Latest news with #ZENITH
Yahoo
02-07-2025
- Business
- Yahoo
Merck's Drug Slashes PAH Risk by 76%--FDA Fast-Tracks Game-Changer
Merck (NYSE:MRK) might be sitting on a game-changer. The FDA just granted priority review to an application that could expand the label for WINREVAIRits new pulmonary arterial hypertension (PAH) drugbased on results from the Phase 3 ZENITH trial. This wasn't just another study. ZENITH was the first of its kind in PAH to focus purely on hard outcomes like death, transplant, or long-term hospitalization. The kicker? WINREVAIR cut those risks by 76% compared to placebo, so convincingly that the trial was stopped early for efficacy. Merck's updated filing comes with a PDUFA date of October 25, 2025. Warning! GuruFocus has detected 3 Warning Sign with MRK. The setup here is compelling: WINREVAIR is already approved in over 45 countries based on the STELLAR trial, but ZENITH takes it a step further. The trial zeroed in on patients in WHO functional class III or IVthose with high risk and limited options. Improvement with WINREVAIR showed up early and kept getting better over time. If the label update goes through, this could unlock broader treatment potential and strengthen Merck's positioning in a niche but high-stakes market where 5-year mortality still hovers around 43%. That said, it's not without baggage. WINREVAIR comes with bleeding and blood-related risks, especially in patients already on aggressive therapy. But for a life-threatening condition with few real advances, Merck's data may be compelling enough to outweigh those concerns. For investors, this isn't just another pipeline updateit's a potential inflection point. If approved, WINREVAIR could emerge as a category-defining drug in PAH, giving Merck a differentiated edge in a complex and underserved segment. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-07-2025
- Business
- Yahoo
Merck's Drug Slashes PAH Risk by 76%--FDA Fast-Tracks Game-Changer
Merck (NYSE:MRK) might be sitting on a game-changer. The FDA just granted priority review to an application that could expand the label for WINREVAIRits new pulmonary arterial hypertension (PAH) drugbased on results from the Phase 3 ZENITH trial. This wasn't just another study. ZENITH was the first of its kind in PAH to focus purely on hard outcomes like death, transplant, or long-term hospitalization. The kicker? WINREVAIR cut those risks by 76% compared to placebo, so convincingly that the trial was stopped early for efficacy. Merck's updated filing comes with a PDUFA date of October 25, 2025. Warning! GuruFocus has detected 3 Warning Sign with MRK. The setup here is compelling: WINREVAIR is already approved in over 45 countries based on the STELLAR trial, but ZENITH takes it a step further. The trial zeroed in on patients in WHO functional class III or IVthose with high risk and limited options. Improvement with WINREVAIR showed up early and kept getting better over time. If the label update goes through, this could unlock broader treatment potential and strengthen Merck's positioning in a niche but high-stakes market where 5-year mortality still hovers around 43%. That said, it's not without baggage. WINREVAIR comes with bleeding and blood-related risks, especially in patients already on aggressive therapy. But for a life-threatening condition with few real advances, Merck's data may be compelling enough to outweigh those concerns. For investors, this isn't just another pipeline updateit's a potential inflection point. If approved, WINREVAIR could emerge as a category-defining drug in PAH, giving Merck a differentiated edge in a complex and underserved segment. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
02-07-2025
- Business
- Business Wire
FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Oct. 25, 2025. The sBLA is based on data from the Phase 3 ZENITH trial. The ZENITH trial was the first PAH Phase 3 outcome study to use a primary endpoint comprised entirely of major morbidity and mortality events. It was also the first PAH Phase 3 study stopped early by an independent data monitoring committee for overwhelming efficacy. In ZENITH, WINREVAIR demonstrated a 76% reduction in the risk of a composite of all-cause death, lung transplantation, and hospitalization for PAH ≥24 hours compared to placebo. Improvement was observed early in treatment with increasing benefit throughout the study. The safety profile of WINREVAIR in ZENITH was generally consistent with that observed in previous studies. These results were published in the New England Journal of Medicine. 'We are pleased that the FDA has accepted our sBLA for WINREVAIR and granted a priority review to consider an update to labeling for WINREVAIR to include the impressive results of ZENITH. There remains a significant unmet medical need for patients living with PAH who, despite being on background therapy, remain at higher risk of morbidity and mortality,' said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. 'The FDA's Priority Review designation acceptance of our sBLA reinforces our confidence in WINREVAIR for a broad range of patients and represents a critical step toward advancing the treatment of PAH.' WINREVAIR is currently approved in more than 45 countries based on the results from the STELLAR trial. *World Health Organization About ZENITH The ZENITH study (NCT04896008) is a global, double-blind, placebo-controlled clinical trial to evaluate WINREVAIR when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in adult participants with WHO functional class III or IV PAH at high risk of mortality. ZENITH study inclusion criteria required Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 risk score of ≥9. The study enrolled 172 participants, who were randomized in a 1:1 ratio to either WINREVAIR plus background PAH therapy or placebo plus background PAH therapy. The primary composite outcome measure was time to first confirmed major morbidity or mortality event. Events were defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours. Secondary outcome measures included overall survival, transplant-free survival and several additional measures. The study excluded patients with PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension as well as diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement. Participants who completed the ZENITH trial were offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA (NCT04796337), consistent with that study's eligibility criteria. About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm 3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (eg, gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Patient Information for WINREVAIR at , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at
Business Wire
23-06-2025
- Health
- Business Wire
Merck Announces Phase 3 HYPERION Study of WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint in Recently Diagnosed Adults with Pulmonary Arterial Hypertension (PAH)
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 HYPERION study evaluating WINREVAIR™ (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression. HYPERION met its primary endpoint of time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization > 24 hours, atrial septostomy, lung transplantation, or PAH deterioration. In HYPERION, WINREVAIR added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. HYPERION is the third Phase 3 study of WINREVAIR to demonstrate significant efficacy in adults with PAH. The first was the STELLAR study previously presented at ACC.23, followed by the ZENITH study presented at ACC.25. In contrast to HYPERION, these previous studies included a patient population where a majority of participants were on triple therapy. The safety profile of WINREVAIR was generally consistent with that observed in previous studies. As announced in January, HYPERION was stopped early and moved to final analysis based on the positive results from the interim analysis of the Phase 3 ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date, and all patients were offered the opportunity to receive WINREVAIR through the SOTERIA open-label extension study. 'PAH is a progressive and debilitating disease with a poor prognosis that can be difficult to diagnose and treat. Patients often struggle for years to find a treatment plan that helps manage the disease, so it's critical to provide new options earlier in the treatment journey,' said Dr. Vallerie McLaughlin**, Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program, University of Michigan in Ann Arbor. 'The HYPERION study demonstrated that WINREVAIR on top of background therapy met its primary outcome measure of reduction in the time to clinical worsening events in adults who have been recently diagnosed with PAH. WINREVAIR has brought significant optimism to patients, their families and investigators and we thank all study participants for being part of this important study.' 'To date, the strong clinical profile of WINREVAIR, a first-in-class activin signaling inhibitor, had been primarily established through previous studies in a prevalent patient population comprised of patients that were several years into their treatment journey. These positive results from HYPERION expand on the body of clinical evidence now including recently diagnosed adults, supporting the practice-changing potential of WINREVAIR in a broad spectrum of PAH patients, including those earlier in their treatment journey," said Dr. Joerg Koglin, senior vice president, head of general and specialty medicine, global clinical development, Merck Research Laboratories. 'We look forward to presenting these data to the scientific community at a future medical meeting.' Results from HYPERION will be presented at an upcoming medical meeting later this year and will be submitted to regulatory authorities. WINREVAIR is currently approved in more than 45 countries based on the results from the STELLAR study. *World Health Organization **Dr. McLaughlin is a member of the adult sotatercept steering committee, an investigator in the ZENITH and HYPERION studies and a paid consultant to Merck. About HYPERION The HYPERION study (NCT04811092) is a global, double-blind, placebo-controlled clinical trial to evaluate WINREVAIR when added to background PAH therapy in newly diagnosed intermediate or high-risk PAH patients. Participants who enrolled in the study had a diagnosis of symptomatic PAH (WHO Group 1, classified as FC II [21.3%; 68/320 participants] or III [78.8%; 252/320 participants] within 12 months of study screening. Eligible participants had a confirmed diagnosis of PAH in any of the following subtypes: idiopathic PAH (59.4%; 190/320), heritable PAH (5.9%; 19/320), PAH associated with connective tissue diseases (CTD) (30.3%; 97/320), drug- or toxin-induced PAH (2.5%; 8/320), or PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair (1.9%; 6/320). The study excluded patients with PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis. The study enrolled 320 study participants over the age of 18, who were randomized in a 1:1 ratio to receive either WINREVAIR or placebo both on top of background therapy. Participants were at an intermediate to high risk of disease progression and on stable doses of double (72.2%; 231/320 participants) or triple (27.8%; 89/320 participants) background PAH therapies for at least 90 days prior to screening. A majority (83.4%; 267/320 participants) were not on prostacyclin-infusion therapy. The primary composite outcome measure is TTCW as measured by first confirmed morbidity or mortality event. Clinical worsening events are defined as all-cause death, non-planned PAH worsening-related hospitalization of ≥ 24 hours, atrial septostomy, lung transplantation, and deterioration in six-minute walk test from baseline combined with at least one of the following changes including worsening of WHO FC from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. Secondary outcome measures were assessed relative to baseline at Week 24: proportion of participants achieving multicomponent improvement (consisting of improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level and improvement in WHO FC or maintenance of WHO FC II) as well as additional measures. About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm 3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (eg, gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Patient Information for WINREVAIR at , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at .
Web Release
04-04-2025
- Business
- Web Release
G.F.J: A NEW COLLECTION BRINGS BACK AN ICONIC MOVEMENT TO CELEBRATE ZENITH'S 160TH ANNIVERSARY
When Georges Favre-Jacot established his manufacture in 1865, his objective was to create 'the perfect watch': the finest, most precise and most reliable timepiece ever made. This quest for perfection is reflected in the very name of his brand, ZENITH, referring to the highest point in the sky. To celebrate its 160th anniversary and its quest for excellence in all fields of watchmaking art, the brand releases a timeless classic powered by an exceptional movement. Named after the initials of Georges Favre-Jacot, the sleek, slender and elegant G.F.J. brings back to life the legendary calibre 135, the most awarded movement from the golden age of observatory chronometer competitions. ZENITH, Chronometry and the legendary calibre 135 Decades ago, observatory trials were extremely important. Beyond chronometric science, the fame associated with these timing competitions was considerable. Observatories witnessed and vouched for the level of precision that expert watchmakers were able to achieve. Aware of the prestige they could acquire, brands submitted specifically prepared movements to these trials. ZENITH took part in trials as early as 1897, and over the years, its movements have won a record 2,333 chronometry prizes, more than any other brand. Among these, a movement outshone all others, the legendary calibre 135. Designed by Ephrem Jobin at the request of Charles Ziegler, Technical Director of ZENITH, this chronometer calibre was specifically developed to compete in chronometry competitions at the Observatories of Neuchâtel, Geneva, Kew Teddington, or Besançon. Its name is derived from its dimensions, 13 lines (or 30mm, the maximum size allowed in the wristwatch category competition at the Neuchatel Observatory trial) and 5mm in thickness. It was produced from 1949 to 1962 in two distinct versions: a commercial variant (135), and an 'O' iteration (135-O) created exclusively for observatory chronometry trials. The calibre 135-O received 235 chronometry prizes, an absolute record in the history of watchmaking. Regulated by renowned Zenith 'chronome?triers' Charles Fleck and Rene? Gygax, this movement set an extraordinary record with five consecutive first prizes in the wristwatch category at the Neuchâtel Observatory, from 1950 to 1954. The calibre 135-O legend was revived in 2022 through an exceptional collaboration with Kari Voutilainen and Phillips in Association with Bacs & Russo. Ten vintage movements from the 1950-1954 'serial winning' years were restored and decorated to the highest degree possible by master watchmaker Kari Voutilainen within an ultra-exclusive limited edition that struck a deeply resonating chord with discerning collectors. Icons stand the test of time, and the beauty of having such a rich heritage is being able to share it. Today, ZENITH takes things a step further, resurrecting the Calibre 135 and bringing it into the 21st century. This new version of the movement uses the dimensions, the look and the architecture of its ancestor. It incorporates an offset center wheel, creating space to accommodate the oversized balance wheel that improves both precision and stability. Yet, far from being a reproduction of the historical calibre, it is a modern re-engineering that integrates up-to-date technical solutions and materials wherever possible. The barrel now delivers 72 hours of power reserve compared to 40 hours in the 1950s version. It drives a new gear train featuring an optimized tooth geometry for enhanced efficiency. Operating at 2.5 Hz, the balance wheel features regulation screws and a Breguet overcoil. A signature feature of the 135-O, the double arrow-shaped regulator allows for precise adjustment, while a stop-second mechanism has been added to set the time to the exact second. The balance staff is now protected by spring-mounted jewel settings. The movements are regulated to be precise within +/-2 seconds per day, and their precision is officially certified by the COSC. The sophisticated yet sober decoration of the calibre 135 is a testament to its history of excellence. Each component is meticulously finished. The bridges are distinguished by their 'brick' guilloché finishing, inspired by the distinctive façade of red and white-painted bricks of the ZENITH Manufacture that proudly spell out the letters G.F.J., the initials of Georges Favre-Jacot. The barrel features circular a satin finish and the crown wheel is black-polished. The large jewels add another refined touch. Perfection is in the details – the G.F.J. After 160 years, the ambition to create a watch at the Zenith of perfection continues to guide the brand's watchmakers. In tribute to this unique legacy, ZENITH designed a timepiece distilled to its quintessential characteristics, where perfection is in the details. True to the era of the calibre 135, the new G.F.J. watch captures the essence of the 1950s, seamlessly blending vintage elegance with contemporary accents. Its slender, elegant 39mm platinum round case features a stepped bezel and curved stepped lugs. Its thin profile and sculptural lines are graced by exceptional finishes with alternating brushed and polished surfaces. The notched crown is emblazoned with the G.F.J. initials. Beneath the sapphire glass box, the G.F.J. is adorned with a blue dial – the ZENITH signature colour symbolizing, together with the star logo, the brand's connection to the sky and its relentless search for precision. Its three-part construction creates a compelling sense of depth while meticulously crafted details add a refined touch of sophistication. The outer ring features a 'brick' guilloche? pattern, faceted white gold hour markers, and a discreet minute track of 40 white gold beads applied by hand. The central part is crafted from deep blue Lapis Lazuli, whose gold-colored pyrite flecks inevitably evoke a starry sky. Their natural texture makes each dial unique. Lastly, indicating the passing seconds, the oversized subdial at 6 o'clock is in mother-of-pearl. The hours, minutes, and seconds are indicated by thin baton-style white gold hands. The ZENITH G.F.J. comes with three different straps: a dark blue alligator leather strap, a black calfskin leather strap, and a blue 'Saffiano' calfskin leather strap. The platinum pin buckle is engraved with the G.F.J initials and the brick pattern. It is also available upon request with a seven-row platinum bracelet, whose center links are embossed with the brick pattern. 'Few movements in watchmaking history have achieved the level of chronometric excellence and recognition as the calibre 135. More than just a technical achievement, it became a true icon of precision. Bringing it back for our 160th anniversary is about honoring this legacy while sharing it with a new generation of collectors. With the G.F.J., we have reimagined this legendary movement, not simply as a nod to the past, but as a way to share a defining part of its heritage while offering a contemporary interpretation that resonates with today's spirit, and we are deeply proud of it.' Benoît de Clerck, CEO of ZENITH WATCHES. Released in a limited edition of 160 pieces, the G.F.J is available for pre-order exclusively from the brand's physical and online boutiques, as well as through authorized retailers worldwide. 3 questions to Romain Marietta, CPO of ZENITH Watches *Following the exclusive edition released with Kari Voutilainen and Phillips in 2022, why did ZENITH decide to re-create this legendary calibre? We decided to bring back the legendary calibre 135 as a celebration of our 160th anniversary and pay tribute to our Maison's rich watchmaking heritage. The exclusive 2022 edition, developed with Kari Voutilainen and Phillips, reignited interest among collectors and enthusiasts, highlighting the historical significance of this calibre for ZENITH. Building on that enthusiasm, we wanted to bring back this emblematic movement, not simply as a nod to the past but as a way to share a defining part of its legacy while offering a contemporary interpretation that resonates with today's spirit. What modern upgrades does this new calibre incorporate? While remaining faithful to the spirit and character of the original, the new calibre has been thoughtfully re-engineered to meet contemporary expectations. It benefits from subtle yet meaningful improvements that enhance its reliability, precision, and overall performance without compromising its true essence. The result is a movement that seamlessly blends the charm of its historical roots with modern advancements, ensuring it remains relevant and captivating for today's discerning collectors. *What were the key principles behind the design of the G.F.J. watch? It was all about striking the right balance—staying true to the original design while bringing a sense of modern refinement. The inspiration came from the clean lines, balanced proportions, and understated sophistication of the 1950s. Every detail was carefully thought out, from the harmonious case design to the beautifully refined dial and movement finishing. The idea was to create a watch that honors Georges Favre-Jacot's vision and legacy while offering a fresh take that speaks to both vintage lovers and modern collectors. As a subtle nod to the Manufacture's iconic façade and Favre-Jacot's ambitious dream of bringing every stage of production under one roof—even down to making the very bricks that built his empire—the guilloche? dial is designed with a unique brick pattern, a tribute to that pioneering spirit. 3 questions to Laurence Bodenmann, Head of Heritage of ZENITH Watches ZENITH has an exceptional history with precision watchmaking and observatory trials. To what extent were these competitions essential for watchmakers at the time? Observatory trials were highly significant for watchmakers, serving as the ultimate test of a movement's precision and technical quality. These competitions were more than just a pursuit of accolades; they represented a benchmark of excellence, with results that enhanced a brand's reputation and credibility, and they were one of the two most important moments of the year along with the watch fairs. Success in observatory trials was seen as a mark of distinction, confirming a watchmaker's technical mastery in an era when mechanical precision was paramount. For ZENITH, taking part in these competitions was a natural extension of its commitment to accuracy and precision, reflected in its record-breaking number of 2,333 prizes. It was the path chosen by its founder, Georges Favre-Jacot, to prove the manufacturing system he pioneered in the world of Swiss watchmaking would produce more reliable, more perfect watches. This long-standing involvement not only pushed the brand to innovate but also reinforced its position as a master of precision. What place does the calibre 135 hold in ZENITH's long tradition of precision watchmaking? The calibre 135 holds a truly exceptional place in ZENITH's history and in the broader landscape of watchmaking. Developed specifically for observatory competitions (135-O), it became the most awarded movement during the golden age of chronometry trials, earning numerous first-place distinctions, including a remarkable series of five consecutive wins at the Neuchâtel Observatory from 1950 ZENITH | | Rue des Billodes 34-36 | CH-2400 Le Locle International Media Relations – Email : [email protected] to 1954. What sets it apart is its extra-large balance wheel, which brings more inertia and shapes its entire architecture in a way never seen before. That is what makes it an icon in the world of watchmaking! How did the historical context of the 1950s influence the design of ZENITH's chronometers of the time? The 1950s were a time of bold graphic exploration and innovation—designers were pushing boundaries, creating lines that felt both fresh and timeless. That same spirit is reflected in the vintage chronometer 135, where elegance comes through in the perfect balance of proportions and meticulous high-end finishing. The goal was always to create something that would stand the test of time, appealing across generations. In 2025, ZENITH is taking this idea even further, refining and modernizing this 'forever design' for the next generation. ZENITH: THE HEART OF WATCHMAKING Founded in 1865 in Le Locle, Switzerland, ZENITH has been at the forefront of Swiss watchmaking for over 160 years, driven by a pioneering spirit and a relentless pursuit of precision. As the first vertically integrated Swiss watch manufacture, ZENITH has continuously revolutionized horology by developing and manufacturing in-house movements, most notably the El Primero, the world's first automatic chronograph calibre launched in 1969, renowned for its unparalleled precision and high-frequency performance. ZENITH's timepieces celebrate its dedication to innovation and exceptional craftsmanship. The CHRONOMASTER collection highlights the brand's mastery of high-precision chronographs, the DEFY showcases technical innovation and bold design, while the PILOT collection celebrates ZENITH's storied aviation legacy with distinctive, adventure-ready timepieces. This unwavering commitment to precision has been recognized with an unparalleled 2,333 chronometry prizes, underscoring ZENITH's enduring legacy of excellence. The calibre 135, having won majority of those prizes went through a modern re-engineering integrating up-to-date technical solutions and materials. ZENITH decided to give it a new home in its newly introduced G.F.J collection. Throughout its history, ZENITH timepieces have accompanied pioneers who dared to dream big and achieve the extraordinary: from Louis Ble?riot's historic flight across the English Channel to Felix Baumgartner's record-breaking stratospheric free-fall jump. This daring spirit continues to drive the Maison as it redefines the future of Swiss watchmaking. Celebrating over a century and a half of excellence, innovation, and purpose, ZENITH remains at the forefront of Swiss horology, empowering those who challenge conventions and strive for greatness. From Le Locle to the world, from 1865 to now, ZENITH is the heart of watchmaking. G.F.J. Reference: 40.1865.0135/51.C200 Key points: Rebirth of the Legendary calibre 135. Chronometer Certified. Breguet Hairspring. Stop-second mechanism. Exclusive Edition for the 160th Anniversary of the Brand: Platinum case, lapis lazuli dial and special 'bricks' guilloche finishing on the movement. Movement: calibre 135 manual Frequency: 18,000 VpH (2.5 Hz) Power reserve: 72 hours Functions: Hours and minutes in the centre. Small seconds at 6 o'clock. Finishes: Exclusive 160th Bricks guilloché Price: 48'900 CHF / 52'900 Euros / 49'900 USD Material: Platinum 950 Water resistance: 5 ATM Case: 39.15mm / Thickness: 10.5 mm / Lug to lug: 45.75 mm Dial: Blue bricks guilloché on the outer ring, lapis lazuli in the center and mother-of-pearl small second counter Hour markers: 18-ct white gold applied indices Hands: 18-ct white gold faceted Bracelet & Buckle: Comes with 3 straps: Dark blue alligator leather strap with platinum pin buckle + black calfskin leather and blue 'Saffiano' calfskin leather. Optional for purchase: Platinum bracelet with double folding clasp
