In­ter­cept Phar­ma­ceu­ti­cals has an­oth­er date with the FDA, as the reg­u­la­tor will de­cide for a sec­ond time whether to ap­prove the biotech’s drug for pa­tients with pre-cir­rhot­ic liv­er fi­bro­sis due to non­al­co­holic steato­hep­ati­tis, or NASH.

The agency set an ac­tion date of June 22. FDA said no around the same time in 2020.

At stake is an ac­cel­er­at­ed ap­proval for obeti­cholic acid, or OCA, which is al­ready on the mar­ket for pri­ma­ry bil­iary cholan­gi­tis. In­ter­cept and ex-US rights own­er Ad­vanz mar­ket the drug as Ocali­va for the bile duct-de­stroy­ing dis­ease.

The drug de­vel­op­er tout­ed two in­ter­im analy­ses from the Phase III RE­GEN­ER­ATE study, which has brought mixed re­sults in the past four years. The once-dai­ly 25 mg group ex­pe­ri­enced a win on the pri­ma­ry end­point at an 18-month analy­sis, In­ter­cept said last Ju­ly, tout­ing 22.4% of pa­tients saw at least one stage of fi­bro­sis im­prove­ment with­out wors­en­ing of the fat­ty liv­er dis­ease. The place­bo group was 9.6%.

Pa­tients in the 10 mg group didn’t have the same ex­pe­ri­ence. That por­tion of the tri­al did not meet the pri­ma­ry end­point. On a sec­ond pri­ma­ry end­point, In­ter­cept said the drug didn’t meet the bar on res­o­lu­tion of NASH with no wors­en­ing of liv­er fi­bro­sis. At the time, Jef­feries an­a­lysts said it wasn’t a sur­prise.

Then, in Sep­tem­ber, In­ter­cept re­port­ed a fail on an­oth­er Phase III tri­al of the drug in NASH. The study, dubbed RE­VERSE, was not men­tioned in In­ter­cept’s Thurs­day morn­ing press re­lease an­nounc­ing the FDA’s ac­cep­tance of the NDA.

With safe­ty da­ta on near­ly 2,500 pa­tients, in­clud­ing 1,000 on the drug for four years, In­ter­cept con­tin­ues to think it can be the first to mar­ket with a NASH drug.

“This reg­u­la­to­ry mile­stone brings us one step clos­er to reach­ing our goal of de­liv­er­ing the first avail­able ther­a­py for pa­tients liv­ing with pre-cir­rhot­ic fi­bro­sis due to NASH – the most rapid­ly grow­ing cause of liv­er trans­plan­ta­tion in the U.S.,” Jer­ry Dur­so, CEO and pres­i­dent of In­ter­cept, said in a state­ment.

Bio­phar­mas have long been tripped up by R&D in NASH, but read­outs in re­cent months might paint a rosier pic­ture in the near fu­ture, with Madri­gal say­ing it will file for ac­cel­er­at­ed ap­proval ear­ly this year af­ter a Phase III win that sent shares sky­rock­et­ing and led to a $300 mil­lion cap­i­tal in­fu­sion. Akero Ther­a­peu­tics al­so buoyed the NASH field with wins on pri­ma­ry and mul­ti­ple sec­ondary goals in its Phase IIb study last fall. Mean­while, Chemomab Ther­a­peu­tics said it cleared a mid-stage test but doesn’t have im­me­di­ate plans to stay in NASH be­cause of the costs as­so­ci­at­ed with Phase III stud­ies in the space.

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.