Category Reports Biotech

Companion EN/IT deep dive on Neurocrine Biosciences: INGREZZA as the main cash engine in movement disorders, CRENESSITY as the first new therapy for classic CAH in 70 years, and an expanding psychiatry pipeline (NBI-1117568 and related muscarinic programmes). Focus on 2025–2026 catalysts, risk map and how NBIX fits in a catalyst-driven biotech watchlist.

Incyte is a classic mid-cap biotech with a single dominant product (Jakafi) and a long history of oncology R&D. After several high-profile pipeline disappointments, the company has shifted from aggressive expansion to a more selective, risk-controlled development strategy.

Key message: the FDA has granted Breakthrough Therapy and Fast Track designations to TARA-002 for the treatment of pediatric macrocystic and mixed cystic lymphatic malformations (LMs), on top of the existing Rare Pediatric Disease designation and inclusion in the FDA’s CMC Development and Readiness Pilot program.

This turns TARA-002 into a rare triple-designation asset in a high-need pediatric space, and gives Protara a clearly accelerated regulatory lane while the stock is still trading in single digits.

Axsome Therapeutics is no longer just “the Auvelity company”. In 2025 it quietly turned into a multi-product CNS platform with three marketed drugs, a late-stage pipeline and, now, a Priority Review from the FDA for AXS-05 in agitation associated with Alzheimer’s disease – with a PDUFA action date set for April 30, 2026.

CRL in one paragraph:
The FDA acknowledged that one of Corcept’s Phase 3 trials in Cushing was successful, but another failed its primary endpoint. Given this mixed picture, the agency said it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness and therefore rejected the NDA via CRL. No insurmountable safety issues were cited; the focus is efficacy and consistency.

News of the day (REGAL): On 29 December 2025, SELLAS reported that the contract research organization running the Phase 3 REGAL trial notified the company that 72 of the 80 required events (deaths) had occurred as of 26 December 2025. REGAL is an overall survival study; the final analysis will be triggered once 80 events are reached. SELLAS remains fully blinded, and this one-time update does not change the statistical plan. Source: SELLAS REGAL update PR (Dec 29, 2025) .

Oncolytics Biotech (ONCY) — Pelareorep, GI focus, catalysts into Q1–H1 2026 | Oncolytics Biotech (ONCY) — Pelareorep, focus GI, catalyst Q1–H1 2026 EN IT Oncolytics Biotech (ONCY) Panel-style report (EN/IT): news-first, catalyst timelines, fundamentals/cash runway, pipeline, management/ownership, retail sentiment, risk…

The FDA approved NEREUS (tradipitant) for the prevention of vomiting induced by motion in adults — described as the first new FDA-approved pharmacologic treatment in this area in over 40 years. The company expects a commercial launch “in the coming months.”

On December 29, 2025, Applied Digital (APLD) and Ekso Bionics (EKSO) announced a non-binding term sheet for a proposed business combination between Applied Digital’s cloud computing arm, Applied Digital Cloud, and EKSO.