TRANSLATE BIO, INC. - TBIO STOCK NEWS

Translate Bio (Nasdaq: TBIO) has made significant strides in its clinical development, resuming enrollment and dosing in its Phase 1/2 trial of MRT5005 for cystic fibrosis following a COVID-related pause. The company showcased promising preclinical data for both MRT5005 and its COVID-19 mRNA vaccine candidate, MRT5500, which is anticipated to enter clinical trials in Q1 2021. Financially, Translate Bio reported $66.4 million in collaboration revenue from its partnership with Sanofi for Q3 2020, up from $1.3 million the previous year, while net income stood at $17.3 million.

Translate Bio (NASDAQ: TBIO) and Sanofi Pasteur announced promising preclinical results for their mRNA-based vaccine candidate MRT5500 against SARS-CoV-2. The findings show that MRT5500 induced significantly higher neutralizing antibody levels than those seen in COVID-19 patients. The companies plan to initiate a Phase 1/2 clinical trial in Q4 2020, marking a key milestone in their collaboration. The results indicate that MRT5500 can elicit a strong immune response in mice and non-human primates, supporting its potential for further clinical development.

Translate Bio (Nasdaq: TBIO) announced presentations at the 34th Annual North American Cystic Fibrosis Conference focusing on its lead mRNA candidate MRT5005 aimed at treating cystic fibrosis (CF). The oral presentation on October 21 outlines MRT5005's potential to address CF's underlying causes, including advancements in mRNA technology and a next-generation CFTR mRNA program. MRT5005 has received Orphan Drug and Fast Track designations from the FDA. The ongoing Phase 1/2 trial aims to evaluate safety and efficacy in adults with CF. Positive preclinical data support MRT5005’s development.

Translate Bio (Nasdaq: TBIO) has resumed enrollment and dosing in its Phase 1/2 clinical trial for MRT5005, aimed at treating cystic fibrosis (CF). This decision follows a temporary pause due to the COVID-19 pandemic. The trial will assess the safety and tolerability of MRT5005, which is designed to deliver mRNA for the CFTR protein to lung cells. MRT5005 has received Orphan Drug and Fast Track designations from the FDA. The trial will include at least 40 adult patients and also measure lung function.

Translate Bio (Nasdaq: TBIO) has expanded its collaboration with Sanofi Pasteur to develop mRNA vaccines for all infectious diseases. The partnership includes a $425 million investment from Sanofi, consisting of a $300 million upfront payment and $125 million in common stock. Translate Bio reported a net loss of $36.3 million for Q2 2020, despite collaboration revenue increasing to $16.3 million from $1.2 million in Q2 2019. The company ended Q2 with $292.2 million in cash, expected to fund operations for at least 36 months while advancing its COVID-19 vaccine trials.

Translate Bio (Nasdaq: TBIO) has expanded its collaboration with Sanofi Pasteur to develop mRNA vaccines for infectious diseases, closing a licensing agreement following the termination of the Hart-Scott-Rodino waiting period. Translate Bio will receive an upfront payment of $425 million and may earn up to $1.9 billion from potential milestones and royalties. Sanofi will cover all collaboration costs and holds exclusive rights to the vaccines. The collaboration, initiated in 2018, aims to leverage both companies' strengths in the mRNA space.

Translate Bio announced a public offering of 12,506,811 shares of common stock at $22.00 per share, aiming for gross proceeds of approximately $125 million. Of the total, Translate Bio will issue 5,681,819 shares while an existing stockholder, Shire, will sell 6,824,992 shares. The offering is expected to close on June 30, 2020. The company plans to utilize the funds to further its mRNA therapeutics development, particularly for treating cystic fibrosis. The offering is made under an effective shelf registration statement with the SEC.

Translate Bio (TBIO) announced a public offering of $125.0 million in common stock on June 24, 2020. Shire Human Genetic Therapies is also offering 6,824,992 shares without proceeds to Translate Bio. The company aims to grant underwriters an option to purchase an additional 15%. The offering is subject to market conditions and will utilize a shelf registration statement filed with the SEC. The firm is focused on mRNA therapeutics for diseases like cystic fibrosis and is currently in Phase 1/2 trials.

Translate Bio and Sanofi Pasteur have expanded their collaboration to develop mRNA vaccines for infectious diseases, building on a 2018 agreement. Translate Bio will receive $425 million upfront, comprising $300 million in cash and a $125 million stock investment, plus potential milestone payments up to $1.9 billion. Sanofi gains exclusive rights to develop and commercialize these vaccines. The partnership combines Translate Bio's mRNA technology with Sanofi's vaccine expertise, aiming for a first-in-human clinical trial for a COVID-19 vaccine by late 2020 and further vaccine programs against influenza and other pathogens.