with first line metastatic PDAC this year
• Daraxonrasib has received FDA Breakthrough Therapy Designation, Orphan Drug Designation and a Commissioner’s National Priority Voucher
• New leadership appointments strengthened global development and commercialization capabilities
• Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time

REDWOOD CITY, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter ended September 30, 2025, and provided an update on corporate progress.

“Our diverse clinical and preclinical RAS(ON) inhibitor programs continue to make encouraging progress and deliver on important milestones,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Backed by robust operational capabilities and a strong financial position, we feel growing momentum in support of our goal to establish new global standards of care for people living with RAS-addicted cancers, including pancreatic, lung and colorectal cancers.”

The company reported significant progress on its near-term strategic priorities:

Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC)

RASolute 302, a global Phase 3 clinical trial of daraxonrasib in patients with previously treated PDAC, is winding down enrollment globally as the company nears completion of enrollment at all U.S. and international sites. The trial remains on track for an expected data readout in 2026.

For daraxonrasib in pancreatic cancer, the FDA recently granted an Orphan Drug Designation as well as a Commissioner’s National Priority Voucher supporting accelerated review, in addition to the previously awarded Breakthrough Therapy Designation.

RASolve 301, a global Phase 3 trial of daraxonrasib in patients with previously treated NSCLC, is now enrolling patients in Europe and Japan in addition to the U.S.

Advance daraxonrasib into earlier line randomized pivotal trials in patients with PDAC and NSCLC

The company recently disclosed new clinical results supporting initiation of RASolute 303, a global Phase 3 registrational trial of daraxonrasib in first line metastatic PDAC. The company remains on track to initiate the trial this year. The trial will evaluate daraxonrasib as monotherapy and in combination with gemcitabine nab-paclitaxel (GnP), each compared with GnP alone. The company expects to share updated daraxonrasib monotherapy and daraxonrasib plus GnP combination data, each in patients with first line PDAC, including preliminary durability, in the first half of 2026.

The company has initiated RASolute 304, a Phase 3 trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and is currently activating trial sites. The trial will evaluate patients who have received surgery and perioperative chemotherapy per standard of care, who will be randomized to either observation or daraxonrasib monotherapy for two years. The primary endpoint is disease-free survival, with secondary endpoints of overall survival and safety.

The company remains on track to initiate a registrational trial in 2026 evaluating daraxonrasib in patients with first line metastatic RAS mutant NSCLC in combination with pembrolizumab and chemotherapy.

Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination

New elironrasib monotherapy data presented recently at the AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics (Triple Meeting) showed encouraging response rate and progression-free survival in patients with RAS G12C NSCLC who had previously been treated with a KRAS G12C(OFF) inhibitor. The company continues to expand enrollment in this and other elironrasib monotherapy and combination trials as it explores options for continued development of this differentiated and promising RAS(ON) G12C-selective inhibitor.

In addition, at the Triple Meeting the company presented encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib, the company’s G12D-selective inhibitor, and daraxonrasib in models of KRAS G12D PDAC, furthering the rationale for this RAS(ON) inhibitor doublet as a therapeutic strategy.

With zoldonrasib’s differentiated profile, the company believes this G12D-selective inhibitor has the potential to contribute as a key component of combination regimens in first line PDAC with current standard of care chemotherapy and/or with daraxonrasib as a RAS(ON) inhibitor doublet. The company expects to initiate a registrational trial for a zoldonrasib combination in patients with first line metastatic PDAC in the first half of 2026 and one or more additional pivotal combination trials in 2026 that incorporate either zoldonrasib or elironrasib.

Zoldonrasib is also being evaluated in a Phase 1 monotherapy expansion cohort in patients with previously treated NSCLC as well as in combination regimens, including zoldonrasib with pembrolizumab or daraxonrasib, in NSCLC.

Progress earlier stage pipeline, including advancing next-generation innovations from the company’s highly productive discovery organization

RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track toward planned initiation of a Phase 1 trial in Q1 2026.

Clinical Collaboration Updates
The company has several discovery and clinical collaborations exploring a range of combinations of a RAS(ON) inhibitor with inhibitors of novel targets, including vopimetostat (TNG462), a PRMT5 inhibitor, under an agreement with Tango Therapeutics, and ivonescimab, a bi-specific PD-1/VEGF inhibitor, under an agreement with Summit Therapeutics.

Other Corporate Updates

In support of the company’s growing late-stage development activities and commercialization plans, the company recently announced the appointment of Alan Sandler, M.D. as chief development officer, Alicia Gardner as senior vice president and general manager for the U.S. region, and Gerwin Winter as senior vice president and general manager of the European region.

Financial Highlights

Third Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $1.93 billion as of September 30, 2025. This balance includes the receipt of the first royalty monetization tranche of $250 million in June 2025 from the company’s partnership with Royalty Pharma, and there remains an additional $1.75 billion in future committed capital under this arrangement.

R&D Expenses: Research and development expenses were $262.5 million for the quarter ended September 30, 2025, compared to $151.8 million for the quarter ended September 30, 2024. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for daraxonrasib, zoldonrasib and elironrasib, and personnel-related expenses and stock-based compensation expense related to additional headcount.

G&A Expenses: General and administrative expenses were $52.8 million for the quarter ended September 30, 2025, compared to $24.0 million for the quarter ended September 30, 2024. The increase was primarily due to increases in personnel-related expenses and stock-based compensation expense associated with additional headcount, an increase in commercial preparation activities, and increased legal expenses.

Net Loss: Net loss was $305.2 million for the quarter ended September 30, 2025, compared to net loss of $156.3 million for the quarter ended September 30, 2024.

Financial Guidance
The company reiterates its full year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million.

Webcast
Revolution Medicines will host a webcast this afternoon, November 5, 2025, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: https://ir.revmed.com/events-and-presentations. Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the company’s financial projections and guidance; the company’s development opportunities, plans and timelines and its ability to build or advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; the company’s expectations regarding timing of clinical trial initiation, enrollment and data readouts or disclosures and clinical trial designs; collaborations, including the aims and expected benefits of the company’s collaboration with Iambic; plans for developing any of the company’s product candidates as part of a combination treatment; sources of capital, including the availability of capital under the Royalty Pharma arrangement and whether the company achieves the milestones associated with certain payments thereunder.

Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” “believe,” “estimate,” “expect,” “plan,” “potential,” “project,” “up to,” “will” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 5, 2025, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.

Revolution Medicines Media & Investor Contact:
media@revmed.com
investors@revmed.com

      (1)   Working capital is defined as current assets less current liabilities.

HealthEquity Announces Third Quarter Earnings Date




HealthEquity Announces Third Quarter Earnings Date

DRAPER, Utah, Nov. 05, 2025 (GLOBE NEWSWIRE) — HealthEquity, Inc. (NASDAQ: HQY) (“HealthEquity” or the “Company”), the nation’s largest Health Savings Accounts (“HSA”) and consumer-directed benefits administrator, today announced plans to release financial results of its third quarter of fiscal 2026 following the close of regular stock market trading hours on Wednesday, December 3, 2025. Following the news release, HealthEquity management plans to host a conference call for investors on Wednesday, December 3, 2025, at 4:30 p.m. Eastern Time during which management will review the Company’s financial results.

A replay of the conference call will be made available on the Company’s website at ir.healthequity.com.

About HealthEquity

HealthEquity and its subsidiaries administer HSAs and various other consumer-directed benefits for over 17 million accounts, working in close partnership with employers, benefits advisors, and health and retirement plan providers who share our unwavering commitment to our mission of saving and improving lives by empowering healthcare consumers. Through cutting-edge solutions, innovation, and a relentless focus on improving health outcomes, we empower individuals to take control of their healthcare journey while ultimately enhancing their overall well-being. Learn more about our “Purple” service and approach at www.healthequity.com. 

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements regarding our industry, business strategy, plans, goals and expectations concerning our markets and market position, product expansion, future operations, expenses and other results of operations, revenue, margins, profitability, acquisition synergies, future efficiencies, tax rates, capital expenditures, liquidity and capital resources and other financial and operating information. When used in this discussion, the words “may,” “believes,” “intends,” “seeks,” “aims,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “will,” “future” and the negative of these or similar terms and phrases are intended to identify forward-looking statements in this press release.

Forward-looking statements reflect our current expectations regarding future events, results or outcomes. These expectations may or may not be realized. Although we believe the expectations reflected in the forward-looking statements are reasonable, we can give you no assurance these expectations will prove to be correct. Some of these expectations may be based upon assumptions, data or judgments that prove to be incorrect. Actual events, results and outcomes may differ materially from our expectations due to a variety of known and unknown risks, uncertainties and other factors. Although it is not possible to identify all of these risks and factors, they include, among others, risks related to the following:

• our ability to adequately place and safeguard our custodial assets, or the failure of any of our depository or insurance company partners;
• our ability to compete effectively in a rapidly evolving healthcare and benefits administration industry;
• our dependence on the continued availability and benefits of tax-advantaged HSAs and other CDBs;
• risks relating to our recent CEO transition;
• the impact of increased fraudulent account activity involving our member accounts or our third-party service providers on our reputation and financial results;
• our ability to successfully identify, acquire and integrate additional portfolio purchases or acquisition targets;
• the significant competition we face and may face in the future, including from those with greater resources than us;
• our reliance on the availability and performance of our technology and communications systems;
• recent and potential future cybersecurity breaches of our technology and communications systems and other data interruptions, including resulting costs and liabilities, reputational damage and loss of business;
• the current uncertain healthcare environment, including changes in healthcare programs and expenditures and related regulations;
• potential regulatory changes and changes in the enforcement environment under the new U.S. administration;
• our ability to comply with current and future privacy, healthcare, tax, ERISA, investment adviser and other laws applicable to our business;
• our reliance on partners and third-party vendors for distribution and important services;
• our ability to develop and implement updated features for our technology platforms and communications systems; and
• our reliance on our management team and key team members.

For a detailed discussion of these and other risk factors, please refer to the risks detailed in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the fiscal year ended January 31, 2025. Past performance is not necessarily indicative of future results. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor Relations Contact:
Richard Putnam
801-727-1000
rputnam@healthequity.com

Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE® (setmelanotide) in Canada in Five Provinces and Under the Federal Non-Insured Health Benefits Program




Rhythm Pharmaceuticals Announces Public Reimbursement for IMCIVREE® (setmelanotide) in Canada in Five Provinces and Under the Federal Non-Insured Health Benefits Program

IMCIVREE now publicly covered for weight management due to Bardet-Biedl syndrome (BBS) in Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia and under NIHB

BOSTON, Nov. 05, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it has entered into Product Listing Agreements in the provinces of Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia and with the Federal Non-Insured Health Benefits (NIHB) Program for the public reimbursement of IMCIVREE for weight management in eligible adult and pediatric patients aged 6 years and older with clinically or genetically confirmed Bardet-Biedl syndrome (BBS) and obesity.

“These listing agreements for IMCIVREE mark a significant milestone for individuals living with obesity due to Bardet-Biedl syndrome,” said Prof. Andrea M. Haqq, M.D., Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta. “Patients and families in these provinces can now access a treatment that addresses a root cause of their disease, offering hope and improved quality of life.”

IMCIVREE was approved by Health Canada in May 2023 following priority review and was recently added to the common list of new drugs for rare diseases, as part of the Government of Canada’s National Strategy for Drugs for Rare Diseases. The Common Drug List ensures that the National Strategy for Drugs for Rare Diseases provides the greatest possible benefit to all patients with rare diseases.

“These agreements are an important recognition of the substantial burden of obesity associated with this rare disease,” said Carol Stiff, General Manager, Rhythm Canada. “We continue to engage with all provinces and territories to work toward equitable access in Canada for all patients living with obesity due to BBS.”

About Bardet-Biedl Syndrome

BBS is a rare autosomal recessive ciliopathy that presents with a variety of symptoms that evolve over time, including hyperphagia, early-onset, severe obesity, visual impairment, polydactyly, genital abnormalities, renal dysfunction, and cognitive impairment.

About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE^® (setmelanotide), an MC4R agonist is approved by the FDA to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication
In Canada, IMCIVREE (setmelanotide solution for subcutaneous injection) is indicated for weight management in adult and pediatric patients 6 years of age and older with obesity due to: Bardet-Biedl syndrome (BBS) Genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency due to variants interpreted as pathogenic, likely pathogenic, or of uncertain significance.

In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use

Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

• Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
• Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

CONTRAINDICATION

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full U.S. Prescribing Information for additional Important Safety Information. Please see the Canadian Product Monograph at https://rhythmtx.ca/wp-content/uploads/2023/05/IMCIVREE-Product-Monograph-EN.pdf for complete safety information for Canada.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the safety, efficacy, potential benefits of, and clinical design or progress of any of our products or product candidates, including setmelanotide, at any dosage or in any indication, the public reimbursement for IMCIVREE (setmelanotide) in Canada in five provinces and under the NIHB and the potential impact of such reimbursement on eligible patient access and on our revenue in Canada. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors, including those discussed under the caption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise.

Corporate Contact:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
dconnolly@rhythmtx.com

Media Contact:
Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com

Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)




Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

NEW YORK, Nov. 05, 2025 (GLOBE NEWSWIRE) — Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that on November 1, 2025, the Company granted inducement awards to purchase up to 143,500 shares of common stock to four new employees under the Company’s 2023 Inducement Plan. The stock options will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the vesting commencement date and 1/48th of the underlying shares vesting monthly thereafter over 36 months, subject to the employee’s continued service relationship with Syndax through the applicable vesting dates.

About Syndax
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include Revuforj^® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com or follow the Company on X and LinkedIn.

Syndax Contact

Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827

VALNEVA Declaration of shares and voting rights: October 31, 2025




VALNEVA Declaration of shares and voting rights: October 31, 2025

VALNEVA

Declaration of shares and voting rights
October 31, 2025
__________________________________________________________________________________________

Company name: VALNEVA
Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France)
Regulated market of Euronext Paris – Compartment B

Declaration date: November 5, 2025

___________________________

* Theoretical voting rights. This number is used as the basis for calculating threshold crossings. In accordance with Article 223-11 of the AMF General Regulations, this number is calculated on the basis of all shares to which voting rights are attached, including those for which voting rights have been suspended.
** Net (or exercisable at a General Meeting) voting rights.

Attachment

• 2025_11_05 DECLARATION_VOTING_RIGHTS October 31 2025 EN_GN