FDA Grants Fast Track Designation to SAB-142
1 report, 1 independent
Updated Sun 00:00
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What happened
The FDA granted Fast Track designation to SAB-142, a drug candidate from SAB Biotherapeutics. Separately, SAB Biotherapeutics reported quarterly earnings of ($0.24) per share, which exceeded the consensus estimate. The company also noted that its cash reserves of $205 million should fund operations through 2028.
From themarketsdaily.com
Why it matters
The Fast Track designation may allow for more frequent interactions with the FDA and a rolling review of a future Biologics License Application. This designation, along with the company's continued clinical enrollment and rising R&D expenses, indicates ongoing investment in the drug's development path.
From themarketsdaily.com
Who's involved
- FDARegulatory agency that granted the Fast Track designation to SAB-142
- United States of AmericaGovernment jurisdiction from which the FDA derives its authority
- Center for Devices and Radiological HealthFormal division of the FDA that issues alerts and holds meetings
- MaharashtraJurisdiction within which the FDA enforces food and drug safety standards
- Heidi OvertonIndividual appointed to the formal leadership role of the FDA Commissioner
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The entities involved
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