On June 2, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported the publication of results from the Company’s randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer, which the Company first announced in December 2024, in The Lancet Oncology, one of the world’s leading peer-reviewed oncology journals (impact factor 35.9).

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"Localized prostate cancer remains an area of significant unmet need, with many patients experiencing disease recurrence after definitive radiotherapy. Innovation in this setting has been limited over the past two decades, making these peer-reviewed data particularly important for patients with intermediate- to high-risk localized prostate cancer," said Dr. Mark Garzotto, Professor of Urology and Radiation Medicine, School of Medicine, Oregon Health & Science University, and Chief of Urology at the Portland VA Medical Center. "The publication of these findings in The Lancet Oncology provides important peer-reviewed validation of the clinical significance of the results observed with aglatimagene in combination with radiotherapy."

The manuscript, titled "Aglatimagene besadenovec (CAN-2409) with radiotherapy for patients with localized prostate cancer: a phase 3, multicentre, randomised, double-blind, placebo-controlled trial," reports results from a pivotal phase 3 clinical trial (NCT01436968) evaluating aglatimagene plus valacyclovir in combination with standard-of-care radiotherapy administered with curative intent. The trial enrolled 745 patients and met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in DFS compared with radiotherapy alone.

The publication reports:

30% improvement in DFS in the aglatimagene arm, compared to placebo (hazard ratio 0.70; 95% confidence interval (CI) 0.52-0.94; p=0.016)
38% improvement in prostate cancer-specific DFS (prostate cancer recurrence or prostate cancer related death) (hazard ratio 0.62; 95% confidence interval 0.44-0.87; p=0.0046)
Aglatimagene improved pathological complete response rate in a post-hoc blinded review of biopsies collected two years after completion of radiotherapy, with 80% (167/209) of patients in the aglatimagene treatment arm observed with negative biopsies, versus 63% (62/98) observed in the placebo group (p=0.0018)
A generally favorable safety profile, with the most common treatment-related adverse events (chills, flu-like symptoms, fatigue, pyrexia, pollakiuria, and nausea) observed to be grades 1-2 and self-limited
While the study was not statistically powered to establish benefit in subgroups, exploratory descriptive analyses suggested clinical benefit of aglatimagene compared to placebo, independent of radiation therapy regimen and independent of androgen deprivation therapy use

The Company recently presented extended follow-up data from this phase 3 trial at the American Urological Association 2026 Annual Meeting, showing a 39% improvement in prostate cancer-specific DFS after an additional 20 months of follow-up (updated median follow-up, as of March 15, 2026, was 58 months). These data also showed consistently favorable trends across secondary and exploratory endpoints, including, time to biochemical failure, time to and incidence of metastasis, and time to salvage anti-cancer treatment in the aglatimagene arm compared with the placebo arm.

"The statistically significant increase in pathological complete response rates — observed in prostate biopsies obtained approximately two years after aglatimagene treatment and reported today in The Lancet Oncology — is particularly meaningful because biopsy findings after radiotherapy have previously been shown to predict later biochemical failure and metastasis with longer follow-up," said Garrett Nichols, M.D., Chief Medical Officer of Candel. "Together, these data strengthen our confidence that earlier tumor control, reflected in biopsy-based DFS events, may translate into durable and clinically meaningful benefit for patients."

"The publication of this pivotal phase 3 trial in The Lancet Oncology provides important peer-reviewed validation of the significance of these findings for patients with localized prostate cancer," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "Patients who elect to undergo radical treatment for localized prostate cancer do so with the goal of increasing their chance of living free from cancer while reducing the risk of recurrence and the need for future anti-cancer therapies that may carry additional toxicity and affect quality of life. These data showed a clinically meaningful reduction in disease recurrence in patients treated with aglatimagene in combination with radiotherapy. The primary endpoint findings were supported by sensitivity analyses and reinforced by secondary and exploratory endpoints and together provide a comprehensive and internally consistent body of evidence that supports the therapeutic potential of aglatimagene in localized prostate cancer."

The published manuscript is available online at The Lancet Oncology

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use.

(Press release, Candel Therapeutics, JUN 2, 2026, View Source [SID1234666375])

On June 2, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it has entered into a settlement and license agreement (the "Agreement"’) with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals, USA, Inc. (collectively, "Teva"). This Agreement resolves the patent litigation UroGen initiated in response to Teva’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration ("FDA") seeking approval to market a generic version of JELMYTO (mitomycin) for pyelocalyceal solution prior to the expiration of the relevant Company patents. Please note, that the Teva ANDA has not received tentative approval from the FDA, according to the Agency’s public database.

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Under the terms of the Agreement, UroGen will grant Teva a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will ask the court to dismiss the pending patent litigation with prejudice.

"We believe this resolution underscores the innovation behind our RTGel technology and the strength of our intellectual property portfolio," said Liz Barrett, President and Chief Executive Officer of UroGen. "We look forward to continuing to execute on our mission to transform paradigms in uro-oncology with our innovative treatments."

JELMYTO has regulatory exclusivity through April 15, 2027, and is covered by Orange Book-listed patents expiring on January 20, 2031. The negotiated license date preserves nearly all of this patent protection period, reflecting the strength of the Company’s intellectual property.

As required by law, the companies will submit the Agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for review.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

About Upper Tract Urothelial Cancer

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as UTUC. In the U.S., there are approximately 6,000 – 7,000 new or recurrent LG-UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often have multiple comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). Treatment with endoscopic surgery can be associated with a high rate of recurrence and relapse.

(Press release, UroGen Pharma, JUN 2, 2026, View Source [SID1234666374])

On June 2, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the Goldman Sachs 47th Annual Healthcare Conference, being held at the Loews Miami Beach Hotel, in Miami Beach, Florida on June 8-10, 2026. The fireside chat is scheduled to take place on Tuesday, June 9, 2026, at 2:00 PM ET.

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A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

(Press release, TG Therapeutics, JUN 2, 2026, View Source [SID1234666373])

On June 2, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported key Revuforj (revumenib) data that was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, including the oral presentation of new data from the post hematopoietic stem cell transplant (HSCT) setting. Revuforj is the first and only menin inhibitor that is FDA approved for patients one year and older with relapsed/refractory (R/R) acute leukemia with a KMT2A translocation or R/R acute myeloid leukemia (AML) with a susceptible NPM1 mutation (NPM1m) who have no satisfactory alternative treatment options.

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"The selection of the revumenib post-transplant data for oral presentation at ASCO (Free ASCO Whitepaper) underscores the clinical importance of this dataset and the potential for revumenib to advance the treatment paradigm," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "Building on the data presented at ASCO (Free ASCO Whitepaper) and other ongoing trials, we look forward to pioneering further research in the post-transplant setting, including the planned MenTain study, the first randomized, placebo-controlled trial specifically focused on evaluating revumenib as post-transplant maintenance."

"We are encouraged by the long-term outcomes observed among a cohort of 24 heavily pretreated patients with KMT2Ar, NPM1m, or NUP98r acute leukemia who resumed revumenib as maintenance after stem cell transplantation," said Ghayas C. Issa, M.D., Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center. "Among this population at high-risk for relapse and poor outcomes, we observed a 2-year overall survival rate of 90%, almost double the historical rate observed prior to the introduction of revumenib. While the sample size is small, these results are promising and strongly support further evaluation of revumenib as post-transplant maintenance."

Overview of key revumenib data presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract title: Revumenib as maintenance for AML following allogeneic stem cell transplantation
Abstract #: 6505

Pooled analysis of 24 patients (13 adults and 11 children) who resumed revumenib as maintenance after receiving a HSCT. 71% (17/24) had KMT2A-rearranged, 25% (6/24) had NPM1 mutated, and 4% (1/24) had NUP98-rearranged acute myeloid leukemia. This was a heavily pretreated cohort with a median of 3 prior lines of therapy (range: 1-11); 54% (13/24) had undergone prior HSCT. At current HSCT, 25% (6/24) of patients were in first complete remission (CR1) and 75% (18/24) were in second complete remission or beyond (CR2+).
Median time to initiate revumenib post-HSCT was 82 days (range: 42 – 174 days). Median duration of revumenib therapy post-HSCT was 10 months (range: 0.5 – 36 months). At last follow-up, 29% (7/24) of patients remained on revumenib.
With a median follow-up of 21 months, median overall survival (OS) and event-free survival from the time of HSCT were not reached.
In this single-arm study, a 2-year overall survival (OS) rate of 90% was observed in the overall population. In contrast, in a historical cohort of patients with the same genetic subtypes of acute leukemia treated prior to the advent of revumenib, a 2-year OS rate of 51% was observed.
The 1-year cumulative relapse rate was 0% and 17% among patients transplanted in CR1 and CR2+, respectively. In contrast, in a historical cohort of patients, the 1-year cumulative relapse rate was 12% and 40% among patients transplanted in CR1 and CR2+, respectively.
The most common any grade adverse event was thrombocytopenia, leading to dose modification in 46% (11/24) and discontinuation in 13% (3/24) of patients. No other significant toxicities were observed.
Outcomes appear favorable compared to historical cohorts, supporting prospective evaluation of revumenib as maintenance in the post-HSCT setting.

Abstract title: Pharmacokinetic (PK) assessment of revumenib in patients with relapsed/refractory (R/R) acute leukemias harboring a KMT2A rearrangement (KMT2Ar) or NPM1 mutation (NPM1m): Impact of food and concomitant medications
Abstract #: 6528

PK data were obtained from 335 patients (286 adults and 49 children) with acute leukemia, including those with KMT2Ar and NPM1m, who were enrolled in the Phase 1/2 AUGMENT-101 trial.
Results highlight differentiating aspects of revumenib’s PK profile, including the ability to:
Administer revumenib with commonly prescribed gastric acid reducing agents, such as proton pump inhibitors, without the risk of reduced exposure and efficacy
Maintain optimal exposure in the presence of strong CYP3A4 inhibitors using a clear revumenib dose adjustment strategy
Administer revumenib with a low-fat meal or under a fasted state

About Revuforj (revumenib)

Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute leukemia with a KMT2A translocation as determined by an FDA-authorized test or R/R acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

Revuforj (revumenib)

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.

In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.

Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia

Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.

Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

Strong CYP3A4 inhibitors: reduce Revuforj dose
Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec

SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNINGS.

(Press release, Syndax, JUN 2, 2026, View Source [SID1234666372])

On June 2, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reproted that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9, 2026, at 11:20 a.m. ET.

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

(Press release, Merck & Co, JUN 2, 2026, View Source [SID1234666371])