The HCPFive: Top News for Healthcare Providers from the Week of 07/06

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 approval of sebetralstat (Ekterly) for hereditary angioedema (HAE), topline phase 2 data for rilparencel in patients with chronic kidney disease (CKD) and diabetes, a supplemental New Drug Application (sNDA) submission for lumateperone (Caplyta) for schizophrenia relapse prevention, the FDA’s public release of > 200 CRLs issued from 2020-2024, and a Breakthrough Therapy designation for TSND-201 (methylone) for the treatment of PTSD.

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 July 06, 2025—let’s jump in!

Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema

On July 7, 2025, the FDA approved KalVista Pharmaceuticals’ sebetralstat (Ekterly), the first and only oral, on-demand therapy for the treatment of acute attacks of HAE in adult and pediatric patients ≥ 12 years of age. The decision was supported by data from the phase 3 KONFIDENT and KONFIDENT-S open-label extension trials.

Rilparencel Improves eGFR Slope in Phase 2 CKD, Diabetes REGEN-007 Trial

ProKidney Corp announced statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (mITT) population of the phase 2 REGEN-007 trial evaluating rilparencel in patients with CKD and diabetes.

The data showed annual estimated glomerular filtration rate (eGFR) slope decline improvement in patients who received 2 scheduled rilparencel injections, 1 in each kidney, approximately 3 months apart. Notably, evidence of a dose response was also observed in a second group of patients who received a single rilparencel injection followed by a second injection only if kidney function worsened and a re-dosing trigger was met.

J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse

On July 8, 2025, Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for lumateperone (Caplyta) to prevent schizophrenia relapse based on long-term phase 3 data showing treatment with lumateperone led to a 63% reduction in the risk of relapse in adults with schizophrenia compared to placebo.

FDA Publishes CRLs for Past Drug, Biological Product Applications

On July 10, 2025, the FDA announced the public release of > 200 Complete Response Letters (CRLs) issued in response to applications submitted to the Agency for approval of drugs or biological products between 2020 and 2024. The initial batch of published decision letters are associated with since-approved applications.

“For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary, MD, MPH, said in a statement. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

FDA Grants TSND-201 Breakthrough Therapy Designation for PTSD

On July 10, 2025, Transcend Therapeutics announced the FDA granted TSND-201 (methylone) Breakthrough Therapy designation for the treatment of PTSD. TSND-201, a rapid-acting neuropathogen, is a proprietary formulation of methylone. Its primary site of action is at the monoamine transporters, with no activity at 5HT-2a (thus not hallucinogenic).

“A rapid-acting, durable treatment for PTSD would be a paradigm shift in psychiatry—and offer a potential lifeline for patients," said Murray B. Stein, MD, MPH, distinguished professor of psychiatry and public health at the University of California San Diego and a consultant to Transcend. "The current treatment standard, SSRIs, can take up to 12 weeks to show maximal effect and often cause side effects during that time. Even then, many patients on SSRIs don't get adequate benefit. This designation offers new hope that faster, more effective treatment may be within reach."