The HCPFive: Top News for Healthcare Providers from the Week of 06/21

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know — whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration’s Complete Response Letter (CRL) for cytisinicline for treating nicotine dependence, phase 3 data for tulisokibart in ulcerative colitis, phase 2 data for CX11 in obesity/overweight, the FDA approval of olezarsen (Tryngolza) for severe hypertriglyceridemia, and a 5-part special report recapping Obesity Medicine Association (OMA) news and updates.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here's your quick dive into the top stories for the week of June 21, 2026 — let's jump in!

FDA Issues CRL for Cytisinicline NDA for Smoking Cessation

On June 22, 2026, the FDA issued a CRL to Achieve Life Sciences’ New Drug Application for cytisinicline as a treatment for nicotine dependence, citing manufacturing-related observations from an FDA current good manufacturing practice inspection of a third-party facility and incomplete final product labeling by the action date. Of note, no clinical efficacy or safety deficiencies were identified by the Agency.

Achieve said it had already partnered with US-based Adare Pharma Solutions as its new primary commercial manufacturing partner.

Tulisokibart Meets Phase 3 Endpoints in Ulcerative Colitis, First for Anti-TL1A

On June 22, 2026, Merck announced topline results from the phase 3 ATLAS-UC induction-only study of tulisokibart (MK-7240) in patients with moderately to severely active UC, making it the first anti-TL1A monoclonal antibody to demonstrate clinical remission at week 12 in a phase 3 trial for this indication. In addition to meeting its primary endpoint, tulisokibart achieved key secondary endpoints and demonstrated a safety profile consistent with previous phase 2 studies.

CX11 Shows Weight Loss in Phase 2 Obesity Trial, Corxel Reports

On June 23, 2026, Corxel Pharmaceuticals reported positive topline findings from a phase 2 trial of CX11 in adults with obesity or overweight with ≥1 weight-related comorbidity. The Company said the trial met its primary endpoints and reported weight loss of up to 11.5% at 36 weeks.

“We are delighted with these positive U.S. Phase 2 results, which are consistent with the competitive profile established in the China Phase 3 program,” Bo Liang, MD, PhD, chief medical officer of Corxel, said in a statement. “Together, these datasets reinforce our confidence in CX11 and our conviction to offer patients around the world an effective and highly tolerable option with dosing flexibility.”

FDA Approves Olezarsen (Tryngolza) for Severe Hypertriglyceridemia

On June 24, 2026, the FDA approved olezarsen (Tryngolza; Ionis Pharmaceuticals) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG; triglycerides ≥500 mg/dL). The approval, which arrived ahead of the June 30, 2026 PDUFA date, makes olezarsen the first therapy approved specifically to reduce acute pancreatitis risk in sHTG.

Advancements and Insights from the Obesity Medicine Association Conference 2026

In this 5-part series, Raghuveer Vedala, MD, and Shagun Bindlish, MD, discuss the most impactful news from and key clinician insights on the Obesity Medicine Association (OMA) Annual Conference 2026, including stigmatization, pharmacotherapy updates, the expanding reach of GLP-1s, and more.