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.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.