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.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.