BioCryst is tak­ing a beat­ing Fri­day morn­ing af­ter re­port­ing it would pause en­roll­ment in three stud­ies for its lead pipeline pro­gram.

In a terse state­ment put out right be­fore the mar­ket opened, the Durham, NC-based biotech said it dis­cov­ered el­e­vat­ed serum cre­a­ti­nine lev­els in some pa­tients, and will halt re­cruit­ment while it in­ves­ti­gates. El­e­vat­ed cre­a­tine lev­els can be a sign of kid­ney dys­func­tion.

The pa­tients were tak­ing the ex­per­i­men­tal drug known as BCX9930, an oral Fac­tor D in­hibitor be­ing eval­u­at­ed in three clin­i­cal stud­ies.

Af­ter Fri­day’s open­ing bell, BioCryst $BCRX shares fell more than 30%,  to $11.92.

Two of the biotech’s clin­i­cal stud­ies were ex­am­in­ing the ex­per­i­men­tal drug in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH), one in an open-la­bel set­ting com­pared to an ac­tive com­para­tor and one con­trolled against place­bo. Both were be­ing eval­u­at­ed as a monother­a­py. BioCryst’s plan was to study BCX9930 in a range of com­ple­ment-me­di­at­ed dis­eases.

Ac­cord­ing to the stud­ies’ clin­i­cal­tri­als.gov web­pages, BioCryst had ex­pect­ed to en­roll about 140 pa­tients be­tween the two tri­als, and it’s not im­me­di­ate­ly clear how many had tak­en the drug as of Fri­day’s up­date. A com­pa­ny spokesper­son de­clined to com­ment, say­ing BioCryst is not pro­vid­ing de­tails on the stud­ies.

The pause marks a set­back for the biotech’s pipeline a lit­tle over a year af­ter it won its first FDA ap­proval for Or­ladeyo, a dai­ly pill meant to pre­vent painful episodes in pa­tients with the rare dis­ease hered­i­tary an­gioede­ma (HAE). BioCryst moved quick­ly to cap­i­tal­ize on the ap­proval, sign­ing a $250 mil­lion deal with Roy­al­ty Phar­ma three days af­ter the green­light.

Late last year, the biotech al­so moved to raise some new cash, get­ting an­oth­er $350 mil­lion from Roy­al­ty and new in­vestors. Some of the mon­ey was planned for ad­vanc­ing BCX9930 to its NDA and build­ing out ad­di­tion­al clin­i­cal tri­als, BioCryst said at the time.

This ar­ti­cle has been up­dat­ed to in­clude BioCryst’s re­sponse to an End­points News re­quest for com­ment.

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.