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ADVANCELL ISOTOPES PTY LIMITED

🇦🇺Australia
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Targeted Radiopharmaceuticals Summit Returns to Europe and US as Industry Momentum Builds

• The 6th Targeted Radiopharmaceuticals Summit Europe will take place in Amsterdam on December 3-5, featuring 40+ speakers across pre-clinical and clinical tracks as radiopharmaceutical innovation accelerates. • Major pharmaceutical companies including Novartis, Eli Lilly, AstraZeneca, and Bayer are driving industry growth through billion-dollar collaborations and clinical advancements in novel radiopharmaceutical targets. • The 4th Targeted Radiopharmaceuticals Summit US returns to San Diego in July, bringing together 275+ global stakeholders to address key challenges in isotope supply, manufacturing, and clinical translation.

Therini Bio's THN391 Shows Promise in Phase 1a Trial for Neurodegenerative Diseases

• Therini Bio's novel monoclonal antibody THN391, targeting fibrin-driven neuroinflammation, demonstrated positive safety and tolerability results in Phase 1a trials with healthy volunteers. • The drug candidate showed a clean hematological profile without affecting coagulation pathways, and its pharmacokinetic profile supports convenient once-monthly dosing regimens. • Following these encouraging results, Therini Bio plans to advance THN391 into Phase 1b trials for both Alzheimer's Disease and Diabetic Macular Edema, addressing fundamental root causes of neurodegeneration.

Debiopharm and Oncodesign Services Partner to Advance Radiopharmaceutical Research with AbYlinkâ„¢ Technology

• Swiss-based Debiopharm and French CRO Oncodesign Services have established a license agreement for AbYlink™, a regio-selective bioconjugation technology designed for therapeutic and non-invasive diagnostic applications. • The collaboration will utilize AbYlink™ to prepare antibody chelator conjugates for preclinical studies in molecular radiotherapy, with initial focus on radioimmunotherapy targeting HER2+ tumors in cancer models. • The partnership aims to provide broader access to non-invasive imaging applications and innovative solutions for biotech and pharmaceutical companies developing antibody and ADC-based therapeutics.

Lilly Licenses Sangamo's Blood-Brain Barrier Capsid Technology in $1.4B CNS Deal

• Eli Lilly has secured rights to Sangamo Therapeutics' STAC-BBB capsid technology for $18 million upfront, with potential milestone payments reaching $1.4 billion plus tiered royalties. • The agreement allows Lilly to utilize Sangamo's proprietary adeno-associated virus capsid that can cross the blood-brain barrier to deliver genomic medicines targeting central nervous system diseases. • This partnership provides critical financial support for Sangamo, which had only enough cash to operate into Q1 2025 following Pfizer's termination of their hemophilia gene therapy collaboration.

Biotech Deal Landscape: February-March 2025 Sees Surge in Partnerships Across Multiple Therapeutic Areas

• The first quarter of 2025 witnessed significant biotech partnership activity, with Eli Lilly, AstraZeneca, and Novo Nordisk emerging as top collaborators in deals worth billions across small molecules, antibodies, and RNA therapeutics. • February 2025 featured notable acquisitions including Novartis's $2.15 billion buyout of Anthos Therapeutics, while March saw AstraZeneca acquire Belgian biotech EsoBiotec and Bristol Myers Squibb purchase 2seventy bio for $286 million. • Obesity therapeutics gained significant traction in March 2025, with AbbVie entering the field through a $350 million upfront deal with Gubra for an amylin analog, while Roche partnered with Zealand Pharma on petrelintide in a deal worth up to $5.25 billion.

Isomorphic Labs Secures $600M to Advance AI-Powered Drug Discovery Platform

• Isomorphic Labs raised $600 million in its first external funding round in March 2025, representing the largest private biotech investment of the month. • The funding will accelerate the company's frontier artificial intelligence research to enhance its next-generation AI drug design engine. • March 2025 showed strong biotech fundraising activity with over $2.2 billion raised across private and public rounds, making it the second-best month of 2025 thus far.

Abcuro Secures $200M Series C to Advance Phase II/III Trial for Rare Muscle Disease Treatment

• Abcuro raises $200 million in Series C financing to support Phase II/III MUSCLE clinical trial of ulviprubart, targeting inclusion body myositis through KLRG1 inhibition. • The funding will facilitate Abcuro's preparation for a Biologics License Application (BLA) submission and subsequent commercial launch of their novel antibody therapy. • The development represents a significant advancement in addressing inclusion body myositis, a rare chronic inflammatory muscle disease with currently limited treatment options.

Abcuro Secures $200M Series C Funding to Advance Novel IBM Treatment Ulviprubart

• Abcuro has raised $200 million in Series C financing led by NEA to advance ulviprubart, a first-in-class monoclonal antibody treatment for inclusion body myositis (IBM). • The funding will support completion of the Phase 2/3 MUSCLE trial for ulviprubart, preparation for BLA filing, and commercial launch activities, with initial data expected in early 2026. • Ulviprubart targets KLRG1 to selectively deplete cytotoxic T cells and has received orphan drug designation from both FDA and EMA for treating IBM, which affects over 50,000 patients across US and Europe.

Merck KGaA in Advanced Talks to Acquire SpringWorks Therapeutics; BridgeBio Secures EU Approval for ATTR Drug

• Merck KGaA confirms advanced acquisition discussions with SpringWorks Therapeutics, though critical conditions remain unmet and no binding agreement has been reached. • BridgeBio Pharma's Beyonttra (acoramidis) receives European Commission approval for transthyretin amyloidosis with cardiomyopathy, triggering a $75 million milestone payment from Bayer. • Biohaven's troriluzole receives FDA priority review for spinocerebellar ataxia, positioning it to potentially become the first approved treatment for this neurodegenerative disorder.

OliX and Eli Lilly Forge $630M Deal for Novel RNAi Therapy Targeting MASH and Obesity

• OliX Pharmaceuticals has secured a landmark $630 million licensing agreement with Eli Lilly for OLX75016, an RNAi-based therapeutic targeting MASH and obesity. • The deal grants Lilly global rights to develop and commercialize OLX75016, with OliX maintaining responsibility for Phase 1 trials before transferring development control to Lilly. • Preclinical studies showed promising results when OLX75016 was combined with semaglutide, demonstrating enhanced weight loss and reduced rebound weight gain in primates.

Eli Lilly Reports Doubled Q4 Profits Driven by Surging Obesity and Diabetes Drug Sales

• Eli Lilly's Q4 net income soared to $4.4 billion, doubling from $2.2 billion year-over-year, propelled by strong performance of Mounjaro and Zepbound in the diabetes and obesity markets. • Mounjaro sales surged 60% to $3.5 billion in Q4, while the newly launched Zepbound generated $1.9 billion in revenue, marking significant growth in the incretin drug market. • The company projects 2025 non-GAAP earnings of $22.50-$24.00 per share and plans to increase incretin drug production capacity by at least 60% in the first half of 2025.

FDA Places Amgen's Obesity Drug AMG 513 Trial on Clinical Hold

• Amgen disclosed during Q4 earnings that the FDA has placed their obesity drug AMG 513 clinical trial on hold, though executives believe the issue is not related to the medication itself. • Regeneron Pharmaceuticals announced its first-ever quarterly dividend of $0.88 per share after 37 years, signaling confidence despite current commercial challenges with Eylea and Dupixent. • The development comes as Amgen continues late-stage testing of another obesity treatment, MariTide, while working with regulators to determine a path forward for the AMG 513 study.

AdvanCell Secures $112M in Oversubscribed Series C to Advance Radiopharmaceutical Cancer Therapies

• AdvanCell, a clinical-stage radiopharmaceutical company, has successfully raised $112 million in an oversubscribed Series C financing round co-led by SV Health Investors, Sanofi Ventures, Abingworth, and SymBiosis. • The company is currently conducting a Phase I/II dose escalation trial of ADVC001, a Pb-212-based Targeted Alpha Therapy for metastatic prostate cancer, with patients being enrolled in the highest dose cohort. • Since its founding in 2019, AdvanCell has grown to 60 team members with a 40,000-square-foot manufacturing facility and will use the new funding to expand manufacturing capacity and accelerate clinical development of its radiopharmaceutical pipeline.

FDA to Review Belantamab Mafodotin and Linvoseltamab Combinations for Multiple Myeloma

• The FDA has accepted a BLA for belantamab mafodotin combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for multiple myeloma treatment. • Regeneron's linvoseltamab BLA resubmission has been accepted by the FDA, with a decision expected by July 10, 2025, for relapsed/refractory multiple myeloma. • Clinical trials DREAMM-7 and DREAMM-8 support the belantamab mafodotin BLA, while LINKER-MM1 supports the linvoseltamab BLA, showcasing improved progression-free survival. • Both belantamab mafodotin and linvoseltamab are under review by other regulatory authorities, potentially expanding treatment options for multiple myeloma patients.
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