Acquisitions, rare disease data, gene therapy approval, and more..
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CLINICAL TRIAL NEWS
Vaccitech
Final data from the Ph 1b/2a HBV002 clinical trial of VTP-300 in adults with chronic Hepatitis B (CHB) at EASL this weekend. A Ph 2a study is underway with interim data in Q4.
UniQure
Announced Interim data from their ongoing Ph 1/2 clinical trial of AMT-130 (gene therapy) for the treatment of Huntington’s disease (rare disease). Additional data expected in Q4 and regulatory interactions in Q1 2024.
REGULATORY NEWS
Sarepta Therapeutics
Announced the FDA accelerated approval of ELEVIDYS, an AAV based gene therapy for the treatment of pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD). The company noted gross treatment pricing of $3.2 million.
Intercept Pharmaceuticals
Was issued a CRL from the FDA for obeticholic acid (OCA) for NASH. The company is also discontinuing all NASH-related activity and are on track for regulatory filings for Ocaliva in PBC this year.
M&A / COLLABORATION NEWS
DICE Therapeutics
Announced a definitive agreement for Lilly to acquire them for $2.4 billion. DICE has a pipeline of oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas, based on their DELSCAPE platform.
Aeglea BioTherapeutics
Announced they completed the acquisition of Spyre Therapeutics, a privately held company with a pipeline of antibody therapeutics for the treatment of inflammatory bowel disease (IBD).
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