Faced with a litany of set­backs over its lead pro­gram last year, An­gion Bio­med­ica is now re­port­ing a new ob­sta­cle in a fol­low-up can­di­date.

An­gion is dis­con­tin­u­ing a Phase II tri­al eval­u­at­ing oral TKI in­hibitor ANG-3070, the com­pa­ny said Wednes­day af­ter­noon, af­ter an un­ex­pect­ed safe­ty is­sue popped up in the study’s treat­ment arm. Re­searchers had been en­rolling pa­tients with se­ri­ous kid­ney dis­eases, in­clud­ing fo­cal seg­men­tal glomeru­loscle­ro­sis (FS­GS) and im­munoglob­u­lin A nephropa­thy (IgAN).

“We be­lieve it to be in the best in­ter­est of pa­tients to dis­con­tin­ue our Phase II JU­NIPER study at this time, notwith­stand­ing the sig­nif­i­cant un­met need for new ther­a­pies in this pa­tient pop­u­la­tion,” CEO Jay Venkate­san said in a state­ment. “We are, of course, dis­ap­point­ed by to­day’s an­nounce­ment and have made the de­ci­sion to de­pri­or­i­tize the study.”

In­vestors re­act­ed neg­a­tive­ly to the news, send­ing An­gion shares $ANGN down 17% pre-mar­ket to about $1.41 apiece.

The biotech had been en­rolling pa­tients since De­cem­ber. An­gion said it de­cid­ed to scrap the tri­al af­ter see­ing an “un­ex­pect­ed and sub­stan­tial de­cline” in one pa­tient’s kid­ney func­tion. While re­searchers did not point to one cause specif­i­cal­ly, they not­ed a re­view of all the da­ta, in­clud­ing blind­ed da­ta and TKI drug class side ef­fects, led to Wednes­day’s move.

Though ANG-3070 hadn’t orig­i­nal­ly been An­gion’s lead clin­i­cal pro­gram, it was anoint­ed the po­si­tion by de­fault af­ter a num­ber of set­backs for the biotech’s or­gan-dam­age drug. Last Oc­to­ber, An­gion re­port­ed a can­di­date for high-risk kid­ney trans­plant pa­tients dubbed ANG-3777 flopped in a piv­otal Phase III study, just a few months af­ter a big miss in Covid-re­lat­ed ARDS.

Then in De­cem­ber, ANG-3777 missed its pri­ma­ry end­point in an­oth­er Phase II tri­al, ef­fec­tive­ly end­ing its path to the FDA. An­gion has since said it doesn’t plan to con­tin­ue de­vel­op­ment here, but as of this May’s first quar­ter re­port, is still work­ing with its part­ner Vi­for Phar­ma to de­ter­mine the best course for­ward.

Al­though those set­backs had al­ready left ANG-3070 as the com­pa­ny’s sole clin­i­cal can­di­date, Wednes­day’s de­vel­op­ment push­es the pro­gram back even fur­ther. An­gion is plan­ning to eval­u­ate the drug in id­io­path­ic pul­monary fi­bro­sis, but on­ly just re­ceived IND clear­ance last month.

A Phase Ib study for IPF is ex­pect­ed to start en­rolling pa­tients some­time lat­er this year, An­gion says.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.