Market Newsdesk

January 17, 2025 7:04 am

Fabrinet to Announce Second Quarter Fiscal Year 2025 Financial Results on February 3, 2025

BANGKOK, Thailand, Jan. 17, 2025 (GLOBE NEWSWIRE) — Fabrinet (NYSE: FN), a leading provider of advanced optical packaging and precision optical, electro-mechanical and electronic manufacturing services to original equipment manufacturers of complex products, today announced it will release financial results for the second quarter of fiscal year 2025, which ended December 27, 2024, after market close on Monday, February 3, 2025. On that day, management will hold a conference call and webcast at 5:00 p.m. EST to review and discuss the Company’s results.

What:	Fabrinet Second Quarter Fiscal Year 2025 Financial Results Call
When:	Monday, February 3, 2025
Time:	5:00 p.m. EST
Live Call & Replay:	https://investor.fabrinet.com/events-and-presentations/events

A recorded version of this webcast will be available approximately two hours after the call and also accessible at https://investor.fabrinet.com/. The webcast will be archived on Fabrinet’s website for a period of one year.

About Fabrinet

Fabrinet is a leading provider of advanced optical packaging and precision optical, electro-mechanical, and electronic manufacturing services to original equipment manufacturers of complex products, such as optical communication components, modules and subsystems, automotive components, medical devices, industrial lasers and sensors. Fabrinet offers a broad range of advanced optical and electro-mechanical capabilities across the entire manufacturing process, including process design and engineering, supply chain management, manufacturing, advanced packaging, integration, final assembly and testing. Fabrinet focuses on production of high complexity products in any mix and any volume. Fabrinet maintains engineering and manufacturing resources and facilities in Thailand, the United States of America, the People’s Republic of China and Israel. For more information visit: https://fabrinet.com/.

SOURCE: Fabrinet

Investor Contact:

Garo Toomajanian
[email protected]

January 17, 2025 7:03 am

Ocular Therapeutix™ Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

BEDFORD, Mass., Jan. 17, 2025 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to redefining the retina experience, today announced that it has granted inducement awards to one newly hired employee. The awards were made as inducements material to the individual’s acceptance of employment with Ocular under Ocular’s 2019 Inducement Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

The inducement equity awards were granted effective as of January 13, 2025 and consist of (i) a non-statutory stock option to purchase up to 95,600 shares of Ocular’s common stock at a per share exercise price equal to the closing price of Ocular’s common stock on The Nasdaq Global Market on the effective date of grant, and (ii) a restricted stock unit award representing the right to receive 31,375 shares of Ocular’s common stock. The stock option has a ten-year term and is scheduled to vest over four years, with 25% of the original number of shares vesting on January 13, 2026 and the remainder vesting in equal monthly installments over the three years thereafter, subject to the individual’s continued service to Ocular through the applicable vesting dates. The restricted stock unit award is scheduled to vest over three years, in equal annual installments, with the first annual installment vesting on January 13, 2026, and subject to the recipient’s continued service to Ocular through the applicable vesting dates.

The inducement equity awards are subject to the terms and conditions of the award agreements covering the grants and Ocular’s 2019 Inducement Stock Incentive Plan.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (axitinib intravitreal injection, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD).

Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, and in its product candidate PAXTRAVA™ (travoprost intracameral injection or OTX-TIC), which is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension.

Follow the Company on its website, LinkedIn, or X.

The Ocular Therapeutix logo and DEXTENZA® are registered trademarks of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc.

Investors & Media

Ocular Therapeutix, Inc.
Bill Slattery
Vice President, Investor Relations
[email protected]

January 17, 2025 7:03 am

Autolus Therapeutics Presents Clinical Data Updates at the 2025 Tandem Meetings

LONDON, Jan. 17, 2025 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces an oral presentation and three poster presentations accepted to the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held from February 12-15, 2025, in Hawai’i Convention Center, Honolulu, HI.

“Building on our data presented at ASH in December, we come to Tandem with an updated health economic cost model directly comparing the cost of adverse events of AUCATZYL® versus other CAR-T cell therapies, which demonstrates that the shorter duration and lower incidence of CRS and ICANS contributes to a reduction in healthcare costs,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “We also show the effectiveness of AUCATZYL® versus non CAR-T standard of care therapies, and have an oral presentation update on the hematotoxicity model and poster presentation on the impact of deep molecular remissions on clinical outcomes, which were both announced in December.”

Oral:

Title: Risk Factors Associated with Sub-Optimal Outcomes and Hematotoxicity Following Obecabtagene Autoleucel (obe-cel) for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)
Session Name: Oral Abstract – Session A – Leukemia and Relapse
Session date and time: Wednesday, February 12, 2025, 3:15 PM

Presenting Author: Karamjeet S. Sandhu, MD

Summary: Risk-stratification for hematotoxicity, using pre-LD clinical parameters together with disease burden, has potential use for identifying patients more likely to benefit from obe-cel treatment and experience reduced toxicity. Patients with low-risk hematotoxicity scores had consistently better outcomes than patients with high-risk hematotoxicity scores.

Abstract 24949 – Poster:

Title: An Economic Model Comparing the Costs Associated with Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Among Patients Treated with Chimeric Antigen Receptor (CAR) T-Cell Therapies for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)
Session Name: Engineered Immune Cells (CAR-T, NK, TCR): Clinical – Immune Effector Cells for Heme Malignancies
Session date and time: Thursday, February 13, 2025, 6:45 PM
Presenting Author: Aaron C. Logan, MD

Summary: A decision tree economic model was developed using rates and median durations of AEs reported in the FELIX (NCT04404660; n=127) and ZUMA-3 (NCT02614066; n=55) trials. Obe-cel was associated with lower CRS- and ICANS-related healthcare costs versus brexu-cel, primarily due to lower rates of Gr 3/4 AEs and faster resolution of these events. These results suggest that obe-cel improves resource utilization and reduces healthcare costs versus other CAR T-cell therapies for R/R B-ALL.

Abstract

26113

– Poster:

Title: Comparison of Obecabtagene Autoleucel (obe-cel) Versus an External Control Arm (ECA) in Adult Patients (pts) with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)
Session Title: Acute and Chronic Leukemia (AML, MDS, MPD ALL, CML,) – Clinical
Session date and time: Thursday, February 13, 2025, 6:45 PM
Presenting Author: Karamjeet S. Sandhu, MD

Summary: The study was designed to report efficacy and safety outcomes of obe-cel in FELIX patients vs. patients treated with non-CAR T-cell standard of care (SOC) therapies in a matched External Control Arm. Obe-cel demonstrated higher ORR and longer OS and EFS vs. SOC in matched ECAs. Safety was comparable between treatment groups, demonstrating a positive benefit-risk profile of obe-cel for treatment of adult R/R B-ALL.

Abstract 26366 – Poster:

Title:
Deep Molecular Remission Predicts Better Clinical Outcomes in Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) Treated with Obecabtagene Autoleucel (obe-cel)

Session Name: Engineered Immune Cells (CAR-T, NK, TCR): Clinical – Immune Effector Cells for Heme Malignancies
Session date and time: Thursday, February 13, 2025, 6:45 PM

Presenting Author: Aaron C. Logan, MD

Summary: Among obe-cel responders for whom measurable residual disease (MRD) by next-generation sequencing could be analyzed, 84% achieved MRD <10^–6 leukemic cells, which was associated with more durable responses, and higher EFS and OS rates than patients with MRD ≥10^–4 and MRD between 10^–4 and 10^–6 leukemic cells. Patients who did not achieve MRD <10^–6 had poorer outcomes.

About Autolus Therapeutics plc

Autolus Therapeutics plc (Nasdaq: AUTL) is a commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has an FDA approved product, AUCATZYL, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com

About
obe-cel
FELIX clinical trial

Autolus’ Phase 1b/2 clinical trial of obe-cel enrolled adult patients with r/r B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint in the pivotal cohort was overall response rate, and the secondary endpoints included duration of response, MRD negative complete remission rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660].

About AUCATZYL^® (obecabtagene autoleucel, obe-cel, AUTO1)

AUCATZYL is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. AUCATZYL is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. AUCATZYL was approved by the FDA for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia on November 16, 2024. In the EU a regulatory submission to the EMA was accepted in April 2024, while in the UK, an MAA was submitted to MHRA in July 2024.

INDICATION

AUCATZYL^® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal and life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies

.

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS)

Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days following the first infusion (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). The most common manifestations of CRS included fever (100%), hypotension (35%), and hypoxia (19%).
Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 14 days at the healthcare facility following the first infusion. Continue to monitor patients for CRS for at least 4 weeks following each infusion with AUCATZYL. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Neurologic Toxicities

Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which were fatal or life-threatening, occurred following treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100) of patients, including Grade ≥ 3 in 12% of patients. The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Among patients with neurologic toxicities, the most common symptoms (> 5%) included ICANS (38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%), anxiety (9%), insomnia (9%), and delirium (8%).

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)

ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7% (7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24) experienced an onset after the first infusion, but prior to the second infusion of AUCATZYL.
The median time to onset for ICANS events after the first infusion was 8 days (range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second infusion, with a median duration of 8.5 days (range: 1 to 53 days).
Eighty-eight percent (21/24) of patients received treatment for ICANS. All treated patients received high-dose corticosteroids and 42% (10/24) of patients received anti-epileptics prophylactically. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage ICANS.
Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity /ICANS, immediately evaluate patients for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Effect on Ability to Drive and Use Machines

Due to the potential for neurologic events, including altered mental status or seizures, patients receiving AUCATZYL are at risk for altered or decreased consciousness or coordination in the eight weeks following AUCATZYL infusion or until resolution of the neurological event by the treating physician. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Prolonged Cytopenias

Patients may exhibit cytopenias including anemia, neutropenia, and thrombocytopenia for several weeks after treatment with lymphodepleting chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade ≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%, 6/41). Monitor blood counts after AUCATZYL infusion.

Infections

Severe, including life-threatening and fatal infections occurred in patients after AUCATZYL infusion. Non-COVID-19 infections of all grades occurred in 67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred in 41% (41/100) of patients. AUCATZYL should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after AUCATZYL infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.
Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients after AUCATZYL infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.
Viral reactivation, potentially severe or life-threatening, can occur in patients treated with drugs directed against B cells. There is no experience with manufacturing AUCATZYL for patients with a positive test for human immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Hypogammaglobulinemia

Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL infusion. Hypogammaglobulinemia was reported in 10% (10/100) of patients treated with AUCATZYL including Grade 3 events in 2 patients (2%).
Immunoglobulin levels should be monitored after treatment with AUCATZYL and managed per institutional guidelines including infection precautions, antibiotic or antiviral prophylaxis, and immunoglobulin replacement.
The safety of immunization with live viral vaccines during or following treatment with AUCATZYL has not been studied. Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until immune recovery following treatment with AUCATZYL.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)

HLH/MAS including fatal and life-threatening reactions occurred after treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41, respectively. One patient experienced a concurrent ICANS events after AUCATZYL infusion and died due to sepsis with ongoing HLH/MAS that had not resolved. Administer treatment for HLH/MAS according to institutional standards.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for hypersensitivity reactions during and after AUCATZYL infusion.
Secondary Malignancies
Patients treated with AUCATZYL may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Autolus at 1-855-288-5227 for reporting and to obtain instructions on the collection of patient samples for testing.

Adverse Reactions

The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 10⁶ CD19 CAR-positive viable T cells (range: 10 to 480 × 10⁶ CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 10⁶ +/- 25%).
The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia. Nine patients (9%) experienced fatal adverse reactions which included infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism, acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients, five patients who died from infections had pre-existing and ongoing neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy treatment and/or AUCATZYL.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding Autolus’ development and commercialization of its products and product candidates. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Autolus’ Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 21, 2024 as well as discussions of potential risks, uncertainties, and other important factors in Autolus’ subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release.

Contact:

Amanda Cray
+1 617-967-0207
[email protected]

Olivia Manser
+44 (0) 7780 471 568
[email protected]

January 17, 2025 7:03 am

CALQUENCE® (acalabrutinib) plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma

CALQUENCE^®(acalabrutinib) plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone

First and only BTK inhibitor approved for the 1st-line treatment of MCL in the US

WILMINGTON, Del.–(BUSINESS WIRE)–
AstraZeneca’s CALQUENCE^®(acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.

The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review. It was based on results from the ECHO Phase III trial which were presented at the European Hematology Association 2024 Congress.

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), often diagnosed at an advanced stage.^1,2 It is estimated that there are more than 21,000 patients diagnosed with MCL in the US, UK, France, Germany, Spain, Italy, Japan and China.³

Michael Wang, MD, Puddin Clarke Endowed Professor, Director of Mantle Cell Lymphoma Program of Excellence and principal investigator in the trial, said: “Managing this aggressive cancer requires maximizing efficacy while maintaining tolerability, especially for elderly patients. Results from the pivotal ECHO trial highlight the promise of the acalabrutinib combination in defining a new standard of care, with today’s approval underscoring the transformative potential of this regimen as a first-line treatment for older patients with mantle cell lymphoma.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “With today’s approval, CALQUENCE provides a critical new treatment option to mantle cell lymphoma patients in the US, with CALQUENCE proven to deliver nearly one and a half years of additional time without disease progression. This approval brings a new and effective treatment option to those living with this disease and further reinforces our belief in CALQUENCEas a backbone therapy across multiple blood cancers.”

Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation, said: “New treatment options have long been needed in the first-line treatment of mantle cell lymphoma in the US. Patients with this rare and often aggressive cancer can experience severe symptoms by the time they are diagnosed – having an effective therapy that can significantly improve outcomes for patients early in the treatment process is a much-needed advancement.”

Results from the ECHO trial showed CALQUENCEplus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). Median PFS was 66.4 months for patients treated with the CALQUENCEcombination versus 49.6 months with chemoimmunotherapy alone.

This approval additionally converts CALQUENCE’s accelerated approval to a full approval for adult patients with MCL treated with at least one prior therapy, as granted by the FDA in October 2017.

The ECHO trial enrolled patients throughout the COVID-19 pandemic. After censoring for COVID-19 deaths, PFS was further improved in both arms, with the CALQUENCE combination reducing the risk of disease progression or death by 36% (HR 0.64; 95% CI 0.48-0.84). Although OS data were not mature at the time of the analysis, when censored for COVID-19, a favorable trend was seen for OS (HR 0.75; 95% CI 0.53-1.04), despite 69% of patients in the chemoimmunotherapy arm receiving treatment with a BTK inhibitor on relapse or disease progression.

The safety and tolerability of CALQUENCE was consistent with its known safety profile, and no new safety signals were identified.

The US regulatory submission was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, CALQUENCEplus chemoimmunotherapy is also under review by regulatory authorities in Australia, Canada, and Switzerland for the same indication. Regulatory applications are also under review in the EU, Japan, and other countries based on the ECHO results.

INDICATIONS AND USAGE

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT), as monotherapy for the treatment of adult patients with MCL who have received at least one prior therapy, and for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

Serious and Opportunistic Infections

Fatal and serious infections, including opportunistic infections, have occurred in patients with hematologic malignancies treated with CALQUENCE.

Serious or Grade 3 or higher infections (bacterial, viral, or fungal) occurred in 32% of 1,764 patients exposed to CALQUENCE in clinical trials, most often due to respiratory tract infections (19% of all patients, including pneumonia in 9%). These infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, with neutropenic infection reported in 2.7% of all patients. Opportunistic infections in recipients of CALQUENCE have included, but are not limited to, hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia, Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal leukoencephalopathy (PML). Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor patients for signs and symptoms of infection and treat promptly.

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients treated with CALQUENCE. Major hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 4.4% of patients, with fatal hemorrhage occurring in 0.2% of 1,764 patients exposed to CALQUENCE in clinical trials. Bleeding events of any grade, excluding bruising and petechiae, occurred in 40% of patients.

Use of antithrombotic agents concomitantly with CALQUENCE may further increase the risk of hemorrhage. In clinical trials, major hemorrhage occurred in 7% of patients taking CALQUENCE without antithrombotic agents and 4% of patients taking CALQUENCE with antithrombotic agents. Consider the risks and benefits of antithrombotic agents when co-administered with CALQUENCE. Monitor patients for signs of bleeding.

Consider the benefit-risk of withholding CALQUENCE for 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Cytopenias

CALQUENCE can cause Grade 3 or 4 cytopenias. Grade 3 or 4 cytopenias included absolute neutrophil count decreased (26%), platelets decreased (10%), hemoglobin decreased (10%), and absolute lymphocyte count decreased (10%) in patients treated with CALQUENCE alone or in combination with obinutuzumab; Grade 4 neutropenia developed in 14% of patients.

Monitor complete blood counts regularly during treatment. Interrupt treatment, reduce the dose, or discontinue treatment as warranted.

Second Primary Malignancies

Second primary malignancies, including skin cancers and other solid tumors, occurred in 18% of 1,764 patients exposed to CALQUENCE in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer, reported in 10% of patients, followed by other solid tumors in 9% (including melanoma, lung cancer, gastrointestinal cancers, and genitourinary cancers) and hematologic malignancies (1%). Monitor patients for the development of second cancers and advise protection from sun exposure.

Cardiac Arrhythmias

Fatal and serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. Grade 3 or 4 atrial fibrillation or flutter was reported in 2.6% of 1,764 patients treated with CALQUENCE, with all grades of atrial fibrillation or flutter reported in 7% of all patients. Grade 3 or higher ventricular arrhythmia events were reported in 0.6% of patients, including fatal cases in 0.3% of all patients. The risk of arrhythmias may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea) and manage as appropriate.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE.

Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE.

ADVERSE REACTIONS

Previously Untreated Mantle Cell Lymphoma

The most common adverse reactions (≥15%) of any grade in patients with previously untreated MCL who received CALQUENCE plus BR were rash (47%), COVID-19 (38%), fatigue (37%), diarrhea (37%), pneumonia (31%), headache (31%), upper respiratory tract infection (30%), pyrexia (29%), cough (27%), vomiting (26%), constipation (25%), hemorrhage (20%), edema (20%), secondary primary malignancy (19%), dizziness (18%), arthralgia (18%), and dyspnea (17%).

Grade 4 laboratory abnormalities in >15% of patients treated with CALQUENCE plus BR include lymphocytes decreased (26%), absolute neutrophils decreased (36%), and uric acid increased (17%).

Serious adverse reactions occurred in 69% of patients who received CALQUENCE plus BR. Serious adverse reactions reported in ≥2% of patients were pneumonia (23%; includes COVID-19 pneumonia), COVID-19 (20%; includes COVID-19 pneumonia), second primary malignancy (7%), pyrexia (6%), rash (3.4%), febrile neutropenia (3.4%), atrial fibrillation (3%), sepsis (2.7%), and anemia (2.4%). Fatal adverse reactions that occurred within 30 days of the last study treatment were reported in 12% who received CALQUENCE plus BR including COVID-19 (6%; includes COVID-19 pneumonia), pneumonia (1%), second primary malignancy (0.7%), sepsis (0.3%), and pneumonitis (0.3%).

Adverse reactions led to permanent discontinuation of CALQUENCE in 43%, dosage interruptions in 74%, and dosage reductions in 10% of patients. Adverse reactions that resulted in dosage modification in >10% included infections, cytopenias, rashes, and gastrointestinal toxicity. Adverse reactions which resulted in permanent discontinuation of CALQUENCE in ≥4% of patients included COVID-19 (includes COVID-19 pneumonia) and neutropenia.

Previously Treated Mantle Cell Lymphoma

The most common adverse reactions (≥20%) of any grade in patients with relapsed or refractory MCL exposed to CALQUENCE were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). The most common Grade ≥3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%).

*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.

Dose reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) occurred in 4.8% of patients.

Chronic Lymphocytic Leukemia

The most common adverse reactions (≥30%) of any grade in patients with CLL exposed to CALQUENCE were anemia,* neutropenia,* thrombocytopenia,* headache, upper respiratory tract infection, and diarrhea.

*Treatment-emergent decreases (all grades) of hemoglobin, platelets, and neutrophils were based on laboratory measurements and adverse reactions.

In patients with previously untreated CLL exposed to CALQUENCE, fatal adverse reactions that occurred in the absence of disease progression and with onset within 30 days of the last study treatment were reported in 2% for each treatment arm, most often from infection. Serious adverse reactions were reported in 39% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (2.8% to 7%).

Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in the CALQUENCE plus obinutuzumab arm (N=178) and CALQUENCE monotherapy arm (N=179), respectively. Adverse events led to discontinuation in 11% and 10% of patients, respectively. Increases in creatinine to 1.5 to 3 times ULN occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively.

In patients with relapsed/refractory CLL exposed to CALQUENCE, serious adverse reactions occurred in 29% of patients. Serious adverse reactions in >5% of patients who received CALQUENCE included lower respiratory tract infection (6%). Fatal adverse reactions within 30 days of the last dose of CALQUENCE occurred in 2.6% of patients, including from second primary malignancies and infection.

Adverse reactions led to CALQUENCE dose reduction in 3.9% of patients (N=154), dose interruptions in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and discontinuation in 10% of patients, most frequently due to second primary malignancies followed by infection. Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will be used short-term, interrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of CALQUENCE.

Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg once daily when co-administered with a moderate CYP3A inhibitor.

Strong CYP3A Inducers: Avoid co-administration of CALQUENCE with a strong CYP3A inducer. If co-administration is unavoidable, increase the dosage of CALQUENCE to 200 mg approximately every 12 hours.

SPECIFIC POPULATIONS

Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women of the potential risk to a fetus.

Pregnancy testing is recommended for females of reproductive potential prior to initiating CALQUENCE therapy. Advise female patients of reproductive potential to use effective contraception during treatment with CALQUENCE and for 1 week following the last dose of CALQUENCE.

It is not known if CALQUENCE is present in human milk. Advise lactating women not to breastfeed while taking CALQUENCE and for 2 weeks after the last dose.

Avoid use of CALQUENCE in patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustment of CALQUENCE is recommended in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

Please see full Prescribing Information, including Patient Information.

Notes

Mantle cell lymphoma

While MCL patients initially respond to treatment, patients do tend to relapse.⁴ MCL comprises about 3-6% of non-Hodgkin lymphomas, with an annual incidence of 0.5 per 100,000 population in Western countries; in the US, it is estimated that approximately 4,000 new patients are diagnosed with MCL each year.^4,5

ECHO

ECHO is a randomized, double-blind, placebo-controlled, multi-center Phase III trial evaluating the efficacy and safety of CALQUENCE plus bendamustine and rituximab compared to SoC chemoimmunotherapy (bendamustine and rituximab) in adult patients at or over 65 years of age (n=635) with previously untreated MCL.⁶ Patients were randomized 1:1 to receive either CALQUENCE or placebo administered orally twice per day, continuously, until disease progression or unacceptable toxicity. Additionally, all patients received six 28-day cycles of bendamustine on days 1 and 2 and rituximab on day 1 of each cycle, followed by rituximab maintenance for two years if patients achieved a response after induction therapy.⁶

The primary endpoint is PFS assessed by an Independent Review Committee; other efficacy endpoints include OS, overall response rate (ORR), duration of response (DoR) and time to response (TTR).⁶ The trial was conducted in 27 countries across North and South America, Europe, Asia and Oceania.⁶

The ECHO trial enrolled patients from May 2017 to March 2023, continuing through the COVID-19 pandemic. Prespecified PFS and OS analyzes censoring for COVID-19 deaths were conducted to assess the impact of COVID-19 on the study outcome in alignment with the FDA. Patients with blood cancer remain at a disproportionately high risk of severe outcomes from COVID-19, including hospitalization and death compared to the general population.^6,7

CALQUENCE

CALQUENCE(acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK).CALQUENCEbinds covalently to BTK, thereby inhibiting its activity.⁸ In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

CALQUENCEhas been used to treat more than 85,000 patients worldwide⁹ and is approved for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the US and Japan, approved for CLL in the EU and many other countries worldwide and approved in China for relapsed or refractory CLL and SLL.CALQUENCEis also approved for the treatment of adult patients with previously untreated MCL in the US, and in China and several other countries for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. CALQUENCEis not currently approved for the treatment of MCL in Japan or the EU.

As part of an extensive clinical development program, CALQUENCE is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.

AstraZeneca in hematology

AstraZeneca is pushing the boundaries of science to redefine care in hematology. Our goal is to help transform the lives of patients living with malignant, rare and other related hematologic diseases through innovative medicines and approaches that are shaped by insights from patients, caregivers and physicians.

In addition to our marketed products, we are spearheading the development of novel therapies designed to target underlying drivers of disease across multiple scientific platforms. Our acquisitions of Alexion, with expertise in rare, non-malignant blood disorders, and Gracell Biotechnologies Inc., pioneers of autologous cell therapies, expand our hematology pipeline and enable us to reach more patients with high unmet needs through the end-to-end discovery, development and delivery of novel therapies.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca-us.com and follow us on social media @AstraZeneca.

References

Lymphoma Research Foundation. Mantle Cell Lymphoma. Accessed January 2025. https://lymphoma.org/aboutlymphoma/nhl/mcl/

National Organization for Rare Disorders. Mantle Cell Lymphoma. Accessed January 2025. Available at: https://rarediseases.org/rare-diseases/mantle-cell-lymphoma/

AstraZeneca 2024. Q3 2024 Financial Results. Accessed January 2025. https://www.astrazeneca.com/investor-relations.html

Cheah C, Seymour J, Wang ML. Mantle cell lymphoma. J Clin Oncol. 2016;34(11):1256-1269. doi: 10.1200/JCO.2015.63.5904.

MD Anderson Cancer Center. What to know about mantle cell lymphoma. Accessed January 2025. https://www.mdanderson.org/cancerwise/what-to-know-about-mantle-cell-lymphoma-symptoms-diagnosis-and-treatment.h00-159385101.html

ClinicalTrials.gov. A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL. Accessed January 2025. https://clinicaltrials.gov/study/NCT02972840

Dube S, et al. Continued Increased Risk of COVID-19 Hospitalization and Death in Immunocompromised Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective Health Database Study in England. Poster P0409 at ECCMID 2024.

Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).

Data on File, REF-236261. AstraZeneca Pharmaceuticals LP.

US-48947 Last Updated 1/25

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Posted on January 17, 2025 7:03 am
Walmart Unveils New 350-Acre Campus in Bentonville

Walmart Unveils New 350-Acre Campus in Bentonville

Modern Campus Defined by Sustainable Design, Associate-Centered Environment, and Community-Friendly Retailers

BENTONVILLE, Ark.–(BUSINESS WIRE)–
Today, Walmart unveiled its New Home Office campus in Northwest Arkansas, a 350-acre sustainably designed workplace to serve as the heartbeat of the world’s largest company. This campus establishes a new standard for corporate headquarters that prioritizes worker well-being, environmental stewardship, and public accessibility.

The state-of-the art campus represents a multibillion-dollar investment in associate experience environmental leadership, and community development, featuring mass timber construction, smart building technology, offices designed to be power renewable energy and seamless integration with Downtown Bentonville. The phased opening approach will continue throughout 2025, with the inaugural celebration marking the commencement of the phased opening strategy.

“Our new Home Office honors our heritage and the contributions that generations of associates have made to help people save and have a better life. Our founder, Sam Walton, knew that when we all work together, ideas flourish, and this campus will allow us to keep making a positive difference in our customers’ lives for generations to come,” said Doug McMillon, Walmart’s CEO.

The transformative project marks the realization of a vision first announced in 2019, when Walmart committed to reimagining its corporate workspace for the future of retail. Through extensive associate feedback and innovative design practices, the company has created a workplace that combines new technology with the warmth and accessibility that have defined Walmart’s culture for more than 60 years.

Advanced Spaces Celebrate Roots while Welcoming the Future

Rooted in our past, yet embracing the future, the campus boasts new facilities designed to enhance the associate experience and foster community connections. At its heart stands Sam Walton Hall, a 200,000-square-foot, two-story auditorium featuring advanced conference, learning and development spaces, where Home Office and field associates can collaborate and celebrate successes together. In an opening ceremony held in the Hall and open to associates from around the world, the retailer unveiled other key locations on the campus, including:

Welcome Center: The campus gateway that welcomes visitors and associates with Walmart’s signature warmth and hospitality.

Helen’s Amphitheatre: An inspiring outdoor venue honoring Helen Robson Walton’s legacy, featuring terraced seating and a tree-canopied lawn for campus and community gatherings.

8th & Plate: A dynamic food hall offering global cuisine through seven coffee shops, food truck pavilions, grab-and-go markets, a rooftop lounge and street-front retail and restaurants.

Office Spaces (Cheer and Ol’ Roy): With design, identity and imagery that evoke history, culture and leaders who have shaped this company, the first two of 12 office spaces and their unique stories will be unveiled, with more opening throughout the year.

Street Front Retail: Retail shops open to the public feature locally and nationally recognized brands, including Bentonville Bicycle Company, Flyway Brewing, Gearhead Outfitters, The Gents Place, Hatch Early Mood Food, Jamba Juice, Riserva Bar + Tapas, Swig, Walmart Pharmacy, Wrights BBQ and Yokozuna Sushi. Street front retail will be available in Spring of 2025.

Associate–Driven Design for a Winning Work Environment

The new campus embodies our associate-first approach, from ample natural light and expanded food offerings to convenient parking, fitness options and a childcare facility. The 360,000-square-foot Walton Family Whole Health & Fitness, as well as the on-site childcare Little Squiggles Children’s Enrichment Center opened in 2024, giving a preview of Walmart’s commitment to associate wellness.

The focus on comprehensive associate wellness extends throughout the outdoor spaces, integrating seamlessly with the community and embracing the natural beauty of the region. The “Big Nature” landscape plan incorporates over 750,000 native plants: including 5,000 planted trees, reflecting the native habitats of the Ozarks. Shaded walkways and dedicated bike paths create an environment that promotes active commuting while reducing traffic and parking demands. An inviting street front retail environment featuring a mix of local and national retail outlets seeks to engage visitors and the community to enjoy the new campus.

A Commitment to Smart, Sustainable Design

In addition to the focus on green space representing 50 percent of the campus, 12 office buildings, built with the largest application of mass timber in the U.S., are designed to achieve LEED Platinum certification, and run on renewable energy. More than 13 acres of lake reservoirs are smart technology-enabled to assist in water management, while dynamic glass designed to reduce energy load and LED lighting is fitted throughout all structures.

Seven miles of pedestrian paths and bike trails connect to a rentable bike fleet, more than 1,000 bike parking spots, and 300 EV charging stations, making sustainable transportation accessible for associates and visitors. Another focus that brings together fresh design principles and an associate-first approach is evident in the deployment of smart technology systems including enhanced mobile applications, drone exterior window washing, autonomous mowing and vacuums, and smart room booking systems.

New Home Office Media Hub

About Walmart

Walmart Inc. (NYSE: WMT) is a people-led, tech-powered omnichannel retailer helping people save money and live better — anytime and anywhere — in stores, online, and through their mobile devices. Each week, approximately 255 million customers and members visit more than 10,500 stores and numerous eCommerce websites in 19 countries. With fiscal year 2024 revenue of $648 billion, Walmart employs approximately 2.1 million associates worldwide. Walmart continues to be a leader in sustainability, corporate philanthropy, and employment opportunity. Additional information about Walmart can be found by visiting corporate.walmart.com, on Facebook at facebook.com/walmart, on X (formerly known as Twitter) at twitter.com/walmart, and on LinkedIn at linkedin.com/company/walmart.

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Walmart Press Office

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Posted on January 17, 2025 7:03 am
Craig Melvin and Savannah Guthrie Reveal How Their Friendship Began in Parade’s Exclusive Cover Story: ‘We Don’t Have to Fake It’

Craig Melvin and Savannah Guthrie Reveal How Their Friendship Began in Parade’s Exclusive Cover Story: ‘We Don’t Have to Fake It’

TODAY’s lead co-anchors detail their long-term friendship, Melvin’s reaction to Hoda Kotb’s resignation and why he missed the Taylor Swift concert.

Link to cover story

Link to Video

NEW YORK–(BUSINESS WIRE)–Parade, the premium legacy entertainment and lifestyle brand, released its latest cover story, featuring an exclusive interview with Craig Melvin, the TODAY show’s new lead co-anchor, and Savannah Guthrie.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250117335099/en/

Parade’s latest cover story features an exclusive interview with Craig Melvin, the TODAY show’s new lead co-anchor, and Savannah Guthrie. (Photo: Business Wire)

In this heartfelt interview, Melvin and Guthrie sat down together to discuss their decades-long friendship, how Guthrie derailed Melvin’s 2010 date with his future wife, their reactions to Hoda Kotb’s resignation, Taylor Swift and more.

Read the full interview here. Video link here. Notable quotes are below.

How Savannah cut short Craig’s date with future wife Lindsay Czarniak: “When [Lindsay and I] were dating, I remember vividly one time we went out to dinner,” Melvin explains, adding that their nightcap had to be cut short due to Czarniak’s appearance on The Daily Rundown. “I was like, ‘The show with Chuck [Todd] and Savannah?’ I [thought], ‘Screw Chuck and Savannah [for] taking you away early.’ I remember the first time that I saw her on the show. She was wearing this yellow dress. Yellow is her favorite color. I just wanted to make sure she wasn’t trying to blow me off, so I woke up the next morning to actually watch, and there she was. So, it’s kind of full-circle.”

“Lindsay and my husband, Mike [Feldman], have all known each other for a thousand years. I’ve known Lindsay for longer [than Craig],” says Guthrie. “I thought she was amazing. We love her. And then I’m like, ‘Oh, my gosh, they’re dating.’”

Craig and Savannah on their longtime friendship: Melvin and Guthrie first became acquainted around 2010 while both were living and working in Washington, D.C. Melvin was a weekend anchor for the local NBC TV news affiliate—“I immediately was like: That guy is good. He’s different. He’s an original,” Guthrie recalls.

“We’ve become legit friends. We’ve got kids that have hung out together, and we’ve hung out together, so we don’t have to fake it,” Melvin says. “The audience can tell when the chemistry is manufactured, and we haven’t had to manufacture anything, which makes it even easier. I’m really excited to be on this adventure with my sister.”

Savannah on replacing Ann Curry as lead co-anchor in 2012: “I came at a time of a lot of controversy for the show, and it wasn’t, I don’t think, a happy occasion, really—for anyone, including me,” Guthrie recalls. “I was as terrified as I could possibly be because the bosses at the time had made a decision, and I quite literally was the last to know, and I was so afraid, and I was pretty sure that I wouldn’t last.”

At the time, Guthrie had been the anchor of the 9 a.m. hour on TODAY, as well as the show’s chief legal correspondent. “All my dreams had already come true,” she says. “It didn’t need to get any better than that. When I was offered the job, I was in tears. And it wasn’t because I didn’t dream of this job like everyone else does. It was because I was sure that it wouldn’t last and that I’d be thrown by the wayside within a few weeks or months…I’m so happy that I survived and I’m still here.”

Craig and Savannah on parenting: “Our kids are essentially the same age,” says Melvin. “So when we bring our kids together, the boys tend to hang out, and the girls [do so], even though there’s an age difference.” Guthrie and Melvin each started families of their own around the same time, and discussion of juggling their jobs and parenting is, says Melvin, “80 percent of our conversation.”

“We talk probably more about that stuff than we do about work,” Guthrie adds. “We talk about our kids. We show each other pictures. He just got a puppy last year. We just got a puppy a month ago. We talk about the joys and pratfalls of puppy ownership.” (“Pratfalls, that’s good,” Melvin chimes in.)

Why Craig missed Taylor Swift’s concert: In October, the families met up in Miami for dinner and a Taylor Swift concert, along with Kotb and her daughters. Melvin, however, ended up skipping the singer’s iconic Eras Tour for dad duty. “I didn’t go to the concert. I was open to it. My 10-year-old son was like, ‘Under no circumstances am I going to a Taylor Swift concert.’” (Father and son ended up playing laser tag.)

To read this story, or any of previous Parade cover stories, click here.

About Parade

Parade, the premium legacy entertainment and lifestyle brand, has been enlightening, delighting and inspiring audiences for more than 80 years. Parade is owned and operated by The Arena Group (NYSE American: AREN), an innovative technology platform and media company with a proven cutting-edge playbook that transforms media brands. Arena’s unified technology platform empowers creators and publishers with tools to publish and monetize their content, while also leveraging quality journalism of anchor brands like TheStreet, Parade, Men’s Journal and Athlon Sports to build their businesses. The company aggregates content across a diverse portfolio of brands, reaching over 100 million users monthly. Visit us at thearenagroup.net and discover how we are revolutionizing the world of digital media.

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Parade’s latest cover story features an exclusive interview with Craig Melvin, the TODAY show’s new lead co-anchor, and Savannah Guthrie. (Photo: Business Wire)

Posted on January 17, 2025 7:03 am
Virtus Investment Partners to Announce Fourth Quarter 2024 Results on Friday, January 31

Virtus Investment Partners to Announce Fourth Quarter 2024 Results on Friday, January 31

Conference Call at 10:00 a.m. Eastern

HARTFORD, Conn.–(BUSINESS WIRE)–Virtus Investment Partners, Inc. (NYSE: VRTS), which operates a multi-boutique asset management business, today announced that it will release its financial results for the fourth quarter of 2024 before the market opens on Friday, January 31, 2025. George R. Aylward, president and chief executive officer, and Michael A. Angerthal, executive vice president and chief financial officer, will host a conference call and webcast with the investment community at 10:00 a.m. Eastern.

The presentation that will accompany the conference call will be available in the Presentations section of virtus.com. A replay of the call will be available in the Investor Relations section for at least one year.

About Virtus Investment Partners, Inc.

Virtus Investment Partners (NYSE: VRTS) is a distinctive partnership of boutique investment managers singularly committed to the long-term success of individual and institutional investors. We provide investment management products and services from our affiliated managers, each with a distinct investment style and autonomous investment process, as well as select subadvisers. Investment solutions are available across multiple disciplines and product types to meet a wide array of investor needs. Additional information about our firm, investment partners, and strategies is available at virtus.com.

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Sean Rourke

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Posted on January 17, 2025 7:03 am
GCT Semiconductor Participates in Exclusive Aramco Digital and 450 MHz Alliance Event on Innovations in Private Networks

GCT Semiconductor Participates in Exclusive Aramco Digital and 450 MHz Alliance Event on Innovations in Private Networks

The event, held January 20-22 in Dhahran, Kingdom of Saudi Arabia, focuses on the advancements in private networks leveraging the 450 MHz spectrum

SAN JOSE, Calif.–(BUSINESS WIRE)–
GCT Semiconductor Holding Inc. (“GCT” or the “Company”) (NYSE: GCTS), a leading designer and supplier of advanced 5G and 4G semiconductor solutions, announced today the participation in the Aramco Digital event, held in collaboration with the 450 MHz Alliance, on January 20-22 at the Sofitel Al Khobar The Corniche Hotel in Dhahran, Saudi Arabia. GCT will gather with industry leaders and innovators to discuss the global evolution and next generation of 450 MHz solutions.

Frank Jungman, Vice President of Technical Marketing of GCT, will be presenting at a panel discussion on “Evolving technologies, devices and MCX innovations,” held on January 21 at 14:15. Jungman will discuss the latest advancements in chipsets for the 450 MHz band and how the 450 MHz ecosystem will evolve in the next five to ten years. The panel will also address how emerging technologies such as artificial intelligence (AI) and machine learning (ML) take part in network and device optimization.

“We look forward to playing a key role in the evolving 450 MHz and 5G ecosystem, and further strengthening our partnership with Aramco as we continue to prepare for our 5G chipset launch,” said John Schlaefer, CEO of GCT. “This event offers a great opportunity to discuss and share ideas on how our latest GCT technology can play a part in transforming the future of critical infrastructure.”

About GCT Semiconductor Holding, Inc.

GCT is a leading fabless designer and supplier of advanced 5G and 4G LTE semiconductor solutions. GCT’s market-proven solutions have enabled fast and reliable 4G LTE connectivity to numerous commercial devices such as CPEs, mobile hotspots, routers, M2M applications, smartphones, etc., for the world’s top wireless carriers. GCT’s system-on-chip solutions integrate radio frequency, baseband modem and digital signal processing functions, therefore offering complete 4G and 5G platform solutions with small form factors, low power consumption, high performance, high reliability, and cost-effectiveness. For more information, visit www.gctsemi.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, statements regarding potential application of GCT’s technology. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside the Company’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results, include, but are not limited to: the ability of the Company to develop its 5G products and generate revenue; the ability of the Company to enter into and meet the obligations under partnership and collaboration agreements; the ability of the Company to grow and manage growth profitability and retain its key employees; the Company’s financial and business performance, including the Company’s financial projections and business metrics; changes in the Company’s strategy, future operations, financial position, estimated revenues and losses, forecasts, projected costs, prospects and plans; the Company’s inability to anticipate the future market demands and future needs of its customers; the impact of component shortages, suppliers’ lack of production capacity, natural disasters or pandemics on the Company’s sourcing operations and supply chain; the Company’s future capital requirements and sources and uses of cash; the ability of the Company to raise sufficient capital to fund its operations; the ability to implement business plans, forecasts, and other expectations, including the growth of the 5G market; the risk that the Company may not be able to repay its debt; the risk of economic downturns that affects the Company’s business operation and financial performance; the risk that the Company may not be able to develop and design its products acceptable to its customers; actual or potential conflicts of interest of the Company’s management with its public stockholders; and other risks and uncertainties indicated from time to time in the Company’s filings with SEC, including registration statements on Form S-1 and quarterly reports on Form 10-Q and those disclosures under the “Risk Factors” sections therein. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and the Company assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

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Investor relations contact: Gateway Group, Matt Glover & Ralf Esper, [email protected]

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Posted on January 17, 2025 7:03 am
Twilio to Announce Fourth Quarter and Fiscal Year 2024 Results on February 13, 2025

Twilio to Announce Fourth Quarter and Fiscal Year 2024 Results on February 13, 2025

SAN FRANCISCO–(BUSINESS WIRE)–
Twilio Inc. (NYSE: TWLO), the customer engagement platform that drives real-time, personalized experiences for today’s leading brands, today announced that its fourth quarter and fiscal year 2024 results will be released on Thursday, February 13, 2025, after market close. Twilio will host a conference call at 2:00 p.m. (PT) / 5:00 p.m. (ET) on Thursday, February 13, 2025 to discuss its results with the investment community. Investors and analysts can register for the webcast at https://edge.media-server.com/mmc/p/auzd77nc, and the live webcast and replay will also be available on the Twilio Investor Relations website at https://investors.twilio.com. The replay will be available until 11:59 p.m. (ET) on February 13, 2026.

Twilio uses its investor relations website (https://investors.twilio.com) and the X (formerly Twitter) account of the company (@twilio) as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

About Twilio

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Posted on January 17, 2025 7:03 am
Castle’s Poster on DecisionDx®-SCC Selected as a “Late Breakers” Top Five Finalist for the Akamai Award, Recognizing the Best Posters at Maui Derm Hawaii 2025

Castle’s Poster on DecisionDx®-SCC Selected as a “Late Breakers” Top Five Finalist for the Akamai Award, Recognizing the Best Posters at Maui Derm Hawaii 2025

Highlights from Castle’s DecisionDx-SCC poster will be shared in a special podium presentation during the Late Breakers 2025 session on Tuesday, Jan. 21, from 10:45-11:15 a.m. local time

FRIENDSWOOD, Texas–(BUSINESS WIRE)–
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share data supporting its dermatologic portfolio of tests for skin cancer, DecisionDx-SCC, DecisionDx®-Melanoma and MyPath® Melanoma, through poster presentations at the annual Maui Derm Hawaii meeting, being held Jan. 20-24, 2025, in Maui, Hawaii.

The Company’s poster on DecisionDx-SCC, which was selected as a “Late Breakers” top five finalist for the best poster Akamai Award, shares new data from a study involving Castle’s largest cohort of patients with cutaneous squamous cell carcinoma (SCC) to date (n=1,408). This study demonstrates improved risk stratification of patients with SCC tumors located on the head or neck when the test’s results are combined with Brigham and Women’s Hospital (BWH) staging.

“Patients with SCC tumors of the head or neck may be at increased risk of metastasis and thus could be candidates for adjuvant treatments, such as radiation, to reduce this risk,” said Dr. Emily Ruiz, M.D., MPH, FAAD, board-certified dermatologist and Mohs micrographic surgeon at Brigham and Women’s Hospital in Boston, and Associate Professor of Dermatology at Harvard Medical School. “As demonstrated in the study, using the DecisionDx-SCC test alongside BWH staging improved the overall accuracy of metastatic risk predictions in patients with these higher-risk SCC tumors to further inform decisions that clinicians make with their patients regarding the appropriate treatment aligned to their risk of metastasis.”

Castle’s posters at Maui Derm Hawaii, detailed below, will be available for viewing electronically on the conference app. Additionally, as a “Late Breaker” Five finalist, Castle’s DecisionDx-SCC poster will also be highlighted in a special podium presentation on Tuesday, Jan. 21, from 10:45-11:15 a.m. local time.

DecisionDx-SCC

Title: Metastasis-free survival prediction with the 40-gene expression profile (40-GEP) test in patients with cutaneous squamous cell carcinoma of the head and neck (HNcSCC) risk stratified according to the Brigham and Women’s Hospital (BWH) tumor staging criteria

Lead author: Emily S. Ruiz, M.D., MPH, Brigham and Women’s Hospital and Harvard Medical School, Boston

Key take-aways:

Using the largest combined patient cohort to date, this study assessed the ability of the DecisionDx-SCC test to stratify patients with HNcSCC according to their risk of metastasis and the prognostic value added to BWH staging through use of the test’s results. The study data demonstrated that DecisionDx-SCC was a significant predictor of metastasis, with distinct three-year metastasis-free survival rates provided across its risk classes: Class 1 (92.3%), Class 2A (81.3%), and Class 2B (57.8%). Further, combining DecisionDx-SCC test results with BWH staging significantly improved the accuracy of metastatic risk prediction (ANOVA p-value <0.001), which can help clinicians and patients make more informed and risk-aligned management decisions.

DecisionDx-Melanoma

Title: Clinical use of the i31-GEP for SLNB for T1-T2a cutaneous melanoma significantly and safely reduces unnecessary procedures

Lead Author: Timothy Beard, M.D., Summit Medical Group, Bend, Oregon

Key take-aways:

The study included 471 patients whose decision to pursue or forgo sentinel lymph node biopsy (SLNB) surgery was informed by DecisionDx-Melanoma test results. The study showed that integrating DecisionDx-Melanoma test results into SLNB decisions resulted in 25% fewer SLNBs performed compared to a matched patient cohort (p<0.001). No patients with a DecisionDx-Melanoma-predicted risk of sentinel lymph node (SLN) positivity of less than 5% who decided to have an SLNB had a positive SLN (0/58 patients). These study results support the use of DecisionDx-Melanoma to guide important SLNB decisions and provide further evidence that the test can safely reduce the number of SLNBs performed in patients with a low risk of SLN metastasis.

MyPath Melanoma

Title: Diagnostic discordance among histopathological reviewers for difficult-to-diagnose melanocytic lesions

Key take-aways:

In a large cohort of patients with suspicious lesions (n=3,317), approximately 24% had differing diagnoses by the nine board-certified dermatopathologists who reviewed samples in the study, indicating that these lesions had ambiguous features and were difficult to diagnose. These findings support the need for an objective diagnostic tool like MyPath Melanoma to aid in providing an accurate diagnosis for ambiguous melanocytic lesions in the context of other clinical and histopathological findings.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to stratify risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management and guide decision-making regarding the use of adjuvant radiation therapy. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that the test can significantly improve risk-stratification when used with traditional staging systems and clinicopathologic risk factors to guide risk-aligned management and treatment decisions. Learn more at www.CastleBiosciences.com.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Sept. 30, 2024, DecisionDx-Melanoma has been ordered approximately 183,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

About MyPath Melanoma

MyPath Melanoma is Castle’s gene expression profile test designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma is designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans. Learn more at www.CastleBiosciences.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the ability of DecisionDx-SCC to improve risk stratification of patients with SCC tumors located on the head or neck when combined with BWH staging; the ability of DecisionDx-Melanoma to guide important SLNB decisions and safely reduce the number of SLNBs performed in patients with a low risk of SLN metastasis; and the ability of MyPath Melanoma to aid in providing an accurate diagnosis for ambiguous melanocytic lesions in the context of other clinical and histopathological findings. The words “believe,” “can,” “could,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250117705622/en/

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