SLTE-1009 / Slate Medicines, Dartsbio Pharmaceuticals - LARVOL DELTA

Slate Medicines…announced that the first participant has been dosed in the company’s Phase 1 clinical study evaluating SLTE-1009, Slate’s subcutaneous anti pituitary adenylate cyclase-activating peptide ('PACAP')/vasoactive intestinal peptide ('VIP') monoclonal antibody candidate for the prevention of migraine (GlobeNewswire) - "The Phase 1 single- and multiple-ascending dose study is a healthy volunteer study being conducted in Australia to assess the pharmacokinetics ('PK') and safety of SLTE-1009. Slate expects to report topline safety and PK data from the study in mid-2027."

P1 data • Trial status • Migraine

Fulcrum Therapeutics and Slate Medicines Announce Merger Agreement to Advance Next-Generation Migraine Therapies (GlobeNewswire) - "Combined company to operate as Slate Medicines and focus on advancing Slate's portfolio of next-generation migraine therapeutics. Slate’s lead product candidate, SLTE-1009, is a clinical stage, potentially best-in-class subcutaneous anti-PACAP/VIP monoclonal antibody for the preventative treatment of migraine. Concurrent oversubscribed private placement financing of $245 million from a leading syndicate of healthcare investors anticipated to fund operations into 2029."

M&A • CNS Disorders • Migraine

Study to Evaluate Safety, Tolerability and PK of study drug SLTE-1009 in Healthy Adult Patients (ANZCTR) - P1 | N=72 | Not yet recruiting | Sponsor: Slate Medicines

New P1 trial • CNS Disorders • Migraine

Slate starts up with $130M and a headache drug from China (BioPharma Dive) - "Slate’s drug, SLTE-1009, is a subcutaneous injection that could be given at home....Phase 1 testing should start in mid-2026."

Financing • New P1 trial • Migraine