For as long as it’s ex­ist­ed — since 2007 and count­ing — Ake­bia has al­ways billed it­self as a kid­ney dis­ease spe­cial­ist. But as it grap­ples with a cost­ly FDA re­jec­tion of its lead ane­mia drug, the biotech is do­ing what­ev­er it can to stay afloat.

And that could mean hold­ing on­to a Covid-19 pro­gram even af­ter fail­ing a tri­al.

Re­port­ing ini­tial find­ings from a study test­ing vadadu­s­tat, its once-re­ject­ed ane­mia drug, for the pre­ven­tion and treat­ment of acute res­pi­ra­to­ry dis­tress syn­drome in pa­tients with Covid-19 and hy­pox­emia, Ake­bia said the drug failed the pri­ma­ry end­point, as mea­sured by the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­ease Or­di­nal Scale.

But, ac­cord­ing to the biotech, the drug on­ly missed the goal by a hair: While the pri­ma­ry su­pe­ri­or­i­ty thresh­old over place­bo was set at 95%, re­searchers cal­cu­lat­ed a 94% prob­a­bil­i­ty that their drug was bet­ter than place­bo. And that means they won’t throw in the tow­el just yet.

“While the tri­al missed its pre­spec­i­fied pri­ma­ry end­point at Day14, we are ex­treme­ly en­cour­aged by the da­ta and be­lieve they sup­port fur­ther de­vel­op­ing vadadu­s­tat as a treat­ment for ARDS due to COVID-19 or oth­er caus­es,” CEO John But­ler said in a state­ment. “We will now work to re­view the full da­ta set more thor­ough­ly, con­sult with ex­perts in the field and ul­ti­mate­ly con­sult FDA on a po­ten­tial path for­ward.”

The tri­al was con­duct­ed by the Uni­ver­si­ty of Texas Health Sci­ence Cen­ter and par­tial­ly fund­ed by Ake­bia. It en­rolled 449 pa­tients.

Ake­bia has been grap­pling with a cas­cade of set­backs that be­gan in March, when the FDA served up a com­plete re­sponse let­ter to its ap­pli­ca­tion for vadadu­s­tat in ane­mia due to chron­ic kid­ney dis­ease. Reg­u­la­tors were con­cerned with safe­ty, specif­i­cal­ly in­creased risk of throm­boem­bol­ic events, and asked Ake­bia to do an­oth­er tri­al.

Just days af­ter the slap­down, the agency is­sued a par­tial clin­i­cal hold on the drug’s pe­di­atric stud­ies, trig­ger­ing a ma­jor round of lay­offs. Then in May, Ot­su­ka called off its years­long li­cens­ing and co-de­vel­op­ment pact with Ake­bia, quash­ing hopes of earn­ing more than $1 bil­lion in fu­ture mile­stones.

Ex­ecs are now bet­ting that rev­enues from their on­ly mar­ket­ed drug, Au­ryx­ia, will fund the com­pa­ny for the next few years while they try to turn things around by seek­ing Eu­ro­pean ap­proval of vadadu­s­tat and find­ing a new part­ner.

Shares $AK­BA, which al­ready nose­dived in­to pen­ny stock, slipped some more to $0.40 in pre-mar­ket trad­ing.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.