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Etripamil Nasal Spray Shows Positive Phase III Results for PSVT Treatment in China

9/6/2024

Ji Xing Pharmaceuticals' Phase III trial of etripamil nasal spray met its primary endpoint, showing a statistically significant conversion to normal heart rhythm within 30 minutes compared to placebo.

Eledon Pharmaceuticals' Tegoprubart Shows Promise in Transplantation Therapies

1/13/2025

Eledon Pharmaceuticals completed Phase 2 BESTOW trial enrollment for tegoprubart in kidney transplantation, with topline results expected in Q4 2025.

Anebulo Pharmaceuticals Advances Selonabant Development with FDA Collaboration

12/24/2024

Anebulo Pharmaceuticals has made significant progress in the development of intravenous selonabant, a potential treatment for acute cannabis-induced toxicity in children. Following a successful Phase 2 proof-of-concept study, the company has engaged in discussions with the FDA to outline a clinical testing plan, highlighting the urgent need for such a treatment. Additionally, Anebulo has secured $15M in funding through a private placement to support its research efforts.

FDA Approves Azurity's Danziten (Nilotinib) for CML Without Mealtime Restrictions

11/15/2024

The FDA has approved Azurity Pharmaceuticals' Danziten (nilotinib) as the first nilotinib formulation for chronic myeloid leukemia (CML) without mealtime restrictions.

Clarity Pharmaceuticals Initiates Phase I/IIa Trial of 64Cu-SAR-bisPSMA for Metastatic Castration-Resistant Prostate Cancer

11/18/2024

Clarity Pharmaceuticals has commenced a Phase I/IIa clinical trial evaluating 64Cu-SAR-bisPSMA in patients with metastatic castration-resistant prostate cancer (mCRPC).

Jazz Pharmaceuticals Acquires Chimerix, Strengthening Late-Stage Pipeline

3/5/2025

Jazz Pharmaceuticals has announced the strategic acquisition of Chimerix, expanding its portfolio with a promising late-stage drug candidate.

LB Pharmaceuticals Advances Schizophrenia Treatment with LB-102

2/7/2024

LB Pharmaceuticals is making strides in the treatment of schizophrenia with its novel drug candidate, LB-102. The company has successfully completed a Phase 1 clinical trial, demonstrating the drug's safety and tolerability in healthy volunteers. With a unique mechanism targeting dopamine D2/3 and 5-HT7 receptors, LB-102 aims to offer improved efficacy and safety over existing treatments. The company plans to advance LB-102 into Phase 2 trials, focusing on its potential to address the significant unmet needs in schizophrenia treatment.

FDA Approves Citius Pharmaceuticals' Lymphir for CTCL Treatment

1/7/2025

The FDA has approved Citius Pharmaceuticals' Lymphir, a reformulated version of a previously withdrawn lymphoma therapy, for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL). This marks a significant advancement for patients with this rare form of non-Hodgkin lymphoma, offering a new treatment option with the potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity.

Acumen Pharmaceuticals' pTau217 Assay Streamlines Alzheimer's Clinical Trials

10/31/2024

Acumen Pharmaceuticals presents data on pTau217 assay for efficient screening in the ALTITUDE-AD trial, reducing the need for invasive procedures.

Hemogenyx Pharmaceuticals Advances HEMO-CAR-T Therapy with New Funding and Clinical Trial Approvals

11/11/2024

Hemogenyx Pharmaceuticals secured £600,000 to advance Phase I clinical trials for its HEMO-CAR-T therapy targeting acute myeloid leukemia.

Syndax Pharmaceuticals Announces Key Updates and 2024 Milestones

1/2/2024

Syndax Pharmaceuticals has shared significant updates, including the submission of a BLA for axatilimab in chronic graft-versus-host disease and an NDA for revumenib in R/R KMT2Ar acute leukemia. The company also anticipates completing enrollment in the AUGMENT-101 trial and reporting topline data in 2024. With a recent $230 million follow-on offering, Syndax is well-positioned to fund its operations through 2026.

FDA Requires Label Update for Agios Pharmaceuticals' Pyrukynd

1/12/2025

The US Food and Drug Administration has mandated Agios Pharmaceuticals to update the label of its hemolytic anemia drug, Pyrukynd, to include the risk of liver injury. This move comes amidst other significant developments in the pharmaceutical sector, including positive Phase II results from Oculis Holdings and a licensing deal between Climb Bio and Mabworks Biotech.

Gildeuretinol Receives FDA Rare Pediatric Disease and Fast Track Designations for Stargardt Disease

11/18/2024

Gildeuretinol (ALK-001) has been granted Rare Pediatric Disease and Fast Track designations by the FDA, highlighting the urgent need for Stargardt disease treatments.

Vertex Pharmaceuticals Reports Strong Q1 2024 Performance, Advances Pipeline

5/12/2024

Vertex Pharmaceuticals reported a 13% revenue increase in Q1 2024, reaching $2.7 billion, driven by cystic fibrosis (CF) drug sales and the launch of CASGEVY for sickle cell disease and beta-thalassemia.

Tonix Pharmaceuticals' Tonmya™ Receives Conditional FDA Acceptance for Fibromyalgia Treatment

1/3/2024

Tonix Pharmaceuticals' TNX-102 SL, conditionally named Tonmya™, has received FDA acceptance as a trade name for fibromyalgia management.

EyePoint's DURAVYU Shows Promise in Phase 2 DME Trial

10/28/2024

EyePoint Pharmaceuticals reported positive interim results from its Phase 2 VERONA trial of DURAVYU for diabetic macular edema (DME).

ORIC Pharmaceuticals Maintains Buy Rating Amidst Competitive Landscape

9/19/2024

H.C. Wainwright reaffirms its Buy rating and $21 price target for ORIC Pharmaceuticals, following a review of competitor Ipsen's trial results at the ESMO 2024 conference. Despite Ipsen's positive outcomes, ORIC's potential in prostate cancer treatments and its financial stability keep investor confidence high.

Marinus Pharmaceuticals Cuts 45% of Workforce After Ganaxolone Trial Failure

11/15/2024

Marinus Pharmaceuticals announced a workforce reduction of approximately 45% following disappointing Phase III trial results for oral ganaxolone in tuberous sclerosis complex.

Quoin Pharmaceuticals Initiates Clinical Testing of QRX003 in Pediatric Netherton Syndrome Patient

11/5/2024

Quoin Pharmaceuticals has begun clinical testing of QRX003 in a young child with Netherton Syndrome at Children’s Health Ireland, marking the first evaluation of the drug in a pediatric patient.

Gan & Lee Pharmaceuticals Partners with Brazil to Localize Insulin Production in Landmark Agreement

5/16/2025

Gan & Lee Pharmaceuticals has signed a cooperation commitment letter with Brazil's Ministry of Health, becoming the first Chinese pharmaceutical company to participate in Brazil's PDP program for localizing insulin production.

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