Provention Bio Reiterates Regulatory Strategy for PRV-031 and Announces Completion of Follow-on Fina | Biotech Message Board Posts

Biotech   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  28309 of 28585  at  9/24/2019 7:15:59 AM  by

CHM_760


 In response to msg 28301 by  CHM_760
view thread

Provention Bio Reiterates Regulatory Strategy for PRV-031 and Announces Completion of Follow-on Financing

  Provention Bio Reiterates Regulatory Strategy for PRV-031 and Announces Completion of Follow-on Financing
 
 
- FDA Meeting Expected in Q4 2019 and BLA Submission for PRV-031 (teplizumab) Targeted for Q4 2020 -
- Total Net Proceeds of $62.7 million from Recent Offerings, Together with Current Cash Position, Expected to Fund Operations for Two Years -

PR Newswire

OLDWICK, N.J., Sept. 24, 2019

OLDWICK, N.J., Sept. 24, 2019 /PRNewswire/ -- Provention Bio, Inc., (Nasdaq: PRVB), a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today reiterated its regulatory strategy regarding PRV-031 (teplizumab) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. Based on written communications from the U.S. Food and Drug Administration (FDA) and FDA's designation of PRV-031 as a breakthrough therapy, the Company believes that existing clinical and non-clinical data for PRV-031 will be sufficient to support a Biologics License Application (BLA) submission for PRV-031 in the fourth quarter of 2020 for the at-risk indication.  The Company expects to meet with the FDA in the fourth quarter of 2019 to discuss this expedited development plan.

(PRNewsfoto/Provention Bio, Inc.)

"Our interactions with the FDA in connection with the 'At Risk' study of PRV-031 (teplizumab) provide us with the confidence to submit a regulatory filing by the end of 2020," stated Ashleigh Palmer, CEO of Provention Bio. "The proceeds from our financing will allow us to execute on our development plans as we work closely with the FDA to bring teplizumab to individuals at-risk of developing clinical T1D."

In the second quarter of 2019, the Company exchanged correspondence with the FDA regarding the regulatory path forward for PRV-031 for the prevention or delay of clinical T1D in individuals at-risk for developing the disease.  Specifically, the FDA:

    Agreed, in principle, that the results from the "At-Risk" study, together with supportive data from prior PRV-031 studies in early onset T1D, may be sufficient for a BLA submission.
    Agreed that the safety database from the "At Risk" study and prior clinical studies in patients with early onset T1D appears adequate to support review of a BLA.
    Agreed that the current non-clinical package for PRV-031 is adequate to support the At-Risk indication.

In a later letter granting Breakthrough Therapy Designation (BTD), the FDA asked the Company to meet for a multidisciplinary, comprehensive discussion of the Company's PRV-031 program, including plans for expediting the manufacturing development strategy.

In connection with the Company's follow-on financing and private placement announced last week, the Company generated total net proceeds of $62.7 million.  The net proceeds reflect an underwritten public offering of 5,750,000 shares of common stock at a price of $8.00 per share, including the full exercise of the over-allotment option, as well as the issuance of 2,500,000 shares of common stock at a price of $8.00 per share in a private placement with Amgen, Inc.

The net proceeds from the financing, together with its current cash position, are expected to fund the Company's operations for two years.


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 2     Views: 95
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board

Replies
Msg # Subject Author Recs Date Posted
28333 Re: Provention Bio (PRVB) - CHM_760 3 9/26/2019 6:29:57 PM


About Us  •  Contact Us  •  Follow Us on Twitter  •  Members Directory  •  Help Center  •  Advertise
Not a member yet? What are you waiting for? Create Account
Want to contribute? Support InvestorVillage by donating
© 2003-2019 Investorvillage.com. All rights reserved. User Agreement
   
Financial Market Data provided by
.


Loading...