Fol­low­ing the ad­vice of a pan­el of out­side ex­perts, the FDA has turned down a po­ten­tial Covid-19 drug that on­ly had da­ta from a small tri­al.

Mi­a­mi, FL-based Veru had re­pur­posed a mi­cro­tubule dis­rup­tor called sabiz­ab­u­lin, which it had been test­ing in can­cer, to treat hos­pi­tal­ized adult pa­tients with mod­er­ate to se­vere Covid-19 who are at high risk for ARDS, or acute res­pi­ra­to­ry dis­tress syn­drome.

CEO Mitchell Stein­er sug­gest­ed that the FDA re­ject­ed the drug “be­cause of the pos­si­bil­i­ty of un­known in­flu­ences, or un­cer­tain­ties that may have af­fect­ed the study.” The com­pa­ny not­ed that the agency of­fered com­ments for a pro­posed con­fir­ma­to­ry Phase III.

Shares $VERU fell more than 30% in pre-mar­ket trad­ing to $2.55.

To sup­port its EUA, Veru sub­mit­ted da­ta from 204 pa­tients hos­pi­tal­ized with Covid. It stopped the tri­al ear­ly be­cause of clin­i­cal ben­e­fit.

In brief­ing doc­u­ments pre­pared ahead of an ad­vi­so­ry com­mit­tee, the FDA had spelled out its con­cerns with the piv­otal da­ta that Veru sub­mit­ted. It ac­knowl­edged that sabiz­ab­u­lin hit the mark on mor­tal­i­ty in the small tri­al, but not­ed un­cer­tain­ties or im­bal­ances that, while not prob­lem­at­ic in­di­vid­u­al­ly, “raise ques­tions about the re­sults.”

FDA’s Pul­monary-Al­ler­gy Drugs Ad­vi­so­ry Com­mit­tee gen­er­al­ly of­fered sup­port, with some qualms, on the sur­vival da­ta. Yet when it came to rec­om­mend­ing an OK, the ad­comm mem­bers large­ly ar­gued that there weren’t enough safe­ty and ef­fi­ca­cy da­ta, un­der­stand­ing of the drug was still lim­it­ed, and that the demon­strat­ed ben­e­fits don’t out­weigh the risks. Vot­ing 8 to 5 against its au­tho­riza­tion, many asked for a new tri­al.

Treat­ment op­tions for Covid-19 re­main lim­it­ed, with many of the new ther­a­pies — from an­ti­bod­ies to an­tivi­rals — in mild-to-mod­er­ate set­tings. For hos­pi­tal­ized pa­tients, the FDA has cleared sev­er­al an­ti-in­flam­ma­to­ry drugs, in­clud­ing Actem­ra, Olu­mi­ant and Kineret.

Veru said it re­mains com­mit­ted to de­vel­op­ing sabiz­ab­u­lin for the high-risk pa­tient pop­u­la­tion, and added that the drug is un­der reg­u­la­to­ry re­view in oth­er coun­tries.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Bluebird bio had expected to submit a BLA for its sickle cell disease gene therapy lovotibeglogene autotemcel, or lovo-cel, by Friday. Now, that deadline is getting punted for at least a couple of weeks.

CEO Andrew Obenshain detailed the update during the company’s full-year earnings call Wednesday morning after the gene therapy specialist reported the development in its Q4 and 2022 report.

“We will likely miss the Q1 2023 submission goal,” Obenshain said, noting the application is fully written and ready to go. But bluebird is still waiting on FDA feedback for the company’s CMC module submitted in early March.