Af­ter fly­ing high on Wall Street for the last few months of a pan­dem­ic, Biond­Vax’s stock and dreams of get­ting ap­proval for its uni­ver­sal flu vac­cine hit the wind­shield.

The Jerusalem-based biotech an­nounced on Fri­day that its on­ly clin­i­cal can­di­date, M-001, failed both pri­ma­ry and sec­ondary end­points in a Phase III study. There was no sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in re­duc­tion of flu ill­ness and sever­i­ty be­tween the vac­cine and place­bo groups, ac­cord­ing to the com­pa­ny. The vac­cine did prove safe, if in­ef­fec­tive, Biond­Vax said.

The news sent Biond­Vax’s stock plum­met­ing 85%, clos­ing at $5.20 per share. The day be­fore, shares closed at $37.88 apiece. For the last few years, the biotech’s share val­ue lin­gered around $5 to $7 per share. Prices be­gan to rise in Jan­u­ary, then surged from April to Ju­ly, like­ly due to the pan­dem­ic. On Ju­ly 14, they peaked at $48.25 apiece. Ever­core ISI an­a­lyst Josh Schim­mer pre­dict­ed back in March that all vac­cine de­vel­op­ers — not just those fo­cused on Covid-19 — would prof­it from the health cri­sis, list­ing $BVXV among the po­ten­tial win­ners.

Biond­Vax’s Phase III tri­al in­clud­ed 12,463 adults ages 50 and up: “the group most ur­gent­ly in need of im­proved pro­tec­tion from the flu,” CSO Tamar Ben-Yedidia said in a state­ment. The can­di­date, de­signed as a com­mon de­nom­i­na­tor to in­fluen­za A and B virus­es, was stud­ied over the course of two flu sea­sons, be­gin­ning in 2018. Each par­tic­i­pant was mon­i­tored for just one flu sea­son.

Ron Babecoff

There was no sug­ar-coat­ing the find­ings. “We are dis­ap­point­ed with these re­sults …” founder, pres­i­dent and CEO Ron Babecoff said be­fore he went on to thank the team for 15 years of “ded­i­ca­tion and pas­sion.”

“Un­for­tu­nate­ly, this study did not have the ef­fi­ca­cy out­comes that we an­tic­i­pat­ed for M-001 on a stand­alone ba­sis. We have ob­served in sev­en pre­vi­ous stud­ies that M-001 safe­ly pro­voked an im­mune re­sponse to a broad range of flu strains, but ul­ti­mate­ly this was not suf­fi­cient on a stand­alone ba­sis to show pro­tec­tion,” Babecoff said in the state­ment.

It’s not look­ing good for the biotech, which said it’s “ex­am­in­ing op­tions to max­i­mize the val­ue” of its as­sets, in­clud­ing IP and a state-of-the-art man­u­fac­tur­ing fa­cil­i­ty.

Back in June, Biond­Vax met both pri­ma­ry end­points in a Phase II tri­al sup­port­ed by the NI­AID. The com­pa­ny had an­nounced that the can­di­date “in­duced sig­nif­i­cant poly­func­tion­al T cell re­spons­es” — but it wasn’t enough to clear Phase III.

Oth­er play­ers in search of the Holy Grail in­clude Vac­citech, which be­gan dos­ing par­tic­i­pants in a Phase IIb study last June, and the NIH, which un­veiled a can­di­date head­ed for the clin­ic last April.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.