Checkpoint Therapeutics

Fortress Biotech secured FDA approvals for two key products in Q4 2024: Emrosi for inflammatory lesions of rosacea and UNLOXCYT for advanced cutaneous squamous cell carcinoma, with commercial launch of Emrosi already underway.

Sun Pharmaceutical Industries will acquire Checkpoint Therapeutics for $355 million upfront, with stockholders receiving $4.10 per share plus a contingent value right worth up to $0.70 per share based on European approval milestones.

• The FDA has rejected Checkpoint Therapeutics' application for cosibelimab in advanced cutaneous squamous cell carcinoma, citing manufacturing facility issues rather than safety or efficacy concerns. • Clinical trials demonstrated promising results with a 55% overall response rate in locally advanced cSCC and 50% in metastatic disease, positioning cosibelimab as a potential low-cost alternative to existing treatments. • Checkpoint Therapeutics plans to address the manufacturing concerns and resubmit their application, aiming for potential approval in 2024, though the news triggered a 45% drop in company stock.

The FDA has approved Neurocrine's Crenessity as an adjunct therapy for classic congenital adrenal hyperplasia, offering patients a way to reduce steroid treatment burden.

The FDA has approved Unloxcyt (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in adults who cannot undergo surgery or radiation.

The FDA has granted approval to Checkpoint Therapeutics' Unloxcyt (cosibelimab-ipdl) for the treatment of advanced cutaneous squamous cell carcinoma (cSCC).

• The FDA is set to decide on Ionis Pharmaceuticals' olezarsen for familial chylomicronemia syndrome (FCS), a rare genetic disease, by December 19, following positive Phase III results. • Lexicon Pharmaceuticals awaits the FDA's decision on sotagliflozin as an adjunct therapy for type 1 diabetes by December 20, despite concerns raised by an advisory committee. • AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC is under FDA review, with a decision expected by December 20, based on Phase III data showing progression-free survival benefits. • Neurocrine Biosciences anticipates FDA decisions on crinecerfont for congenital adrenal hyperplasia (CAH) by December 29 and 30, potentially marking the first new treatment in 70 years.

Fortress Biotech announced FDA approval for Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea in adults, marking their first FDA approval.