Drug Discovery Weekly — 2026-03-31

FDA & Regulatory Decisions

The pharmaceutical industry's attention is firmly fixed on a packed Q2 2026 FDA calendar. Based on the latest coverage, several significant regulatory actions are anticipated:

Orforglipron (obesity) — Eli Lilly's oral GLP-1 receptor agonist is among the most closely watched Q2 2026 PDUFA decisions, widely expected to intensify competition in the booming weight-loss market.

Cytisinicline (smoking cessation) — Another closely tracked Q2 2026 FDA decision, cytisinicline would offer a novel mechanism for smoking cessation if approved.

Alzheimer disease agitation, focal segmental glomerulosclerosis, and hematological malignancies — Multiple FDA approval decisions expected in April 2026 span these rare and high-need indications, alongside HIV-1 and obesity treatments under review.

BioSpace 6 FDA Q2 2026 Watch List — BioSpace's updated tracker confirms six major verdict dates in Q2 2026, headlined by the obesity drug expected to reshape the GLP-1 competitive landscape.

Clinical Trial Spotlight

MAIA Biotechnology — NSCLC Phase 2 (THIO-101) MAIA Biotechnology (NYSE American: MAIA) announced on March 31, 2026 that eight patients in its ongoing Phase 2 clinical trial for non-small cell lung cancer (NSCLC) have achieved overall survival exceeding two years. The company positions its telomere-targeting THIO compound as a potential breakthrough therapeutic targeting the $50B+ global immunotherapy market.

Zanidatamab — HERIZON-GEA-01 (Gastroesophageal Adenocarcinoma) Results from the HERIZON-GEA-01 trial indicate potential first-line (1L) use of zanidatamab with or without tislelizumab plus chemotherapy in HER2-positive advanced or metastatic gastroesophageal adenocarcinoma. The data suggest a meaningful expansion of the addressable population for HER2-targeted therapy in GI oncology.

Chemoimmunotherapy — Endometrial Cancer Targeted Oncology's latest coverage highlights a new era in endometrial cancer management driven by chemoimmunotherapy combinations, as updated Phase 3 data reshape treatment sequencing and reinforce immunotherapy's role in this indication. Expert oncologists are weighing in on key takeaways for clinical practice.

IMUNON — Phase 3 Ovarian Cancer (IMNN-001) IMUNON reported 2025 financial results alongside a business update highlighting significant progress with its pivotal Phase 3 study. IMNN-001 is described as the first frontline immunotherapy to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer, with final Phase 2 data continuing to show median OS improvement.

Deals & Partnerships

Merck / Terns Pharma — ~$6 Billion Acquisition Merck is nearing an all-cash deal worth approximately $6 billion to acquire Terns Pharma, a biotech with a pipeline focused on oncology. The Financial Times first reported the deal, citing people familiar with the matter. The acquisition would strengthen Merck's cancer portfolio as the company faces increasing pressure to replenish its pipeline. The deal is expected to close pending regulatory approvals.

AbbVie / Gilgamesh Pharmaceuticals — $1.2 Billion Licensing Deal AbbVie and Gilgamesh Pharmaceuticals struck a landmark licensing agreement worth up to $1.2 billion for bretisilocin, a psychiatric disorder candidate. The deal follows earlier M&A speculation and reflects the surging appetite for novel psychiatric assets, particularly as the industry eyes psychedelic-derived compounds. The agreement is part of a broader trend: average biotech licensing deal size has reached $1.3 billion in early 2026, a 76% increase from 2025 levels, driven in part by China-originated assets and platform technologies.

Pipeline & Discovery Breakthroughs

RAS-Directed Therapy in Pancreatic Cancer OncLive reports that RAS-directed therapies and refined patient selection are emerging as sectors to watch in pancreatic cancer. Dr. Eileen M. O'Reilly detailed how RAS-targeting approaches could potentially transform the pancreatic cancer treatment landscape, with updated clinical data highlighting patient enrichment strategies as a key factor in driving meaningful outcomes.

2025 ESMO GI Congress Takeaways Oncologists shared key abstracts and takeaways from the 2025 ESMO Gastrointestinal Cancers Congress, with implications extending into pipeline development for 2026. GI oncology remains a hotbed of novel drug development activity, with several compounds expected to advance toward pivotal trials on the basis of congress data.

AI as Drug Discovery Partner in 2026 A Forbes Technology Council analysis published March 30, 2026 argues that 2026 marks a turning point: AI is transitioning from a data-processing tool to a genuine partner in drug development. With patient safety, regulatory approval, and real-world effectiveness all on the line, the piece cautions that AI cannot act autonomously — but as a collaborative co-pilot, it is reshaping compound screening, biomarker identification, and clinical trial design.

What to Watch Next Week

1. Merck / Terns Pharma (~$6B) — Deal Confirmation: An official announcement is expected imminently following the FT report. Watch for formal terms, an expected close timeline, and analyst commentary on strategic rationale and pipeline fit.

2. April 2026 FDA PDUFA Actions: Multiple decisions are due in April 2026 for treatments targeting Alzheimer disease agitation, focal segmental glomerulosclerosis, hematological malignancies, HIV-1, and obesity — any one of which could move markets and reshape competitive dynamics.

3. IMUNON Phase 3 Enrollment/Milestones (IMNN-001): With pivotal Phase 3 progress reported and promising Phase 2 OS data in advanced ovarian cancer, the company's next clinical milestones and any interim data updates will be closely monitored by investors and the oncology community.

4. Q1 2026 Biotech Earnings Season Kicks Off: With Q1 2026 wrapping up today, biotech and pharma companies will begin reporting financial results and updated pipeline guidance over the next two weeks. Average licensing deal size up 76% YoY signals a robust capital environment heading into the season.