Category Archives: Global News Feed


Cabaletta Bio Announces FDA Granted Orphan Drug Designation to CABA-201 for Treatment of Myositis

PHILADELPHIA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of idiopathic inflammatory myopathies (IIM, or myositis). CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells. Four RESET™ (REstoring SElf-Tolerance) Phase 1/2 trials are advancing for the evaluation of CABA-201 across multiple autoimmune conditions, including the Phase 1/2 RESET-Myositis™ trial.

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Cabaletta Bio Announces FDA Granted Orphan Drug Designation to CABA-201 for Treatment of Myositis

Arvinas to Present at 6th Annual Guggenheim Biotechnology Conference

NEW HAVEN, Conn., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Ron Peck, M.D., Chief Medical Officer, and Randy Teel, Ph.D., Senior Vice President, Corporate and Business Development will participate in a fireside chat at the 6th Annual Guggenheim Biotechnology Conference on Wednesday, February 7 at 10:30 a.m. ET in New York.

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Arvinas to Present at 6th Annual Guggenheim Biotechnology Conference

Adverum Biotechnologies will Host Webcast to Review LUNA Phase 2 Preliminary Efficacy and Safety Results on February 8, 2024

- Preliminary safety and efficacy data from ongoing LUNA Phase 2 study of Ixo-vec for the treatment of wet AMD will be presented at the 47th Annual Meeting of the Macula Society, with company-sponsored webcast on Thursday, February 8, 2024 at 8:00am ET -

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Adverum Biotechnologies will Host Webcast to Review LUNA Phase 2 Preliminary Efficacy and Safety Results on February 8, 2024

Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

SHANGHAI, China, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the Singapore Health Sciences Authority (“HSA") had accepted the New Drug Application (“NDA”) for toripalimab, both in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (“NPC”), and as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Additionally, the HSA has also granted priority review designation to the NDA.

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Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority