A tough year for mes­enchy­mal stem cell com­pa­nies just got tougher.

Pluris­tem, the NASA-al­lied Is­raeli stem cell biotech, an­nounced Mon­day that a da­ta mon­i­tor­ing com­mit­tee de­ter­mined the Phase III tri­al for a lead pro­gram wouldn’t meet the pri­ma­ry end­point. The com­pa­ny will aban­don the ef­fort, which had fo­cused on pre­vent­ing am­pu­ta­tions in peo­ple with crit­i­cal limb is­chemia.

They blamed a low num­ber of am­pu­ta­tions in the place­bo group, which they ar­gued made it more dif­fi­cult to prove that their stem cells were pro­vid­ing a ben­e­fit.

Pluris­tem’s stock $PSTI was cut near­ly in half on the news, falling from $11.46 to $6.60 pre-mar­ket.

The hit makes Pluris­tem the sec­ond mes­enchy­mal de­vel­op­er to take a beat­ing on the mar­ket this year, af­ter the Aus­tralia-based Mesoblast $MESO saw shares drop off in Au­gust. They had risen in an­tic­i­pa­tion of an FDA de­ci­sion on their graft-ver­sus-host-dis­ease ap­pli­ca­tion, and fell when the agency de­liv­ered a CRL.

Mesoblast re­cov­ered, though, af­ter No­var­tis bought in­to their ef­fort to ap­ply their stem cells in peo­ple with se­vere Covid-19 and oth­er pa­tients with acute res­pi­ra­to­ry dis­tress syn­drome.

Yaky Yanay

Pluris­tem has its own Covid-19 pro­gram — one of over a dozen such ef­forts in the US to use stem cells as a way of mod­u­lat­ing the over­ac­tive im­mune re­sponse in se­vere pa­tients — and CEO Yaky Yanay sought to turn at­ten­tion to it on a call with in­vestors Wednes­day morn­ing.

He not­ed that they were like­ly to com­plete en­roll­ment in the first quar­ter of 2021 and an­nounce da­ta around 60 days lat­er. He al­so point­ed to read­outs next year in mus­cle re­gen­er­a­tion fol­low­ing hip frac­ture and in pa­tients ex­pe­ri­enc­ing in­com­plete hematopoi­et­ic re­cov­ery fol­low­ing hematopoi­et­ic cell trans­plan­ta­tion.

Asked, though, about their work in in­ter­mit­tent clau­di­ca­tion, a con­di­tion that af­fects the ar­ter­ies and can progress to crit­i­cal limb is­chemia, Yanay made clear they were mov­ing on. He said that they would de­vote their ef­forts to in­di­ca­tions where they be­lieve they have the best chance of suc­ceed­ing.

But not every­one agrees that Covid is one of those in­di­ca­tions. Mes­enchy­mal stem cells, short-lived stem cells that can pass through the body safe­ly, have been in the clin­ic for two decades in a range of dis­eases, but re­searchers have strug­gled to show ben­e­fits in large, place­bo-con­trolled stud­ies

“In a way, it’s like giv­ing as­pirin for Covid,” Jeanne Lor­ing, an ear­ly stem cell pi­o­neer and a pro­fes­sor emer­i­tus at the Scripps Re­search Cen­ter for Re­gen­er­a­tive Med­i­cine told End­points News in Sep­tem­ber. “It’s not go­ing to hurt them, but the chances of it help­ing them? It’ll be a mir­a­cle.”

So­cial im­age: Yaky Yanay, Pluris­tem (Twit­ter)

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.