http://new.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Thu, 27 Aug 2026 16:00:41 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://new.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/Corporate+News/FDA+clears+Adicet+Bio+IND+application+for+prostate+cancer+therapy/26989688.html <p>Adicet Bio, Inc. (Nasdaq: ACET) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ADI-212, a cell therapy candidate targeting metastatic castration-resistant prostate cancer (mCRPC).</p><p>According to the press release, the company plans to begin Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026.</p><p>ADI-212 is described as a gene-edited cell therapy targeting prostate-specific membrane antigen (PSMA). It incorporates membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex, designed to act within the tumor microenvironment.</p><p>Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio, said the therapy is http://www.streetinsider.com/Corporate+News/FDA+clears+Adicet+Bio+IND+application+for+prostate+cancer+therapy/26989688.html Thu, 27 Aug 2026 16:00:41 -0400 ACET http://www.streetinsider.com/FDA/FDA+clears+Adicet+Bio+IND+application+for+prostate+cancer+therapy/26989688.html <p>Adicet Bio, Inc. (Nasdaq: ACET) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ADI-212, a cell therapy candidate targeting metastatic castration-resistant prostate cancer (mCRPC).</p><p>According to the press release, the company plans to begin Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026.</p><p>ADI-212 is described as a gene-edited cell therapy targeting prostate-specific membrane antigen (PSMA). It incorporates membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex, designed to act within the tumor microenvironment.</p><p>Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio, said the therapy is http://www.streetinsider.com/FDA/FDA+clears+Adicet+Bio+IND+application+for+prostate+cancer+therapy/26989688.html Thu, 27 Aug 2026 16:00:41 -0400 ACET http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Press+Releases/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html <p class="bwalignc"> <i>Phase 1 study in patients with mCRPC expected to begin enrollment in the fourth quarter of 2026</i> </p> <p> REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and <i>in vivo</i> CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with http://www.streetinsider.com/Business+Wire/Adicet+Bio+Announces+FDA+Clearance+of+IND+Application+for+ADI-212/26989676.html Thu, 27 Aug 2026 16:00:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++Adicet+Bio%2C+Inc.+++++++++++++++++++++++Filed+by%3A+RA+CAPITAL+MANAGEMENT%2C+L.P./26932036.html si-local-file:///var/storage/secattach/20260814/26932036.html http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++Adicet+Bio%2C+Inc.+++++++++++++++++++++++Filed+by%3A+RA+CAPITAL+MANAGEMENT%2C+L.P./26932036.html Fri, 14 Aug 2026 16:45:00 -0400 ACET O.37270417 http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++Adicet+Bio%2C+Inc.+++++++++++++++++++++++Filed+by%3A+RA+CAPITAL+MANAGEMENT%2C+L.P./26932036.html si-local-file:///var/storage/secattach/20260814/26932036.html http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++Adicet+Bio%2C+Inc.+++++++++++++++++++++++Filed+by%3A+RA+CAPITAL+MANAGEMENT%2C+L.P./26932036.html Fri, 14 Aug 2026 16:45:00 -0400 ACET O.37270417 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05++Filed+by%3A+Klickstein+Lloyd/26890837.html si-local-file:///var/storage/secattach/20260807/26890837.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05++Filed+by%3A+Klickstein+Lloyd/26890837.html Fri, 07 Aug 2026 16:02:00 -0400 ACET O.37270417 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05++Filed+by%3A+Klickstein+Lloyd/26890837.html si-local-file:///var/storage/secattach/20260807/26890837.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05++Filed+by%3A+Klickstein+Lloyd/26890837.html Fri, 07 Aug 2026 16:02:00 -0400 ACET O.37270417 http://www.streetinsider.com/Analyst+PT+Change/Adicet+Bio+Inc.+%28ACET%29+PT+Lowered+to+%2490+at+Guggenheim/26877995.html (Updated - August 6, 2026 7:27 AM EDT) <p>Guggenheim analyst Yatin Suneja lowered the price target on Adicet Bio Inc. (NASDAQ: ACET) to $90.00 (from $100.00) while maintaining a Buy rating.</p><p>The analyst commented: "Key takeaways from ACET's 2Q26 print include: (1) Management now expects to disclose updated topline results from the Phase I trial evaluating prula cel (formerly ADI-001) across multiple autoimmune indications, in 3Q26 (pushed from mid-2026), with the update to include 22 lupus nephritis (LN) and systemic lupus erythematosus (SLE) patients, of which 13 will have ≥12 months of follow-up. Investor focus, per our conversations, remains on durability (see http://www.streetinsider.com/Analyst+PT+Change/Adicet+Bio+Inc.+%28ACET%29+PT+Lowered+to+%2490+at+Guggenheim/26877995.html Thu, 06 Aug 2026 07:27:37 -0400 ACET http://www.streetinsider.com/Analyst+Comments/Adicet+Bio+Inc.+%28ACET%29+PT+Lowered+to+%2490+at+Guggenheim/26877995.html (Updated - August 6, 2026 7:27 AM EDT) <p>Guggenheim analyst Yatin Suneja lowered the price target on Adicet Bio Inc. (NASDAQ: ACET) to $90.00 (from $100.00) while maintaining a Buy rating.</p><p>The analyst commented: "Key takeaways from ACET's 2Q26 print include: (1) Management now expects to disclose updated topline results from the Phase I trial evaluating prula cel (formerly ADI-001) across multiple autoimmune indications, in 3Q26 (pushed from mid-2026), with the update to include 22 lupus nephritis (LN) and systemic lupus erythematosus (SLE) patients, of which 13 will have ≥12 months of follow-up. Investor focus, per our conversations, remains on durability (see http://www.streetinsider.com/Analyst+Comments/Adicet+Bio+Inc.+%28ACET%29+PT+Lowered+to+%2490+at+Guggenheim/26877995.html Thu, 06 Aug 2026 07:27:37 -0400 ACET http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Jun+30/26874783.html si-local-file:///var/storage/secattach/20260805/26874783.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Jun+30/26874783.html Wed, 05 Aug 2026 16:21:00 -0400 ACET O.37270417 http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Jun+30/26874783.html si-local-file:///var/storage/secattach/20260805/26874783.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Jun+30/26874783.html Wed, 05 Aug 2026 16:21:00 -0400 ACET O.37270417 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05/26874698.html si-local-file:///var/storage/secattach/20260805/26874698.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05/26874698.html Wed, 05 Aug 2026 16:18:00 -0400 ACET O.37270417 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05/26874698.html si-local-file:///var/storage/secattach/20260805/26874698.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Adicet+Bio%2C+Inc.++++++++++For%3A+Aug+05/26874698.html Wed, 05 Aug 2026 16:18:00 -0400 ACET O.37270417 http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html <p class="bwalignc"> <i>Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of follow-up; topline results now anticipated in 3Q/2026</i> </p><p class="bwalignc"> <i>Productive interactions with the U.S. Food and Drug Administration (FDA) informing potential pivotal trial design for LN, supporting planned start up activities in 2H/2026</i> </p><p class="bwalignc"> <i>On track for regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026 with enrollment anticipated to begin 4Q/2026, pending regulatory http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html Wed, 05 Aug 2026 16:15:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html <p class="bwalignc"> <i>Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of follow-up; topline results now anticipated in 3Q/2026</i> </p><p class="bwalignc"> <i>Productive interactions with the U.S. Food and Drug Administration (FDA) informing potential pivotal trial design for LN, supporting planned start up activities in 2H/2026</i> </p><p class="bwalignc"> <i>On track for regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026 with enrollment anticipated to begin 4Q/2026, pending regulatory http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html Wed, 05 Aug 2026 16:15:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html <p class="bwalignc"> <i>Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of follow-up; topline results now anticipated in 3Q/2026</i> </p><p class="bwalignc"> <i>Productive interactions with the U.S. Food and Drug Administration (FDA) informing potential pivotal trial design for LN, supporting planned start up activities in 2H/2026</i> </p><p class="bwalignc"> <i>On track for regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026 with enrollment anticipated to begin 4Q/2026, pending regulatory http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html Wed, 05 Aug 2026 16:15:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html <p class="bwalignc"> <i>Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of follow-up; topline results now anticipated in 3Q/2026</i> </p><p class="bwalignc"> <i>Productive interactions with the U.S. Food and Drug Administration (FDA) informing potential pivotal trial design for LN, supporting planned start up activities in 2H/2026</i> </p><p class="bwalignc"> <i>On track for regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026 with enrollment anticipated to begin 4Q/2026, pending regulatory http://www.streetinsider.com/Press+Releases/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html Wed, 05 Aug 2026 16:15:00 -0400 A.06822034 ACET O.20026344 O.37270417 http://www.streetinsider.com/Business+Wire/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html <p class="bwalignc"> <i>Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of follow-up; topline results now anticipated in 3Q/2026</i> </p><p class="bwalignc"> <i>Productive interactions with the U.S. Food and Drug Administration (FDA) informing potential pivotal trial design for LN, supporting planned start up activities in 2H/2026</i> </p><p class="bwalignc"> <i>On track for regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026 with enrollment anticipated to begin 4Q/2026, pending regulatory http://www.streetinsider.com/Business+Wire/Adicet+Bio+Reports+Second+Quarter+2026+Financial+Results+and+Provides+Business+Updates/26874348.html Wed, 05 Aug 2026 16:15:00 -0400 A.06822034 ACET O.20026344 O.37270417