Translate Bio (TBIO) saw a big move last session, as its shares jumped nearly 6% on the day, amid huge volumes.

Translate Bio (TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today announced two updates related to its MRT5005 clinical development program in cystic fibrosis (CF). First, the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for MRT5005 for the treatment of CF.

Sanofi announced a new effort to develop a vaccine to prevent the novel coronavirus, Covid-19, using messenger RNA, in a collaboration with the biotech firm Translate Bio.

Translate Bio (TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today announced that Ronald Renaud, chief executive officer, will participate in a fireside chat at the Bank of America Securities Virtual 2020 Health Care Conference on Thursday, May 14, 2020, at 9:00 a.m. ET. Translate Bio is a clinical-stage mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Translate Bio is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease.

Here's a roundup of top developments in the biotech space over the last 24 hours.None of the NYSE- or Nasdaq-listed biotech stocks hit 52 week highs Thursday.Down In The Dumps (Biotech Stocks Hitting 52-week lows on March 26) * Aptevo Therapeutics Inc (NASDAQ: APVO) (reacted to its fourth-quarter results) * TFF Pharmaceuticals Inc (NASDAQ: TFFP)Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Stocks In Focus Sanofi's Multiple Myeloma Drug Gets Positive European Regulatory Agency Committee Opinion Sanofi SA (NASDAQ: SNY) said the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Sarclisa in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.In premarket trading Friday, the stock was up 1.28% to $43.50.Translate Bio, Sanofi to Partner for COVID-19 Vaccine Research Translate Bio Inc (NASDAQ: TBIO) Bio said it will collaborate with Sanofi to develop a mRNA vaccine for COVID-19, joining a host of companies working on a vaccine for the SARS-CoV-2. Translate Bio has begun to produce multiple mRNA constructs, and it expects to use its mRNA platform for developing SARS-CoV-2 vaccine candidate.Separately, Translate Bio said the FDA has granted Rare Pediatric Disease designation for MRT5005 for the treatment of cystic fibrosis, its first inhaled mRNA therapeutic. The company also said it expects interruptions in enrolment, dosing and follow-up in the ongoing Phase 1/2 trial in patients with cystic fibrosis.It said it will provide an updated timing on the interim data readout of the additional single-ascending dose group and the multiple ascending dose portion of the trial at a later date.Translate Bio shares were jumping 21.95% to $12.50 in premarket trading Friday.TherapeuticsMD Suspends FY20 Guidance, Announces Cost Cuts TherapeuticsMD Inc (NASDAQ: TXMD) pre-announced first-quarter total net revenues of more than $11 million, while analysts expect revenues of $11.64 million. The company said it is suspending its 2020 guidance, citing the unknown impact of COVID-19 on its business.The company also announced measures to cut or defer more than $30 million in annual spending.The stock was slipping 7.75% to $1.19 in premarket trading Friday.Zealand Announces Private Placement of Common Stock Danish biotech ZEALAND PHARMA/S ADR (NASDAQ: ZEAL) announced a private placement and directed share issue of 741,816 new ordinary shares to a U.S.-based investor at 185 Danish Krone per new ordinary share. The company said it expects to receive gross proceeds from the placement of about 137,236,000 Danish Krone.The company said it will use the net proceeds for supporting its peptide platform, accelerating development of late stage assets, and prepare for the launch of its first fully-owned asset.Arbutus Announces Positive Early-stage Results For Hepatitis B Drug Arbutus Biopharma Corp (NASDAQ: ABUS) announced positive preliminary results from a Phase 1a/1b clinical study of its RNAi therapy AB-729 in healthy subjects and two cohorts of chronic hepatitis B subjects on nucleos(t)ide antiviral therapy. The study was meant to determine the most effective dose and dosing interval for use in future Phase 2 combination clinical trials.View more earnings on IBB"These encouraging preliminary results demonstrate that AB-729 is a potent RNAi agent capable of reducing HBsAg plasma levels and support its further development as a treatment for people living with chronic hepatitis B," the company said.The stock was advancing 3.98% to $2.35 in premarket trading Friday.Earnings Neubase Therapeutics Inc's (NASDAQ: NBSE) fourth quarter net loss widened from 25 cents in 2018 to 26 cents in 2019, but was narrower than the consensus loss estimate of 32 cents per share. The company said its current cash balance will provide sufficient capital to fund operations through the end of fiscal year 2020.In premarket trading Friday, Neubase shares were rallying 19.28% to $6.99.NovaBay Pharmaceuticals, Inc.'s (NYSE: NBY) fourth-quarter revenues fell from $3.6 million in 2018 to $1.7 million in 2019. The net loss per share widened from 7 cents to 13 cents. Analysts had estimated a loss of 7 cents per share.The stock was plunging 10.92% to 78 cents in premarket trading Friday.aTyr Pharma Inc (NASDAQ: LIFE) reported total revenues of $0.1 million and a loss of $1.54 per share for the fourth quarter of 2019. In the year-ago quarter, the company reported no revenues and a loss of $2.92 per share. The consensus estimate had called for a loss of $1.59 per share for the recent fourth quarter.As of Dec. 31, the company had cash, cash equivalents and investments of about $31.1 million.In premarket trading, the shares were adding 5.84% to $3.26.Vir Biotechnology Inc (NASDAQ: VIR), which is working on a cure for the new coronavirus, reported a decline in its fourth-quarter revenues from $3.1 million in 2018 to $1 million in 2019. The net loss per share widened from $3.05 to 71 cents, while analysts estimated a loss of 67 cents per share for the quarter.The stock was advancing 5% to $33.60 in premarket trading.On The Radar Earnings TELA Bio Inc (NASDAQ: TELA) (before the market open) Zyla Life Sciences (OTC: ZCOR) (before the market open) Ocugen Inc (NASDAQ: OCGN) (before the market open) Altimmune Inc (NASDAQ: ALT) (before the market open)See more from Benzinga * The Daily Biotech Pulse: FDA Nod For Bristol-Myers Squibb, Xencor Licenses Tech To Vir For COVID-19 Treatment, Delay In Pfizer's Upjohn-Mylan Merger * The Daily Biotech Pulse: T2 Biosystems Licenses COVID-19 Test, Immuron CEO Steps Down * Novavax Shares Rally On Flu Vaccine Study Results: What You Need To Know(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

French drugmaker Sanofi (SNY) said that the U.S. would likely get its Covid-19 vaccine first once it is available.“The U.S. government has the right to the largest pre-order because it’s invested in taking the risk,” Sanofi CEO Paul Hudson said in an interview with Bloomberg News. The U.S., which expanded a vaccine partnership with the company in February, expects “that if we’ve helped you manufacture the doses at risk, we expect to get the doses first.”Hudson cautioned that Europe needs to step up efforts to find protection against the pandemic if it doesn’t want to fall behind.Last month Sanofi entered into a collaboration with GlaxoSmithKline (GSK) to jointly develop an adjuvanted vaccine for COVID-19. The two companies said they expected a candidate vaccine to enter Phase 1 clinical trials in the second half of 2020 and, if successful, they plan to make it available in the second half of 2021. The vaccine candidate is being supported through funding by the U.S. Biomedical Advanced Research and Development Authority (BARDA).While funding from the Biomedical Advanced Research and Development Authority puts the U.S. first in line, the country may be only days or weeks ahead of everyone else, Hudson said.“I’ve been campaigning in Europe to say the U.S. will get vaccines first,” Hudson said. “That’s how it will be because they’ve invested to try and protect their population, to restart their economy.”Sanofi also announced that it is in talks with the European Union and the French and German governments to accelerate regional vaccine development.Separately to its GSK collaboration, Sanofi’s vaccines division Sanofi Pasteur in March partnered with Translate Bio (TBIO) for the development of a messenger RNA (mRNA) vaccine against Covid-19.Shares in Sanofi were down 2.3% to $47.20 in pre-market U.S. trading. The stock has soared 27% in the past two months.TipRanks data shows that Goldman Sachs and Argus Research both have a Buy rating on the stock. The $56 price target set by Argus Research reflects 16% upside potential in the shares in the coming 12 months. (See Sanofi stock analysis on TipRanks).Related News: Gilead Signs Remdesivir Licensing Agreements With Five Drugmakers Allogene Explodes 28% After-Hours On Initial ALLO-501 Data Moderna’s COVID-19 Vaccine Candidate Progressing at ‘Warp Speed,’ Says Top Analyst More recent articles from Smarter Analyst: * Twilio To Power New York’s COVID-19 Contact Tracing Initiative; Shares Jump 7.5%   * NBA In Talks With Disney To Reopen Season At Disney World In July * GM Delays Some Production Shifts At 3 U.S. Truck Plants - Report * Gilead’s Remdesivir Most ‘Beneficial’ In Covid-19 Patients Who Need Extra Oxygen, Study Shows

Shares in Translate Bio (TBIO) surged 24% on Friday, after Sanofi (SNYNF) made several positive comments about the outlook for their joint coronavirus vaccine program. In late March, Sanofi added a second program to develop an mRNA vaccine candidate in collaboration with Translate Bio.During Sanofi’s first quarter earnings call, company CEO Paul Hudson stated that the two companies are targeting initial clinical studies in Q4 2020, aiming for approval in late 2021. “I can’t stress enough from that point” he added.“Our collaboration partner Translate Bio has significant investment in mRNA capacity in place today already that can be applied towards the vaccine. And we’re scaling up from a current capacity up to 360 million doses by H1 2021” said Hudson.According to Hudson “Our mRNA vaccine approach provides a second shot on goal based on innovative technology with the potential for accelerated development.”As the CEO pointed out although others have moved into the clinic with mRNA vaccines faster, it’s unclear how soon these other mRNA vaccines can be produced at the industrial scale required.“Now, there is a lot of activity in the vaccine sector and I think the WHO [World Health Organization] last count was 76 active COVID-19 vaccine projects. Let’s be really honest, very few of the sponsors of those 76 programs have the expertise or the capacity to produce a vaccine at required scale” he said.In contrast, as one of the world vaccine leaders, Sanofi already boasts over 10,000 people producing over a billion doses of its own vaccine portfolio.Overall Sanofi receives a Strong Buy Street consensus, while Translate Bio shows a more cautiously optimistic Moderate Buy analyst consensus. That’s with a $21.50 average analyst price target indicating upside potential of 68%. (See Translate Bio stock analysis on TipRanks).Most recently Roth Capital’s Anthony Butler published a buy rating on TBIO with a $25 price target explaining that Translate sees its scalable mRNA platform “deliver[ing] vaccine doses in the hundreds of millions which is essential for an effective pandemic response.”Related News: Gilead’s Remdesivir US Trial Currently Ahead of Schedule- Reuters Gilead Dips on Leaked Trial Data Showing No ‘Benefit’ of Antiviral Drug Inovio Pharmaceuticals (INO) Stock Is up 65% in a Month. How Much Higher Can It Go? More recent articles from Smarter Analyst: * Can Seanergy Maritime Stock Add 150% Over the Next Year? This Analyst Says 'Yes' * Disney (DIS): Is It Time to Buy? * JPMorgan: 3 Stocks That Could Surge Over 30% * 3 Big Dividend Stocks Yielding at Least 10%; Maxim Says ‘Buy’

Translate Bio stock initially rose Friday after the biotech company inked a deal with Sanofi to develop a coronavirus vaccine using messenger RNA. The two companies began partnering in 2018.

Sanofi Pasteur, the vaccines global business unit of Sanofi (EURONEXT: SAN and NASDAQ: SNY), and Translate Bio (TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company will collaborate to develop a novel mRNA vaccine for COVID-19. Translate Bio has begun to produce multiple mRNA constructs and will use its mRNA platform to discover, design and manufacture SARS-CoV-2 vaccine candidates. Sanofi will provide deep vaccine expertise and support from its external research networks to advance vaccine candidates for potential further development.

Translate Bio, Inc. (TBIO) delivered earnings and revenue surprises of -33.33% and 27.00%, respectively, for the quarter ended December 2019. Do the numbers hold clues to what lies ahead for the stock?

Stock price gains about 40% in 2 weeks Continue reading...

Investors seem to like company’s chances, driving stock up 60% in the past 3 weeks Continue reading...

Renowned guru slims position in biotech company that focuses on kidney disease Continue reading...

Translate Bio Inc (TBIO) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Translate Bio (TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today announced that Ronald Renaud, chief executive officer, will participate in a fireside chat at the Jefferies Virtual  Healthcare Conference on Wednesday, June 3, 2020, at 1:00 p.m. ET. Translate Bio is a clinical-stage mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Translate Bio is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease.

Translate Bio stock rose Friday after the biotech company inked a deal with Sanofi to develop a coronavirus vaccine using messenger RNA. The two companies began partnering in 2018.

Translate Bio (TBIO) gains on collaboration with Sanofi for a mRNA vaccine development for COVID-19.

Diagnostic testing, treatment, and a coronavirus vaccine could allow near-normal distancing and nonessential business recovery by mid-2021.

Companies hope to begin human testing by year end Continue reading...

-- Pursuing development of mRNA vaccine against COVID-19 through expanded collaboration with Sanofi Pasteur -- -- Existing large-scale manufacturing capacity expected to.