An oft-trou­bled pro­gram at San­thera Phar­ma­ceu­ti­cals {SWX: $SANN} is head­ed for the chop­ping block.

The Swiss biotech an­nounced Tues­day morn­ing that it is dis­con­tin­u­ing a Phase III study for idebenone in pa­tients with Duchenne mus­cu­lar dy­s­tro­phy and re­ceiv­ing steroid treat­ment. In a re­lease, San­thera said that the tri­al failed an in­ter­im analy­sis, and as a re­sult will pull its EMA ap­pli­ca­tion and end glob­al de­vel­op­ment.

San­thera will al­so re­struc­ture its busi­ness plans to fo­cus on a sep­a­rate DMD can­di­date, va­morolone.

“While this is ob­vi­ous­ly not the out­come we ex­pect­ed, all our ef­forts in DMD will now be fo­cused on pro­gress­ing the promis­ing drug can­di­date va­morolone, which we re­cent­ly li­censed from Rever­a­Gen to its next in­flec­tion point,” CEO Dario Ek­lund said in a state­ment.

With the news, the biotech’s stock price cratered more than 43% as the Swiss stock ex­change opened, but has since lev­eled off to falling about 25 to 30%.

Idebenone was de­signed to im­prove lung func­tion in pa­tients by en­er­giz­ing weak­ened mus­cle cells, and the pri­ma­ry end­point for the Phase III tri­al sought to demon­strate an im­prove­ment in de­lay­ing the loss of res­pi­ra­to­ry func­tion af­ter 18 months. Though there were no safe­ty con­cerns not­ed by the tri­al in­ves­ti­ga­tors, the like­li­hood of meet­ing that end­point was deemed too small to mer­it con­tin­u­ing the tri­al. San­thera has not shared ex­act­ly what da­ta prompt­ed the shut­down.

Tues­day marks the end of an era as idebenone faced sev­er­al set­backs in its even­tu­al road to nowhere. San­thera orig­i­nal­ly ap­plied for US ap­proval back in 2016, but the FDA swat­ted down its ap­pli­ca­tion and asked for a con­fir­ma­to­ry tri­al — the tri­al which has now been ter­mi­nat­ed. At the time, that move proved con­sis­tent with the agency’s his­to­ry of pump­ing the brakes on com­pa­nies like Sarep­ta seek­ing swift OKs in the DMD field.

But idebenone al­so ran in­to trou­ble in Eu­rope when reg­u­la­tors shot down a la­bel ex­pan­sion in­to DMD in 2017 and an ap­peal in 2018. Ap­proved on the con­ti­nent as Rax­one to treat Leber’s hered­i­tary op­tic neu­ropa­thy, the drug al­so failed an NIH-backed mul­ti­ple scle­ro­sis tri­al in March 2018 af­ter show­ing no dif­fer­ence from a place­bo.

With a re­newed fo­cus on va­morolone, San­thera is not giv­ing up its DMD ef­forts. The com­pound is cur­rent­ly in a Phase IIb tri­al look­ing to mea­sure im­prove­ment in time to stand over base­line af­ter 24 weeks. This tri­al en­rolled DMD pa­tients that are not tak­ing steroid treat­ments, and San­thera says va­morolone has the po­ten­tial to be an al­ter­na­tive to such ther­a­pies al­to­geth­er by slow­ing dis­ease progress with­out steroidal side ef­fects.

In ear­ly Sep­tem­ber, San­thera picked up glob­al rights to va­morolone af­ter sign­ing on to an op­tion from Rever­a­Gen and Idor­sia in 2018.

The re­struc­tur­ing will al­so al­low San­thera to fo­cus on lon­ode­le­stat for cys­tic fi­bro­sis and oth­er lung dis­eases, as well as its dis­cov­ery-stage gene ther­a­py ap­proach for con­gen­i­tal mus­cu­lar dy­s­tro­phy.

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.”