---
title: "Wall Street Analysts: 503A Peptide Drugs Still Have a Chance of Approval!"
type: "Topics"
locale: "en"
url: "https://longbridge.com/en/topics/42352620.md"
description: "Needham 分析师 Ryan MacDonald 表示，FDA 工作人员此前提出的建议 “确实有些出乎意料”，但这并不意味着最终被否决。他在 Hims 投资者社区中表示：“这并不是这件事的终点。” 他补充称，虽然目前获批概率可能略有下降，但他仍然认为最终会获得批准..."
datetime: "2026-07-01T15:13:50.000Z"
locales:
  - [en](https://longbridge.com/en/topics/42352620.md)
  - [zh-CN](https://longbridge.com/zh-CN/topics/42352620.md)
  - [zh-HK](https://longbridge.com/zh-HK/topics/42352620.md)
author: "[ST欧阳昆汀(被困Hims版)](https://longbridge.com/en/profiles/4868421.md)"
---

# Wall Street Analysts: 503A Peptide Drugs Still Have a Chance of Approval!

Needham analyst Ryan MacDonald stated that the suggestions previously put forward by FDA staff were "indeed somewhat unexpected," but this does not mean it will ultimately be rejected.

He said in the Hims investor community, "This is not the end of the story." He added that although the probability of approval may have slightly decreased at present, he still believes it will ultimately be approved.

MacDonald further explained: The FDA Advisory Committee still needs to review the relevant evidence; listen to the opinions of various stakeholders; and form a formal recommendation before the FDA makes its final decision.

He also pointed out: The final decision-making authority still lies with the FDA management, but the U.S. Department of Health and Human Services (HHS) is responsible for overseeing the FDA; and the U.S. Secretary of Health, Robert F. Kennedy Jr. (RFK Jr.), has been publicly supportive of relaxing (deregulating) policies related to peptide drugs.

In a nutshell: Needham's view is relatively optimistic: although the opinions previously given by FDA staff have increased uncertainty, the entire approval process is not over yet, and the final decision on approval still rests with the FDA management. The analyst still believes there is a high likelihood of the peptide drug ultimately being approved, just that the probability of success has slightly decreased compared to before.$Hims & Hers Health(HIMS.US) $HIMS 2X Long ETF(HIMZ.US)

### Related Stocks

- [HIMZ.US](https://longbridge.com/en/quote/HIMZ.US.md)
- [HIMS.US](https://longbridge.com/en/quote/HIMS.US.md)

## Comments (3)

- **初次驾血 · 2026-07-01T16:03:39.000Z**: I sold it the day before yesterday and then it took off
  - **ST欧阳昆汀(被困Hims版)** (2026-07-01T16:14:06.000Z): What should we do then?
  - **初次驾血** (2026-07-01T16:26:33.000Z): This stock is destined not to let me make money