That oth­er mes­sen­ger RNA biotech uni­corn is look­ing to jump in­to Wall Street with an IPO that may seek a record $800 mil­lion and a val­u­a­tion of some $4 bil­lion.

Ugur Sahin, CEO, BioN­Tech

Bankers are buzzing that Bank of Amer­i­ca and JP Mor­gan have al­ready been tapped for the IPO on be­half of BioN­Tech, a Ger­man biotech that has at­tract­ed con­sid­er­able at­ten­tion for its role as a leader in the mR­NA field, ac­cord­ing to a re­port in Reuters.

Some­thing is bound to be go­ing on here. Reuters’ re­port comes a few weeks af­ter Bloomberg pub­lished a piece on the prospec­tive IPO for BioN­Tech, cit­ing a pos­si­ble val­u­a­tion of $5 bil­lion.

Mod­er­na blazed the IPO $MR­NA path for mR­NA a lit­tle more than 3 months ago, rais­ing $604 mil­lion in a his­toric of­fer­ing that quick­ly soured as its stock blew south. But that was just tem­po­rary. The stock lat­er climbed back up and now sits at $19.75 with a $6.5 bil­lion mar­ket cap.

Ear­ly this year Sanofi dou­bled down on its al­liance with the biotech, fronting an ex­pand­ed pact with $91 mil­lion in cash for im­munother­a­pies de­signed to go af­ter sol­id tu­mors. Ear­li­er Pfiz­er lined up a siz­able deal to de­vel­op an mR­NA flu vac­cine, of­fer­ing cash for an up­front and eq­ui­ty. And a lit­tle more than a year ago BioN­Tech came up with a $270 mil­lion round, bring­ing its to­tal raise at the time to close to $1 bil­lion.

The ini­tial seed mon­ey was of­fered by the bil­lion­aire Strüng­mann broth­ers, who are the ma­jor­i­ty share­hold­ers.

The IPO win­dow re­mains open for biotechs, but af­ter a big string of new of­fer­ings in 2018, the gen­er­al con­sen­sus is that there will be a de­cline in the num­ber of com­pa­nies mak­ing the leap on­to the pub­lic stage.

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.