For 13 years, the Cana­di­an biotech Cor­re­vio tried to get the FDA to ac­cept a heart drug since aban­doned by Mer­ck and Astel­las. Yes­ter­day, the agency’s out­side ex­perts vot­ed 11-2 against ap­proval, all but as­sur­ing an­oth­er re­jec­tion for the atri­al fib­ril­la­tion com­pound ver­nakalant.

Mark Cor­ri­g­an

And to­day Cor­re­vio an­nounced that Cor­re­vio may soon be no more. The com­pa­ny said it is look­ing to sell it­self as its stock plum­mets in­to pen­ny-stock ter­ri­to­ry $CORV and its po­ten­tial mon­ey­mak­er sput­ters once more.

“It is in the best in­ter­est of our stake­hold­ers to ex­pand our in­ter­nal cor­po­rate de­vel­op­ment ef­forts and for­mal­ly eval­u­ate strate­gic al­ter­na­tives for the com­pa­ny,” CEO Mark Cor­ri­g­an said in state­ment.

Ver­nakalant could have made Cor­re­vio up to $150 mil­lion per year if ap­proved, ac­cord­ing to Bloom Bur­ton an­a­lyst David Mar­tin. Then known as Car­diome, the biotech had first tried to get the drug ap­proved in 2006. When the FDA re­ject­ed them in 2008, they planned an­oth­er Phase III tri­al.

That Phase III came to a halt when the FDA slapped a hold over a pa­tient death, bur­nish­ing safe­ty con­cerns that prompt­ed the first re­jec­tion and were front and cen­ter in yes­ter­day’s FDA out­side re­view.

The drug is ap­proved in Eu­rope, Cana­da and oth­er coun­tries. Even with sales from that and oth­er drugs, in­clud­ing two an­tibi­otics, Cor­re­vio post­ed $10.8 mil­lion in loss­es last quar­ter.

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.