Alzheimer's agitation data, clinical hold lifted, new studies planned, and more..
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CLINICAL TRIAL NEWS
Eiger BioPharmaceuticals
Portfolio prioritization, will focus on drug candidate avexitide in hyperinsulinemic hypoglycemia indications, planned ph 3 study. Evaluating strategic partnering options for its virology assets, lonafarnib and peginterferon lambda.
BioXcel Therapeutics
Ph 3 TRANQUILITY II study of BXCL501 for Alzheimer’s disease-related agitation met it's primary endpoint. Company plans to submit sNDA in H2 2023.
Atossa Therapeutics
Six patients have been dosed with (Z)-endoxifen in the I-SPY 2 TRIAL for breast cancer. This data, along with their ph 2 EVANGELINE study will inform the planned ph 3 protocol.
MoonLake Immunotherapeutics
Announced positive results from global ph 2 MIRA study evaluating sonelokimab for hidradenitis suppurativa. Sonelokimab is also in a phase 2 study (ARGO) in patients with active psoriatic arthritis.
Pharvaris
The US FDA lifted the clinical hold on the IND for deucrictibant for hereditary angioedema (HAE) attacks. They are preparing for their global ph 3 study (RAPIDe-3) to include US sites.
Lantern Pharma
Published new findings for drug candidate LP-284 that further support development. They are planning a first-in-human ph 1 study in non-Hodgkin’s lymphomas later this year.
REGULATORY NEWS
Eton Pharmaceuticals
The US FDA has issued a CRL for dehydrated alcohol injection for the treatment of methanol poisoning due to chem/manufacturing (CMC) issues. The company plans to address this issue and move forward with the FDA.
M&A / COLLABORATION NEWS
Sigilon Therapeutics
Announced they will be acquired by Lily. The total purchase price, including contingent value rights, is ~$340M.
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