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CLMT Investors Have Opportunity to Join Calumet, Inc. Fraud Investigation with SBS Law

LOS ANGELES–(BUSINESS WIRE)–Schall, Brown & Schwartz LLP (“SBS”), a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Calumet, Inc. (“Calumet” or “the Company”) (NASDAQ: CLMT) for violations of the securities laws.

INVESTIGATION DETAILS: The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Calumet reported its Q2 2026 financial results on August 7, 2026. The Company’s Performance Brands suffered a decline in EBITDA amongst other business challenges and headwinds the Company faced. Based on this news, shares of Calumet fell by more than 5.7% on the same day.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall or David Schwartz of Schall, Brown & Schwartz LLP, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm’s website at www.schallfirm.com, or by email at [email protected].

WHY SBS? Schall, Brown & Schwartz LLP represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. Bringing together the extensive experience and diverse skillsets of founding partners Brian Schall, Andrew Brown, and David Schwartz, SBS is dedicated to aggressively advocating for every investor.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

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Arrowhead Pharmaceuticals Presents Phase 3 SHASTA-3 and SHASTA-4 Data Demonstrating Plozasiran Reduced Acute Pancreatitis Events in Patients with Severe Hypertriglyceridemia

– Plozasiran reduced triglycerides (TG) by 79% and 81% versus placebo in SHASTA-3 and SHASTA-4 across the broad sHTG population –

– More than 90% of plozasiran-treated patients achieved triglycerides below thresholds for AP risk, 500 mg/dL at Month 12, and more than half achieved triglycerides below 150 mg/dL –

– Plozasiran reduced cumulative acute pancreatitis (AP) events by 78% versus placebo in patients with TG above 500 mg/dL, with or without a prior history of AP –

– Greater absolute benefit of AP risk reduction was observed in patients at higher risk –

– In the highest-risk subgroup, patients with TG above 880 mg/dL and a prior history of AP, there was a 100% reduction in events versus placebo –

– Plozasiran demonstrated a favorable safety and tolerability profile, with overall treatment-emergent adverse events similar between plozasiran and placebo groups –

– Arrowhead plans to file a supplemental New Drug Application with the U.S. FDA by year-end 2026 and utilize a Priority Review Voucher –

– Detailed results presented at the European Society of Cardiology (ESC) Congress 2026 in Munich as a Hot Line Late-Breaking Science session –

PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented results from the pivotal Phase 3 SHASTA-3 and SHASTA-4 studies of plozasiran in adults with severe hypertriglyceridemia (sHTG) during a Hot Line Late-Breaking Science session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany.

SHASTA-3 and SHASTA-4 met their primary and all prespecified secondary endpoints and demonstrated deep and durable reductions in triglycerides (TG), with median reductions from baseline of 79% and 81%, respectively at Month 12 (p<0.0001 in both studies). In a prespecified pooled analysis, plozasiran also significantly reduced acute pancreatitis (AP) events across the broad sHTG study population, with greater absolute benefit observed among patients at higher risk of AP. More than 90% of plozasiran-treated patients in both studies achieved TG levels below 500 mg/dL (<5.65 mmol/L) at Month 12, and more than half achieved TG levels below 150 mg/dL (<1.69 mmol/L).

“These SHASTA-3 and -4 results build on the compelling topline data we reported in July and further strengthen our view that plozasiran has the potential to fundamentally change how severe hypertriglyceridemia is treated,” said Christopher Anzalone, Ph.D., President and Chief Executive Officer at Arrowhead. “The depth and consistency of triglyceride lowering across two large pivotal studies are impressive, but what may be most important for patients and physicians is the significant reduction in acute pancreatitis. The benefit was particularly pronounced among patients with a prior history of pancreatitis, a population with substantial ongoing risk. Combined with quarterly dosing and a favorable safety and tolerability profile, we believe these data demonstrate a highly differentiated profile for plozasiran and unequivocally support our plans to seek regulatory approval for the broader sHTG population. Our purchase of a U.S. FDA Priority Review Voucher, announced earlier this month, will potentially accelerate our goal of getting this important new medicine to patients.”

James Hamilton, M.D., MBA, Chief Medical Officer and Head of R&D at Arrowhead, added, “SHASTA-3 and SHASTA-4 enrolled a broad population that reflects the heterogeneity and substantial disease burden seen in patients with severe hypertriglyceridemia. Plozasiran produced deep and durable reductions in triglycerides and other atherogenic lipoproteins, and more than 90% of treated patients achieved triglyceride levels below the severe hypertriglyceridemia threshold at Month 12. Importantly, the reduction in acute pancreatitis events was observed across the pooled population and became increasingly more meaningful in patients at higher risk. We believe the totality of these data provides strong evidence supporting APOC3 reduction in the liver with plozasiran as a potentially important treatment approach for patients with sHTG.”

Arrowhead intends to leverage data from the Phase 3 SHASTA-3, SHASTA-4 and MUIR-3 studies to seek marketing authorization for plozasiran in the broader sHTG population in multiple global geographies, beginning with a planned supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) before the end of 2026. On August 4, 2026, the company announced it had purchased an FDA Priority Review Voucher, which it intends to utilize for this application.

SHASTA-3 and SHASTA-4 Phase 3 Results

SHASTA-3 and SHASTA-4 were global, randomized, double-blind, placebo-controlled Phase 3 studies evaluating plozasiran 25 mg administered subcutaneously once every three months in adults with sHTG. Across the two studies, 757 patients were randomized to receive plozasiran or placebo.

Triglyceride and Lipoprotein Effects

• At Month 12, median TG levels were reduced from baseline by 79% in SHASTA-3 and 81% in SHASTA-4 in patients receiving plozasiran 25 mg (p<0.0001 in each study).

• Among patients with baseline TG ≥880 mg/dL (≥9.94 mmol/L), median TG reductions at Month 12 were 85% in both SHASTA-3 and SHASTA-4.

• At Month 12, 91% and 93% of plozasiran-treated patients in SHASTA-3 and SHASTA-4, respectively, achieved TG levels <500 mg/dL (<5.65 mmol/L), compared with 51% and 50% of placebo-treated patients (p<0.0001 for each comparison).

• 52% and 55% of plozasiran-treated patients in SHASTA-3 and SHASTA-4, respectively, achieved TG levels <150 mg/dL (<1.69 mmol/L), compared with 7.9% and 2.0% of placebo-treated patients (p<0.0001 for each comparison).

• Plozasiran also produced significant reductions in APOC3, remnant cholesterol (VLDL-C) and non-HDL cholesterol.

Acute Pancreatitis

In a prespecified pooled analysis of AP events from SHASTA-3 and SHASTA-4:

• Plozasiran reduced the rate of all AP events by 78% versus placebo (RR 0.22; 95% CI: 0.07, 0.67; p=0.008), corresponding to a 4.1% absolute risk reduction and a number needed to treat to prevent one AP event over one year (NNT), of 24.

• Plozasiran significantly reduced the risk of a first AP event (HR 0.26; 95% CI: 0.09, 0.78; p=0.016).

• Among patients with TG ≥ 500 mg/dl (5.65 mmol/L) any prior history of AP, plozasiran reduced the AP event rate by 91% versus placebo (RR 0.09; 95% CI: 0.02, 0.41; p=0.002), corresponding to a 34% absolute risk reduction and NNT over one year, of 3.

Safety and Tolerability

Plozasiran demonstrated a favorable safety and tolerability profile in SHASTA-3 and SHASTA-4. Overall treatment-emergent adverse events (TEAEs) were reported in 73% of patients in both the pooled plozasiran and placebo groups. Serious TEAEs occurred in 8.3% of patients receiving plozasiran and 10% receiving placebo. TEAEs leading to study drug discontinuation were uncommon, occurring in 1.4% of plozasiran-treated patients and 0.8% of placebo-treated patients.

The most common TEAEs occurring in at least 5% of plozasiran-treated patients included worsening glycemic control (14.3%) and diarrhea (5.6%), compared with 8.7% and 3.2%, respectively, in placebo-treated patients. Despite the imbalance in reported glycemic control-related TEAEs, mean HbA1c showed minimal to modest absolute change from baseline with no worsening of mean HbA1c over time.

Injection-site reactions occurred in 3.2% of plozasiran-treated patients and 2.0% of placebo-treated patients. There were no cases of anaphylaxis or systemic hypersensitivity. No clinically meaningful changes in platelet counts or meaningful elevations in ALT or AST relative to placebo were observed, and no cases met Hy’s law criteria. In a prespecified MRI-PDFF sub study, there was no statistically significant treatment-emergent increase in hepatic fat fraction (p=0.70).

Three fatal events occurred in plozasiran-treated patients, consisting of two cardiovascular deaths and one death due to chronic myelomonocytic leukemia. All three were attributed to pre-existing cardiovascular or hematologic disease and assessed as unrelated to study treatment.

Conference Call and Webcast

Arrowhead will host a conference call and webcast on August 31, 2026 (14:00 CEST/ 8:00 am EDT/ 5:00 am PDT) to discuss the detailed SHASTA-3 and SHASTA-4 results presented at ESC Congress 2026. For more information and to register for the webcast, visit Events & Presentations on www.arrowheadpharma.com.

About Severe Hypertriglyceridemia

Severe hypertriglyceridemia (sHTG) is characterized by triglyceride (TG) levels greater than 500 mg/dL (5.65 mmol/L), with the most severe form being familial chylomicronemia syndrome (FCS) where TGs typically exceed 880 mg/dL (9.94 mmol/L). SHTG significantly increases the risk of acute pancreatitis (AP), which can often include recurrent attacks requiring repeat hospital admissions and worsening outcomes. AP risk is proportional to the number, characteristics, and concentration of triglyceride rich lipoproteins (TRLs), particularly chylomicrons, and increases as TGs rise. Elevated TGs can also increase the risk of atherosclerotic cardiovascular disease (ASCVD). Limited treatment options exist to sustainably reduce TGs below guideline directed risk thresholds.

About SHASTA-3 and SHASTA-4 Phase 3 Studies

SHASTA-3 (NCT06347003) and SHASTA-4 (NCT06347016) are global double-blind, placebo-controlled, Phase 3 studies to evaluate the efficacy and safety of plozasiran in adults with severe hypertriglyceridemia. Between the two studies, approximately 750 participants were randomized to receive 4 doses (once every 3 months) of 25 mg plozasiran or placebo. The primary endpoint is percent change in fasting serum triglyceride levels from baseline to month 12 compared to placebo. After Month 12, eligible participants are offered an opportunity to continue in an optional open-label extension.

About REDEMPLO^® (plozasiran)

REDEMPLO (plozasiran) is currently approved by the U.S. Food and Drug Administration, Health Canada, China’s National Medical Products Administration, the Australian Therapeutic Goods Administration, and by the European Commission as an adjunct to diet to reduce triglycerides for adults with FCS. REDEMPLO is the first and only siRNA treatment approved in these countries to be studied in both clinically diagnosed and genetically confirmed patients living with FCS.

REDEMPLO is designed to suppress the production of apolipoprotein C-III (APOC3), a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting APOC3 with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is self-administered via subcutaneous injection once every three months.

REDEMPLO has been granted Orphan Medicinal Product Designation by the EMA for the treatment of patients with FCS, and Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the U.S. FDA for the treatment of patients with FCS and was also granted Breakthrough Therapy designation by the U.S. FDA in severe hypertriglyceridemia.

Sanofi acquired the rights to develop and commercialize REDEMPLO in Greater China, with Arrowhead retaining rights to REDEMPLO in all geographies, outside of Greater China.

For more information about REDEMPLO, visit Our Medicines.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals (NASDAQ: ARWR) is a commercial-stage pharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them, harnessing the natural RNA interference (RNAi) mechanism. The company has built a broad portfolio of clinical and commercial RNAi therapeutics through its industry-leading targeted RNAi molecule (TRiM™) platform, which can precisely silence genes in a wide range of cell types, including liver, lung, muscle, adipose, and central nervous system tissue. At Arrowhead, we rapidly advance potential best- and first-in-class RNAi treatments for diseases with significant unmet medical need, because every day matters to the patients we serve.

For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline, products or product candidate or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about our beliefs and expectations regarding the long-term impacts of REDEMPLO^® (plozasiran) on patient health and the health care system; our beliefs and expectations regarding the pricing, value, or expected timing for availability of our drugs and drug candidates; and our believes and expectations around the potential uses and value of the TRiM™ platform. These statements are based upon our current expectations and speak only as of the date hereof. Actual results or outcomes may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products, demand for our products, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

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L3Harris Celebrates Successful Launch of NASA’s Nancy Grace Roman Space Telescope

CAPE CANAVERAL, Fla.–(BUSINESS WIRE)–
L3Harris Technologies (NYSE: LHX) has contributed key elements to NASA’s successfully launched Nancy Grace Roman Space Telescope, an observatory designed to map the universe. The milestone also marks the culmination of more than a decade of engineering, innovation and collaboration between L3Harris and NASA’s Goddard Space Flight Center.

L3Harris provided the 2.4-meter Optical Telescope Assembly (OTA) for NASA, which serves as Roman’s eye. The company also supported the mission with radiation-hardened electronics, which keep the telescope in operation approximately 1 million miles from Earth.

“It’s a great source of pride for L3Harris that the optical eye we engineered will survey the cosmos 1,000 times faster than the Hubble Space Telescope and is expected to unveil billions of galaxies, hundreds of millions of stars and more than 100,000 distant worlds,” said Jeff Hanke, President, Space Systems, Space & Mission Systems, L3Harris. “This L3Harris technology is helping to rewrite our understanding of the universe.”

Roman’s L3Harris-built OTA will conduct three primary surveys, once operational, including peering through the Milky Way’s dense galactic center to build the largest astronomical catalog ever compiled. It will scan roughly 12% of the entire sky in under 18 months to measure how quickly the universe is expanding and study supernova explosions from up to 8 billion years ago.

This milestone continues L3Harris’ tradition of enabling space exploration, as its technology was integral to landmark missions, including the James Webb Space Telescope, Mars Perseverance and Curiosity rovers, the GPS satellite constellation and International Space Station systems.

About L3Harris Technologies

L3Harris is the Trusted Disruptor in defense tech. With customers’ mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security. Visit L3Harris.com for more information.

Forward-Looking Statements

This press release contains forward-looking statements that reflect management’s current expectations, assumptions and estimates of future performance and economic conditions. Such statements are made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The company cautions investors that any forward-looking statements are subject to risks and uncertainties that may cause actual results and future trends to differ materially from those matters expressed in or implied by such forward-looking statements. Statements about system capabilities are forward-looking and involve risks and uncertainties. L3Harris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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Alnylam Presents New Data at ESC Congress 2026 Reinforcing Strength in RNAi-Powered TTR Silencing Across ATTR-CM Patient Populations and Treatment Settings

–Late-Breaking Prespecified Subgroup Analysis of HELIOS-B Demonstrates that Vutrisiran Provided Consistent Clinical Benefit Across All-Cause Mortality and Recurrent Cardiovascular Events in Patients With or Without Tafamidis Use at Baseline –

–Additional Post Hoc Analyses Highlight Positive Impact of Vutrisiran in Addressing the Multisystemic Manifestations of ATTR-CM –

–Pooled Analysis Across Four Positive Phase 3 Studies of Vutrisiran and Patisiran Shows Consistent Treatment Effect Across Sexes –

–New Subgroup Analysis from KARDIA-3 Phase 2 Study of Zilebesiran Highlights Potential to Provide Enhanced Blood Pressure Control –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new data at the European Society of Cardiology (ESC) Congress 2026 demonstrating the strength of RNAi-powered silencing for cardiovascular disease. The findings further reinforce the clinical profile of AMVUTTRA^® (vutrisiran) across transthyretin amyloidosis (ATTR) patient populations, treatment settings, and manifestations of disease. Additionally, the data expand the potential application of RNAi to uncontrolled hypertension, the world’s leading cause of cardiovascular disease.

“With the power of our RNAi therapeutics platform, we have the potential to make a transformational impact on cardiovascular care,” said Pushkal Garg, M.D., Chief Research and Development Officer at Alnylam. “The data presented at ESC demonstrate the consistency of clinical outcomes achieved by RNAi-powered TTR silencing, reinforcing our conviction in AMVUTTRA as a first-line treatment option for ATTR-CM. With zilebesiran, we have the potential to extend the precision and durability of RNAi to uncontrolled hypertension. Together, these programs reflect our ambition to change the course of cardiovascular disease for patients with high unmet need.”

Vutrisiran Analyses

HELIOS-B Prespecified Subgroup Analysis Demonstrates Consistent Clinical Benefit with Vutrisiran Across Contemporary ATTR-CM Treatment Settings

A late-breaking oral presentation featured a prespecified subgroup analysis of the HELIOS-B Phase 3 clinical trial evaluating the treatment effect of vutrisiran according to baseline tafamidis use. The results were simultaneously published in the Journal of the American College of Cardiology.

Among 654 randomized and treated patients in HELIOS-B, 259 patients (40%) were receiving tafamidis at baseline. The treatment effect for vutrisiran on the primary composite endpoint of all-cause mortality and recurrent cardiovascular events through 33-36 months was consistent irrespective of baseline tafamidis use, suggesting clinical benefits across broad patient populations, including those receiving stabilizers.

All-cause mortality and additional cardiovascular outcomes showed a similar benefit among patients who were receiving tafamidis at baseline (“combination population”) and those who were not (“monotherapy population”). Across both groups, treatment with vutrisiran preserved functional capacity versus placebo, as measured by the Six-Minute Walk Test. Improvement in health status by vutrisiran versus placebo, as measured by the Kansas City Cardiomyopathy Questionnaire-overall summary score, was observed in both the monotherapy and combination populations with an attenuated effect seen among patients receiving tafamidis at baseline. Safety outcomes were generally similar between combination vutrisiran and tafamidis versus tafamidis alone, and between vutrisiran monotherapy versus placebo. HELIOS-B was not powered to establish the benefit of vutrisiran specifically in the population of patients receiving background tafamidis at baseline. These findings reinforce the impact of vutrisiran across contemporary ATTR-CM treatment settings and warrant further evaluation of TTR silencing and stabilization combination strategies.

Additional HELIOS-B Analyses Highlight the Potential Impact of Vutrisiran on the Multisystemic Burden of ATTR-CM

Additional analyses presented at ESC further underscore the multisystemic burden of ATTR-CM and the importance of evaluating measures beyond traditional cardiac endpoints. Real-world evidence from the French National Health Data System showed that patients with ATTR-CM had a significantly higher burden of extra-cardiac manifestations across multiple organ systems compared with matched controls, and multiple manifestations were recorded years before ATTR-CM identification and tended to accumulate over time, suggesting a prolonged pre-diagnostic phase with evolving multisystem involvement.

A post hoc analysis of HELIOS-B evaluated the impact of treatment with vutrisiran on intrinsic capacity, a composite measure encompassing locomotion, cognition, vitality, psychological well-being and sensory function aligned with the World Health Organization Integrated Care for Older People framework. In the overall study population, compared with placebo, patients treated with vutrisiran demonstrated 25% less decline from baseline intrinsic capacity score and a 52% reduction in the risk of decline, suggesting that treatment with vutrisiran may help preserve functional reserve and support healthy aging in patients with ATTR-CM.

A separate post hoc safety analysis of HELIOS-B showed that patients treated with vutrisiran had fewer adverse events overall compared with placebo across the overall study population, monotherapy population and combination population. Among the most frequent system organ classes in the overall population, the lowest adverse event rate ratios were observed for gastrointestinal disorders and nervous system disorders, with 42% and 41% lower adverse event rates, respectively, with vutrisiran compared with placebo; eye disorders showed a 46% lower event rate with vutrisiran compared with placebo.

Pooled Phase 3 Data Reinforce Consistent Treatment Effects of RNAi-Powered TTR Silencing Across Sexes

A pooled analysis of 1,402 patients (203 females, 1,199 males) across four Phase 3 studies of vutrisiran and patisiran further reinforces the clinical benefits of RNAi-mediated TTR silencing across sexes. Despite sex-specific baseline differences in disease presentation, treatment effects were consistent between females and males across both ATTR-CM and the polyneuropathy of hereditary ATTR (hATTR-PN), including clinical, biomarker, functional, health status and echocardiographic measures.

“These data add to the deep and consistent evidence base supporting RNAi-mediated TTR silencing in ATTR-CM,” said Teresa Trenkwalder, M.D., Senior Physician, TUM University Hospital German Heart Center. “Across patient populations, treatment settings, and manifestations of disease, the analyses of vutrisiran demonstrate the clinical benefit that can be achieved by reducing TTR production at its source.”

Zilebesiran Analysis

The KARDIA-3 Phase 2 study evaluated zilebesiran, an investigational RNAi therapeutic with the potential to provide continuous control of blood pressure (BP) with biannual dosing, in patients with uncontrolled hypertension with high cardiovascular (CV) risk treated with two or more background antihypertensives. In patients who were receiving a background diuretic with an office systolic BP (SBP) ≥140 mmHg at baseline, zilebesiran achieved greater reductions in mean office and 24-hour ambulatory SBP than in the overall study population. Furthermore, patients treated with zilebesiran experienced SBP reductions across the diurnal cycle, including at nighttime. Similar findings were observed in patients who had impaired nocturnal dipping at baseline. These findings are potentially important given the association between elevated nighttime BP and CV risk. The safety profile in this post hoc subgroup was consistent with the broader zilebesiran Phase 2 program. These findings further support the evaluation of zilebesiran in the ongoing global Phase 3 CV outcomes trial, ZENITH.

Zilebesiran will be featured as part of Alnylam’s 10th “RNAi Roundtable” series on September 17, 2026, at 10:30 a.m. ET.

To view Alnylam’s ESC Congress 2026 presentations, please visit Capella. Alnylam may share additional data and information during the Congress through its Investors website and/or Capella.

AMVUTTRA^® (vutrisiran) INDICATIONS AND IMPORTANT SAFETY INFORMATION

Indications

In the EU, AMVUTTRA^® (vutrisiran) is indicated for the treatment of:

• hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (hATTR-PN).

• wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Availability across the EU is subject to local reimbursement timelines.

Important Safety Information

Reduced Serum Vitamin A Levels and Recommended Supplementation

Vutrisiran treatment can lower serum vitamin A levels, therefore supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients.

Adverse Reactions

Commonly reported adverse reactions with vutrisiran were injection site reactions and increase in blood alkaline phosphatase and alanine transaminase.

For additional information about vutrisiran, please see the full Summary of Product Characteristics.

ONPATTRO^® (patisiran) INDICATION AND IMPORTANT SAFETY INFORMATION

Indication

In the EU, ONPATTRO^® (patisiran) is indicated for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy.

Important Safety Information

Reduced Serum Vitamin A Levels and Recommended Supplementation

Patisiran treatment can lower serum vitamin A levels, therefore supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients.

Adverse Reactions

The most common adverse reactions that occurred in patients treated with patisiran were peripheral oedema (30%) and infusion-related reactions (19%).

For additional information about patisiran, please see the full Summary of Product Characteristics

About AMVUTTRA^® (vutrisiran)

AMVUTTRA^® (vutrisiran) demonstrates strength in RNAi-powered transthyretin (TTR) silencing, delivering rapid knockdown of TTR at the source of disease to address the underlying cause of transthyretin amyloidosis (ATTR). In the HELIOS-B Phase 3 study, AMVUTTRA reduced the risk of all-cause mortality and recurrent CV events compared to placebo in the overall and monotherapy populations by 28.2% and 32.8%, respectively, through 36 months. It is the only TTR silencer approved for both the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) and cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in countries globally. AMVUTTRA is administered once quarterly via subcutaneous injection.

About Transthyretin Amyloidosis (ATTR)

Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by pathogenic transthyretin (TTR) proteins, which accumulate as amyloid deposits in various parts of the body, including the nerves, heart, and gastrointestinal tract. Patients may present with polyneuropathy, cardiomyopathy, or both manifestations of disease. There are two different forms of ATTR – hereditary ATTR (hATTR), which is caused by a TTR gene variant, and wild-type ATTR (wtATTR), which occurs without a TTR gene variant. It is estimated that more than 500,000 people worldwide live with ATTR, with ~80% remaining undiagnosed.

About Zilebesiran

Zilebesiran is an investigational, subcutaneously administered RNAi therapeutic in development for cardiovascular (CV) risk reduction in hypertensive patients at high risk or with established CVD. Zilebesiran targets angiotensinogen (AGT), the most upstream precursor in the renin-angiotensin-aldosterone system (RAAS), which plays a role in blood pressure (BP) regulation and impacts CV and renal health. Clinical trial results have shown the potential for zilebesiran to provide continuous control of BP with biannual dosing in a broad population of patients with hypertension. Zilebesiran is being evaluated in a Phase 3 CV outcomes trial, ZENITH, which will assess its ability to reduce the risk of CV death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events in patients with hypertension and established or at high risk of CVD, despite the use of at least two or more antihypertensives. The safety and efficacy of zilebesiran have not been established or evaluated by the FDA, EMA, or any other health authority. Zilebesiran is being co-developed and co-commercialized by Alnylam and Roche.

About Cardiovascular Disease and Hypertension

Cardiovascular disease (CVD) is a global health crisis and a leading cause of death worldwide, responsible for approximately 20 million deaths annually. Hypertension is the primary cause of and number one modifiable risk factor for CVD. An estimated one in three adults worldwide have hypertension, and despite wide availability of antihypertensives, up to 80% of all patients, and up to one-third of treated patients, do not reach and maintain blood pressure (BP) targets. Even when BP appears well-managed, continuous control of BP may remain suboptimal, leading to variability in BP during the 24-hour period and in the long-term, putting patients at greater risk of cardiovascular events and end organ damage.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is a leading global biopharmaceutical company and the pioneer of the RNA interference (RNAi) revolution. The Company is focused on developing transformative therapies with the potential to prevent, halt, or reverse disease. For more than two decades, Alnylam has advanced the Nobel-Prize-winning science of RNAi, delivering critical breakthroughs and six approved medicines. Alnylam has medicines available in more than 70 countries and a rapidly expanding and robust pipeline, in addition to consistently being recognized as an exceptional workplace and socially responsible organization. The Company is executing on its Alnylam 2030 strategy to accelerate innovation and scale impact to transform human health. Alnylam routinely posts information that may be important to investors in the “Investors” section of its website at https://investors.alnylam.com/. Investors and potential investors are encouraged to consult the Alnylam website regularly.

Alnylam Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, statements regarding the potential efficacy or safety of vutrisiran for the treatment of ATTR CM, including in combination with a stabilizer; the potential clinical benefit that can be achieved by reducing TTR production at its source across patient populations, treatment settings and manifestations of disease; the potential for AMVUTTRA to be a first-line treatment for ATTR-CM; the potential for zilebesiran to extend the precision and durability of RNAi, and to provide continuous control of blood pressure with biannual dosing, in patients with uncontrolled hypertension; Alnylam’s ability to make a transformational impact on cardiovascular care and to change the course of cardiovascular disease for patients with high unmet need; and Alnylam’s ability to execute on its Alnylam 2030 strategy to accelerate innovation and scale impact to transform human health. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to: Alnylam’s ability to successfully execute on its Alnylam 2030 strategy; Alnylam’s ability to successfully launch, market and sell Alnylam’s approved products globally, including AMVUTTRA; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; delays, interruptions or failures in the manufacture and supply of Alnylam’s marketed products or its product candidates; obtaining, maintaining and protecting intellectual property; Alnylam’s ability to manage its growth and operating expenses through disciplined investment in operations; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products; the outcome of litigation and government investigations; the risk of future litigation and government investigations; and unexpected expenditures; as well as those risks and uncertainties more fully discussed in the “Risk Factors” filed with Alnylam’s 2025 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam’s subsequent Quarterly Reports on Form 10-Q, and in other filings that Alnylam makes with the SEC. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

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Josh Brodsky

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Bristol Myers Squibb Presents Data Up to Five Years Reinforcing the Long-Term Efficacy and Safety of Camzyos (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) at the European Society of Cardiology (ESC) Congress 2026

New single-arm, open-label data extend the body of evidence supporting consistent clinical benefit and safety with Camzyos, adding to the longest-running clinical development experience for a cardiac myosin inhibitor (CMI) in symptomatic oHCM

Additional presentations at ESC Congress build upon the established effectiveness and safety profile of Camzyos in real-world settings

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today presented results from the EXPLORER-LTE cohort of the MAVA-LTE study (NCT03723655) in a late-breaker presentation at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. EXPLORER-LTE is the largest and longest evaluation of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients treated with Camzyos, the most-studied cardiac myosin inhibitor (CMI) and a standard of care for patients with oHCM in New York Heart Association (NYHA) class II-III. These data add to the understanding that the effects of Camzyos are sustained for up to five years with continuous, consistent treatment. Additional presentations at ESC Congress from COLLIGO-HCM, a global retrospective real-world data study, add to the well-established real-world evidence supporting Camzyos, helping inform treatment decisions for people living with the condition.

“The EXPLORER-LTE data up to five years reflect the sustained and clinically meaningful effects of Camzyos for patients living with symptomatic oHCM,” said Anjali T. Owens, MD, Medical Director of the Center for Inherited Cardiac Disease and an Associate Professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania. “For a chronic, progressive condition that requires ongoing treatment and monitoring, long-term evidence is essential to helping clinicians better understand how a therapy may benefit patients over time.”

EXPLORER-LTE is a single-arm, open-label, dose-blinded extension of the Phase 3 EXPLORER-HCM study, evaluating the long-term safety and efficacy of Camzyos. A total of 231 patients who completed EXPLORER-HCM enrolled in the long-term extension study. A substantial portion of patients experienced sustained and clinically meaningful reduction of left ventricular outflow tract (LVOT) obstruction, improved by at least one NYHA class and experienced notable improvements in echocardiographic measures and biomarkers. No new safety signals were observed that were not observed in the primary EXPLORER-HCM study.

At 252 weeks, Camzyos treatment resulted in mean changes from baseline at initiation of the long-term extension study of -38.7 mm Hg for resting LVOT gradient and -55.6 mm Hg in Valsalva LVOT gradient. Nearly all patients (97.4%) achieved a Valsalva LVOT gradient ≤ 30 mm Hg, which is the threshold for obstruction in patients with oHCM. 69.6% of patients improved by ≥1 NYHA class and 59.2% of patients were asymptomatic. Mean left ventricular ejection fraction (LVEF) decreased by 10.2% and remained within the normal range. Safety findings were consistent with reported results from the primary EXPLORER-HCM study.

Additional data presented at ESC Congress further support Camzyos and our understanding of the impact of oHCM. Two presentations from COLLIGO-HCM, a global retrospective real-world data study, added to the well-established real-world evidence supporting Camzyos in clinical practice, with a real-world effectiveness and safety profile that is consistent across patients, providing symptom improvement and reduction in LVOT obstruction. A complementary analysis of a real-world observational registry study in Germany reinforces the effectiveness of Camzyos across geographic populations, with patients achieving NYHA class reductions consistent with previously reported real-world studies. These findings build on the existing evidence base for Camzyos and reinforce that the improvements seen in clinical trials are also achieved in real-world settings. An additional analysis of a healthcare resource utilization (HCRU) study in Sweden adds to the understanding of the broader disease burden of HCM and oHCM, including the increased impact of oHCM, and emphasizes the importance of accurate diagnosis and consistent care for patients living with oHCM.

“For people living with symptomatic oHCM, long-term and real-world evidence provides greater confidence in treatment decisions and a clearer understanding of what sustained therapy may mean over time,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “As part of our dedication to advancing cardiovascular research, the data presented at ESC Congress add to the understanding and trust of Camzyos and its role in helping patients manage oHCM, a serious condition affecting daily activities for many patients.”

Camzyos is supported by the largest body of worldwide evidence in the CMI treatment class, reinforcing its role in transforming care for symptomatic oHCM by improving functional capacity and symptoms, allowing patients to be more active in their daily lives.

About EXPLORER-LTE

EXPLORER-LTE, a cohort of the MAVA-LTE study (NCT03723655), is a single-arm, open-label, dose-blinded extension of the Phase 3 EXPLORER-HCM study evaluating the long-term safety and efficacy of Camzyos. A total of 231 patients in the United States, Europe and Israel who completed EXPLORER-HCM enrolled in the long-term extension study.

About CAMZYOS^® (mavacamten)

CAMZYOS^® (mavacamten) is the most extensively studied cardiac myosin inhibitor (CMI), approved by regulatory bodies in more than 60 countries and regions across five continents worldwide. In the U.S., CAMZYOS is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. In the European Union, CAMZYOS is indicated for the treatment of symptomatic (NYHA, class II-III) oHCM in adult patients.

A selective, reversible, allosteric inhibitor of cardiac myosin, CAMZYOS targets hypercontractility, the source of oHCM. Reduction in cardiac contractility with CAMZYOS treatment leads to reduced LVOT obstruction, improved energy consumption, and lower cardiac filling pressures in oHCM patients. These effects have translated to demonstrated symptom improvements in clinical studies for adults with symptomatic oHCM, enabling them to be more active in their daily lives. CAMZYOS can be used with or without background therapies, including for newly diagnosed patients.

CAMZYOS is supported by the largest body of worldwide evidence in the CMI treatment class, with up to five years of follow up across multiple long-term evidence and real-world studies, demonstrating the consistent and sustained benefits of CAMZYOS to improve symptoms and impact cardiac structure. CAMZYOS has been prescribed by more than 5,000 healthcare providers (HCPs) to over 25,000 patients in the U.S. alone.

Bristol Myers Squibb: Changing the Course of Cardiovascular Disease

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. Cardiovascular disease is the leading cause of death worldwide, and despite major advances in how we prevent and treat it, the human and societal burden continues to worsen over time. Whether a cardiovascular disease that affects millions of people around the world, or a rarer condition, the need is the same: new and better treatment options that allow people to continue to live their fullest lives.

Bristol Myers Squibb is committed to developing new treatments to address the global burden of cardiovascular disease. Building on our 70-year legacy of discovering and delivering paradigm-changing cardiovascular medicines, we are leveraging our experience and expertise, to take cardiovascular research to the next level and delivering meaningful, life‑changing outcomes for patients.

CAMZYOS U.S. IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:

• Strong CYP2C19 inhibitors
• Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called CAMZYOS REMS PROGRAM.

CONTRAINDICATIONS

CAMZYOS is contraindicated with concomitant use of:

• Strong CYP2C19 inhibitors

• Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

WARNINGS AND PRECAUTIONS

Heart Failure

CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.

Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function.

Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.

Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

CYP450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness

CAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.

Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment.

CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program

CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following:

• Prescribers must be certified by enrolling in the REMS Program

• Patients must enroll in the REMS Program and comply with ongoing monitoring requirements

• Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS

• Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at www.CAMZYOSREMS.com or by telephone at 1-833-628-7367.

Embryo-Fetal Toxicity

CAMZYOS may cause fetal toxicity when administered to a pregnant female, based on findings in animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.

ADVERSE REACTIONS

In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM.

Effects on Systolic Function

In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.

DRUG INTERACTIONS

Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS

CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS.

Impact of Other Drugs on CAMZYOS:

• Strong CYP2C19 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated.
• Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers: Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated.
• Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate CAMZYOS until 12 weeks after inhibitor initiation. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a weak inhibitor of CYP2C19 or a moderate inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.
• Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use with a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Discontinuing use of a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor after long-term concomitant use may decrease CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. Initiate CAMZYOS at a starting dosage of 2.5 mg orally once daily in patients who are on a stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS and intend to initiate a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Avoid initiation of concomitant moderate CYP2C19 and strong CYP3A4 inhibitors in patients who are on a stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. An increase in dose of CAMZYOS may be needed if the moderate inhibitor of CYP2C19 or strong inhibitor of CYP3A4 is discontinued after long-term concomitant use. Monitor for new or worsening symptoms. For short-term use (ie, when CAMZYOS dose modification is not feasible), interrupt CAMZYOS for the duration of treatment with a moderate inhibitor of CYP2C19 or a strong inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.

Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs

CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used with concomitant CYP3A4, CYP2C9, or CYP2C19 substrates unless otherwise recommended in the Prescribing Information.

Certain Combined Hormonal Contraceptives (CHCs): Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) during concomitant use and for 4 months after the last dose of CAMZYOS.

Drugs That Reduce Cardiac Contractility

Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.

SPECIFIC POPULATIONS

Pregnancy

Based on animal data, CAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com.

Lactation

The presence of CAMZYOS in human or animal milk, the drug’s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.

Females and Males of Reproductive Potential

Confirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method during concomitant use and for 4 months after the last dose of CAMZYOS.

Please see U.S. Full Prescribing Information, including Boxed WARNING and Medication Guide.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of this study, that Camzyos (mavacamten), may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of Camzyos may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. It should be noted that acceptance of the application does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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