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.

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

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As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.