Oramed Phar­ma­ceu­ti­cals’ quest to de­vel­op an in­sulin pill for Type II di­a­betes just got stonewalled.

The biotech said its Phase III tri­al test­ing the oral in­sulin cap­sule OR­MD-0801 failed to im­prove glycemic con­trol com­pared to place­bo. The tri­al didn’t meet its pri­ma­ry end­point, which mea­sured the mean change in A1C, a blood sug­ar lev­el test, from base­line af­ter half a year.

The biotech’s stock $ORMP fell by over 70%, from $10.79 at Wednes­day’s clos­ing to less than $3 a share Thurs­day morn­ing.

The Phase III tri­al al­so did not meet a sec­ondary end­point look­ing at a dif­fer­ent blood sug­ar test — fast­ing plas­ma glu­cose — which mea­sured the amount of glu­cose in the blood of par­tic­i­pants who haven’t eat­en for at least eight hours.

As a re­sult, Oramed plans to dis­con­tin­ue de­vel­op­ment of its in­sulin pill for Type II di­a­betes, it said in a press re­lease. Oramed CEO Na­dav Kidron said in a state­ment, “To­day’s out­come is very dis­ap­point­ing, giv­en the pos­i­tive re­sults from pri­or tri­als. Once full da­ta from the stud­ies are avail­able, we ex­pect to share rel­e­vant learn­ings and fu­ture plans.”

The biotech had been de­vel­op­ing the pill as an eas­i­er way of de­liv­er­ing in­sulin, as op­posed to through a nee­dle or pump. Oramed says its cap­sule can pro­tect the in­sulin from the harsh pH and en­zymes of the gut, and can help it get ab­sorbed through the in­testi­nal wall. An­oth­er biotech, i2o Ther­a­peu­tics, which is part­nered with J&J and Sanofi, is like­wise work­ing on an oral de­liv­ery method that can pro­tect treat­ments from the caus­tic gut en­vi­ron­ment. And one of the in­di­ca­tions it’s work­ing to­wards is al­so Type II di­a­betes.

Oramed is al­so test­ing its oral in­sulin treat­ment for NASH and has an oral GLP-1 ana­log in ear­ly-stage stud­ies, ac­cord­ing to its web­site. Oramed com­plet­ed a Phase II for its oral in­sulin in NASH in No­vem­ber, but the study was not pow­ered to look at sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ences be­tween treat­ment groups.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”