---
title: "Biotech Stocks Facing FDA Decision In September 2026"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/297065559.md"
description: "Biotech stocks face critical FDA decisions in September 2026. The regulatory calendar covers diverse conditions including brain cancer, rare diseases like Sanfilippo syndrome and spinal muscular atrophy, and others. This follows August approvals such as Takeda's narcolepsy drug, Aletta robotic blood-drawing device, Ultragenyx's glycogen storage disease therapy, and Abbott's dual glucose-ketone monitor."
datetime: "2026-08-26T15:16:46.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/297065559.md)
  - [en](https://longbridge.com/en/news/297065559.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/297065559.md)
generator: "portal-rs"
---

# Biotech Stocks Facing FDA Decision In September 2026

Add  as your preferred news source on Google

 Add Now

As September ushers in the first hints of autumn, it also brings a packed FDA regulatory calendar.

But before we turn the page to September, here's what happened on the regulatory front in August - a month marked by several notable firsts. 

On August 5, 2026, the FDA approved Takeda Pharmaceutical's (TAK) Orzeyful tablets for the treatment of narcolepsy type 1 in adults, making it the first and only medicine to directly target the underlying cause of the disorder.

On August 19, the FDA authorized Aletta, the first standalone robotic device capable of drawing blood from a patient's arm without hands-on operator intervention - a development aimed at easing the growing shortage of phlebotomists.

The same day, Ultragenyx Pharmaceutical's Genglycos received accelerated FDA approval, becoming the first therapy approved for patients aged 8 years and older with glycogen storage disease type Ia.

And on August 25, the FDA authorized Abbott Diabetes Care's Libre Duo 10 Day, the first wearable device designed to continuously monitor both ketone levels and blood glucose, potentially helping people with diabetes identify warning signs of a serious complication before it develops into a medical emergency.

Now, let's take a look at the companies awaiting FDA decisions in September. 

For comments and feedback contact: editorial@rttnews.com

Business News

### Related Stocks

- [ABT.US](https://longbridge.com/en/quote/ABT.US.md)
- [RARE.US](https://longbridge.com/en/quote/RARE.US.md)
- [TAK.US](https://longbridge.com/en/quote/TAK.US.md)
- [BBH.US](https://longbridge.com/en/quote/BBH.US.md)
- [LABD.US](https://longbridge.com/en/quote/LABD.US.md)
- [4502.JP](https://longbridge.com/en/quote/4502.JP.md)

## Related News & Research

- [Ultragenyx to weigh ‘significant’ cost cuts as Angelman drug fails key study](https://longbridge.com/en/news/298117874.md)
- [Abbott receives FDA approval for its TactiFlex™ Duo Ablation Catheter to treat people with abnormal heart rhythms](https://longbridge.com/en/news/298316210.md)
- [Roche Holding (SWX:ROP) Gets Phase III Win And FDA Priority Review For Two Drugs](https://longbridge.com/en/news/298826245.md)
- [IFP Advisors Inc Grows Stock Holdings in Abbott Laboratories $ABT](https://longbridge.com/en/news/298421693.md)
- [09:28 ETNew LabCentral Program "The Loop" Offers International Biotech Start-Ups and Partner Organizations Curated Learnings Directly from U.S. Market](https://longbridge.com/en/news/298328140.md)

---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**