Mi­a­mi biotech Longeveron has sold it­self to in­vestors on the promise of us­ing cell ther­a­py to im­prove the lives of ag­ing pa­tients un­able to walk for long dis­tances, but new da­ta don’t look promis­ing at all.

Longeveron’s lome­cel-B, a cell ther­a­py for ag­ing frailty, flopped the key six-minute walk test end­point of a Phase 2b tri­al of the drug, the biotech said Fri­day, and in­vestors weren’t pleased.

At 180 days, pa­tients re­ceiv­ing the drug post­ed no sig­nif­i­cant im­prove­ment on a walk test com­pared to place­bo, Longeveron said, “af­ter ad­just­ing for mul­ti­ple com­par­isons us­ing the Hochberg method” to de­ter­mine false dis­cov­ery. Lome­cel-B is an off-the-shelf prod­uct us­ing “med­i­c­i­nal sig­nal­ing cells” de­rived from healthy donors’ bone mar­row.

But all hope is not lost in Longeveron’s telling: At that same 180-day mark, the drug post­ed a sta­tis­ti­cal­ly sig­nif­i­cant dose-re­sponse curve com­pared with place­bo — a pos­i­tive sign, it said. Mean­while, Longeveron said pa­tients did post a sig­nif­i­cant im­prove­ment on the walk test at day 270 us­ing what it called a pre-spec­i­fied analy­sis, but was not part of the pri­ma­ry end­point.

What those sup­port­ing fig­ures could mean in the long term or whether they have any ef­fect on clin­i­cal out­comes is un­clear, but Longeveron said it would re­view the da­ta with an in­de­pen­dent steer­ing com­mit­tee and con­sid­er the best path for­ward for the pro­gram.

Mean­while, Longeveron tout­ed safe­ty da­ta from the study but those da­ta weren’t avail­able in the topline re­lease.

Shares of $LGVN were trad­ing down around 25% late Fri­day af­ter­noon.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”