Regeneron Announces Positive Phase 3 Trial in Adults with Ultra-Rare Genetic Disorder Fibrodysplasia Ossificans Progressiva (FOP), Demonstrating that Garetosmab Prevents Greater than 99% of Abnormal Bone Formation
Regeneron (NASDAQ: REGN) announced breakthrough results from its Phase 3 OPTIMA trial for garetosmab in treating fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder. The trial met its primary endpoint, demonstrating that garetosmab reduced new bone lesions by 90-94% and achieved a greater than 99% reduction in total lesion volume compared to placebo.
The study involved 63 adult FOP patients who received either placebo or garetosmab (3 mg/kg or 10 mg/kg) every four weeks. Both dosing regimens showed high efficacy, with the 10 mg/kg dose reducing flare-ups by 89%. Based on these positive results, the Independent Data Monitoring Committee recommended transitioning placebo patients to garetosmab treatment. Regeneron plans to submit for U.S. regulatory approval by year-end 2025.
Regeneron (NASDAQ: REGN) ha annunciato risultati innovativi dal suo studio di fase 3 OPTIMA su garetosmab per trattare la fibromatosi ossificante progressiva (FOP), una rara malattia genetica. Lo studio ha raggiunto l'obiettivo primario, dimostrando che il garetosmab ha ridotto le nuove lesioni ossee del 90-94% e ha ottenuto una riduzione superiore al 99% del volume totale delle lesioni rispetto al placebo. Lo studio ha coinvolto 63 pazienti FOP adulti che hanno ricevuto placebo o garetosmab (3 mg/kg o 10 mg/kg) ogni quattro settimane. Entrambi i regimi di dosaggio hanno mostrato alta efficacia, con la dose di 10 mg/kg che ha ridotto le riacutizzazioni dell'89%. Sulla base di questi risultati positivi, il Comitato Indipendente di Monitoraggio dei Dati ha raccomandato di passare i pazienti del placebo al trattamento con garetosmab. Regeneron prevede di presentare una domanda di autorizzazione regolatoria negli Stati Uniti entro la fine del 2025.
Regeneron (NASDAQ: REGN) anunció resultados revolucionarios de su ensayo de fase 3 OPTIMA para garetosmab en el tratamiento de la fibrodisplasia osificante progresiva (FOP), una rara enfermedad genética. El ensayo cumplió su punto final primario, demostrando que el garetosmab redujo las nuevas lesiones óseas en un 90-94% y logró una reducción de más del 99% en el volumen total de lesiones en comparación con el placebo. El estudio involucró a 63 pacientes adultos con FOP que recibieron placebo o garetosmab (3 mg/kg o 10 mg/kg) cada cuatro semanas. Ambos regímenes de dosificación mostraron alta eficacia, con la dosis de 10 mg/kg reduciendo las recidivas en un 89%. Con base en estos resultados positivos, el Comité Independiente de Monitoreo de Datos recomendó pasar a los pacientes del placebo al tratamiento con garetosmab. Regeneron planea presentar una solicitud de autorización regulatoria estadounidense para finales de 2025.
Regeneron (NASDAQ: REGN)은 희귀 유전 질환인 섬유성 골화 진행성 질환(FOP) 치료제 garetosmab에 대한 3상 OPTIMA 시험의 획기적인 결과를 발표했다. 이번 연구는 주요 평가 지표를 충족했으며, garetosmab가 새로운 골 병변을 90-94% 감소시키고 위약 대비 총 병변 부피를 99% 이상 감소시켰다. 연구에는 매 4주마다 위약 또는 garetosmab(3 mg/kg 또는 10 mg/kg)을 투여받은 63명의 성인 FOP 환자가 포함되었다. 두 용량 모두 높은 유효성을 보였으며, 10 mg/kg 용량은 재발을 89% 감소시켰다. 이러한 긍정적인 결과를 바탕으로 독립 데이터 모니터링 위원회는 위약 환자를 garetosmab 치료로 전환할 것을 권고했다. Regeneron은 2025년 말까지 미국 규제 승인을 위한 제출을 계획하고 있다.
Regeneron (NASDAQ : REGN) a annoncé des résultats révolutionnaires de son essai de phase 3 OPTIMA concernant le garetosmab pour traiter la fibrodysplasie ossifiante progressive (FOP), une maladie génétique rare. L'essai a atteint son critère d'évaluation principal, montrant que le garetosmab réduisait les nouvelles lésions osseuses de 90-94% et obtenait une réduction de plus de 99% du volume total des lésions par rapport au placebo. L'étude a impliqué 63 patients adultes atteints de FOP qui ont reçu soit un placebo soit le garetosmab (3 mg/kg ou 10 mg/kg) toutes les quatre semaines. Les deux régimes posologiques ont montré une grande efficacité, avec une dose de 10 mg/kg réduisant les poussées de 89%. Sur la base de ces résultats positifs, le Comité indépendant de surveillance des données a recommandé de faire passer les patients sous placebo au traitement par garetosmab. Regeneron prévoit de soumettre une autorisation réglementaire aux États‑Unis d'ici fin 2025.
Regeneron (NASDAQ: REGN) hat bahnbrechende Ergebnisse des Phase-3-OPTIMA-Studiengantages zu Garetosmab zur Behandlung der fibrodysplasia ossificans progressiva (FOP), einer seltenen genetischen Erkrankung, bekannt gegeben. Die Studie erfüllte ihren primären Endpunkt und zeigte, dass Garetosmab neue Knochenschäden um 90-94% reduzierten und eine über 99%-ige Reduktion des gesamten Läsionsvolumens im Vergleich zu Placebo erzielte. Die Studie umfasste 63 erwachsene FOP-Patienten, die entweder Placebo oder Garetosmab (3 mg/kg oder 10 mg/kg) alle vier Wochen erhielten. Beide Dosierungen zeigten eine hohe Wirksamkeit, wobei die Dosis von 10 mg/kg einen Rückgang der Flare-ups um 89% bewirkte. Basierend auf diesen positiven Ergebnissen empfahl das Independent Data Monitoring Committee, Placebo-Patienten auf Garetosmab-Behandlung umzustellen. Regeneron plant, bis Ende 2025 eine US-Regulierungszulassung zu beantragen.
أعلنت Regeneron (بورصة ناسداك: REGN) عن نتائج رائدة من تجربة المرحلة الثالثة OPTIMA لـ garetosmab في علاج التصلّب العظمي التكاثري التقدمي (FOP)، وهو اضطراب وراثي نادر. حقّقت الدراسة هدفها الأساسي، حيث أظهر أن garetosmab خفّض آفات العظام الجديدة بنسبة 90-94% وحقق انخفاضاً يتجاوز 99% في إجمالي حجم الآفات مقارنة بالدواء الوهمي. شملت الدراسة 63 مريضاً بالغاً بـFOP تلقوا إما دواءً وهمياً أو garetosmab (3 mg/kg أو 10 mg/kg) كل أربعة أسابيع. أظهرت كلا الجرعتين فعالية عالية، حيث خفضت الجرعة 10 mg/kg النوبات بمقدار 89%. بناءً على هذه النتائج الإيجابية، أوصى لجنة مراقبة البيانات المستقلة بتغيير مرضى الدواء الوهمي إلى علاج garetosmab. تخطط Regeneron لتقديم طلب للموافقة التنظيمية في الولايات المتحدة بنهاية عام 2025.
Regeneron（纳斯达克股票代码：REGN）宣布了其阶段三OPTIMA试验在治疗纤维骨化进展性疾病（FOP）方面的突破性结果，所用药物为garetosmab，这是一种罕见的遗传疾病。试验达到其主要终点，显示garetosmab将新骨病变减少了90-94%，在总病变体积方面相较安慰剂实现了超过99%的降低。研究涉及63名成年FOP患者，他们每四周接受安慰剂或garetosmab（3 mg/kg或10 mg/kg）。两种给药方案均显示出高效性，其中10 mg/kg剂量将发作减少了89%。基于这些积极结果，独立数据监测委员会建议将安慰剂患者转为garetosmab治疗。Regeneron计划在2025年底前提交美国监管审批申请。
- None.
- Dose-dependent increase in skin and soft tissue infections observed
- Serious treatment-emergent adverse events occurred in 3 patients across both garetosmab doses
Insights
Regeneron's garetosmab shows >99% reduction in abnormal bone formation in FOP patients, representing a breakthrough for this incapacitating rare disease.
Regeneron's Phase 3 OPTIMA trial results for garetosmab mark a significant breakthrough in treating Fibrodysplasia Ossificans Progressiva (FOP), an ultra-rare genetic disorder where muscles and connective tissues progressively transform into bone. The data demonstrates remarkable efficacy with both tested doses (3 mg/kg and 10 mg/kg) showing 90-94% reduction in new heterotopic ossification (HO) lesions compared to placebo at 56 weeks.
What's particularly impressive is the greater than 99% reduction in total volume of new HO lesions—essentially halting the disease's hallmark bone formation. The 10 mg/kg dose also reduced clinical flare-ups by 89%, which is especially meaningful as these flare-ups typically precede new bone formation and cause significant patient suffering.
The
The Independent Data Monitoring Committee's recommendation to transition placebo patients to active treatment as soon as possible further validates the compelling efficacy and acceptable safety profile. This intervention, which targets Activin A protein, represents the first disease-modifying therapy for FOP and demonstrates how targeted biological approaches can address previously untreatable genetic disorders. Regulatory submissions planned for year-end 2025 could potentially bring this first-in-class therapy to patients within 1-2 years.
Regeneron's garetosmab shows unprecedented efficacy in FOP, potentially creating a high-value rare disease franchise with limited competition.
Regeneron's garetosmab Phase 3 data represents a potential blockbuster opportunity in an ultra-rare disease with no approved treatments. FOP affects approximately 1 in 1.6 million people globally, suggesting a small but commercially viable patient population where orphan drug pricing would be justified by the dramatic efficacy demonstrated.
The >99% reduction in new bone lesion volume positions garetosmab as a transformative therapy that could command premium pricing in the orphan drug market. With both doses showing overwhelming efficacy, Regeneron has flexibility in dose selection, potentially optimizing for the
The perfect 100% retention rate in both treatment arms indicates strong patient satisfaction and suggests high compliance and persistency can be expected post-approval—critical factors for commercial success in rare disease markets. The planned regulatory submission by year-end
Importantly, this success validates Regeneron's proprietary technology platform and research capabilities in identifying Activin A's role in FOP pathogenesis. The planned pediatric trial (OPTIMA 2) indicates a strategy to expand the addressable market and establish garetosmab as the standard of care across all age groups. The first-mover advantage in this indication with no approved therapies could establish a new franchise area for Regeneron in rare genetic disorders, diversifying their revenue streams beyond their current portfolio of inflammatory and ophthalmology products.
FOP is a disease in which muscles, tendons and ligaments are progressively replaced by bone, leading to eventual incapacitation
Garetosmab is the first and only treatment to demonstrate a dramatic reduction in both number and volume of abnormal bone lesions (heterotopic ossification, or HO lesions) in adults with FOP
Primary endpoint was met, showing a
Based on these data and the safety profile, the Independent Data Monitoring Committee (IDMC) recommended those receiving placebo be transitioned to garetosmab as soon as possible; U.S. regulatory submission of garetosmab in adults planned for year-end 2025
TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the primary endpoint was met in the Phase 3 OPTIMA trial investigating garetosmab in adults with fibrodysplasia ossificans progressiva (FOP). At 56 weeks, both doses of garetosmab, 3 mg/kg and 10 mg/kg, were highly efficacious in reducing the number of new bone lesions (heterotopic ossification, or HO lesions) as compared to placebo, demonstrating a
“Heterotopic ossification is a hallmark of FOP, a horrific disease in which muscles, tendons and ligaments are progressively replaced by bone, gradually incapacitating patients,” said Professor Richard Keen, Director of the Metabolic Bone Disease Centre, Royal National Orthopaedic Hospital, London, and global primary investigator of the OPTIMA trial. “The OPTIMA trial results clearly illustrate the potential of garetosmab to alter the disease and reduce new lesions that define this condition. Notably, garetosmab is the first and only investigational therapy to demonstrate a dramatic reduction in both the number and volume of abnormal bone lesions."
OPTIMA, a global, multi-center, randomized, double-blind, placebo-controlled trial, enrolled 63 people with FOP aged 18 years and older. Trial participants were randomized to intravenously receive either placebo, 3 mg/kg garetosmab, or 10 mg/kg garetosmab once every four weeks. Following this, participants could elect to extend their treatment through at least 84 weeks or discontinue treatment and enter into an observation-only arm.
In OPTIMA, the primary and key secondary endpoints were assessed at 56 weeks. As seen in the table below, the total number of new HO lesions was significantly reduced, which was further reaffirmed by the reduction in total new lesion volume.
| Endpoints | placebo (n=21) | garetosmab 3 mg/kg (n=19) | garetosmab 10 mg/kg (n=23) |
| Patients completing treatment (%) | 20 ( | 19 ( | 23 ( |
| Primary endpoint: Total number of new HO lesions in total treated population† and reduction compared to placebo | 19 lesions | 1 lesion (p=0.0274) | 2 lesions (p=0.0260) |
| Key secondary endpoint: Total number of clinician-assessed flare-ups and reduction compared to placebo | 70 flare-ups | 53 flare-ups (p=0.7125) | 9 flare-ups (p=0.0007) |
| Post-hoc analysis: Mean total volume (cm3) and reduction in mean total volume of new HO lesions compared to placebo‡ | 10.45 cm3 | 0.01 cm3 ( | 0.02 cm3 ( |
† As assessed by computed tomography (CT) scan
‡ A supportive parametric post-hoc analysis was performed using a statistical model that utilized the actual total lesion volume
§ Nominal p-value
At 56 weeks, there were no discontinuations among the garetosmab treatment arms, and there was one discontinuation in the placebo arm due to an ovarian cyst. There was a dose-dependent increase in skin and soft tissue infections (n=7, n=9, n=15 for the placebo, 3 mg/kg garetosmab, and 10 mg/kg garetosmab arms, respectively). There was no dose-dependent increase in epistaxis (n=5, n=10, n=4 for the placebo, 3 mg/kg garetosmab, and 10 mg/kg garetosmab arms, respectively); and there were no serious bleeding events. There was a decrease in musculoskeletal pain-related adverse events, similar in both garetosmab arms (n=14, n=6, n=4 for the placebo, 3 mg/kg garetosmab and 10 mg/kg garetosmab arms, respectively). Serious treatment-emergent adverse events occurred in 2 patients treated with placebo, 1 patient treated with 3 mg/kg garetosmab, and 2 patients treated with 10 mg/kg garetosmab. No deaths were reported in the trial.
"The success of the OPTIMA trial is a direct result of Regeneron’s relentless pursuit of science and use of proprietary technologies to improve the lives of people with debilitating and life-threatening diseases, no matter their prevalence,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron. “Our research in FOP began decades ago – leading to the discovery of the role Activin A plays in driving this devastating disease, and now, a medicine with the potential to prevent the uncontrolled formation of new bone. We are thankful to the many patients, healthcare providers, and others who have been active partners on this journey, and we look forward to submitting garetosmab for evaluation by regulatory authorities as soon as possible.”
Based on these data and the safety profile, the Independent Data Monitoring Committee (IDMC) recommended those receiving placebo be transitioned to garetosmab as soon as possible. A U.S. regulatory submission for garetosmab to treat FOP is planned for year-end 2025, with global regulatory submissions slated for 2026. These data are also planned for future presentation and publication. A Phase 3 trial of garetosmab in adolescents and children with FOP, OPTIMA 2, is intended to begin next year.
The potential use of garetosmab for the treatment of FOP is investigational and has not been approved by any regulatory authority.
About the OPTIMA Clinical Trial
OPTIMA is a Phase 3, multi-center, multinational trial to assess the efficacy of garetosmab on the reduction of heterotopic bone formation, as well as its safety, tolerability, and pharmacokinetics, in patients with active fibrodysplasia ossificans progressiva (FOP).
The trial enrolled 63 patients aged 18 years and older who have any FOP-causing variant of type I Activin A receptor (ACVR1), exhibited FOP disease activity or progression of heterotopic ossification (HO) lesions, and had a cumulative analogue joint involvement (CAJIS) score at screening of ≤19. CAJIS is a clinician-assessed tool, with higher scores representing greater disease severity (scale: 0 to 30). Eligible participants were randomized to intravenously receive 3 mg/kg garetosmab, 10 mg/kg garetosmab, or placebo once every four weeks for 56 weeks. Following this, participants could elect to extend their treatment for at least 84 weeks or discontinue treatment and enter into an observation-only arm.
During the treatment period, efficacy was evaluated through whole body computed tomography (CT) scans for HO lesions; physician and patient assessment of flare-ups; utilization of the CAJIS scale to rate joint functionality; and observances of change in disease severity. Safety assessment includes reports of adverse events, measurement of vital signs, physical examination, and coagulation testing.
A Phase 3 trial of garetosmab in adolescents and children with FOP, OPTIMA 2, is planned to begin next year. For more information, visit the Regeneron clinical trials website, contact clinicaltrials@regeneron.com, or call +1 844-734-6643.
About Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia ossificans progressiva (FOP) is a relentless, progressive, ultra-rare genetic disorder in which muscles, tendons and ligaments are progressively replaced by bone, a process known as heterotopic ossification (HO). Approximately 900 people are diagnosed with FOP worldwide, with many others thought to remain undiagnosed or misdiagnosed.
HO of the jaw, spine, hip and rib cage can make it difficult to speak, eat, walk or breathe, leading to weight loss and escalating loss of mobility and skeletal deformity. People with FOP also experience episodic, localized inflammation known as "flare-ups," although HO may occur both silently as well as in association with symptoms. Most people with FOP are wheelchair bound by 30 years old and the median age of survival is approximately 56 years. Death often results from complications, such as pneumonia, heart failure and aspiration stemming from HO and loss of mobility in the chest, neck and jaw.
About Garetosmab
Regeneron has been engaged in FOP research for decades and helped to provide fundamental insights in the biology and natural history of the disease. Regeneron scientists discovered that Activin A plays a key role in FOP by driving HO, the main pathology of FOP. Garetosmab is a VelocImmune-derived fully-human monoclonal antibody that binds and neutralizes Activin A, which is involved in the development of heterotopic bone in people with FOP.
In 2017, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for garetosmab for the prevention of HO in patients with FOP. In the U.S. and European Union (EU), garetosmab has been granted Orphan Designation. Garetosmab is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.
About Regeneron’s VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Garetosmab was also created using Regeneron's VelocImmune technology.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
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This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation garetosmab; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as garetosmab); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as garetosmab) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. 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