Latest news with #FL
Yahoo
17 hours ago
- Business
- Yahoo
BFCH Unveils Business Plan and Platform Vision Following Leadership Transition and Structural Reset
CRESTVIEW, FL - July 30, 2025 (NEWMEDIAWIRE) - BitFrontier Capital Holdings, Inc. (OTC: BFCH), doing business as EVERMIND Holdings, Inc., today announced the publication of its updated strategic business plan following a recent change in control, leadership transition, and material restructuring of its capital base. On July 21, 2025, physician-entrepreneur Dr. Jordan P. Balencic was appointed Chief Executive Officer following a formal change of control and board resolution. As the Company's new controlling shareholder and CEO, Dr. Balencic brings a long-term ownership mindset and has moved quickly to realign BFCH's corporate strategy, strengthen its financial position, and begin rebuilding trust with the Company's investor base. The roadmap ahead centers on transforming BFCH into a restructured public platform focused on human optimization, cognitive performance, and longevity infrastructure. "In just one week, we've made meaningful progress in resetting the structure of the Company," said Dr. Balencic. "The newly released business plan outlines our preliminary roadmap and current thinking as we work to reposition the organization toward long-term value creation. This is an exciting and rapidly evolving space, and I encourage investors to conduct their own research into the total addressable market and emerging opportunities - we believe there's more potential here than most people realize." Early Restructuring Milestones Achieved in First Week Post-Transition: Since the leadership transition, BFCH has taken the following actions: Retired more than $2 million in legacy convertible debt through a fixed-price equity settlement Capped dilution through a $0.01 per share fixed-price conversion ceiling, with a 200 million share hard cap Reduced total liabilities to under $94,000 Submitted updated documentation to OTC Markets and initiated corporate rebranding to EVERMIND Holdings, Inc. As outlined in the business plan, the $0.01 per share threshold reflects a negotiated, fixed-price equity conversion designed to eliminate variable-rate dilution from legacy obligations. Beyond that, it serves as a structural benchmark - establishing a transparent, disciplined floor from which the Company intends to build. Management views this threshold not as a reflection of intrinsic value, but as a structural reference point aligned with the Company's current capital position and operating strategy. At an implied market cap of approximately $12 million, it establishes a consistent baseline from which future corporate activities - such as early-stage acquisitions or capital formation - may be planned and evaluated. Future equity activity will be structured in alignment with measurable execution milestones and long-term value creation. EVERMIND Holdings: Targeting Growth at the Intersection of Health, Technology, and Infrastructure The EVERMIND Holdings platform is designed to operate across three synergistic divisions - each targeting scalable, asset-backed opportunities in human optimization, cognitive performance, and longevity-focused innovation. EVERMIND Labs - Focused on acquiring, developing, and scaling consumer-facing wellness brands that address the rising demand for brain health, mood support, longevity, and performance enhancement. This division is expected to serve as the Company's primary revenue driver as the platform matures. EVERMIND Technologies - A future-focused division designed to identify, acquire, and incubate technologies at the intersection of brain performance, digital health, and longevity. This includes potential investments in neuro-assessment platforms, cognitive health apps, wearable devices, biometric feedback tools, and AI-driven performance analytics. The goal is to build a portfolio of scalable assets that complement EVERMIND's consumer and infrastructure strategy while enabling data-backed optimization across physical, cognitive, and biological domains. EVERMIND Manufacturing - A long-term strategic initiative to explore the development of domestic co-manufacturing infrastructure for functional consumer products. This division is designed to increase supply chain resilience, support internal brands, and serve third-party partners in the functional beverage, nutrition, and supplement categories. The business plan anticipates that each division may operate independently, contribute to overall platform growth, and, where appropriate, support future spin-off potential. Planned Capital Formation and Initial Asset Development To support the next phase of development, the Company is preparing to initiate a $150,000 seed round to fund near-term objectives, including: Completion of rebranding and regulatory filings Initiation of operational planning within EVERMIND Labs Legal and accounting infrastructure to support asset integration Design and buildout of corporate communications and investor relations strategy The Company is also evaluating a potential Regulation A offering, which may commence later in 2025, subject to share price, applicable filings, and qualifications. Any securities offerings will be conducted pursuant to available exemptions under federal and state securities laws. As of the date of this release, no definitive agreements for acquisitions have been signed. The Company is, however, in preliminary discussions regarding one or more potential transactions. Corporate Communications & Disclosure Infrastructure EVERMIND Holdings, Inc. is in the process of developing an updated FINRA-compliant corporate website featuring a dedicated investor relations section. All required documentation has been submitted to OTC Markets, and Company fees are paid in full. Once portal access is granted, BFCH will begin updating public disclosures and corporate information. A corporate communications plan is in development to ensure ongoing transparency and alignment with evolving investor expectations. In accordance with SEC guidance encouraging issuers to identify their official disclosure channels, BFCH advises investors and media that it uses the following platforms to share material information: Corporate Website: X / Twitter: OTC Markets Disclosure Portal: Press Releases and Public Conference Calls This list may be updated from time to time on the Company's website. ACCESS TO STRATEGIC BUSINESS PLAN The new business plan is available on a landing page for public viewing at: About BitFrontier Capital Holdings, Inc. (OTC: BFCH) BitFrontier Capital Holdings, Inc. (d/b/a EVERMIND Holdings, Inc.) is a Wyoming-based public company undergoing a strategic transformation under new leadership and ownership control. The Company is building a multi-division platform at the intersection of human optimization, cognitive performance, and longevity-focused innovation - with a focus on acquiring, incubating, and scaling high-impact assets in emerging wellness and performance categories. Led by its new CEO and controlling shareholder, Dr. Jordan P. Balencic, the Company is committed to executing a disciplined growth strategy while rebuilding trust and delivering long-term value to its shareholders. No assurances can be made regarding the timing or success of future developments. Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable laws. These statements are based on current management expectations and are subject to risks, uncertainties, and assumptions that are difficult to predict. Forward-looking statements include, but are not limited to, statements about the Company's business strategy, potential acquisitions, planned capital raises, and other future events or performance. Actual results may differ materially due to factors such as market conditions, regulatory developments, and the Company's financial position. Readers are cautioned not to place undue reliance on these statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements except as required by law. Contact:Jordan P. Balencic, D.O.813-693-1377jbalencic@ View the original release on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-07-2025
- Automotive
- Yahoo
Tampa woman turns to Ramsey Show hosts after her brother refused to repay a car loan she took out to help him
Four years ago, Carmen from Tampa, FL, did her brother a solid by letting him move into her home when he was low on cash. She didn't charge him rent and she even took out a car loan for him — in her name. Fast forward to now, and their fortunes are reversed. Carmen needs the money, but her brother doesn't want to repay the car loan. During an episode of The Ramsey Show, Carmen said her brother has 'fully recovered' from his financial woes. He works on commission, has stocks, CDs and retirement savings, and 'is living a good life,' she said. Yet, when it comes to the car loan, he told his sister he wasn't going to 'take that upon my credit.' As Carmen pondered whether she should pay off the remaining loan herself — which is around $11,000 — co-host Ken Coleman told her: 'You know what you're supposed to do.' Don't miss Thanks to Jeff Bezos, you can now become a landlord for as little as $100 — and no, you don't have to deal with tenants or fix freezers. Here's how I'm 49 years old and have nothing saved for retirement — what should I do? Don't panic. Here are 6 of the easiest ways you can catch up (and fast) Want an extra $1,300,000 when you retire? Dave Ramsey says this 7-step plan 'works every single time' to kill debt, get rich in America — and that 'anyone' can do it What happened? Carmen's husband made a career switch that she says will eventually pay off, but in the meantime, they're bringing in less money. And to get a mortgage, they were told by their lender that they need to get rid of the car loan debt first. Carmen didn't just co-sign the loan; she put it under her name. So her brother is making monthly payments to Carmen on a car that's not in his name and that 'he's never going to own,' said co-host Jade Warshaw. If he's not willing to pay back the full amount of the loan, then Carmen has every right to repossess the vehicle. 'That is not mean, Carmen. That is not a bad sister,' said Warshaw. 'That is just you doing something that is very normal and fair by saying, 'if I'm paying for a car that's in my name, I'm going to be the one owning it and driving it.'' If her brother wants to keep making monthly payments, 'then he needs to go rent a car,' said Warshaw. Carmen said a private seller would pay $19,000 for the vehicle. 'I would go get that car from your brother today and sell it instantaneously,' said Coleman. At that point, her brother can decide whether he wants to buy the car from her, in which case he can pay back his sister for the full amount of the loan and she can transfer the title over to him. If he's not interested in buying it, she can find another buyer and pay back the loan from the proceeds. Still, Carmen is hesitant because she doesn't want to cause a rift in the family. 'It already has,' said Warshaw. 'The damage you're worried about being done has already been done.' Warshaw said she wants Carmen to be respected. 'It's a disrespectful transaction and if you let it continue, he's not just disrespecting you — you're disrespecting yourself at that point.' Read more: Americans are 'revenge saving' to survive — but millions only get a measly 1% on their savings. Should you loan a family member money? While you may want to help out a family member in need, a 'friends and family' loan should still be treated as any other loan. Otherwise, you could consider the money a gift (particularly if you don't think you'll ever see that money again). About one-third of U.S. adults have provided financial support to friends or family, according to the Consumer Financial Protection Bureau (CFPB). It could make sense in some circumstances — for example, parents may loan their adult child some money when they're just starting out in their career or don't yet have a credit history to qualify for a loan. Whatever the case, if you're thinking about lending money to a friend or family member, first consider your own financial situation — for example, it's probably not a good idea to drain your own emergency fund to pay for a family member's emergency. And, if you do have some extra cash, how much of it can you afford to part with and for how long? If you do lend money to a friend or family member, put it in writing (you can find several options for templates online by searching under loan agreements). This contract should outline the terms of the loan, such as when you expect it to be repaid (either in a lump sum or a series of payments over a specified period of time). You should also specify whether you'll be charging interest on the loan (perhaps the rate you'd be getting if that money was sitting in your high-interest savings account) and what the consequences will be if they can't pay you back. For example, in Carmen's case, if she had made her brother sign a contract before getting a car loan, she could have specified that she'd take back possession of the vehicle if he didn't pay back the loan in full by a certain period of time. Another option is co-signing a loan, but only do so if you trust this person — not because you're feeling pressured by your family to do so. A co-signer is a person 'who agrees to be legally responsible for someone else's debt,' according to Equifax, one of the three major credit reporting agencies in the U.S., along with Experian and TransUnion. This provides a safety net to lenders, but it also means the co-signer is legally responsible for that debt if the borrower is unable to pay it back. Plus, if you're the co-signer, that debt will show up on your credit report and could influence your credit score and/or debt-to-income ratio. If the borrower fails to make payments, that will harm your credit rating — and it will likely put a strain on your relationship. If you're already in that situation, like Carmen, there's no easy way out. 'We didn't say this was going to be fun but… it's already not fun,' said Coleman, 'so let's go ahead and rip the band-aid off and take possession of the car.' What to read next Robert Kiyosaki warns of 'massive unemployment' in the US due to the 'biggest change' in history — and says this 1 group of 'smart' Americans will get hit extra hard. Are you one of them? How much cash do you plan to keep on hand after you retire? Here are 3 of the biggest reasons you'll need a substantial stash of savings in retirement Rich, young Americans are ditching the stormy stock market — here are the alternative assets they're banking on instead Here are 5 'must have' items that Americans (almost) always overpay for — and very quickly regret. How many are hurting you? Stay in the know. Join 200,000+ readers and get the best of Moneywise sent straight to your inbox every week for free. This article provides information only and should not be construed as advice. It is provided without warranty of any kind. Sign in to access your portfolio
Business Upturn
24-06-2025
- Business
- Business Upturn
Coherent Launches ACE FL, an All-New, Two-Micron Fiber Laser to Address the Expanding Opportunities in Urology and Other Medical Markets
By GlobeNewswire Published on June 25, 2025, 01:35 IST SAXONBURG, Pa., June 24, 2025 (GLOBE NEWSWIRE) — Coherent Corp. (NYSE: COHR), a global leader in photonics, today announced the launch of its ACE FL series, thulium fiber laser (TFL), engineered specifically for therapeutic medical applications – most notably for lithotripsy and benign prostatic hyperplasia (BPH) treatment. The new two-micron ACE FL system delivers superior precision, improved patient outcomes, and enhanced procedural efficiency compared to legacy laser technologies such as holmium:YAG systems. It is optimized for integration into surgical devices and laser systems used in minimally invasive procedures. 'Our new thulium fiber laser is a breakthrough platform that enables medical OEMs to deliver safer, faster, and more effective treatments for kidney stones and BPH,' said Martin Seifert, Vice President, High-Power Fiber Laser Business Unit at Coherent. 'With the growing shift toward outpatient and minimally invasive procedures, the market opportunity for fiber-based surgical lasers is stronger than ever.' Thulium fiber lasers offer superior cutting precision in BPH enucleation, a compact form factor ideal for OEM integration, and enhanced energy efficiency through lower power consumption and improved thermal management. The ACE FL platform leverages proprietary fiber designs and manufacturing capabilities to offer OEM partners a scalable, high-performance solution for next-generation surgical tools. In addition, Coherent enhances rapid ease of integration by multiplying the power of our new ACE FL series with the surgically proven capabilities of our superb range of disposable fiber assemblies. With vertically integrated manufacturing and IP-protected fiber designs, Coherent is uniquely positioned to support global medical device manufacturers with reliable supply and long-term innovation. Coherent will showcase the ACE FL at LASER World of Photonics Munich 2025. About Coherent Coherent empowers market innovators to define the future through breakthrough technologies, from materials to systems. We deliver innovations that resonate with our customers in diversified applications for the industrial, communications, electronics, and instrumentation markets. Coherent has research and development, manufacturing, sales, service, and distribution facilities worldwide. For more information, please visit us at Media Contact : [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Business Wire
18-06-2025
- Business
- Business Wire
Incyte Announces FDA Approval of Monjuvi ® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). "Patients living with relapsed or refractory FL have been waiting for new options that improve progression-free survival without substantial increase in side effects. Based on the data from the inMIND trial of Monjuvi, today's approval brings to this patient population the first CD-19 and CD20-targeted immunotherapy combination and a potential new treatment standard,' said Hervé Hoppenot, Chief Executive Officer, Incyte. 'This second U.S. approval for Monjuvi reinforces our commitment to advancing innovation for the lymphoma community.' The Priority Review and FDA approval of the supplemental Biologics License Application (sBLA) for Monjuvi was based on data from the pivotal, randomized, double-blind, placebo-controlled Phase 3 inMIND trial evaluating the efficacy and safety of Monjuvi in combination with rituximab and lenalidomide in adult patients with relapsed or refractory FL. Data from the trial was featured in the Late-breaking Session (LBA-1) at the 2024 American Society of Hematology (ASH) Annual Meeting. 1 The study met its primary endpoint demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment, which demonstrated 27.5% (N=273) of patients with an event in the Monjuvi group vs. 47.6% (N=275) of patients with an event in the control arm. Patients receiving Monjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Monjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the control arm (HR: 0.41 [95% CI, 0.29-0.56]. The PFS benefit was consistent across prespecified patient subgroups, including number of previous lines of therapy. The safety of Monjuvi in patients with FL was evaluated in 546 patients in the inMIND trial. Serious adverse reactions occurred in 33% of patients who received Monjuvi in combination with rituximab and lenalidomide, including serious infections in 24% of patients (including pneumonia and COVID-19 infection). Other serious adverse reactions in ≥ 2% of patients included renal insufficiency (3.3%), second primary malignancies (2.9%), and febrile neutropenia (2.6%). Fatal adverse reactions occurred in 1.5% of patients, including from COVID-19, sepsis, and adenocarcinoma. The most common adverse reactions (≥ 20%) in recipients of Monjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes. 'Follicular lymphoma is generally an indolent yet chronic cancer that frequently recurs after treatment, making long-term disease control a critical objective,' said Christina Poh, M.D., Assistant Professor of Medicine at the University of Washington and Fred Hutchinson Cancer Center. 'The FDA approval of Monjuvi in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease.' FL is the second most common type of non-Hodgkin lymphoma (NHL) and represents up to 30% of NHL cases. 2 While considered an indolent, slow-growing disease with prolonged survival, FL is challenging to treat due to its tendency for frequent relapse, need for multiple lines of therapy and potential transformation into large B-cell lymphoma. 2,3 'While the initial responses to FL treatment are often positive, recurrence can become increasingly difficult for patients to manage as they navigate emotions and the next treatment steps related to relapse,' said Mitchell Smith, M.D., Ph.D., Chief Medical Officer, Follicular Lymphoma Foundation. "We are pleased that the FDA has approved tafasitamab, part of a treatment combination offering a new option for patients living with this chronic disease.' In July 2020, Monjuvi in combination with lenalidomide received FDA approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication was approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval of Monjuvi for this indication may be contingent on verification and description of clinical benefit in confirmatory trial(s). Tafasitamab is also being evaluated as a therapeutic option in an ongoing pivotal trial for first-line DLBCL. Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Monjuvi have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering personalized patient support, including financial assistance and ongoing education and additional resources. More information about IncyteCARES is available by visiting or calling 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET. About inMIND A global, double-blind, randomized, controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years). The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population. For more information about the study, please visit About Monjuvi ® (tafasitamab-cxix) Monjuvi ® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In the U.S., Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the 'triangle' design are registered trademarks of Incyte. IMPORTANT SAFETY INFORMATION What are the possible side effects of MONJUVI? MONJUVI may cause serious side effects, including: Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or any bruising or bleeding Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or develop any signs or symptoms of an infection The most common side effects of MONJUVI when given with lenalidomide in people with DLBCL include: respiratory tract infection feeling tired or weak diarrhea cough fever swelling of lower legs or hands decreased appetite The most common side effects of MONJUVI when given with lenalidomide and rituximab in people with FL include: respiratory tract infections diarrhea rash feeling tired or weak muscle and bone pain constipation cough These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects. Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you Have an active infection or have had one recently Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby You should use an effective method of birth control (contraception) during treatment and for 3 months after your last dose of MONJUVI Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with MONJUVI Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment and for at least 3 months after your last dose of MONJUVI You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation. Tell your healthcare provider about all the medications you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements. Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Incyte Medical Information at 1-855-463-3463. Please see the full Prescribing Information including the Medication Guide for Monjuvi. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether Monjuvi may provide a successful treatment option for patients with FL, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities outside of the United States; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2024 and its quarterly report on form 10Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.
Yahoo
13-06-2025
- Business
- Yahoo
Innate Pharma Highlights Preclinical Antitumor Activity of IPH6501 in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma at the 2025 European Hematology Association (EHA) Congress
Preclinical data from IPH6501, Innate's proprietary ANKET® targeting CD20, demonstrating potent antitumor activity in vitro on patient-derived samples from Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL), will be presented Preclinical in vivo models support enhanced antitumor efficacy for the combination of IPH6501 with R-CHOP, the standard of care in untreated DLBCL and FL patients IPH6501 is currently under investigation in a Phase 1/2 clinical study in relapsed and/or refractory (R/R) CD20+ B-cell non-Hodgkin lymphoma MARSEILLE, France, June 13, 2025--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today announced the presentation of preclinical data for IPH6501, its proprietary ANKET® targeting CD20 currently under investigation in a Phase 1/2 study in relapsed and/or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (NCT06088654), at the European Hematology Association (EHA) Congress 2025, taking place June 12-15 in Milan, Italy. R-CHOP is an established standard of care for treatment-naïve patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL), two subtypes of B-NHL. The treatment landscape continues to evolve with novel approaches including T cell engagers, antibody-drug conjugates, their combination with standard of care therapies, and CAR-T cells. Yet, there remains an unmet medical need for patients ineligible, refractory to, or relapsing from these therapies. In preclinical in vitro models, IPH6501 demonstrated potent NK cell proliferation and tumor cell killing activity in DLBCL and FL patient samples, supporting its therapeutic potential in these indications. In preclinical in vivo xenografted mouse tumor models, IPH6501 showed strong activity in a rituximab-resistant model — even in the presence of rituximab highlighting their combination potential. Additionally, when combined with R-CHOP, IPH6501 showed enhanced antitumor efficacy, leading to tumor eradication that was maintained after treatment discontinuation. These findings underscore the potential of IPH6501 in improving standard-of-care R-CHOP treatment in previously untreated DLBCL and FL patients and support further evaluation of additional combination strategies in B-NHL. "Patients with R/R DLBCL and FL continue to face significant unmet medical needs. The encouraging activity observed in preclinical models with IPH6501, including in rituximab-resistant settings, suggests its potential to offer new treatment options for B-cell non-Hodgkin lymphoma. The enhanced antitumor activity in combination with R-CHOP could support further investigation in untreated patients. These findings support further clinical development aimed at improving outcomes in this challenging patient population," commented Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma. The poster will be available in the publication section of Innate Pharma's website. Abstract detailsAntitumor characterization of IPH6501, a novel il2v-armed tetraspecific NK cell engager targeting CD20 B cells, in DLBCL and FL patient samples, and in preclinical combination with R-CHOP Abstract Code: PS2004Session: Poster session 2Session Date/Time: Saturday, June 14, 2025, 18:30 – 19:30 CEST About ANKET® ANKET® (Antibody-based NK cell Engager Therapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. About IPH6501 IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not the alpha subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule. This unique multispecific design provides targeted proliferation and activation signals to NK cells, promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better antitumor efficacy compared to approved benchmark antibodies in preclinical tumor models (Demaria, EHA 2023, Carrette, SITC 2024, Demaria et al, Science Immunology 2024). IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with relapsed and/or refractory CD20-expressing B-cell Non-Hodgkin's Lymphoma. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate's portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at Follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including "anticipate," "believe," "can," "could," "estimate," "expect," "may," "might," "potential," "intend," "should," "will," or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company's reliance on third parties to manufacture its product candidates, the Company's commercialization efforts and the Company's continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority ("AMF"), which is available on the AMF website or on Innate Pharma's website, and public filings and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company's Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company's website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. View source version on Contacts For additional information, please contact:InvestorsInnate Pharma Henry WheelerTel.: +33 (0)4 84 90 32 Media RelationsNewCap Arthur RouilléTel.: +33 (0)1 44 71 00 15innate@
