Among the 7 patients on VBI-1901 treatment long enough to have 1+ MRI scan at the time of analysis, one partial tumor response (PR) and two stable disease (SD) observations have occurred as of May 15, 2024The partial response, which demonstrated a 67% reduction in tumor size vs. baseline, was observed at week 6, after 2 doses of VBI-1901The disease control rate (DCR) in the VBI-1901 study arm was 43% (n=3/7) compared to 0% in the control arm (n=0/6) – n=5/6 patients in the control arm have experienced a 2-8x increase in tumor size vs. baseline and have been taken off study protocolFDA has granted both Fast Track Designation and Orphan Drug Designation to VBI-1901 in recurrent GBM following p

VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company's cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.The presentation at ASCO will provide an update to the encouraging data previously shared at the World Vaccine Congress Washington in April, including additional data from those initially evaluable patients, as well as data fro

VBI Vaccines (NASDAQ:VBIV) reported quarterly losses of $(0.73) per share. This is a 77.33 percent increase over losses of $(3.22) per share from the same period last year. The company reported $1.21 million in sales this quarter. This is a 150.31 percent increase over sales of $485.00 thousand the same period last year.

Shares of Fastenal Company (NASDAQ:FAST) fell sharply during Thursday’s session following worse-than-expected first-quarter financial results. Fastenal reported first-quarter FY24 sales growth of 1.9% Y/Y to $1.895 billion, missing the consensus of $1.914 billion. The company's first-quarter EPS was 52 cents, missing the consensus of 53 cents. Fastenal shares dipped 6.7% to $69.73 on Thursday. Here are some other stocks moving in today's mid-day session. Gainers Rallybio Corporation (NASDAQ:RLYB) shares climbed 89.6% to $3.09 after the company announced a collaboration with Johnson & Johnson to advance therapeutics for pregnant individuals at risk of FNAIT. Rent the Runway, Inc. (NA

Shares of Biophytis S.A. (NASDAQ:BPTS) rose sharply in today’s pre-market trading after reporting FY23 results. Biophytis posted a FY23 loss of €0.03 per share, versus a year-ago loss of €0.14 per share, according to data from Benzinga Pro. Biophytis shares jumped 55.2% to $0.4920 in pre-market trading. Here are some other stocks moving in pre-market trading. Gainers MyMD Pharmaceuticals, Inc. (NASDAQ:MYMD) shares rose 40% to $3.64 in pre-market trading after jumping 22% on Monday. MediaCo Holding Inc. (NASDAQ:MDIA) shares rose 20.2% to $3.63 in pre-market trading after falling 22% on Monday. On April 4, an SEC filing showed Standard General L.P. reported a 95.2% stake in the compa

VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided an update on the restructuring proceedings announced on July 30, 2024. U.S. Chapter 15 Filing On August 2, 2024, the United States Bankruptcy Court for the District of Delaware granted provisional relief under Chapter 15 of the U.S. Bankruptcy Code, and scheduled a further hearing to consider the recognition of the July 30, 2024, Ontario Superior Court of Justice (Commercial List) order ("Initial Order"), which granted the company protection under the Companies' Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended ("C

VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the Ontario Superior Court of Justice (Commercial List) ("Court") has issued an initial order ("Initial Order") granting the company protection under the Companies' Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended ("CCAA"). The Initial Order provides for, among other things: (i) a stay of proceeding in favour of VBI, (ii) approval of the DIP Loan (as described below), and (iii) the appointment of Ernst & Young Inc. ("EY") to serve as monitor ("Monitor") in the Court during the restructuring ("Restructuring Pro

VBI Vaccines Inc. (NASDAQ:VBIV) ("VBI" or the "Company"), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the voting results from its annual general meeting of shareholders held on June 25, 2024 (the "Meeting"). The total number of common shares of the Company ("Common Shares") represented by shareholders ("Shareholders") present in person or represented by proxy at the Meeting was an aggregate of 13,879,327 Common Shares, representing 48.39% of VBI's issued and outstanding Common Shares as of the record date for the Meeting, April 26, 2024. The voting results with respect to each of the following eight dir

Among the 7 patients on VBI-1901 treatment long enough to have 1+ MRI scan at the time of analysis, one partial tumor response (PR) and two stable disease (SD) observations have occurred as of May 15, 2024 The partial response, which demonstrated a 67% reduction in tumor size vs. baseline, was observed at week 6, after 2 doses of VBI-1901 The disease control rate (DCR) in the VBI-1901 study arm was 43% (n=3/7) compared to 0% in the control arm (n=0/6) – n=5/6 patients in the control arm have experienced a 2-8x increase in tumor size vs. baseline and have been taken off study protocol FDA has granted both Fast Track Designation and Orphan Drug Designation to VBI-1901 in recurrent G

VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company's cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation at ASCO will provide an update to the encouraging data previously shared at the World Vaccine Congress Washington in April, including additional data from those initially evaluable patients, as well as data

PreHevbrio® (Hepatitis B Vaccine [Recombinant]) global net revenue increased 105% year-over-year in the first quarter of 2024 compared to the first quarter of 2023 Initial encouraging tumor response data from randomized Phase 2b study of VBI-1901 in recurrent glioblastoma (GBM) announced in April ­– additional data expected mid-year and year-end 2024 Evaluation of novel mRNA-launched eVLP (MLE) platform technology underway by potential partners VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended M

PreHevbrio® (Hepatitis B Vaccine [Recombinant]) global net revenue increased 234% year-over-year from 2022 to 2023 Preliminary 2024 PreHevbrio U.S. sales demonstrate continued growth, with approximately 65% of 2023 full-year volume sold in Q1 2024 alone Early data from randomized Phase 2b study of VBI-1901 in recurrent glioblastoma (GBM) demonstrate encouraging separation of tumor response trends between VBI-1901 study arm and standard-of-care arm Upcoming milestones across lead pipeline programs include: Additional interim data readouts from randomized, controlled Phase 2b study of VBI-1901 in recurrent GBM expected mid-year and year-end 2024 Evaluation of novel mRNA-launche

VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules of 2,272,728 of its common shares and warrants to purchase up to 2,272,728 common shares, at an offering price of $0.88 per common share and associated warrant. The warrants have an exercise price of $0.76 per share, are exercisable on the date of issuance, and will expire five years following the date of issuance. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. The gross proceeds to VB

VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that it has entered into definitive agreements for the sale and issuance of 2,272,728 common shares (or pre-funded warrants in lieu thereof) of VBI at an offering price of $0.88 per common share (or per pre-funded warrant in lieu thereof), in a registered direct offering priced at-the-market under the Nasdaq rules. In a concurrent private placement, VBI will issue unregistered warrants to purchase up to 2,272,728 common shares. The warrants have an exercise price of $0.76 per share, will be exercisable on the date of issuance

Data highlighted in oral presentation at World Vaccine Congress 2024 on April 3, 2024 Early data from patients eligible for evaluation at week 12 show two observations of stable disease, indicating no tumor progression, in VBI-1901 treatment arm (n=2/5; 40% disease control rate [DCR]) By comparison, no tumor responses have been observed in the control arm to-date (n=0/6; 0% DCR), with all patients seeing a 2-8x increase in tumor size by week 6 FDA has granted both Fast Track Designation and Orphan Drug Designation to VBI-1901 in recurrent GBM following encouraging Phase 1/2a study results Additional interim data expected mid-year and year-end 2024 VBI Vaccines Inc. (NASDAQ:V

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Transitioning HBV cure programs into multiple late-stage combination studies with interim results throughout 2024 and 2025 informing Company's registrational strategy Integrating R&D, manufacturing and commercial upsides by acquiring full intellectual property rights of BRII-179 and expanding its manufacturing footprint Prioritizing company resources with a robust cash balance of US$376 million supporting operations until 2027 Company to host a conference call (English session) on March 25 at 8:30 AM ET / 8:30 PM HKT DURHAM, N.C. and BEIJING, March 22, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapie

PreHevbrio (Hepatitis B Vaccine [Recombinant]) global net revenue increased 52% quarter-over-quarter from Q2 to Q3 2023 Continued execution across earlier-stage pipeline, including: Initiation of Phase 2b study of VBI-1901 in recurrent glioblastoma (GBM) patients Interim Phase 1 data announced for pan-coronavirus candidate, VBI-2901 Novel mRNA-launched eVLP platform technology announced VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended September 30, 2023. "In Q3, we were focused on pip

First patient dosed in a PEG-IFN-α controlled BRII-835 + PEG-IFN-α combination Phase 2 study for HBV functional cure First of several studies to investigate the potential of BRII-179 in enriching patients with strong intrinsic anti-HBsAg responses for curative treatments to start before the end of 2023 Regulatory submissions and preparation for launches of PreHevbri® in APAC countries and regions are underway Near-term revenue opportunities with PreHevbri® and strong balance sheet supporting operations through 2026 Company to host earnings call on August 22 at 8:00 PM ET / August 23 at 8:00 AM HKT and an HBV R&D Day on August 24 from 1:00-2:30 PM HKT DURHAM, N.C. and BEIJING, Aug. 22, 2023 /

Extension of BRII-179 license from VBI Vaccines to global rights bolsters Brii Bio's position to achieve best-in-class HBV functional cure in broad patient populations Company also acquires exclusive rights to PreHevbri®, a clinically differentiated, 3-antigen prophylactic vaccine, from VBI in Greater China and Asia Pacific markets Company to host conference call on July 6 at 8:30 AM (HKT) / July 5 at 8:30 PM (EST) BEIJING and DURHAM, N.C., July 5, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced that

Company maintains priority focus on clinical programs to develop a novel functional cure for hepatitis B viral (HBV) infection and a potential first-of-its-kind treatment for postpartum depression (PPD) and major depressive disorders (MDD) Multiple Phase 2a proof-of-concept (POC) clinical data readouts and Phase 2b clinical trial initiations expected in 2023 Operations well-funded through 2025 Company to host conference call today at 8:00 PM HKT / 8:00 AM ET DURHAM, N.C. and BEIJING, March 24, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across disease

- PreHevbrio™ is the only approved 3-antigen hepatitis B vaccine for adults in the U.S. - Shareholder conference call to be held today, December 1, at 8:30 AM ET VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.

- New preclinical data demonstrate VBI-2905 induced robust neutralizing and antibody binding activity, as a 2-dose course and as a single booster dose, against COVID-19 and variants of concern including Beta and Delta - Data also demonstrate trivalent VBI-2901 induced robust and consistent levels of immunity against the ancestral COVID-19 strain and a panel of variants including Beta, Delta, Kappa, and Lambda - First subject dosed in Phase 1b portion of ongoing study to assess VBI-2905 as (i) a 1-dose booster in individuals previously immunized with an mRNA vaccine, and (ii) a primary 2-dose series in unvaccinated individuals - Initial VBI-2905 data expected early Q1 2022, subject to speed