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NEWS & INSIGHTS

Dive into the Biopharma Space

Stay up-to-date on major biopharma news, deeper dives into specific companies and biopharma themes, and how it all relates to biopharma partners.

Biopharma Bite Sized News May 6th - 10th

ASGCT is coming to a close and you can see the breakdown of clinical trial-related abstracts in our post (LI post here). You can see just how early everything is still but such a promising space..



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Azurity Pharmaceuticals

🎯 FDA approved Myhibbin, the only ready-to-use liquid form of mycophenolate mofetil, an immunosuppressant used for organ transplant patients.


MacroGenics 

🔬 Reported five deaths in a Ph2 clinical trial. Two deaths, one in each study arm, were due to cardiovascular events and considered unrelated to the study drug. Three deaths, all in the higher dose group, occurred due to pneumonitis, an inflammatory lung condition, and are currently under investigation. 


NRx Pharmaceuticals 

🔬 Reported final trial data showing superior safety profile for NRX-101 vs. Lurasidone in suicidal bipolar depression. 


Calliditas 

🔬 Topline results from the Ph2 trial of Setanaxib in head and neck cancer demonstrate significant improvements in progression-free survival and overall survival rates.

 

CG Oncology

🔬 Reported trial result showing Cretostimogene monotherapy demonstrated 75.2% complete response rate in high-risk, BCG-unresponsive non-muscle invasive bladder cancer.


EyePoint Pharmaceuticals 

🔬 DURAVYU™ demonstrated stable or improved disease severity in the Ph2 PAVIA trial for non-proliferative diabetic retinopathy, with a favorable safety profile and no drug-related SAEs.


GlycoMimetics 

🔬 Ph3 trial result reported for Uproleselan in r/r AML showing endpoint of overall survival (OS) was not met.


Lyra Therapeutics 

🔬 Topline results from the Ph3 ENLIGHTEN 1 trial indicate that LYR-210 did not meet the primary endpoint of statistically significant improvement in chronic rhinosinusitis symptoms compared to sham control.


Teva Pharmaceutical & Medincell

🔬 Announced Ph3 efficacy data from SOLARIS trial evaluating TEV-‘749 (olanzapine) as a once-monthly subcutaneous long-acting injectable in adults with Schizophrenia. 


Anaptys 

🔬 Imsidolimab (IL-36R) demonstrated consistent safety and tolerability in the Ph3 GEMINI-2 trial for generalized pustular psoriasis (GPP), aligning with the profile observed in GEMINI-1.


Cytokinetics 

🔬 Topline Ph1 data show CK-4021586 is safe and well-tolerated in healthy participants, demonstrating linear pharmacokinetics (PK). 


Novavax & Sanofi 

🤝  Announced co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel COVID-19-influenza combination vaccines.


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Data:

May 6-10, 2024


Article History:

RF, DV, DG (05/10/24)






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