J&J and Leg­end Biotech’s next step in turn­ing their CAR-T ther­a­py Carvyk­ti in­to a po­ten­tial megablock­buster has suc­ceed­ed, the com­pa­nies said Fri­day.

Carvyk­ti achieved the pri­ma­ry end­point — pro­gres­sion-free sur­vival — in an open-la­bel Phase III study test­ing the treat­ment in sec­ond- to fourth-line mul­ti­ple myelo­ma pa­tients. The CAR­TI­TUDE-4 tri­al, for which there aren’t any hard da­ta yet, rep­re­sents the biggest de­vel­op­ment for Carvyk­ti’s abil­i­ty to com­pete with Bris­tol My­ers Squibb’s Abec­ma since its ap­proval last Feb­ru­ary.

Leg­end shares went up briefly about 4% in pre-mar­ket trad­ing Fri­day, but re­turned to even af­ter the open­ing bell.

Carvyk­ti is ex­pect­ed to be one of J&J’s top up­com­ing mon­ey­mak­ers, and the Big Phar­ma has care­ful­ly laid out plans to make it a best­seller. The first was get­ting it ap­proved last Feb­ru­ary for re­lapsed or re­frac­to­ry MM pa­tients who have re­ceived at least four pre­vi­ous ther­a­pies.

CAR­TI­TUDE-4 marked the next step in the strat­e­gy, mov­ing Carvyk­ti in­to ear­li­er lines of the same pa­tient pop­u­la­tion. The re­sults were hot­ly an­tic­i­pat­ed ahead of J&J’s fourth-quar­ter re­sults pre­sent­ed ear­li­er this week, but didn’t end up mak­ing the cut. Cowen an­a­lysts did say, how­ev­er, that Leg­end told them the study met its pre-spec­i­fied end­points.

Al­though there aren’t any num­bers to pore over just yet, J&J said the study looked at PFS as the pri­ma­ry and safe­ty, over­all sur­vival and over­all re­sponse rate as sec­ondary end­points, among oth­er da­ta. Re­searchers pit Carvyk­ti against po­ma­lido­mide, an im­munother­a­py; dex­am­etha­sone, a cor­ti­cos­teroid; and ei­ther borte­zomib (tar­get­ed chemo) or Darza­lex (mon­o­clon­al an­ti­body).

Carvyk­ti’s suc­cess Fri­day helps it pass a key test in its fight for mar­ket share with Abec­ma, as the two ther­a­pies are the sole an­ti-BC­MA CAR-Ts on the mar­ket — and both are ap­proved in late-line mul­ti­ple myelo­ma. But Bris­tol My­ers reached the mar­ket first, in March 2021, leav­ing Carvyk­ti play­ing from be­hind.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.