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Saol Therapeutics received a complete response letter for its pyruvate dehydrogenase complex deficiency treatment a week after the FDA unveiled its Rare Disease Evidence Principles program. On Dec. 18, in a Type A meeting, the biotech will attempt to convince the agency that its drug fits perfectly into the framework.

hubXchange’s AI in Drug Discovery Xchange Boston 2026 convenes senior-level scientists and biotech/pharma executives to explore how AI is transforming drug discovery. The one-day, highly interactive event includes roundtable discussions, 1:1 meetings, expert presentations, poster sessions and networking — diving into critical topics like data quality, target identification, lead generation & optimization, drug response prediction, and drug design & modeling. Join peers and industry experts in Boston on May 6, 2026 to collaborate, share insights, and accelerate AI-driven drug discovery efforts.

The Oligonucleotides & Peptides Xchange Boston 2026 is a one-day, invitation-level forum for senior scientists and executives in pharma and biotech, focused on accelerating the development of oligonucleotide and peptide therapeutics. Through interactive roundtables, expert talks, 1:1 meetings, poster sessions, and networking, we will tackle key challenges across discovery, delivery, CMC, and quality control. The event is designed for collaboration and innovation — and registration is complimentary for qualified delegates. Join us in Boston on April 30, 2026.

Advanced Therapies Xchange Boston 2026 brings together senior leaders from pharma and biotech for a highly interactive, one-day forum focused on accelerating cell and gene therapy innovation. Featuring expert presentations, roundtable discussions, 1:1 meetings, and networking, the event explores next-generation vector engineering, cell therapy development, and scalable gene therapy manufacturing. Registration is complimentary for qualified delegates. Join us on May 4, 2026 in Boston.

hubXchange’s Antibody Therapeutics Xchange Boston 2026 brings together senior scientists and executives from leading pharma and biotech companies for a highly interactive, discussion-driven meeting focused on advancing next-generation antibody therapeutics. The event features expert presentations, roundtables, 1:1 meetings, and networking sessions covering target selection, lead optimization, multispecific engineering, and ADC innovation. Designed to foster collaboration and accelerate discovery, this one-day forum offers valuable insights from top industry leaders. Join us in Boston on April 28, 2026

Join leading scientists and innovators at the CNS Discovery Xchange Boston 2026 — a high-energy, one-day forum designed to spark collaboration and accelerate breakthroughs in CNS drug discovery. Across five focused tracks—Biomarkers, Target Discovery, Disease Models, Novel Modalities, and BBB/Drug Delivery—you’ll explore the latest science, debate new approaches, and gain insights you can apply immediately to your CNS pipeline. With interactive roundtables, expert talks, targeted 1:1 meetings, and exceptional networking, this is where meaningful connections and actionable ideas come together. If you’re working to advance CNS therapeutics, this is the room you need to be in.

Step into a room full of the people shaping the future of biologics at the Antibody Manufacturing Xchange Boston 2026. This one-day, invitation-only forum brings together senior experts across Cell Line Development, Upstream and Downstream Processing, Formulation, and Quality Control to tackle the real-world challenges of scaling and optimizing antibody production. Through focused discussions, expert insights, and high-value networking, you’ll gain practical solutions, new collaborations, and fresh perspectives to accelerate manufacturing efficiency and product quality. If driving better, faster, more reliable antibody manufacturing is on your agenda, this is the event you won’t want to miss.

Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting Company reiterates end of January 2026 timeline for MAA submission

TERN-701 more than doubled the response rate of Novartis’ rival approved therapy in an early-stage trial, sending the biotech’s shares flying.

Pfizer apparently had more in the tank after the high-profile battle to acquire Metsera earlier this fall. The company has licensed a new GLP-1 from YaoPharma.