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Provention Bio (Nasdaq: PRVB) announced the pricing of its public offering of 6,250,000 common shares at $16.00 per share, aiming to raise gross proceeds of $100 million. The offering includes a 30-day option for underwriters to purchase an additional 937,500 shares. The funds will support activities related to its clinical programs and potential acquisitions. The offering is expected to close around January 19, 2021. SVB Leerink and Cantor Fitzgerald are the joint bookrunning managers for this offering.
Provention Bio, Inc. (Nasdaq: PRVB) has announced an underwritten public offering of 6,000,000 shares of its common stock, with a 30-day option for underwriters to purchase an additional 900,000 shares. The offering's completion is subject to market conditions. Proceeds will support pre-commercial and clinical development activities, particularly for PRV-031, as well as other product candidates and general corporate purposes. The registration statement related to this offering was filed with the SEC on January 12, 2021.
Provention Bio, Inc. (Nasdaq: PRVB) will participate in a fireside chat at the H.C. Wainwright BioConnect 2021 Conference, held virtually from January 11-14, 2021. The pre-recorded chat will be available from 6:00 am E.T. on January 11 and can be accessed via the company's website. The company focuses on developing therapies for immune-mediated diseases and has submitted a Biologics License Application (BLA) for its investigational drug, teplizumab, aimed at delaying type 1 diabetes. For more information, visit www.ProventionBio.com.
Provention Bio, Inc. (Nasdaq: PRVB) has filed a Biologics License Application (BLA) with the FDA for teplizumab, aimed at delaying or preventing clinical type 1 diabetes (T1D) in at-risk individuals. The FDA has granted Priority Review, targeting a decision by July 2, 2021. CEO Ashleigh Palmer highlights this milestone as a potential game-changer in T1D treatment. An advisory committee meeting is scheduled for May 27, 2021. Teplizumab has shown promise in preserving beta-cell function in prior studies, earning Breakthrough Therapy Designation and PRIME status in Europe.
Provention Bio, Inc. (Nasdaq: PRVB) is now included in the NASDAQ Biotechnology Index effective Dec. 21, 2020. The index tracks biotechnology and pharmaceutical securities on the Nasdaq Stock Market, requiring compliance with minimum market value and share volume criteria. The inclusion may enhance PRVB's visibility and attract additional investment, as the index is the basis for several ETFs. Provention Bio is developing investigational therapies for immune-mediated diseases, including teplizumab, aimed at preventing clinical type 1 diabetes.
Provention Bio, Inc. (Nasdaq: PRVB) announced the initiation of PROVENT, a first-in-human study for its investigational vaccine candidate PRV-101 targeting coxsackievirus B (CVB). The study aims to evaluate PRV-101's safety and immunogenicity in healthy adults, potentially preventing acute CVB infections and delaying or preventing type 1 diabetes (T1D) and celiac disease. Conducted in Turku, Finland, results are expected in H2 2021. CVB infection is linked to T1D and celiac disease, making PRV-101 a significant advance in autoimmunity prevention.
On December 8, 2020, JDRF launched T1Detect, a pioneering initiative aimed at facilitating early detection of type 1 diabetes (T1D). Supported by Provention Bio (Nasdaq: PRVB), this program offers financial assistance for screening to a wide population. The screening targets individuals with diabetes-related autoantibodies, aiming to identify those at risk before symptoms arise. Early detection is crucial, as it can prevent severe complications. Provention Bio's involvement emphasizes their commitment to advancing T1D research and patient empowerment.
Provention Bio, Inc. (Nasdaq: PRVB) announced its participation in the Stifel Virtual Healthcare Conference on November 18, 2020, at 8:00 am E.T. During the event, management will present their innovative biopharmaceutical strategies focused on preventing autoimmune diseases. The company has submitted a Biologics License Application (BLA) for its lead drug candidate, teplizumab, aimed at delaying or preventing clinical type 1 diabetes in at-risk individuals. A webcast of the presentation will be accessible on the company's website and archived for 90 days.
Provention Bio (Nasdaq: PRVB) reported Q3 2020 financial results with a net loss of $31.3 million, a significant increase from $9.8 million in Q3 2019. The company completed a rolling Biologics License Application (BLA) for teplizumab aimed at delaying or preventing clinical type 1 diabetes (T1D) in at-risk individuals, with a Priority Review requested from the FDA. Provention also initiated campaigns to increase awareness about T1D screening and commenced a Phase 2 study for PRV-015, targeting non-responsive celiac disease. Cash reserves stand at $147.2 million, with expected Q4 cash outflows of $24 million to $28 million.
Provention Bio (Nasdaq: PRVB) announced the completion of its rolling submission of a Biologics License Application (BLA) to the FDA for teplizumab, aimed at delaying or preventing type 1 diabetes (T1D) in at-risk individuals. The FDA will review the submission within 60 days. Teplizumab holds Breakthrough Therapy Designation, and Provention has requested Priority Review, potentially accelerating the decision timeline to six months. If approved, teplizumab could be the first disease-modifying therapy for T1D since insulin was introduced.
