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08:46:02 AM

BNTX - BioNTech SE

08/20/20 8:16 PM
Nasdaq : BNTX
Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. The newly released manuscript describes key safety and immunogenicity data from the U.S. Phase 1 trial for the BNT162b2 vaccine candidate, which at 30ug recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults. Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants. As previously announced, these data informed the companies' decision to advance a 2-dose regimen of the 30ug dose level of BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), into a Phase 2/3 evaluation. The manuscript is now available on an online preprint server at https://www.medrxiv.org/content/10.1101/2020.08.17.20176651v1 and is concurrently undergoing scientific peer review for potential
RHEA-AI
neutral
08/05/20 4:30 AM
Nasdaq : BNTX
BioNTech and Fosun Pharma Announce Start of Clinical Trial of mRNA-based COVID-19 Vaccine Candidate in China
BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") and Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma" or "Group"; Stock Symbol: 600196.SH, 02196.HK), today announced that the first 72 participants have already been dosed with BNT162b1 following IND approval by the Chinese regulatory authority, National Medical Products Administration (NMPA). BioNTech and Fosun Pharma are jointly developing the COVID-19 vaccine candidate in China. The trial is part of BioNTech's global development program aimed at supporting a global supply upon regulatory
RHEA-AI
very positive
07/31/20 2:00 AM
Nasdaq : BNTX
BioNTech Announces Strategic Collaboration with Regeneron to Advance FixVac and Libtayo(R) (cemiplimab) Combination in Melanoma
BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced a strategic collaboration with Regeneron for a clinical trial combining BioNTech's BNT111 FixVac product candidate and Libtayo(R) (cemiplimab), a fully human anti-PD-1 therapy, for the treatment of melanoma. The companies plan to jointly conduct a randomized Phase 2 study in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma. Melanoma is the deadliest skin cancer and estimated to kill more than 63,000 people around the world this
RHEA-AI
neutral
07/30/20 3:00 AM
Nasdaq : BNTX
BioNTech Publishes Data from mRNA-based BNT111 FixVac Melanoma Trial in Nature
BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), announced today the publication of interim Phase 1 data for the Company's FixVac cancer vaccine program BNT111 in the journal Nature. The Lipo-MERIT trial is a multicenter, open-label, dose-escalation Phase 1 trial (NCT02410733) to evaluate safety and tolerability of vaccinated patients with stage IIIB-C and stage IV melanoma. The publication titled "An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma" summarizes the findings of an exploratory interim analysis (data extraction date July 29, 2019). Safety assessment was performed in 89 advanced melanoma patients treated with intravenously delivered repeated doses of mRNA-based cancer vaccine BNT111 ranging from 7.2ug to 400ug. Overall, BNT111 treatment was well tolerated with no dose limiting toxicity. Most common adverse events were mild to moderate, transient flu-like symptoms, such as pyrexia and chills. Assessment of blood cytokines showed transient upregulation of cytokines such as Interferon-alpha (IFNa), Interferon-gamma (IFN?) and Interleukin-12 (IL12) in line with a toll-like-receptor (TLR)-mediated antiviral immune modulation critical for expansion of Th1 type antigen-specific T
RHEA-AI
neutral
07/27/20 4:15 PM
Nasdaq : BNTX
BioNTech Announces Closing of $512 Million Underwritten Offering of American Depositary Shares
BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") announced today the closing of its previously announced underwritten offering (the "Underwritten Offering") of 5,500,000 American Depositary Shares ("ADSs"), each representing one of its ordinary shares, at a public offering price of $93.00 per ADS, for gross proceeds of approximately $512 million, before deducting underwriting discounts and commissions and other offering expenses payable by BioNTech. In addition, a selling shareholder granted the underwriters a 30-day option to purchase up to 825,000 additional ADSs at the same public offering price, which has not yet been exercised. BioNTech would not receive any of the proceeds from such a sale of ADSs by the selling shareholder.
RHEA-AI
neutral