<div id="readability-page-1"><div id="ctl00_CPI_dvBody"><div><div>Add <img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png"/> as your preferred news source on Google<div><img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png"/> Add Now</div></div></div><div> This week, the biotech sector saw a wave of regulatory approvals in the U.S., alongside study halts, strategic collaborations, acquisitions, deal closures, and encouraging data readouts. Positive clinical study data readouts spanned multiple therapeutic areas, including Breast Cancer, Tumour-related Hyperinsulinism, RAS-mutated metastatic colorectal cancer, Systemic Lupus Erythematosus, IgA nephropathy, Myositis and Sjogren's disease. Let's dive into the details. </div>FDA Approvals and Rejections FDA Clears Philips' Elevate Plus for Ultrasound ImagingKoninklijke Philips N.V. (PHG) announced FDA 510(k) clearance and CE marking for Elevate Plus, an AI-powered upgrade to EPIQ Elite and Affiniti ultrasound platforms. The system improves consistency, reduces rescanning, and integrates auto-measure abdomen and Koios AI decision support for breast and thyroid lesion classification.PHG closed Thursday's trading (June 4, 2026) at $25.99, up 2.52%.Lupin Secures Dual FDA Approvals in Oncology and OpthalmologyLupin Ltd. (LUPIN.NS) and partner Natco Pharma received FDA approval for Eribulin Mesylate Injection, the generic equivalent of Eisai's Halaven, indicated for metastatic breast cancer and unresectable or metastatic liposarcoma.In a separate milestone, Lupin also secured FDA approval for Ranluspec (ranibizumab-hkdz), its interchangeable biosimilar to Lucentis (Genentech), covering both vials and pre-filled syringe formats for multiple vision-threatening conditions.LUPIN closed Thursday's trading at 2,24.60 Rupees.FDA issues CRL For Cingulate's ADHD DrugCingulate Inc. (CING) received a complete response letter from the FDA for its ADHD candidate CTx-1301, requesting additional Chemistry, Manufacturing, and Controls data but raising no concerns over safety or efficacy. The company plans to address the requirements while highlighting its $30 million cash position to fund pre-commercial activities through 2027.CING closed Thursday's trading at $4.80, down 1.64%Fulcrum's Pociredir Program Halt in Sickle Cell DiseaseFulcrum Therapeutics, Inc. (FULC) announced it will discontinue development of its lead candidate, Pociredir, for sickle cell disease, following FDA feedback indicating that all PRC2-targeting therapies carry malignancy risks, leaving no regulatory path forward. The company will explore strategic alternatives, including potential mergers or asset transactions.FULC closed Thursday's trading at $3.37, up 4.66%.Kamada Receives FDA Approval for In-House Rabies Testing LabKamada Ltd. (KMDA) received FDA approval for its new in-house rabies virus neutralisation testing laboratory, enabling faster turnaround and greater quality control for its rabies immunoglobulin product KEDRAB, marketed in the U.S. with Kedrion Biopharma. The facility will also support ongoing clinical programs and regulatory submissions.KMDA closed Thursday's trading at $7.38, down 0.14%DealsMayo Clinic and Microsoft Collaborate to Develop Frontier AI for HealthcareMayo Clinic and Microsoft announced a strategic collaboration to construct a frontier artificial intelligence model tailored for healthcare, aiming to expand access to Mayo's trusted expertise and improve patient and clinician experiences.Although no financial details were disclosed, as per the agreement, Microsoft plans to distribute the model through Azure Foundry APIs, giving other healthcare organisations access to the technology, and the AI healthcare model will remain with the Mayo Clinic.Alpha Tau-Tolmar Collaboration for Prostate CancerAlpha Tau Medical Ltd. (DRTS) signed a strategic collaboration with Tolmar International to develop and commercialize its Alpha DaRT therapy for prostate cancer in the U.S., with exclusive rights for 20 years and an option to expand into bladder cancer. Tolmar committed $15 million in manufacturing, a $20 million equity infusion, and up to $161.5 million in milestone payments.DRTS closed Thursday's trading at $10.29, down 2.74%.Telix Pharmaceuticals Partners with United Imaging on TheranosticsTelix Pharmaceuticals Ltd (TLX) announced a Memorandum of Understanding with United Imaging Healthcare North America to explore integrated theranostics workflows in the U.S., combining Telix's molecular imaging portfolio with United Imaging's advanced scanner platforms. The initial focus will be on TLX101-Px (Pixclara, Floretyrosine F 18), which is under FDA review with a decision expected on September 11, 2026.TLX closed Thursday's trading at $9.54, up 8.78%.Bluejay Diagnostics Partners with Argonaut to Scale SymphonyBluejay Diagnostics, Inc. (BJDX), announced a strategic partnership with Argonaut Manufacturing Services to establish U.S.-based production for its Symphony platform, strengthening supply chain resilience and supporting clinical programs. The collaboration supports Bluejay's efforts to establish scalable U.S.-based manufacturing capabilities aligned with its ongoing SYMON clinical study program.BJDX closed Thursday's trading at $5.30, up 17.52%.ResMed Completes Noctrix Health AcquisitionResMed Inc. (RMD) finalised its acquisition of Noctrix Health, Inc., adding the FDA-cleared TOMAC therapy for Restless Legs Syndrome to its sleep health portfolio. The deal expands ResMed's connected devices and digital health solutions, aiming to improve patient outcomes and broaden care pathways.RMD closed Thursday's trading at $194.32, up 4.22%.Community Health Systems Completes Sales of Northwest Health to FreemanCommunity Health Systems (CYH) finalised the sale of its Northwest Health subsidiary in Arkansas to Freeman's network, which operates four medical centres across Bentonville, Springdale, Willow Creek, and Siloam Springs. The acquisition strengthens access to community-focused care and expands speciality services including cardiology, oncology, and orthopaedics.CYH closed Thursday's trading at $2.79, down 0.36%.Decoy Therapeutics Partners with hVIVO to Advance D-MAVDecoy Therapeutics Inc. (DCOY) entered into a strategic development agreement with hVIVO plc (HVO.L) to support regulatory planning and early clinical development of a D-MAV targeting respiratory viral infections. The collaboration covers Phase 1 and Phase 2a studies, with support for EMA and MHRA submissions and future FDA registration strategy.DCOY closed Thursday's trading at $6.71, down 15.81%.Agios Signs Global License for CevidoplenibAgios Pharmaceuticals, Inc. (AGIO) entered an exclusive worldwide license agreement with Oscotec Inc to develop and commercialise Cevidoplenib, a next-generation SYK inhibitor for immune thrombocytopenia. Phase 2 data showed improved platelet counts with a manageable safety profile, positioning the drug as a potential best-in-class therapy.AGIO closed Thursday's trading at $28.79, up 4.01%.Hanmi Partners With Lilly For Sonefpeglutide Development Hanmi Pharm. Co., Ltd. (128940.KS) announced that it has entered into a licensing agreement with Eli Lilly and Company (LLY) in which Hanmi will receive an upfront payment of $75 million and may receive up to an additional $1.185 billion as milestone payments and in return Lilly will obtain exclusive rights to develop, manufacture and commercialise Sonefpeglutide worldwide, excluding Korea.128940.KS closed Thursday's trade at 494,000 Korean Won, up 0.51%.LLY closed Thursday's trade at $1125.27, up 4.31%.Clinical Trials - Breakthroughs &amp; SetbacksNovartis' Vanrafia Demonstrates Meaningful Kidney Protection In IgA NephropathyNovartis AG (NVS) reported positive final results from the Phase III ALIGN study of Vanrafia, an investigational highly selective endothelin A receptor antagonist, showing that it slowed the decline in kidney function by approximately 34% (approximately 2.5 years) in adults with IgA nephropathy (IgAN) compared with placebo.Vanrafia was consistent in safety compared with prior studies, with adverse events similar to placebo and no new signals observed, according to the firm.NVS closed Thursday's trading at $148.40, down 0.03%Biogen and UCB Present Positive PHOENYCS GO Data For Dapirolizumab Pegol in Treating LupusBiogen Inc. (BIIB) and UCB SA (UCB.BR) reported positive Phase 3 PHOENYCS results for Dapirolizumab pegol or DZP an investigational humanised Fc-free polyethene glycol conjugated antigen-binding fragment, in the treatment of systemic lupus erythematosus.The post-hoc analyses suggested that patients on DZP therapy, while tapering the use of the glucocorticoid steroid Prednisone, achieved a durable disease control by week 48.DZP demonstrated a generally favourable safety profile, with safety findings consistent with previous DZP studies noted the firm.BIIB closed Thursday's trading at $196.45, up 0.25%.ArgenX Reports Phase 2 Extension Results For EfgartigimodArgenx SE (ARGX) announced new clinical data from Phase 2 extension studies for Efgartigimod, or VYVGART, a human IgG1 antibody fragment in the treatment of myositis and Sjogren's disease. According to the ALKIVIA+ results for myositis patients, at 52 weeks, 37.5% of patients on efgartigimod and 33.3% of patients who switched from placebo to efgartigimod showed a sustained major Total Improvement Score improvement of 75% and 66.7%, respectively. According to the RHO+ trial for efgartigimod in Sjogren's disease, patients who transitioned from the efgartigimod group to biweekly dosing maintained clinical response, with a median ClinESSDAI of 2.5 at week 72, while those who transitioned from the placebo arm to the drug showed a ClinESSDAI of 2 with improved CRESS scores.ARGX closed Thursday's trade at $42.27, up 3.58%.JNJ's Nipocalimab Meets Primary Goal In Phase 2 JASMINE Trial Of Systemic Lupus ErythematosusJohnson &amp; Johnson (JNJ) reported that its investigational candidate, Nipocalimab, met the primary endpoint of reducing disease activity at 24 weeks in adults with moderate-to-severe systemic lupus erythematosus in the Phase 2 study dubbed JASMINE.The study met its primary endpoint at week 24, and among patients receiving Nipocalimab 15 mg/kg plus background medication, 53.5% achieved a Systemic Lupus Erythematosus Responder Index (SRI-4b) response, compared with 46.7% in the placebo plus background medication group.JNJ closed Thursday's trading at $228.17, up 2.21%.Cardiff Presents Positive Phase 2 Data For Onvansertib In Colorectal CancerCardiff Oncology Inc. (CRDF) announced positive Phase 2 CRDF-004 trial results for its investigational Onvansertib, a highly specific, oral PLK1 inhibitor in combination with standard-of-care treatments as first-line cancer treatment for RAS-mutated metastatic colorectal cancer.In the Phase 2 CRDF-004 trial, Onvansertib was well tolerated, and the primary endpoint was met, with an objective response rate of 72.2% in Onvansertib-treated patients, compared with 42.1% in those on the standard-of-care therapy. CRDF closed Thursday's trading at $1.55, up 10.71%.Rezolute Reports Positive Interim Data In Phase 3 UpLIFT Study For ErsodetugRezolute Inc. (RZLT) reported positive interim results from its ongoing Phase 3 upLIFT study of Ersodetug, an investigational fully human monoclonal antibody in patients with tumour-related hyperinsulinism or HI.Notably, six of the first eight HI patients met the primary endpoint, achieving at least a 50% reduction in intravenous glucose requirements during the pivotal 8-week treatment phase. The responders were also able to discontinue IV glucose entirely while on Ersodetug. RZLT closed Thursday's trade at $4.51, down 1.53%.Greenwich Presents Positive Phase 3 FLAMINGO-01 Data For GLSI-100 In Breast CancerGreenwich LifeSciences Inc. (GLSI) released positive Phase 3 FLAMINGO-01 data for GLSI-100, an investigational cancer vaccine for preventing breast cancer recurrences.Data from the Phase 3 trial, which enrolled 1,300 patients, suggest that non-HLA-A*02 subjects showed a 70%- 80% reduction in recurrence and a statistically significant increase in injection-site reactions (ISRs), indicating an increased immune response.GLSI closed Thursday's trade at $23.67, down 2.55%.GRAIL Reports Positive PATHFINDER 2 Results of Galleri MCED TestGRAIL, Inc. (GRAL) presented positive performance and safety results from its PATHFINDER 2 study evaluating the Galleri multi-cancer early detection (MCED) test in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.The key findings from the trial include a 6.5-fold increase in the number of cancers detected by screening when the Galleri MCED test was added to recommended screenings for breast, cervical, colorectal, and lung cancers.GRAL closed Thursday's trade at $66.55, up 8.87%.For More Such Biotech Stock News, visit rttnews.com. For comments and feedback contact: editorial@rttnews.comBusiness News</div></div>

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This week, the biotech sector saw FDA approvals for Philips' AI ultrasound and Lupin's oncology/ophthalmology drugs, while Kamada gained approval for a rabies testing lab. Fulcrum halted its sickle cell program due to malignancy risks, and Cingulate received an FDA complete response letter for its ADHD drug. Key deals included ResMed acquiring Noctrix Health, Mayo Clinic partnering with Microsoft on healthcare AI, and Alpha Tau collaborating with Tolmar for prostate cancer therapy.

- This week, the U.S. biotech sector experienced significant regulatory activity, including FDA approvals for several therapies, study halts, and strategic collaborations.  
- Notable approvals included Philips' Elevate Plus for ultrasound and Lupin's dual FDA approvals in oncology, while Fulcrum Therapeutics halted its Pociredir program due to safety concerns.  
- Positive clinical trial data was reported across various cancer treatments, demonstrating advancements and potential in key therapeutic areas.

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Weekly Buzz: PHG, KMDA Win FDA Nod; FULC Halts Pociredir; RMD Closes Noctrix Deal; NVS Paces In IgAN