Funding & Financings
Star Therapeutics raises $200M
Fresh off selling Vega to Incyte and floating Electra, the team is restarting with a preclinical hematology and immunology pipeline. Janus Henderson says it rarely invests this early.
Read the full story →Epicrispr wins an $8M CIRM grant
Non-dilutive money for the Phase 1/2 trial of EPI-321, a one-time epigenetic therapy that silences DUX4 in FSHD without cutting DNA.
Read the full story →FDA & Regulatory
FDA lifts Aardvark's clinical hold
ARD-101 for Prader-Willi hunger can return to the clinic once a new Phase 3 design is agreed, after a fresh ECG study found no cardiac events.
Read the full story →Xylyx Bio gets orphan status and $2.99M from the NIH
Its bioengineered Inspirex Lung aims to rescue injured donor lungs. The grant funds first-in-human studies.
Read the full story →Medicovestor's MC001 gets Fast Track
The pancreatic cancer ADC now has orphan status, an active IND and Fast Track, all before its first Phase 1 patient.
Read the full story →Talent Insight
Small biotechs need regulatory muscle early
- Regulatory affairs is the first senior hire that matters for small biotechs coming off a designation or a hold. People who have negotiated directly with the FDA are scarce.
- Lean, grant-funded teams want hybrids: a clinical lead who can also own filings, or a founding executive who has run a first-in-human study before.
- For 2027 plans: If a Phase 1 is on your roadmap, line up clinical operations and regulatory leadership before first patient in, not after.
Building a team in Biotech, R&D & Clinical?
Jordan Griffiths specialises in Biotech, R&D & Clinical hiring at QP Group. Talk to Jordan about the market, salaries or a search.
jordan.griffiths@qpexec.com