Ad­vax­is has tak­en its in­vestors on a bit of a roller coast­er ride this year.

The FDA slapped a clin­i­cal hold on a com­bo study of its lead drug ax­al­imo­gene filolis­bac and As­traZeneca’s Imfinzi in wake of a pa­tient death, which re­solved months lat­er af­ter a C-suite over­haul. Late Wednes­day, the New Jer­sey biotech added to the dra­ma by qui­et­ly dis­clos­ing that Am­gen has dropped their $540 mil­lion im­munother­a­py pact.

First inked in 2016 with $65 mil­lion up­front, the deal cen­tered around ADXS-NEO, which is de­signed to re­cruit a T cell at­tack on can­cer us­ing bio­engi­neered bac­te­ria. But Am­gen is re­turn­ing world­wide rights for de­vel­op­ment and com­mer­cial­iza­tion just as Ad­vax­is is en­rolling pa­tients for its proof-of-con­cept work — the last step be­fore Am­gen was sup­posed to take over.

The news sent shares $ADXS in­to a steep drop, plung­ing 28% in pre-mar­ket trad­ing.

With­out giv­ing any rea­sons for the ter­mi­na­tion, Ad­vax­is says it will now eval­u­ate whether to re-part­ner the ADXS-NEO pro­gram. Nei­ther com­pa­nies have re­spond­ed to my re­quests for com­ment.

Am­gen $AMGN will have un­til Feb­ru­ary 8, 2019 to tie up any loose ends.

In 2017 and 2018 Ad­vax­is has re­ceived $5.8 mil­lion and $7.5 mil­lion in re­im­burse­ments re­spec­tive­ly for an al­liance that once promised $475 mil­lion in mile­stones.

The biotech is al­so part­nered with Bris­tol-My­ers on an Op­di­vo com­bi­na­tion pro­gram for ax­al­imo­gene filolis­bac.

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”