- Spark Newswire

1 minute read

FDA Accepts Travere Therapeutics’ NDA for Sparsentan with Priority Review

Today, 11:02 AM

The U.S. Food and Drug Administration (FDA) has accepted Travere Therapeutics’ (NASDAQ: TVTX) New Drug Application (NDA) under Subpart H and granted Priority Review of sparsentan for the treatment of IgA nephropathy (IgAN).

TVTX

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PolarityTE Shares Jump After FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for SkinTE

By Ragothaman Srinivasan

Today, 11:02 AM

The U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PolarityTE’s (NASDAQ: PTE) SkinTE under the its open investigational new drug application (IND).

PTE

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Acutus Medical Completes Patient Enrolment In AcQForce Flutter IDE Trial

By Ragothaman Srinivasan

Today, 11:02 AM

Acutus Medical (NASDAQ: AFIB) completed patient enrollment in the AcQForce Flutter Investigational Device Exemption (IDE) clinical trial. The trial was designed to evaluate the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system in the treatment of right atrial typical flutter.

AFIB

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Stealth BioTherapeutics Shares Rally following FDA Orphan Drug Designation To Elamipretide For Duchenne muscular dystrophy (DMD)

By Ragothaman Srinivasan

Today, 11:02 AM

Stealth BioTherapeutics Corp (NASDAQ: MITO) received Orphan Drug Designation to Elamipretide from the United States Food and Drug Administration (FDA) for the treatment of patients with Duchenne muscular dystrophy (DMD).

MITO

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Salarius Pharmaceuticals Successfully Completes pre-IND Meeting with FDA for SP-3164

By Ragothaman Srinivasan

Today, 11:02 AM

Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) successfully completed the pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration (FDA) for SP-3164 in hematological cancers and solid tumors.

SLRX

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FDA Accepts IND for Cue Biopharma’s CUE-102 in the treatment of Wilms’ Tumor 1 (WT1)

By Ragothaman Srinivasan

Today, 11:02 AM

Cue Biopharma, Inc. (NASDAQ: CUE) received the U.S. Food and Drug Administration (FDA) acceptance of the Investigational New Drug (IND) application for the evaluation of CUE-102 in the treatment of Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers.

CUE

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FDA Clears Regulus Therapeutics’ IND for RGLS8429 In Autosomal Dominant Polycystic Kidney Disease (ADPKD)

By Ragothaman Srinivasan

Today, 11:02 AM

Regulus Therapeutics Inc. (NASDAQ: RGLS) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

RGLS

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Arcellx Doses First Patient in Phase 1 study of ACLX-001 in Relapsed or Refractory Multiple Myeloma

By Ragothaman Srinivasan

Today, 11:02 AM

Arcellx, Inc. (NASDAQ: ACLX) announced that the first patient has been dosed in its open-label, multi centre phase 1 clinical study of ACLX-001 for patients with Relapsed or Refractory Multiple Myeloma (r/r MM).

ACLX

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Immatics Initiates Phase 1 Clinical Trial of IMA401 in Advanced Solid Tumors

By Ragothaman Srinivasan

Today, 11:02 AM

Immatics N.V. (NASDAQ: IMTX) announced the initiation of a Phase 1 clinical trial of its drug candidate IMA401 for patients with recurrent and/or refractory solid tumors.

IMTX

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Achilles Therapeutics Doses First Patient with Higher-dose cNeT in CHIRON Phase 1/2a Trial for Advanced NSCLC

By Ragothaman Srinivasan

Today, 11:02 AM

Achilles Therapeutics plc (NASDAQ: ACHL) announced that the first patient has been dosed with personalized clonal neoantigen-reactive T cells, or cNeT, manufactured with the Company's higher-dose VELOS™ Process 2 in the ongoing Phase I/IIa CHIRON clinical trial for the treatment of advanced non-small cell lung can

ACHL