Gos­samer Bio is stop­ping en­roll­ment on a Phase Ib/II tri­al of its BTK in­hibitor in CNS lym­phoma, it said in its an­nu­al re­port Fri­day morn­ing.

The San Diego-based biotech said, “​​Based up­on the ben­e­fit / risk pro­file ob­served to date and a pri­or­i­ti­za­tion of re­sources to sup­port the ser­a­lu­tinib pro­gram,” it de­cid­ed to stop en­rolling the tri­al of the BTK in­hibitor known as GB5121. Next, Gos­samer plans to dis­cuss the avail­able da­ta with the tri­al’s da­ta re­view com­mit­tee, an in­de­pen­dent pan­el of ex­perts, to fig­ure out next steps. The tri­al orig­i­nal­ly ex­pect­ed to en­roll around 160 pa­tients, ac­cord­ing to a fed­er­al clin­i­cal tri­als data­base.

A num­ber of Big Phar­ma com­pa­nies have ap­proved BTK in­hibitors, start­ing with Ab­b­Vie and J&J’s block­buster Im­bru­vi­ca, which was first ap­proved in 2013. Eli Lil­ly re­cent­ly won ap­proval for a dif­fer­ent BTK in­hibitor in man­tle cell lym­phoma two months ago.

Gos­samer is in­stead pour­ing its re­sources in­to ser­a­lu­tinib, a drug for pul­monary ar­te­r­i­al hy­per­ten­sion (PAH), a rare type of high blood pres­sure in the ves­sels that car­ry blood from the heart to the lungs. The biotech is plan­ning a piv­otal Phase III tri­al for the sec­ond half of this year.

In­vestors weren’t im­pressed by the drug’s Phase II da­ta that were re­leased in De­cem­ber, drop­ping the biotech’s stock by 70% at the time. Com­par­ing re­sults on a six-minute walk test — which was a key sec­ondary end­point in the Phase II and will be the pri­ma­ry in the Phase III — pa­tients in the drug arm on­ly did 6.5 me­ters bet­ter than the con­trol arm, with a p-val­ue of p=0.5972.

Mer­ck re­leased the full da­ta on the Phase III study of its PAH drug so­tater­cept at the Amer­i­can Col­lege of Car­di­ol­o­gy an­nu­al meet­ing in New Or­leans ear­li­er in March. In that study of over 300 pa­tients, so­tater­cept im­proved scores on the six-minute walk test by about 40 me­ters com­pared to the con­trol arm. So­tater­cept was the cen­ter­piece of Mer­ck’s $11.5 bil­lion buy­out of Ac­celeron in 2021.

Mer­ck said it was work­ing on fil­ing the drug for ap­proval with the FDA, and if all goes well, it could launch next year.

Gos­samer did not im­me­di­ate­ly re­spond to re­quest for com­ment.

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

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.

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.