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Provention Bio

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Namestring
Provention Bio
Company typeenum
Private
Founded yearint
2016
Descriptiontext

Provention Bio was a US-based, clinical- to commercial-stage biopharmaceutical company founded in 2016 and headquartered in Red Bank, New Jersey, that sourced, developed, and commercialized novel therapeutics targeting immune-mediated diseases. The company's stated focus areas included type 1 diabetes, celiac disease, and lupus, with the lead clinical asset being teplizumab, an anti-CD3 monoclonal antibody designed to delay the progression of type 1 diabetes by modulating the immune system's attack on insulin-producing pancreatic beta cells. Teplizumab was granted FDA approval in November 2022 as the first disease-modifying therapy for type 1 diabetes, and subsequently secured approvals in China and the United Kingdom, with a positive EU approval recommendation (branded as Teizeild in the EU). The technology platform was centered on proprietary anti-CD3 antibody biology, supported by issued patents covering methods for preventing or delaying T1D in at-risk non-diabetic subjects, including dosing regimens and immunological markers.

From a business model perspective, Provention Bio generated revenue (where present) primarily through prescription pharmaceutical product sales, with teplizumab (branded Tzield in the US) being the core commercial product following late-2022 FDA approval. The go-to-market motion relied on traditional specialty-pharma channels: physician-targeted detailing, medical science liaison outreach, peer-reviewed publication, and medical conference engagement with endocrinologists and other T1D-treating providers. Distribution post-launch leveraged specialty pharmacies, hospital systems, and retail pharmacy channels. Pre-acquisition, the company operated with 101–250 employees and had raised cumulative equity and debt of approximately $498.5 million across multiple financing rounds between 2017 and early 2023. In March 2023, Provention Bio was acquired by Sanofi for approximately $2.9 billion, after which commercial operations were integrated into Sanofi's global pharmaceutical distribution and sales infrastructure.

Short descriptiontext

Provention Bio was a US clinical- to commercial-stage biopharmaceutical company developing disease-modifying therapies for immune-mediated diseases, with teplizumab (Tzield) as the first FDA-approved treatment to delay progression of type 1 diabetes; acquired by Sanofi for $2.9B in March 2023.

Operating statusenum
Acquired
Ownership categoryenum
Headcount rangeband
101–250
akta.pro rankint
HeadquartersRed Bank, United States
HQ citystring
Red Bank
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
biopharmaceutical therapeutics, monoclonal antibody drugs, type 1 diabetes therapy, immune-mediated disease treatments, specialty pharmaceutical products
Industry3 codes
1Immunology & Autoimmune Specialty Pharmaceuticals
CodeHLAIACABPrimaryYes
2Immunology & Inflammation Pharmaceuticals
CodeHLAIAAADPrimaryNo
3Type 1 Diabetes Care
CodeHLAKADABPrimaryNo
NAICS code2 codes
  • Biological Product (except Diagnostic) Manufacturing325414
  • Pharmaceutical and Medicine Manufacturing3254
SIC code2 codes
  • Biological Products, (No Disgnostic Substances)2836
  • Pharmaceutical Preparations2834
Product category
Biopharmaceutical Therapeutics
Social media profiles2 records
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1Pharmaceutical product sales
TypeOne Time License
Description

Revenue generated from the sale of prescription pharmaceutical products, primarily teplizumab (branded as Tzield) for type 1 diabetes treatment. As a commercial-stage biopharmaceutical company, Provention Bio was focused on bringing disease-modifying therapies to market through traditional pharmaceutical commercialization.

openpr.com
Marketing channels3 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Provention Bio developed and commercialized novel therapeutics for immune-mediated diseases, with its lead product teplizumab (branded as Tzield) being an anti-CD3 monoclonal antibody approved as the first disease-modifying therapy for delaying the progression of stage 3 type 1 diabetes. The company also had pipeline candidates targeting celiac disease and lupus.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 value
  • First disease-modifying therapy approved for type 1 diabetes in the US, China, UK, with EU approval recommendation
Product and service1 record
1Teplizumab (Tzield/Teizeild)
CategoryBiopharmaceutical therapeutic (monoclonal antibody)
Scale indicator5 records

Each record includes

Type, Value, Description, Source

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeBroad incumbent
Description

Acquired Provention Bio for $2.9 billion in March 2023 to add teplizumab (Tzield) to its immunology portfolio. Comparable because Sanofi is now the direct commercial vehicle for the very asset Provention developed and has deep autoimmune/diabetes infrastructure overlapping with Provention's focus.

TypeBroad incumbent
Description

Global diabetes incumbent with multiple insulin franchises (Humalog, Humulin, Trulicity, Mounjaro) and active autoimmune R&D. Comparable because Eli Lilly operates in the same diabetes end-market where Provention's Tzield competes for payer budget and physician mindshare.

TypeBroad incumbent
Description

World leader in diabetes therapy (insulin, GLP-1, oral semaglutide) with growing autoimmune-adjacent pipeline. Comparable as the dominant incumbent in T1D insulin management — the symptomatic treatment Tzield is designed to delay — making it the most relevant market-context peer.

TypeBroad incumbent
Description

Previously developed otelixizumab, a competing anti-CD3 monoclonal antibody for type 1 diabetes. Comparable because BMS pursued the same mechanism of action and clinical indication as Provention's teplizumab, making it the most direct mechanistic precedent in the field.

TypeBroad incumbent
Description

Early equity investor in Provention Bio (2017 round) and broad biopharmaceutical incumbent with diabetes and autoimmune programs. Comparable because J&J represents the type of strategic biopharma investor/acquirer Provention engaged with, and operates in overlapping therapeutic areas.

TypeDirect peer
Description

Clinical-stage biopharmaceutical company developing monoclonal antibodies for cancer and autoimmune diseases, including DART and Fc-optimized antibody platforms. Comparable because MacroGenics uses the same modality (mAbs) targeting immune-mediated disease pathways, mirroring Provention's anti-CD3 antibody approach.

TypeDirect peer
Description

Specialty biopharmaceutical focused on antibody therapeutics for severe autoimmune diseases (lead asset efgartigimod/Vyvgart). Comparable because Argenx pursues a similar specialist biotech strategy of advancing differentiated antibody drugs for autoimmune indications, with comparable commercial-stage trajectory.

TypeDirect peer
Description

Swedish clinical-stage biotech developing Diamyd, a GAD65 antigen-specific immunotherapy for type 1 diabetes. Comparable because Diamyd targets the same disease-modifying mechanism (immune tolerance induction) in T1D, making it the most direct disease-area competitor to Provention's teplizumab.

TypeDirect peer
Description

Small-cap biopharmaceutical historically focused on diabetes and T1D therapies (e.g., LX4211/sotagliflozin). Comparable because Lexicon pursued disease-modifying approaches to T1D alongside insulin management, operating at a similar company scale and clinical-stage profile.

TypeDirect peer
Description

Commercial-stage biopharmaceutical with Afrezza (inhaled insulin) and endocrine disease pipeline (Tyvaso DPI, MNK-6105). Comparable because Mannkind is a small-cap, commercially focused diabetes biopharma with a single lead asset model similar to Provention's teplizumab-centric strategy.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat3 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment1 record

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature1 record

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles7 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds7 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors7 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Provention Bio

Biopharmaceutical Therapeuticsproventionbio.com

Provention Bio was a US clinical- to commercial-stage biopharmaceutical company developing disease-modifying therapies for immune-mediated diseases, with teplizumab (Tzield) as the first FDA-approved treatment to delay progression of type 1 diabetes; acquired by Sanofi for $2.9B in March 2023.

What Provention Bio does

Provention Bio was a US-based, clinical- to commercial-stage biopharmaceutical company founded in 2016 and headquartered in Red Bank, New Jersey, that sourced, developed, and commercialized novel therapeutics targeting immune-mediated diseases. The company's stated focus areas included type 1 diabetes, celiac disease, and lupus, with the lead clinical asset being teplizumab, an anti-CD3 monoclonal antibody designed to delay the progression of type 1 diabetes by modulating the immune system's attack on insulin-producing pancreatic beta cells. Teplizumab was granted FDA approval in November 2022 as the first disease-modifying therapy for type 1 diabetes, and subsequently secured approvals in China and the United Kingdom, with a positive EU approval recommendation (branded as Teizeild in the EU). The technology platform was centered on proprietary anti-CD3 antibody biology, supported by issued patents covering methods for preventing or delaying T1D in at-risk non-diabetic subjects, including dosing regimens and immunological markers.

From a business model perspective, Provention Bio generated revenue (where present) primarily through prescription pharmaceutical product sales, with teplizumab (branded Tzield in the US) being the core commercial product following late-2022 FDA approval. The go-to-market motion relied on traditional specialty-pharma channels: physician-targeted detailing, medical science liaison outreach, peer-reviewed publication, and medical conference engagement with endocrinologists and other T1D-treating providers. Distribution post-launch leveraged specialty pharmacies, hospital systems, and retail pharmacy channels. Pre-acquisition, the company operated with 101–250 employees and had raised cumulative equity and debt of approximately $498.5 million across multiple financing rounds between 2017 and early 2023. In March 2023, Provention Bio was acquired by Sanofi for approximately $2.9 billion, after which commercial operations were integrated into Sanofi's global pharmaceutical distribution and sales infrastructure.

Provention Bio firmographics

Firmographics
Name
Provention Bio
Website
https://proventionbio.com
Company type
Private
Founded year
2016
Operating status
Acquired
Headcount range
101–250 employees
Short description
Provention Bio was a US clinical- to commercial-stage biopharmaceutical company developing disease-modifying therapies for immune-mediated diseases, with teplizumab (Tzield) as the first FDA-approved treatment to delay progression of type 1 diabetes; acquired by Sanofi for $2.9B in March 2023.
Ownership category
akta.pro rank

Provention Bio industry classification

Industry
Product category
Biopharmaceutical Therapeutics
NAICS
Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)
SIC
Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
akta.pro primary industry
Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)
akta.pro secondary industries
Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Type 1 Diabetes Care (HLAKADAB)

Keywords

  • Biopharmaceutical therapeutics
  • Monoclonal antibody drugs
  • Type 1 diabetes therapy
  • Immune-mediated disease treatments
  • Specialty pharmaceutical products

Where Provention Bio is headquartered

Location

Headquarters

HQ city
Red Bank
HQ country
United States
HQ region
North America

Markets served

Provention Bio business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations

Revenue model

  1. Pharmaceutical product sales: Revenue generated from the sale of prescription pharmaceutical products, primarily teplizumab (branded as Tzield) for type 1 diabetes treatment. As a commercial-stage biopharmaceutical company, Provention Bio was focused on bringing disease-modifying therapies to market through traditional pharmaceutical commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Provention Bio product offering

Product offering

Core offering

Provention Bio developed and commercialized novel therapeutics for immune-mediated diseases, with its lead product teplizumab (branded as Tzield) being an anti-CD3 monoclonal antibody approved as the first disease-modifying therapy for delaying the progression of stage 3 type 1 diabetes. The company also had pipeline candidates targeting celiac disease and lupus.

Differentiator

Problem solved

Functional benefit

Products and services

  • Teplizumab (Tzield/Teizeild)

Quantifiable outcome

  • First disease-modifying therapy approved for type 1 diabetes in the US, China, UK, with EU approval recommendation

Companies that use Provention Bio

Customer profile

Segments1 record

Ideal customer profiles1 record

Provention Bio technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature1 record

Provention Bio partnerships and signals

Strategic signal

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Provention Bio competitors and assessment

Company assessment

Broad incumbents

  • Sanofi: Acquired Provention Bio for $2.9 billion in March 2023 to add teplizumab (Tzield) to its immunology portfolio. Comparable because Sanofi is now the direct commercial vehicle for the very asset Provention developed and has deep autoimmune/diabetes infrastructure overlapping with Provention's focus.
  • Eli Lilly: Global diabetes incumbent with multiple insulin franchises (Humalog, Humulin, Trulicity, Mounjaro) and active autoimmune R&D. Comparable because Eli Lilly operates in the same diabetes end-market where Provention's Tzield competes for payer budget and physician mindshare.
  • Novo Nordisk: World leader in diabetes therapy (insulin, GLP-1, oral semaglutide) with growing autoimmune-adjacent pipeline. Comparable as the dominant incumbent in T1D insulin management — the symptomatic treatment Tzield is designed to delay — making it the most relevant market-context peer.
  • Bristol Myers Squibb: Previously developed otelixizumab, a competing anti-CD3 monoclonal antibody for type 1 diabetes. Comparable because BMS pursued the same mechanism of action and clinical indication as Provention's teplizumab, making it the most direct mechanistic precedent in the field.
  • Johnson & Johnson: Early equity investor in Provention Bio (2017 round) and broad biopharmaceutical incumbent with diabetes and autoimmune programs. Comparable because J&J represents the type of strategic biopharma investor/acquirer Provention engaged with, and operates in overlapping therapeutic areas.

Direct peers

  • MacroGenics: Clinical-stage biopharmaceutical company developing monoclonal antibodies for cancer and autoimmune diseases, including DART and Fc-optimized antibody platforms. Comparable because MacroGenics uses the same modality (mAbs) targeting immune-mediated disease pathways, mirroring Provention's anti-CD3 antibody approach.
  • Argenx: Specialty biopharmaceutical focused on antibody therapeutics for severe autoimmune diseases (lead asset efgartigimod/Vyvgart). Comparable because Argenx pursues a similar specialist biotech strategy of advancing differentiated antibody drugs for autoimmune indications, with comparable commercial-stage trajectory.
  • Diamyd Medical: Swedish clinical-stage biotech developing Diamyd, a GAD65 antigen-specific immunotherapy for type 1 diabetes. Comparable because Diamyd targets the same disease-modifying mechanism (immune tolerance induction) in T1D, making it the most direct disease-area competitor to Provention's teplizumab.
  • Lexicon Pharmaceuticals: Small-cap biopharmaceutical historically focused on diabetes and T1D therapies (e.g., LX4211/sotagliflozin). Comparable because Lexicon pursued disease-modifying approaches to T1D alongside insulin management, operating at a similar company scale and clinical-stage profile.
  • Mannkind Corporation: Commercial-stage biopharmaceutical with Afrezza (inhaled insulin) and endocrine disease pipeline (Tyvaso DPI, MNK-6105). Comparable because Mannkind is a small-cap, commercially focused diabetes biopharma with a single lead asset model similar to Provention's teplizumab-centric strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Provention Bio social profiles

Digital presence

Provention Bio financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Provention Bio leadership team

Management profile

Number of profiles

Profiles7 records

Provention Bio funding detail

Funding detail

Funding overview

Funding rounds7 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Provention Bio M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Provention Bio

What does Provention Bio do?

Provention Bio developed and commercialized novel therapeutics for immune-mediated diseases, with its lead product teplizumab (branded as Tzield) being an anti-CD3 monoclonal antibody approved as the first disease-modifying therapy for delaying the progression of stage 3 type 1 diabetes. The company also had pipeline candidates targeting celiac disease and lupus.

Is Provention Bio a public or private company?

Provention Bio is a private company. It is classified as corporate owned and is currently acquired.

When was Provention Bio founded?

Provention Bio was founded in 2016. It employs 101 to 250 people.

Where is Provention Bio based?

Provention Bio is headquartered in Red Bank, United States, in the North America region.

How does Provention Bio make money?

One revenue line is on record: pharmaceutical product sales.

Who are Provention Bio's main competitors?

Broad incumbents on record are Sanofi, Eli Lilly, Novo Nordisk, Bristol Myers Squibb and Johnson & Johnson. Direct peers are MacroGenics, Argenx, Diamyd Medical, Lexicon Pharmaceuticals and Mannkind Corporation.

Does Provention Bio have an API?

No public API is recorded for Provention Bio.

What industry is Provention Bio in?

Provention Bio's product category is Biopharmaceutical Therapeutics. Its primary akta.pro industry code is HLAIACAB, Immunology & Autoimmune Specialty Pharmaceuticals, with a secondary code of HLAIAAAD, Immunology & Inflammation Pharmaceuticals. Its NAICS code is 325414 and its SIC code is 2836.

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Live signals
BioSpaceBreakthrough T1D Celebrates Approval of Tzield for use in Stage 3 Type 1 Diabetes in the USThe FDA approved Tzield for individuals ages 8-17 within eight weeks of a stage 3 type 1 diabetes diagnosis, marking the first disease-modifying therapy for this stage. The PROTECT study showed Tzield preserved beta cell function and delayed disease progression. Sanofi's confirmatory BETA-PRESERVE study is ongoing.openPR.comTrends in Growth, Market Segmentation, and Competitive Approaches Influencing the Type 1 Diabetes MarketThe Type 1 Diabetes market is projected to grow to $25.73 billion by 2030, representing a compound annual growth rate of 13.9%, driven by adoption of closed-loop insulin delivery systems and digital diabetes management platforms. In March 2023, Sanofi acquired Provention Bio Inc. for $2.9 billion to strengthen its immune-mediated disease portfolio and expand disease-modifying diabetes therapies. In June 2023, CellTrans Inc. received FDA approval for Lantidra (donislecel), the first cellular therapy approved to treat Type 1 diabetes, representing a landmark advancement in regenerative medicine.pharmaphorumFDA delays decision on Sanofi's subcutaneous SarclisaThe FDA extended its review of Sanofi's subcutaneous Sarclisa by three months, setting a July 23 action date. The OBI version could narrow the gap with Darzalex, which made nearly $4 billion in Q1. Sanofi also announced FDA approval of Tzield for younger children with type 1 diabetes.Market ScoopGeneric Pharmaceuticals Market Expected To Hit US$ 740.5 BillionThe global generic pharmaceuticals market is projected to grow from US$374.6 billion in 2023 to US$740.5 billion by 2032, at a CAGR of 8.1%, driven by rising chronic disease prevalence and patent expirations on blockbuster drugs. Major pharmaceutical companies are actively consolidating through strategic acquisitions, including Pfizer's $43 billion acquisition of Seagen, its $6.7 billion purchase of Arena Pharmaceuticals, and Sanofi's $2.9 billion acquisition of Provention Bio. The sector is also undergoing structural changes, with Novartis spinning off its Sandoz generics division and Sanofi divesting its Zentiva generics unit to Advent International for €1.9 billion.PharmiWeb.comSanofi completes acquisition of Provention Bio, Inc.Sanofi completed the acquisition of Provention Bio, Inc., thereby adding the type 1 diabetes therapy TZIELD to its General Medicines portfolio. The transaction involved Sanofi paying $25.00 per share for all outstanding shares of Provention Bio following the satisfaction of tender offer conditions. This move aligns with Sanofi's strategic shift toward products with differentiated profiles in areas of high unmet need.GlobeNewswirePress Release: Sanofi completes acquisition of Provention Bio, Inc.Sanofi completed its acquisition of Provention Bio on April 27, 2023, adding TZIELD, a first-in-class therapy for type 1 diabetes, to its portfolio. The FDA approved TZIELD on November 17, 2022, to delay stage 3 type 1 diabetes in adults and children 8 and older. Provention Bio's stock will cease trading on NASDAQ.YahooPress Release: Sanofi completes acquisition of Provention Bio, Inc.Sanofi completed its acquisition of Provention Bio, Inc., adding the TZIELD therapy to its portfolio as part of a strategic shift toward immune-mediated disease treatments. The transaction was finalized after satisfying all tender conditions, with shares ceasing trading on NASDAQ and becoming an indirect wholly owned subsidiary of Sanofi. This move positions Sanofi at the intersection of growth in differentiated therapies for areas of high unmet need.GlobeNewswirePress Release: Hart-Scott-Rodino waiting period expires for Sanofi’s acquisition of Provention Bio, Inc.Sanofi announced the expiration of the Hart-Scott-Rodino waiting period for its acquisition of Provention Bio. The cash tender offer is $25 per share, expiring April 26, 2023, with consummation subject to conditions including a majority tender.BenzingaSanofi's $3B Acquisition Of Provention Bio Hits Regulatory Roadblock: FTC Requests More Information - SanSanofi withdrew and refiled its premerger notification with the FTC following informal discussions, as the agency requested more time and information to review the $2.9 billion acquisition of Provention Bio. The refiling reset the FTC's 15-day preliminary review clock, with the agency now having until April 25 to decide and Sanofi extending its offer by six days to April 26. Despite the regulatory hurdle, Sanofi stated it still expects to close the deal in the second quarter of this year.BenzingaShort Volatility Alert: Provention Bio IncProvention Bio Inc (NASDAQ: PRVB) experienced a 153.6% increase in securities lending volatility on March 15, 2023, resulting in a 0.25% decline in its stock price to $23.91. The generated signal indicates a bullish trend with unusual short activity, prompting a recommendation to decrease short exposure. This alert is based on an algorithmic analysis of lending volumes, rates, and collateral by Tidal Markets and Benzinga Insights.