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.

GSK has landed a new first from UNICEF — the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.