Iterum knew its odds were slim as it awaited an FDA ruling on a key urinary tract infection drug with its bank account running low. The FDA, however, wasn’t impressed, and Iterum’s days look numbered.

The FDA has sent the tiny biotech a complete response letter for the antibiotic sulopenem, shutting down hopes at getting the oral medication across the finish line, the drugmaker revealed Monday.

Little Tonix Pharmaceuticals has run into another brick wall as its lead drug — a reformulated muscle relaxant originally approved 44 years ago — has failed another Phase III study, sending shares back into penny stock territory.

Three years after going down in their first Phase III trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for symptoms of PTSD, the biotech — which had been encouraged by a breakthrough designation at the FDA — reported late Friday the drug also failed its second late-stage challenge for pain associated with fibromyalgia. Outside data monitors recommended the Phase III trial be halted for futility after deciding interim data made it unlikely the drug would pass muster.

Bristol Myers Squibb has agreed to pull a second-line liver cancer indication for its blockbuster Opdivo as a monotherapy, becoming the second PD-(L)1 indication to bite the dust after the FDA’s oncology adcomm reviewed six “dangling” accelerated approvals in April.

The outside experts voted against two of the six indications discussed at the meeting, including Opdivo as a monotherapy for hepatocellular carcinoma (HCC) patients who have previously been treated with sorafenib, and Merck’s Keytruda as a third-line treatment for stomach cancer. The adcomm voted 5 to 4 not to maintain Opdivo’s indication, after it failed to show clinical benefit in a confirmatory trial.

A combination of unvaccinated Americans and the Delta variant has led a frustrated NIAID director Anthony Fauci to say the US is headed in the wrong direction, he said on CNN’s show “State of the Union.”

Booster shots may be required for those with suppressed immune systems and public health officials are considering a mask recommendation for those who are already vaccinated, the Associated Press reported. More than 163 million people are vaccinated, but that number is less than half of the US population. And 57% of those who are eligible for the vaccine have been inoculated.

It appears the PD-(L)1 honeymoon is finally over.

Incyte $INCY revealed late Friday the FDA has slammed its PD-1 retifanlimab — which was under priority review for locally advanced or metastatic squamous cell carcinoma of the anal canal — with a complete response letter, demanding “additional data” to show clinical benefit.

On one hand, the rejection should come as no surprise: Regulators spelled out the problems they saw with Incyte’s data package in no uncertain terms, raising concerns about the low response rates, lack of diversity and dearth of safety data in the single-arm trial. During the ensuing adcomm, the FDA’s cancer czar, Richard Pazdur, suggested the whole episode underscores the need to “reassess” how drugs get approved under the accelerated approval pathway without randomized studies.