Durect’s shares are crash­ing again.

Two years af­ter a No­var­tis-part­nered Phase III flop sent them in­to pen­ny stock ter­ri­to­ry, Durect has failed an­oth­er tri­al for a top can­di­date. This time, though, the biotech may have bet­ter fall­back op­tions.

DUR-928, the lead drug in Durect’s epi­ge­net­ic reg­u­la­tor pro­gram, was test­ed in 28 plaque pso­ri­a­sis pa­tients. Each pa­tient served as their own con­trol, with the drug ad­min­is­tered to one arm and the place­bo ad­min­is­tered to the oth­er. The good news was that there was no mean­ing­ful dif­fer­ence in ad­verse ef­fects be­tween the two arms. The bad news was there didn’t seem to be much of a dif­fer­ence at all, as DUR-928 “did not demon­strate a ben­e­fit over ve­hi­cle (place­bo)” and missed all pri­ma­ry and sec­ondary end­points.

Durect’s shares $DR­RX, which had been ris­ing for months, fell 34% to $2.50.

Durect an­nounced it is dis­con­tin­u­ing the top­i­cal pso­ri­a­sis pro­gram, but that is on­ly one of the three in­di­ca­tions in which the biotech is test­ing DUR-928. They al­so have an in­jectable form of the drug in Phase II for al­co­holic he­pati­tis and an oral form in Phase I for non­al­co­holic steato­hep­ati­tis, bet­ter known as NASH. Pos­i­tive re­sults came out for the al­co­holic he­pati­tis pro­gram in No­vem­ber; pa­tients in the treat­ment arm saw a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in biliru­bin, the yel­low sub­stance in bile that gives pa­tients the well-known jaun­diced look.

The tri­al fail­ure comes as the biotech pre­pares for a key reg­u­la­to­ry date for the No­var­tis-part­nered drug, a post-op­er­a­tion non-opi­oid pain drug now called Posimir. The drug has had a rocky his­to­ry, in­clud­ing a 2012 tri­al fail­ure, a 2014 CRL from the FDA, and a 2016 re­quest from the agency to change their tri­al de­sign, help­ing lead to the 2017 fail­ure.

Durect re­spond­ed to the CRL this past June, repack­ag­ing their orig­i­nal sub­mis­sion to fo­cus on six tri­als. It’s not yet clear what the FDA will say, but the new sub­mis­sion con­vinced the agency to de­lay an ear­ly PDU­FA date of De­cem­ber 27 and give the biotech an ad­comm meet­ing for lat­er this month.

The Durect pro­gram with the most po­ten­tial, though, may end up be­ing their long-act­ing in­jectable HIV can­di­date, part of their SABER plat­form. Gilead paid $25 mil­lion up­front and promised mil­lions more in mile­stones to latch on­to that plat­form. They op­tioned the HIV drug in Sep­tem­ber for a $10 mil­lion pay­ment.

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.”

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.

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.

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.”

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.