Invasive, deadly fungus affecting bats found in Rocky Mountain National Park
In a Thursday press release from the national park, tests done by the U.S. Geological Survey confirmed the fungus known as Pseudogymnoascus destructans, or Pd, has been detected in bats in the Holzwarth Historic Site on the west side of Rocky Mountain National Park.
According to the park, this is the first confirmed detection of the fungus in Grand County.
Pd is described as an invasive fungus that causes white-nose syndrome — a deadly and infectious disease that impacts bats.
'Any new detection of Pd is worrisome because bats are vital for healthy ecosystems. Rocky Mountain National Park is home to nine known species of bats, five of which have been found living in areas above 11,000 feet,' said Rocky Mountain National Park in a press release.
How much snow will fall in the high country this weekend?
While white-nose syndrome does not pose a risk to humans, people can spread the disease.
Following the detection, Rocky Mountain National Park has provided protection tips to visitors. The park asks people to report dead or injured bats to park personnel. The park also said people should never touch a bat, because they could carry other dangerous diseases aside from white-nose syndrome.
If you do visit a cave or bat habitat, Rocky Mountain National Park recommends you properly decontaminate gear and outerwear.
The national park said white-nose syndrome was first confirmed in 2022 in southeastern Colorado, it has also been confirmed in Larimer County.
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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Business Upturn
4 hours ago
- Business Upturn
FDA Approves Apellis' EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older
Proven efficacy across all three key markers of disease—68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence Well-established safety profile, consistent across >2,200 patient years in approved indications C3G and primary IC-MPGN are rare kidney diseases with high risk of kidney failure Conference call tomorrow at 8:00 a.m. ET WALTHAM, Mass., July 28, 2025 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States.1 'I'm excited to now have a highly effective therapy for a broad range of patients living with C3G and primary IC-MPGN,' said Carla Nester, M.D., MSA, FASN, lead principal investigator for the VALIANT study, professor of internal medicine and pediatrics and director of pediatric nephrology, University of Iowa Stead Family Children's Hospital. 'With standard of care, patients living with these rare and severe diseases frequently progress to kidney failure, necessitating lifelong dialysis and/or a kidney transplant. Given the urgent need, particularly in children, the approval of EMPAVELI marks a pivotal moment in the treatment of rare kidney diseases.' In the Phase 3 VALIANT study, EMPAVELI demonstrated an unprecedented 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits as measured by C3 staining, compared to placebo. The positive results were consistent across adolescent and adult patients with C3G and primary IC-MPGN, and in C3G patients with post-transplant disease recurrence. 'EMPAVELI has the potential to be truly transformational for patients with C3G and primary IC-MPGN, who until now have had very few treatment options. In the largest pivotal study of these diseases, EMPAVELI demonstrated its potential to preserve kidney function by controlling all three key markers of disease,' said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. 'As Apellis' third approval in four years, this milestone underscores the unique ability of targeting C3 to improve patients' lives. We are deeply grateful to everyone who made this approval possible and look forward to building on this momentum as we advance pivotal studies of EMPAVELI in other rare kidney diseases.' 'The approval of EMPAVELI is a historic milestone for people living with C3G and primary IC-MPGN, many of whom are adolescents or young adults,' said Josh Tarnoff, chief executive officer, NephCure. 'We recognize Apellis' commitment to these patients and their families, and to the research and innovation that will bring this life-changing treatment into the hands of patients that need it most.' The approval of EMPAVELI is based on positive six-month results from the VALIANT study, demonstrating benefits across all three key markers of disease: Proteinuria reduction: The study met its primary endpoint, demonstrating a statistically significant 68% (p<0.0001) proteinuria reduction in EMPAVELI-treated patients compared to placebo. The study met its primary endpoint, demonstrating a statistically significant 68% (p<0.0001) proteinuria reduction in EMPAVELI-treated patients compared to placebo. Stabilization of kidney function: EMPAVELI-treated patients achieved stabilization of kidney function compared to placebo (nominal p=0.03) as measured by estimated glomerular filtration rate (eGFR). EMPAVELI-treated patients achieved stabilization of kidney function compared to placebo (nominal p=0.03) as measured by estimated glomerular filtration rate (eGFR). Reduction of C3 staining: A majority of EMPAVELI-treated patients achieved a reduction in C3 staining intensity (nominal p<0.0001) compared to placebo. 71% of EMPAVELI-treated patients achieved zero C3 staining intensity, demonstrating complete clearance of C3 deposits. The safety profile of EMPAVELI is well-established, with >2,200 patient years across all approved indications. The most common adverse reactions in the VALIANT study (≥10%) were infusion site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea. Apellis is committed to helping patients with treatment access and support. ApellisAssist® is a program designed to help EMPAVELI patients along their treatment journey by providing a comprehensive system of support including help navigating insurance coverage, financial assistance for eligible patients, disease education, and ongoing product support. Patients and healthcare providers can call 1-888-273-5547 for more information. Conference Call and Webcast Apellis will host a conference call and webcast to discuss the FDA's approval of EMPAVELI tomorrow, July 29, 2025 at 8:00 a.m. ET. To access the live call by phone, please pre-register for the call here. A live audio webcast of the event and accompanying slides may also be accessed through the 'Events and Presentations' page of the 'Investors and Media' section of the company's website. A replay of the webcast will be available for 30 days following the event. About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis therapy.2-4 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.5 The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.1 About the VALIANT Study The VALIANT Phase 3 study (NCT05067127) was a randomized, placebo-controlled, double-blinded, multi-center study that evaluated EMPAVELI® (pegcetacoplan) efficacy and safety in 124 patients who were 12 years of age and older with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include pediatric and adult patients, with native and post-transplant kidneys. Study participants were randomized to receive EMPAVELI or placebo twice weekly for 26 weeks. Following this 26-week randomized controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received EMPAVELI. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at Week 26 compared to baseline. About EMPAVELI ® /Aspaveli ® (pegcetacoplan) EMPAVELI®/Aspaveli® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. It is approved for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in the United States and paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally. The therapy is also under investigation for other rare diseases. U.S. Important Safety Information for EMPAVELI BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae , Neisseria meningitidis , and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS. CONTRAINDICATIONS Hypersensitivity to pegcetacoplan or to any of the excipients For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae , Neisseria meningitidis , and Haemophilus influenzae type B WARNINGS AND PRECAUTIONS Serious Infections Caused by Encapsulated Bacteria EMPAVELI, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae , Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria. Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria. Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections. EMPAVELI is available only through a restricted program under a REMS. EMPAVELI REMS EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following: Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients' vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified. Further information is available at or 1-888-343-7073. Infusion-Related Reactions Systemic hypersensitivity reactions (eg, facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved. Interference with Laboratory Tests There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels. ADVERSE REACTIONS Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3G or primary IC-MPGN (incidence ≥10%) were infusion-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea. USE IN SPECIFIC POPULATIONS Females of Reproductive Potential EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose. Please see full Prescribing Information, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide. About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit or follow us on LinkedIn and X. Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential market opportunity of EMPAVELI for C3G and IC-MPGN. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the clinical trial results of EMPAVELI for C3G and IC-MPGN indicate an effect that is greater than the actual positive effect; and any other factors discussed in the 'Risk Factors' section of Apellis' Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2025 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media:Tracy Vineis [email protected] 617.420.4839


Business Wire
5 hours ago
- Business Wire
Community Health Systems, Inc. Announces Pricing of Upsized Offering of Senior Secured Notes Due 2034
FRANKLIN, Tenn.--(BUSINESS WIRE)--Community Health Systems, Inc. (the 'Company') (NYSE: CYH) today announced that its wholly owned subsidiary, CHS/Community Health Systems, Inc. (the 'Issuer'), has priced an offering of $1,790 million aggregate principal amount of its 9.750% Senior Secured Notes due 2034 (the 'Notes') (the 'Notes Offering'). The size of the offering was increased by $290 million aggregate principal amount of Notes subsequent to the initial announcement of the proposed offering. The sale of the Notes is expected to be consummated on or about August 12, 2025, subject to customary closing conditions. The Issuer intends to use the net proceeds of the Notes Offering, together with cash on hand, to retire all of its 5.625% Senior Secured Notes due 2027 (the '2027 Notes') and to pay related fees and expenses. In particular, the Issuer intends to use the net proceeds from the Notes Offering to (i) purchase the Issuer's outstanding 2027 Notes that are validly tendered and accepted for purchase in the cash tender offer announced July 28, 2025 and (ii) to the extent the aggregate principal amount of the 2027 Notes validly tendered and accepted for purchase in the cash tender offer is less than the total aggregate principal amount outstanding of the 2027 Notes, redeem any unpurchased principal amount of the 2027 Notes on December 15, 2025. This press release shall not constitute a notice of redemption for or an offer to repurchase any 2027 Notes. The Notes are being offered in the United States to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the 'Securities Act'), and outside the United States pursuant to Regulation S under the Securities Act. The Notes have not been registered under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offers of the Notes will be made only by means of a private offering memorandum. This notice is being issued pursuant to and in accordance with Rule 135(c) under the Securities Act. Forward-Looking Statements This press release may include information that could constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risk and uncertainties. The Company undertakes no obligation to revise or update any forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law.


Business Wire
7 hours ago
- Business Wire
Exelixis Announces Second Quarter 2025 Financial Results and Provides Corporate Update
ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones. 'Exelixis continued to execute on our corporate objectives in the second quarter of 2025, delivering on key commercial, development and pipeline milestones,' said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. 'While early in the launch, we're very pleased with the reception that CABOMETYX ® has received in advanced neuroendocrine tumors (NET). Our commercial team rapidly mobilized on the U.S. NET launch following approval in March, capturing a leading share of new patient starts among oral therapies in second-line and later settings with NET representing approximately four percent of our overall CABOMETYX business in the second quarter. We will continue to track the launch trajectory and provide updates to our 2025 full year financial guidance, as appropriate.' Dr. Morrissey continued: 'Turning to the zanzalintinib development program, in June, we announced positive topline results from the STELLAR-303 pivotal study in colorectal cancer. We plan to discuss these results with regulators with the intention of filing for approval in this indication as quickly as possible. In May, we completed enrollment into the STELLAR-304 pivotal study in non-clear cell renal cell carcinoma with top-line results expected in the first half of 2026, depending on study event rates. Based on our evaluation of emerging data from the phase 2 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck, emerging competition in this indication and assessment of other potentially larger commercial opportunities, we have made the decision not to proceed to the phase 3 portion of the trial. We also initiated the STELLAR-311 pivotal study in advanced NET during the quarter and plan to announce an additional wave of zanzalintinib pivotal trials in the coming months. Finally, our early-stage pipeline is advancing quickly with phase 1 clinical studies ongoing for our XL309, XB010 and XB628 programs, and XB371 moving into clinical investigation. As we look ahead to the second half of the year, I'd like to thank the entire Exelixis team for their continued execution across our business, and for their dedication to our mission to help cancer patients recover stronger and live longer.' Second Quarter 2025 Financial Results Total revenues for the quarter ended June 30, 2025 were $568.3 million, as compared to $637.2 million for the comparable period in 2024. Total revenues for the quarter ended June 30, 2025 included net product revenues of $520.0 million, as compared to $437.6 million for the comparable period in 2024. The increase in net product revenues was primarily due to an increase in sales volume. Collaboration revenues, composed of license revenues and collaboration services revenues, were $48.2 million for the quarter ended June 30, 2025, as compared to $199.6 million for the comparable period in 2024. The decrease in collaboration revenues was primarily related to a $150.0 million commercial milestone recognized during the second quarter of 2024 in connection with Ipsen achieving $600 million in cumulative net sales of cabozantinib in its related license territory over four consecutive quarters. Research and development expenses for the quarter ended June 30, 2025 were $200.4 million, as compared to $211.1 million for the comparable period in 2024. The decrease in research and development expenses was primarily related to decreases in manufacturing costs to support our development candidates and clinical trial costs, partially offset by increases in stock-based compensation, consulting and outside services, and personnel expenses. Selling, general and administrative expenses for the quarter ended June 30, 2025 were $134.9 million, as compared to $132.0 million for the comparable period in 2024. The increase in selling, general and administrative expenses was primarily related to increases in marketing expenses, stock-based compensation, and personnel expenses, partially offset by a decrease in corporate giving. Provision for income taxes for the quarter ended June 30, 2025 was $45.6 million, as compared to $66.7 million for the comparable period in 2024. GAAP net income for the quarter ended June 30, 2025 was $184.8 million, or $0.68 per share, basic and $0.65 per share, diluted, as compared to GAAP net income of $226.1 million, or $0.78 per share, basic and $0.77 per share diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended June 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs. Non-GAAP net income for the quarter ended June 30, 2025 was $212.6 million, or $0.78 per share, basic and $0.75 per share, diluted, as compared to non-GAAP net income of $245.6 million, or $0.85 per share, basic and $0.84 per share diluted, for the comparable period in 2024. Non-GAAP Financial Measures To supplement Exelixis' financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented. Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Exelixis' results from period to period, and to identify operating trends in Exelixis' business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis' business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release. 2025 Financial Guidance Exelixis is maintaining the previously provided financial guidance for fiscal year 2025. ____________________ (1) Exelixis' 2025 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.8% for CABOMETYX effective Jan. 1, 2025. (2) Includes $50.0 million of non-cash stock-based compensation. (3) Includes $80.0 million of non-cash stock-based compensation. Expand Second Quarter 2025 Highlights Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $520.0 million during the second quarter of 2025, with net product revenues of $517.9 million from CABOMETYX (cabozantinib) and $2.1 million from COMETRIQ ® (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis' collaboration partners during the quarter ended June 30, 2025, Exelixis earned $43.4 million in royalty revenues. Partner Ipsen Received Approval from the European Commission (EC) for CABOMETYX for Patients with Previously Treated Advanced NET. In July, Exelixis announced that its partner Ipsen received approval from the EC for CABOMETYX for adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This approval follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland. In March, Exelixis received approval from the U.S. Food and Drug Administration (FDA) for CABOMETYX in this setting. These approvals were based on the positive results of the phase 3 CABINET pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET. Announcement of Positive Top-line Results from the Phase 3 STELLAR-303 Pivotal Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Patients with Metastatic Colorectal Cancer (CRC). In June, Exelixis announced positive top-line results from the phase 3 STELLAR-303 pivotal trial in which the combination of zanzalintinib with atezolizumab (Tecentriq ®) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population. The STELLAR-303 study is evaluating zanzalintinib in combination with atezolizumab versus regorafenib in patients with metastatic, refractory non-microsatellite instability-high or non-mismatch repair-deficient (non-MSI-H/dMMR) CRC. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The top-line findings were from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases or NLM). The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Exelixis plans to discuss these results with regulators with the intention of filing for approval in this indication as soon as possible. Detailed results will be presented at a future medical meeting. Presentation of Encouraging Results from Phase 1b/2 STELLAR-002 Trial Evaluating Zanzalintinib in Combination with Immune Checkpoint Inhibitors in Advanced Kidney Cancer at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025). In June, Exelixis presented results from multiple dose-escalation cohorts of patients with advanced solid tumors, and an expansion cohort of patients with previously untreated advanced clear cell renal cell carcinoma (ccRCC) from the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo ®) or a fixed-dose combination of nivolumab and relatlimab (Opdualag ™) at ASCO 2025. The results from the ccRCC expansion cohort demonstrated encouraging activity across all efficacy parameters, including objective response rate (ORR), progression-free survival (PFS) and disease control rates. The findings from the dose-escalation cohorts showed that the toxicity profile of these combinations was manageable and consistent with each agent administered as monotherapy. Zanzalintinib Pivotal Development Program Updates. Today, Exelixis announced several updates to the zanzalintinib development program, including: STELLAR-304 study enrollment completed in May 2025. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (nccRCC). The primary endpoints in the trial are PFS and ORR. Top-line results are expected in the first half of 2026, depending on study event rates. Based on the company's evaluation of emerging data from the phase 2 portion of the STELLAR-305 trial in advanced squamous cell carcinoma of the head and neck (SCCHN), emerging competition in this indication, and assessment of other, potentially larger, commercial opportunities, Exelixis has decided not to proceed to phase 3. Initiation of the STELLAR-311 phase 3 pivotal trial in advanced NET. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review. Plans to announce the next wave of zanzalintinib pivotal trials in the coming months. Preclinical Data Presentations from Four Pipeline Programs in Advanced Cancers at the American Association for Cancer Research Annual Meeting (AACR 2025). In April, Exelixis presented preclinical data from four pipeline molecules at AACR 2025. Presentations included data for XL309 and XL495, small molecules that have demonstrated synthetic lethality in the context of certain genetic anomalies found in varying frequencies across a broad array of tumor types. The XL309 findings demonstrated activity of XL309 as monotherapy or in combination with PARP or topoisomerase inhibitors. Data analysis from the XL495 program demonstrated the potential for anti-tumor activity both as monotherapy and in combination with DNA-damaging agents. However, based on early clinical data generated for XL495, Exelixis has discontinued further development of this program. Preclinical data were also presented for the PD-L1 + NKG2A-targeting bispecific antibody XB628 and for the tissue factor (TF)-targeting antibody-drug conjugate (ADC) XB371. Data analysis from the XB628 program demonstrated the molecule's tumor cell killing activity both in vitro and in vivo, supporting advancement of this molecule into clinical development. Findings from XB371 non-clinical experiments demonstrated potent anti-tumor activity in vivo across a range of human tumor xenograft models including colorectal, lung, and pancreatic cancers, supporting the molecule's advancement into phase 1 clinical development. Advancement of XB628 and XB371 Pipeline Programs into Clinical Development. Today, Exelixis provided an update on the recent progress of its early-stage pipeline programs, including XB628 (PD-L1 + NKG2A-targeting bispecific antibody) and XB371 (TF-targeting ADC). In April, Exelixis initiated the phase 1 study of XB628, following the U.S. FDA clearance of its Investigational New Drug (IND) application in March. Exelixis now has three ongoing phase 1 trials for its pipeline programs XL309, XB010 and XB628. Additionally, in July, the U.S. FDA cleared Exelixis' IND application for XB371 and the company plans to initiate the phase 1 study in the coming months. Federal Income Tax Impact from the One Big Beautiful Bill Act. On July 4, 2025, the One Big Beautiful Bill Act was signed into law which, among other provisions, permanently repeals the requirement to capitalize domestic research and experimental (R&E) expenditures for federal income tax purposes for taxable years beginning after December 31, 2024, and allows for the accelerated deduction of any remaining unamortized domestic R&E expenditures. Foreign R&E expenditures are still required to be capitalized and amortized ratably over 15 years. Exelixis estimates its federal cash tax benefit for previously unamortized domestic R&E expenditures is $147 million with no corresponding impact to the federal income tax provision. Positive Developments Across Cabozantinib Patent Estate. Today, Exelixis announced recent positive developments with regards to the company's defense of its cabozantinib patent estate. First, in June and July 2025, the United States Patent and Trademark Office (USPTO) declined to institute Azurity Pharmaceuticals' petitions for inter partes review (IPRs) of U.S. Patent Nos. 11,298,349 and 12,128,039, respectively. Second, in July 2025, Exelixis entered into a settlement agreement with Biocon Pharma Limited, which resolved the patent litigation Exelixis brought in response to Biocon's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of CABOMETYX prior to the expiration of the applicable patents. Pursuant to the terms of the agreement, Exelixis will grant Biocon a license to market its generic version of CABOMETYX in the U.S. beginning on January 1, 2031, if approved by the FDA and subject to conditions and exceptions common to agreements of this type. Stock Repurchase Program. In August 2024, Exelixis' Board of Directors authorized a stock repurchase program to acquire up to $500 million of the company's common stock before December 31, 2025. In February 2025, the Board of Directors authorized the repurchase of up to an additional $500 million of the company's common stock before December 31, 2025. Under these programs, as of June 30, 2025, Exelixis has repurchased $796.3 million of the company's common stock, at an average price of $36.69 per share. Since the approval of the first stock repurchase program in March 2023, the weighted-average diluted common shares outstanding has decreased from 326.3 million shares to 284.4 million shares as of June 30, 2025. Stock repurchases under these programs may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase programs will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended July 4, 2025 and June 28, 2024, are indicated as being as of and for the periods ended June 30, 2025 and June 30, 2024. Conference Call and Webcast Exelixis management will discuss the company's financial results for the second quarter 2025 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Monday, July 28, 2025. To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on for one year. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX ® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis' plans to discuss the results of STELLAR-303 with regulators and intention of filing for approval in this indication as soon as possible; anticipated timing for zanzalintinib pivotal data milestones with respect to the STELLAR-304 and STELLAR-311 trials and plans to announce additional zanzalintinib pivotal trials; Exelixis' assessment of other potential commercial growth opportunities; Exelixis' plans to present data from STELLAR-303 at a future medical meeting; Exelixis' plans to initiate the phase 1 study for XB371 in the coming months; the terms of Exelixis' settlement agreement with Biocon Pharma Limited which is subject to FDA approval and subject to conditions and exceptions common to agreements of this type; and Exelixis' scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis' and its partners' ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; the level of costs associated with Exelixis' commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis' ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib, zanzalintinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis' dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis' continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib, zanzalintinib and other Exelixis product candidates; Exelixis' dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis' ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis' marketed products; changes in economic and business conditions, including as a result of changing trade policies and tariffs and the related uncertainty thereof; and other factors detailed from time to time under the caption 'Risk Factors' in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered trademarks of Exelixis, Inc. Opdivo ® is a registered trademark of Bristol Myers Squibb. Opdualag ™ is a trademark of Bristol Myers Squibb. ____________________ (1) Non-cash stock-based compensation used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. Expand