The HCPFive: Top News for Healthcare Providers from the Week of 02/08

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 Administrations’ acceptance of a New Drug Application from Takeda for oveporexton in narcolepsy type 1 and issuance of a Complete Response Letter for Disc Medicine’s bitopertin as a treatment for erythropoietic protoporphyria as well as phase 2 data for ribupatide in obesity, phase 2 data for verekitug in severe asthma, and phase 3 data for oral infigratinib in children living with achondroplasia.

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 February 08, 2026—let’s jump in!

FDA Accepts NDA, Grants Priority Review for Oveporexton to Treat Narcolepsy Type 1

On February 10, 2026, Takeda announced that the FDA accepted the Company’s New Drug Application (NDA) and granted Priority Review to oveporexton (TAK-861) for the treatment of narcolepsy type 1. The investigational oral orexin receptor (OX2R)-selective agonist addresses the underlying orexin deficiency that causes narcolepsy type 1 by restoring orexin signaling.

The FDA assigned oveporexton a Prescription Drug User Fee Act (PDUFA) target date in the third quarter of 2026.

FDA Issues Complete Response Letter to Bitopertin For Erythropoietic Protoporphyria

On February 13, 2026, the FDA issued a Complete Response Letter for the New Drug Application (NDA) of Disc Medicine’s bitopertin as a treatment for patients with erythropoietic protoporphyria. The Agency acknowledged sufficient evidence of reduced whole blood metal-free protoporphyrin IX (PPIX) from the AURORA and BEACON trials, but stated a need to see results of the ongoing phase 3 APOLLO study before bitopertin receives approval. The trial began enrollment in March 2025 and has an estimated completion timeline of October 2026.

Ribupatide, An Oral Dual GLP-1/GIP, Achieves Weight Loss in Phase 2 Obesity Trial

On February 10, 2026, Hengrui Pharma and Kailera Therapeutics announced positive topline data from Hengrui’s phase 2 clinical trial of once-daily oral ribupatide (HRS9531 tablet; KAI-9531-T), a GLP-1/GIP receptor dual agonist peptide, in adults living with obesity in China.

Results showed participants receiving oral ribupatide demonstrated a mean weight reduction from baseline of up to 12.1% at 26 weeks based on the efficacy estimand with no observed plateau in weight loss, and vomiting was reported in ≤ 11.4% of participants taking oral ribupatide.

VALIANT: Verekitug Reduces Average Annual Asthma Flare-Ups in Phase 2 Trial

On February 11, 2026, Upstream Bio announced positive topline results from the phase 2 VALIANT clinical trial evaluating the safety and efficacy of verekitug in adults with severe asthma. Results showed VALIANT met the study’s primary endpoint of a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) with both every 12 week (q12w) and every 24 week (q24w) dosing, with verekitug demonstrating a reduction in AAER of 56% (P <.0003) when dosed at 100 mg q12w and 39% (P<.02) when dosed at 400 mg q24w, as compared with placebo.

Oral Infigratinib Meets Annualized Height Velocity Endpoint in Phase 3 Achondroplasia Trial

On February 12, 2026, BridgeBio Pharma announced positive topline results from PROPEL 3, a global phase 3 study of oral infigratinib in children living with achondroplasia, showing it met the primary endpoint of change from baseline in annualized height velocity (AHV) at week 52 (P <.0001).1

Based on these data, FDA NDA and Marketing Authorization Application (MAA) submissions are planned in the second half of 2026 for achondroplasia. Additionally, given the strength of the PROPEL 3 data, BridgeBio described plans to accelerate the development of oral infigratinib in hypochondroplasia, and is enrolling the observational run-in for the phase 3 trial.