Breaking News
Get 40% Off 0
Is NVDA a 🟢 buy or 🔴 sell? Unlock Now

FDA Fast Tracks BioXcel's BXCL701 for SCNC Treatment

Published Feb 12, 2024 23:24
Saved. See Saved Items.
This article has already been saved in your Saved Items
© Reuters.
Add to/Remove from a Portfolio
Add to Watchlist
Add Position

Position added successfully to:

Please name your holdings portfolio

NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for BXCL701, an investigational treatment for metastatic small cell neuroendocrine prostate cancer (SCNC), the company announced Monday. The FDA's Fast Track program aims to accelerate the development and review of drugs intended to treat serious conditions and fill unmet medical needs.

BXCL701, an oral innate immune activator, is designed to stimulate inflammation within the tumor microenvironment and enhance the activity of checkpoint inhibitors (CPIs). This designation follows promising clinical trial results for BXCL701 in treating SCNC, a subtype of prostate cancer with limited treatment options and poor prognosis.

The American Cancer Society estimates that in 2024, approximately 299,010 men will be diagnosed with prostate cancer in the U.S., and about 20% are expected to advance to a more aggressive metastatic form. SCNC accounts for an estimated 11,960 of these cases. The Fast Track status acknowledges BXCL701's potential to meet the significant need for new treatments in this patient population.

BioXcel Therapeutics plans to discuss the registration path for BXCL701 with the FDA in an upcoming meeting. The drug has already shown clinical proof of concept in SCNC and adenocarcinoma, with positive survival results from a Phase 2 trial reported at the end of last year.

The company's subsidiary, OnkosXcel Therapeutics, is also exploring strategic options in light of this development. BXCL701 has also received Orphan Drug Designation from the FDA for several indications, including SCNC, acute myelogenous leukemia, pancreatic cancer, melanoma, and soft tissue sarcoma.

BioXcel Therapeutics leverages artificial intelligence in its drug re-innovation approach, using approved drugs and clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications.

This news is based on a press release statement from BioXcel Therapeutics. The company's approach and the FDA's recognition may offer new hope for patients with aggressive forms of prostate cancer. However, as BXCL701 is still investigational, its efficacy and safety must be established in further clinical trials before it becomes available for widespread clinical use.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

FDA Fast Tracks BioXcel's BXCL701 for SCNC Treatment

Related Articles

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind: 

  • Enrich the conversation
  • Stay focused and on track. Only post material that’s relevant to the topic being discussed.
  • Be respectful. Even negative opinions can be framed positively and diplomatically.
  •  Use standard writing style. Include punctuation and upper and lower cases.
  • NOTE: Spam and/or promotional messages and links within a comment will be removed
  • Avoid profanity, slander or personal attacks directed at an author or another user.
  • Don’t Monopolize the Conversation. We appreciate passion and conviction, but we also believe strongly in giving everyone a chance to air their thoughts. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at’s discretion.

Write your thoughts here
Are you sure you want to delete this chart?
Post also to:
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
Are you sure you want to delete this chart?
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Continue with Google
Sign up with Email