NDA

Cellevolve Bio Submits Investigational New Drug (IND) Application for Global Phase 2, Placebo-controlled Study of CE-VST01-JC for the Treatment of Progressive Multifocal Leukoencephalopathy (PML)

10/04/2022

CE-VST-01-JC is a novel, allogeneic, off-the-shelf, T cell therapy that targets the JC Virus, the virus that causes progressive multifocal leukoencephalopathy (PML) ASCEND-JC is a randomized, double-blind, placebo-controlled, phase 2 study with sites planned across US, Europe, and Canada Licensed and developed in collaboration with QIMR Berghofer Medical Research Institute’s Professor Rajiv Khanna; NIH’s Irene…

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Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes

09/30/2022

Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes…

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TRACON Pharmaceuticals Announces Submission of IND Application for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab

09/29/2022

Excerpt from the Press Release: SAN DIEGO, Aug. 08, 2022 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced that the company submitted an Investigational…

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AISA Pharma Announces Positive Data Safety Monitoring Board Review of First Phase 2 Data of Profervia® to treat Raynaud’s Disease in Scleroderma Patients

08/05/2022

Company to Move Forward with Key U.S. Regulatory Applications – Investigational New Drug and Orphan Drug Designation BOSTON, July 26, 2022 (GLOBE NEWSWIRE) — Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist…

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Acer Therapeutics and Relief Therapeutics Announce ACER-001 IND Submission for the Treatment of Maple Syrup Urine Disease

08/03/2022

Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital Excerpt from the Press Release: NEWTON, Mass. and GENEVA, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today…

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Omega Therapeutics Announces Submission of Investigational New Drug Application for OTX-2002, an Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma

06/22/2022

Investigational New Drug Application Submitted by Omega Represents the First Epigenomic Controller in a New Class of Programmable mRNA Therapeutics Excerpt from the Press Release: CAMBRIDGE, Mass., June 15, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”) today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug…

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Nexus Medical Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test Using the RHINOstic™ Automated Nasal Swab from Rhinostics

06/03/2022

Automated and Easily Scalable Swab-Based Workflow Supports Increased Sample Throughput and Processing Consistency Excerpt from the Press Release: WALTHAM, Mass. & WATERTOWN, Mass.–(BUSINESS WIRE)–Rhinostics Inc. and Nexus Medical Labs recently received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a molecular SARS-CoV-2 test enabling unsupervised self-collection. The test, based on…

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Cue Biopharma Receives FDA Acceptance of Investigational New Drug (IND) Application for CUE-102 in Wilms’ Tumor 1 (WT1) – expressing cancers

05/20/2022

Company to initiate Phase 1 dose escalation and expansion trial for the treatment of Wilms’ Tumor 1 (WT1) positive recurrent/metastatic cancers Starting dose of 1 mg/kg expected to reduce time and cost of dose escalation phase of trial, supporting development efficiency of CUE-100 series platform BOSTON, May 11, 2022 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE),…

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Gamida Cell Presents New Data from NAM-Enabled Genetically Modified Natural Killer (NK) Pipeline at International Society for Cell & Gene Therapy 2022

05/11/2022

Poster selected for inclusion in conference’s Elevator Pitch Session: GDA-301 produces enhanced potency and persistence with combined genetic manipulation of CISH gene editing and the engineered expression of membrane-bound IL-15 for targeting hematologic malignancies and solid tumors GDA-601 generates promising immunotherapeutic potential to target multiple myeloma cells Company plans to select a genetically modified NK…

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KVK Tech Announces Phase II Trial of COVID-19 Oral Therapy is Currently Enrolling in Nepal

05/10/2022

Excerpt from the Press Release: NEWTOWN, Pa., May 5, 2022 /PRNewswire/ — Sen-Jam Pharmaceuticals and KVK Tech are collaborating to develop a Covid-19 oral therapy. The companies will operate in parallel while they complete the Phase II clinical trials in Nepal. KVK Tech will offer formulation and chemistry, manufacturing and controls (CMC) for the oral therapy. Furthermore, KVK…

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