In a rare move for any reg­u­la­tor, the Eu­ro­pean Med­i­cines Agency said Wednes­day it’s be­gun re­view­ing da­ta on the use of an ex­per­i­men­tal can­cer drug for treat­ing Covid-19, even though the Mi­a­mi-based spon­sor, Veru, has not sub­mit­ted an ap­pli­ca­tion.

The EMA re­view by its emer­gency task force fol­lows the re­lease of study re­sults ear­li­er this month show­ing the drug, known as sabiz­ab­u­lin, re­duced the risk of death by 55% in a study of 134 vol­un­teers hos­pi­tal­ized with Covid-19 who re­ceived sabiz­ab­u­lin and 70 who re­ceived place­bo. But ex­perts have been cau­tious about over­in­ter­pret­ing the re­sults, which were pub­lished in the NE­JM, par­tic­u­lar­ly as there have been very few ef­fec­tive treat­ments for those hos­pi­tal­ized with Covid.

Still, the tri­al showed that af­ter 60 days, 45.1% of those in the place­bo group died com­pared with just 20.2% of those who re­ceived the new drug, which amount­ed to a 55.2% rel­a­tive re­duc­tion in the risk of death. The In­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee unan­i­mous­ly halt­ed the study for over­whelm­ing ef­fi­ca­cy and safe­ty.

Mitchell Stein­er

Sabiz­ab­u­lin works by dis­rupt­ing mi­cro­tubules, which form part of the in­ter­nal skele­ton in cells, ac­cord­ing to the EMA, and which play a role in help­ing SARS-CoV-2 en­ter and leave cells. By bind­ing to parts of the mi­cro­tubules, sabiz­ab­u­lin is ex­pect­ed to in­ter­fere with the life cy­cle of the virus and lim­it its repli­ca­tion and spread.

The Veru drug, which is al­so un­der re­view in the US — for an EUA — and the UK, is the first to be trig­gered un­der Ar­ti­cle 18 of the new EU reg­u­la­tion that ex­pand­ed the role of the agency dur­ing pub­lic health emer­gen­cies.

Shares of Veru stock are up more than 170% over the last six months.

Mitchell Stein­er, chair­man, pres­i­dent, and CEO of Veru, said in a state­ment on Wednes­day:

COVID-19 in­fec­tions are sharply ris­ing in Eu­rope. Un­for­tu­nate­ly, the death rate in hos­pi­tal­ized pa­tients with mod­er­ate to se­vere COVID-19 who are at risk for ARDS re­mains un­ac­cept­ably high with cur­rent stan­dard of care. By re­duc­ing deaths in hos­pi­tal­ized COVID-19 pa­tients, sabiz­ab­u­lin has great po­ten­tial to play a crit­i­cal role in the bat­tle against COVID-19 in the EU. We are ex­cit­ed with this de­vel­op­ment at the EMA by the Emer­gency Task Force. We were just no­ti­fied yes­ter­day that sabiz­ab­u­lin trig­gered Ar­ti­cle 18.

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.