HOUSTON, Texas & PARIS, France — RadioMedix, Inc. and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing...
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HOUSTON, TX and MARSEILLE, France — RadioMedix, Inc., a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and cancer therapy, and Vect-Horus, an expert in the design and development of molecular vectors to facilitate targeted delivery of therapeutic molecules and imaging agents, today announced that the first...
SEATTLE, WA – Aptevo Therapeutics (“Aptevo”) (NASDAQ:APVO), a clinical-stage biotechnology company developing novel bispecific immuno-oncology therapeutics based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies, today announced two additional frontline AML patients have achieved remission* within 30 days of treatment in the Company’s RAINIER dose optimization trial evaluating mipletamig in...
NEW HAVEN, Conn. – Rallybio, a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare disorders, today announced that clinical proof of concept has been established in the ongoing Phase 1/2 study of RLYB211. RLYB211, a polyclonal anti-HPA-1a antibody, is...
NEW HAVEN, Conn. — Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced a collaboration with Johnson & Johnson to support the development of complementary therapeutic approaches aimed at reducing the risk...
NEW HAVEN, Conn. — Rallybio Corporation announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases. The Phase 1 MAD study for RLYB116 evaluated the safety, tolerability, pharmacokinetics (PK),...
NEW HAVEN, Conn. – Rallybio, a clinical-stage biopharmaceutical company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare disorders, today announced the details of two previously undisclosed pipeline programs. RLYB212 is a novel monoclonal antibody to human platelet antigen (HPA)-1a in preclinical development...
Bellingham, Washington – More than 50 million people worldwide live with epilepsy, with approximately half of them being children. For about one-third of these patients, medications do not control their seizures, leaving surgery as the only viable option for seizure relief. Seizures in 60 percent of these drug-resistant cases start...
Cambridge, Mass. – Drug development is typically slow: the pipeline from basic research discoveries that provide the basis for a new drug to clinical trials to production of a widely available medicine can take decades. But decades can feel impossibly far off to someone who currently has a fatal disease....
NOVATO, California — The Phase 2b clinical trial will enroll up to six cystinosis patientswith a history of good compliance using the currently availableimmediate-release form of cysteamine bitartrate, the only drug cleared formarketing by the U.S. Food and Drug Administration (“FDA”) and EuropeanMedicines Agency (“EMEA”) to treat cystinosis. The clinical...