FDA Approval for TZIELD issued to PROVENTION BIO INC

11/21/22 12:03:06 AM ET

$PRVB

Biotechnology: Pharmaceutical Preparations

Health Care

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Biologic License Application (BLA): 761183
Company: PROVENTION BIO INC

Products on BLA 761183

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TZIELD	TEPLIZUMAB-MZWV	2MG/2ML(1MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2022	ORIG-1	Approval		N/A		Label is not available on this site.

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Recent Analyst Ratings for
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Date	Price Target	Rating	Analyst
9/20/2022	$10.00	Buy	Jefferies
11/23/2021		Neutral → Outperform	SMBC Nikko
8/6/2021	$18.00 → $16.00	Outperform	Oppenheimer
8/6/2021	$27.00 → $25.00	Buy	HC Wainwright & Co.

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Market Insights

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Sanofi Announced Earlier: Hart-Scott-Rodino Waiting Period Expired For Sanofi's Acquisition Of Provention Bio
Sanofi announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), applicable to Sanofi's proposed acquisition of Provention Bio, Inc. (("Provention Bio", NASDAQ:PRVB) has expired.
4/26/23 4:49:00 AM ET
$PRVB
$SNY
Biotechnology: Pharmaceutical Preparations
Health Care
Sanofi's $3B Acquisition Of Provention Bio Hits Regulatory Roadblock: FTC Requests More Information
Sanofi SA (NASDAQ:SNY) withdrew and refiled the Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act “following informal discussions with the staff of the” Federal Trade Commission (FTC) regarding the acquisition of Provention Bio Inc (NASDAQ:PRVB). Sanofi agreed to acquire Provention Bio at $25 per share in a deal valued at $2.9 billion. The agency, it added, needed more time to look at the deal and “information recently provided to them,” Sanofi said in an SEC filing. In its disclosure, Sanofi added that “withdrawing and refiling premerger notifications is a standard procedure to provide additional time for antitrust review of certain transac
4/11/23 2:14:29 PM ET
$PRVB
$SNY
Biotechnology: Pharmaceutical Preparations
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Sanofi Announces Withdrawal, Refiling Of Premerger Notification And Report Form Under HSR Act And Extension Of Tender Offer To Acquire Provention Bio
Sanofi announced today that it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), in connection with Sanofi’s pending acquisition of Provention Bio, Inc. As previously announced on March 24, 2023, Sanofi commenced a cash tender offer to purchase all outstanding shares of common stock of Provention Bio, Inc. (the “Shares”), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law. Sanofi has elected to withdraw and refile its Premerger Notification and Report Form, which was initially filed on March 24, 2023,
4/10/23 4:19:35 PM ET
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Biotechnology: Pharmaceutical Preparations
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Leadership Updates

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Provention Bio Announces Appointment of Rita Jain, M.D., to Board of Directors
RED BANK, N.J., Jan. 5, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the appointment of Rita Jain, M.D., to the Company's Board of Directors. Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, Inc., AbbVie, Abbott Laboratories, and G.D. Searle and Co. prior to the latter's merger with Pharmacia & Upjohn and subsequent acquisition by Pfizer. "
1/5/23 4:01:00 PM ET
$PRVB
Biotechnology: Pharmaceutical Preparations
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Provention Bio Appoints Jan Hillson, M.D., as Senior Vice President of Clinical Development
RED BANK, N.J., Nov. 17, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the appointment of Jan Hillson, M.D., as Senior Vice President of Clinical Development. Dr. Hillson bolsters the Company's clinical development leadership group with significant experience in all phases of clinical development across various autoimmune disorders, including systemic lupus erythematosus, which is the lead target indication for PRV-3279, a DART® (bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B.
11/17/21 7:30:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Provention Bio Appoints Miguel Sanjuan, Ph.D. as Senior Vice President of Research and Early Development
RED BANK, N.J., Nov. 5, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the appointment of Miguel Sanjuan, Ph.D. as Senior Vice President of Research and Early Development. Dr. Sanjuan further strengthens the Company's internal expertise in the core areas of immunomodulatory therapy, translational medicine and autoimmune disease. "As we continue to grow as an organization pioneering early interception and prevention of debilitating and life-threatening autoimm
11/5/21 4:30:00 PM ET
$PRVB
Biotechnology: Pharmaceutical Preparations
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Financials

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Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call
RED BANK, N.J., March 13, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced it has cancelled the release of its fourth quarter and full year financial results for the period ended December 31, 2022 due to the announcement earlier today that Provention has entered into a definitive agreement to be acquired by Sanofi, Provention's U.S. TZIELD co-promotion partner, subject to customary regulatory and other closing conditions. In addition, Provention will no longer hold its fourth quarter and full year results conference call that had been scheduled for 8:00 am E.T. Thursday, Marc
3/13/23 7:00:00 AM ET
$PRVB
Biotechnology: Pharmaceutical Preparations
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Provention Bio to Report Fourth Quarter and Full Year 2022 Financial Results on March 16, 2023
RED BANK, N.J., Feb. 23, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it will report its fourth quarter and full year 2022 financial results on Thursday, March 16, 2023, before the opening of the U.S. financial markets. Subsequently, at 8:00 am E.T., the company will host a conference call to discuss its financial results and provide a corporate update. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (intern
2/23/23 8:30:00 AM ET
$PRVB
Biotechnology: Pharmaceutical Preparations
Health Care
TZIELD™ (teplizumab-mzwv) approved by FDA as the first and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D
TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune diseaseIn a clinical trial, in Stage 2 T1D patients, TZIELD delayed the median onset of Stage 3 T1D by 25 months, or approximately 2 years, compared to placeboStage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threateningPatients who progress to Stage 3 T1D eventually require insulin injections for lifeInvestor Conference call at 8:00am ET tomorrowRED BANK, N.J., Nov. 17, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced
11/17/22 5:45:00 PM ET
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Biotechnology: Pharmaceutical Preparations
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Press Releases

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Press Release: Hart-Scott-Rodino waiting period expires for Sanofi's acquisition of Provention Bio, Inc.
Hart-Scott-Rodino waiting period expires for Sanofi's acquisition of Provention Bio, Inc. Paris, France – April 26, 2023 – Sanofi announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), applicable to Sanofi's proposed acquisition of Provention Bio, Inc. (("Provention Bio", NASDAQ:PRVB) has expired. On March 24, 2023, Sanofi commenced a cash tender offer (the "Offer") to purchase all outstanding shares of common stock of Provention Bio (the "Shares"), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law. As a result of the expiration of
4/26/23 2:00:00 AM ET
$PRVB
Biotechnology: Pharmaceutical Preparations
Health Care
Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call
RED BANK, N.J., March 13, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced it has cancelled the release of its fourth quarter and full year financial results for the period ended December 31, 2022 due to the announcement earlier today that Provention has entered into a definitive agreement to be acquired by Sanofi, Provention's U.S. TZIELD co-promotion partner, subject to customary regulatory and other closing conditions. In addition, Provention will no longer hold its fourth quarter and full year results conference call that had been scheduled for 8:00 am E.T. Thursday, Marc
3/13/23 7:00:00 AM ET
$PRVB
Biotechnology: Pharmaceutical Preparations
Health Care
Provention Bio Announces the Grant of Inducement Awards
RED BANK, N.J., March 3, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the Company granted stock options to a new non-executive employee to purchase an aggregate of 10,000 shares of common stock. The stock options were granted without stockholder approval as inducements, material to the new non-executive employee entering into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4) and were approved by the Company's compensation committee of the board of directors.
3/3/23 4:05:00 PM ET
$PRVB
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for TZIELD issued to PROVENTION BIO INC

Products on BLA 761183

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761183

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $PRVB

$PRVB Insider Trading

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SEC Form 4 filed by Sessa Capital (Master), L.P.

SEC Form 4 filed by Wysenski Nancy

SEC Form 4 filed by Pisano Wayne

$PRVB FDA approvals

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FDA Approval for TZIELD issued to PROVENTION BIO INC

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Jefferies initiated coverage on Provention Bio with a new price target

Provention Bio upgraded by SMBC Nikko

Oppenheimer reiterated coverage on Provention Bio with a new price target

$PRVB Market Insights

Live Market Insights

Sanofi Announced Earlier: Hart-Scott-Rodino Waiting Period Expired For Sanofi's Acquisition Of Provention Bio

Sanofi's $3B Acquisition Of Provention Bio Hits Regulatory Roadblock: FTC Requests More Information

Sanofi Announces Withdrawal, Refiling Of Premerger Notification And Report Form Under HSR Act And Extension Of Tender Offer To Acquire Provention Bio

$PRVB Leadership Updates

Live Leadership Updates

Provention Bio Announces Appointment of Rita Jain, M.D., to Board of Directors

Provention Bio Appoints Jan Hillson, M.D., as Senior Vice President of Clinical Development

Provention Bio Appoints Miguel Sanjuan, Ph.D. as Senior Vice President of Research and Early Development

$PRVB Financials

Live finance-specific insights

Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call

Provention Bio to Report Fourth Quarter and Full Year 2022 Financial Results on March 16, 2023

TZIELD™ (teplizumab-mzwv) approved by FDA as the first and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D

$PRVB Press Releases

Fastest customizable press release news feed in the world

Press Release: Hart-Scott-Rodino waiting period expires for Sanofi's acquisition of Provention Bio, Inc.

Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call

Provention Bio Announces the Grant of Inducement Awards

$PRVB SEC Filings

SEC Form 15-12G filed by Provention Bio Inc.

SEC Form EFFECT filed by Provention Bio Inc.

SEC Form EFFECT filed by Provention Bio Inc.

$PRVB Large Ownership Changes

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SEC Form SC 13G/A filed by Provention Bio Inc. (Amendment)

SEC Form SC 13G/A filed by Provention Bio Inc. (Amendment)

SEC Form SC 13G filed by Provention Bio Inc.

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