---
title: "AstraZeneca breast cancer pill fails pivotal trial; Scholar Rock wins FDA approval for SMA muscle-"
id: "stat-news-1-stat-pharmalittle-we-re-reading-about-another-astrazeneca-trial-failure-a-novo"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-1-stat-pharmalittle-we-re-reading-about-another-astrazeneca-trial-failure-a-novo"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "STAT News"
source_url: "https://www.statnews.com/pharmalot/2026/09/14/another-astrazeneca-trial-failure-novo-name-change/?utm_campaign=rss"
published_at: "2026-09-14T13:07:51.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# AstraZeneca breast cancer pill fails pivotal trial; Scholar Rock wins FDA approval for SMA muscle-
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-1-stat-pharmalittle-we-re-reading-about-another-astrazeneca-trial-failure-a-novo
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/pharmalot/2026/09/14/another-astrazeneca-trial-failure-novo-name-change/?utm_campaign=rss)
- **Published At:** 2026-09-14T13:07:51.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- AstraZeneca reported that its oral breast cancer agent **camizestrant** failed a pivotal first-line trial in advanced disease, where the combination regimen did not beat the standard therapy on a key measure of time until disease progression. The company had won **accelerated approval** earlier in the month for a narrower indication tied to a tumor mutation associated with resistance. - The failed pivotal study could constrain the overall use and commercial opportunity of camizestrant because a positive result might have expanded the drug into a larger first-line market; the source states the trial did not reach that goal. - **Scholar Rock** received U.S. **FDA** approval for **Isembyld**, described as the first therapy that specifically targets the loss of muscle in **spinal muscular atrophy (SMA)**. The approval covers adults and children aged 2 years and older who are already receiving SMA therapies that target **SMN2**. - The approval of Isembyld is framed as an advance for patients with a rare, progressive neurological disease that destroys motor neurons controlling movement, speaking, and breathing; untreated infants typically die by age 2, underscoring the severity of SMA. - The article references a potential **Novo** company name or branding change as an item of interest, noting coverage elsewhere on the site. - This Pharmalittle column is a STAT+ item; parts of the story are exclusive to STAT+ subscribers and the full article requires subscription access. The piece is authored by Ed Silverman and dated Sept. 14, 2026. - The column mixes brief industry updates and links to full STAT reporting: coverage of the camizestrant trial result links to a separate STAT story, and the Scholar Rock FDA approval is linked to a dedicated report with trial and approval context.
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [STAT Plus](https://www.statnews.com/stat-plus/)Newsletter[Pharmalot](https://www.statnews.com/category/pharma/pharmalot/) # Pharmalittle: We’re reading about another AstraZeneca trial failure, a Novo name change, and more ## Scholar Rock won approval for the first therapy to target muscle loss in spinal muscle atrophy * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * Email this article * [Share this article](https://www.statnews.com/pharmalot/2026/09/14/another-astrazeneca-trial-failure-novo-name-change/?utm_campaign=rss) ![an anthropomorphized red and blue pill illustrated in the style of the famous american gothic painting](https://www.statnews.com/wp-content/uploads/2015/11/PHARMALOT_LITTLE-copy-645x645.jpg) Alex Hogan/STAT ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) By [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) Sept. 14, 2026 Pharmalot Columnist, Senior Writer ![](https://www.statnews.com/wp-content/uploads/2021/02/ed-s-avatar-small4-80x80.png) [Ed Silverman](https://www.statnews.com/staff/ed-silverman/) 1. [](https://www.linkedin.com/in/edsilverman/ "Linkedin") 2. [](https://x.com/Pharmalot "X") ed.silverman@statnews.com Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning [Pharmalittle newsletter](https://www.statnews.com/signup/pharmalittle/) and the afternoon [Pharmalot newsletter](https://www.statnews.com/signup/pharmalot/). Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is blueberry hibiscus. Feel free to join us. Remember, no prescription or prior authorization is required. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. … **AstraZeneca disclosed that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors, a result that could limit the use of the medicine** , [STAT](https://www.statnews.com/2026/09/12/astrazeneca-breast-cancer-camizestrant-etcamah-serena-4-trail-failure/) notes. The drug, camizestrant, in combination with another medicine did not outperform standard treatment on a measure of how long patients went before their cancer progressed. The drug earlier this month won accelerated approval[ ](https://www.statnews.com/2026/09/08/biotech-news-fda-approves-astrazeneca-breast-cancer-drug/)in the U.S. as a treatment for patients who develop a mutation in their tumors that’s a sign of emerging drug resistance. Had the trial been successful, it could have opened up a much larger market for the drug. Advertisement **Scholar Rock received U.S. Food and Drug Administration approval for the first-ever therapy that targets the loss of muscle in spinal muscle atrophy, raising hopes that patients with the rare neurological disorder might have a better chance of moving and walking independently** , [STAT](https://www.statnews.com/2026/09/11/scholar-rock-spinal-muscular-atrophy-isembyld-clinical-trial-fda-approval/) writes. The FDA approved the drug, Isembyld, for use in adults and children 2 years and older who are currently receiving SMA therapies that target SMN2, a key gene for neurons that control movement. The approval marks another step forward for patients with spinal muscular atrophy, a rare and progressive disease that destroys nerve cells that control speaking, breathing, and walking. Babies who go untreated usually die by the age of 2. 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[](https://www.linkedin.com/in/edsilverman/ "Linkedin") Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning [Pharmalittle newsletter](https://www.statnews.com/signup/pharmalittle/) and the afternoon [Pharmalot newsletter](https://www.statnews.com/signup/pharmalot/). ![](https://www.statnews.com/wp-content/themes/stat/images/article-new/envelope-open.svg) ![](https://www.statnews.com/wp-content/uploads/2023/06/Morning-Rounds-Logo-Black-640x295.png) ### Newsletter Understand how science, health policy, and medicine shape the world every day Please enter a valid email address. Sign Up Your data will be processed in accordance with our [Privacy Policy](https://www.statnews.com/privacy/) and [Terms of Service](https://www.statnews.com/terms-conditions/). You may opt out of receiving STAT communications at any time. 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