Hav­ing qui­et­ly launched its own mR­NA vac­cine ef­forts against the nov­el coro­n­avirus to match the high­er pro­file cam­paigns of Mod­er­na and Cure­Vac, Ger­many’s BioN­Tech has of­fered a glimpse on its progress as it un­veils an al­liance with a promi­nent Chi­nese play­er.

Ugur Sahin

Fo­s­un Phar­ma will team up with BioN­Tech to con­duct tri­als of its Covid-19 vac­cine, BNT162, in Chi­na. To get on board, Fo­s­un bought $50 mil­lion worth of BioN­Tech eq­ui­ty $BN­TX and promised up to $85 mil­lion more in pay­ments.

In a sep­a­rate state­ment, BioN­Tech said it plans to ini­ti­ate clin­i­cal test­ing in late April, rolling out a glob­al de­vel­op­ment pro­gram in Eu­rope (start­ing in Ger­many), the US and Chi­na.

Shares surged 39.02% to $43 in pre-mar­ket trad­ing, buck­ing the down­ward trend in a tur­bu­lent mar­ket (the Nas­daq Biotech In­dex is al­so trad­ing up).

While Fo­s­un has rights to com­mer­cial­ize the re­sult­ing vac­cine in Chi­na, BioN­Tech is still ex­plor­ing what to do in the rest of the world. It’s in “ad­vanced dis­cus­sions” with Pfiz­er around that — echo­ing com­ments made by its phar­ma part­ner ear­li­er this month.

The deal marks the first pub­lic an­nounce­ments BioN­Tech has made on Pro­ject Light­speed, its de­vel­op­ment pro­gram in re­sponse to the vi­ral in­fec­tion that’s fast en­gulf­ing the world, since qui­et­ly dis­clos­ing the project ini­ti­a­tion in a Feb­ru­ary SEC fil­ing. As of Mon­day morn­ing, world­wide cas­es are edg­ing to­ward 170,000, with mul­ti­ple Eu­ro­pean coun­tries and parts of the US now on lock­down.

Like fel­low Ger­man biotech Cure­Vac — whom the US gov­ern­ment has re­port­ed­ly tried to lure in­to mov­ing state­side — BioN­Tech’s vac­cine ap­proach in­volves us­ing mR­NA to trick the body in­to pro­duc­ing a ver­sion of the SARS-CoV-2, which would then in­cite an im­mune re­sponse. Its man­u­fac­tur­ing part­ner Poly­mun will be in charge of pro­duc­ing a glob­al sup­ply out of fa­cil­i­ties in Eu­rope.

“In ad­di­tion, we are work­ing on a nov­el ther­a­peu­tics ap­proach for those pa­tients who have al­ready been in­fect­ed – we plan to dis­close more on that ef­fort in the com­ing weeks,” Ugur Sahin, founder and CEO, said in a state­ment.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.