Avacta Therapeutics (Avacta Group plc) has obtained IND clearance from the FDA for FAP-Exd (AVA-6103), a Precision peptide-drug conjugate based on exatecan.

Neok Bio Inc. has obtained IND clearance from the FDA for NEOK-001, enabling initiation of a phase I trial for solid tumors. Dosing is expected to begin in the coming months, and initial clinical data are anticipated next year.

After selling off amyotrophic lateral sclerosis therapeutics last month, Tanabe Pharma America Inc. emerged a forerunner in another rare disease space with positive top-line phase III data of dersimelagon (MT-7117) for erythropoietic protoporphyria/X-linked protoporphyria.

Aidoc Medical Ltd.'s Care AI foundation model secured 11 new U.S. FDA-cleared indications for use in emergency department triage. Now, with 14 total cleared indications enabling comprehensive evaluation and prioritization of abdomen CTs in a single workflow, Aidoc Care can help health systems identify critical findings more quickly and mitigate delays caused by overcrowding and imaging backlogs.

Immunomic Therapeutics Inc. has received FDA clearance of its IND application for ITI-5000, enabling initiation of a first-in-human study.

Boundless Bio Inc. has obtained IND approval from the FDA for its novel kinesin oral degrader program, BBI-940. A first-in-human trial (KOMODO-1) for metastatic breast cancer is expected to begin in the first half of this year.

Rakuten Medical Inc. raised $100 million in a series F round to support late-stage clinical development of ASP-1929, its Alluminox-derived photoimmunotherapy being tested with Keytruda (pembrolizumab) as a first-line treatment for recurrent head and neck cancer.

D3 Bio Inc. has obtained IND clearance from the FDA for D3S‑003, enabling initiation of a first‑in‑human phase I trial in patients with advanced solid tumors harboring KRAS G12D mutations.

The Centers for Medicare & Medicaid Services has cracked open its coverage policy for transcatheter aortic valve replacement devices a second time, and a wide range of stakeholders are providing feedback. Where the agency will land on questions such as the need for continued evidence development is difficult to predict, however, given that the agency is hearing anything but unanimity on the question.

Adolore Biotherapeutics Inc. has announced that the FDA has granted orphan drug designation to the company’s Kv7-activating rdHSV-CA8* gene therapy for treatment of primary and secondary erythromelalgia.