Finch Ther­a­peu­tics’ lead pro­gram may fly again.

The mi­cro­bio­me com­pa­ny an­nounced Thurs­day that the FDA lift­ed a two-month hold on clin­i­cal tri­als for its ex­per­i­men­tal treat­ment for re­cur­rent C. diff, a po­ten­tial­ly fa­tal bac­te­r­i­al in­fec­tion. Al­though the com­pa­ny still has to take sev­er­al steps be­fore it can re­sume its piv­otal study, the lift re­moves an un­usu­al pan­dem­ic-re­lat­ed hur­dle for Finch as the biotech looks to get its first ther­a­py over the fin­ish line and sta­bi­lize a pre­car­i­ous fi­nan­cial sit­u­a­tion.

Finch is one of sev­er­al com­pa­nies at­tempt­ing to de­vel­op treat­ments for C. diff and oth­er dis­eases by giv­ing pa­tients tablets — some­times jok­ing­ly or not-so-jok­ing­ly re­ferred to as crap­sules — con­tain­ing bac­te­ria strains ex­tract­ed from donor stool. In the­o­ry, the new strains will re­col­o­nize the pa­tients’ gut, cre­at­ing an en­vi­ron­ment where C. diff can’t take hold.

In a pan­dem­ic, though, the FDA feared that stool sam­ples might be able to trans­mit SARS-CoV-2 be­tween pa­tients. (Oth­er se­ri­ous in­fec­tions have been passed through fe­cal trans­plant, a close­ly re­lat­ed but dis­tinct pro­ce­dure.)

In March 2020, the agency pro­hib­it­ed Finch from dos­ing tri­al pa­tients with drug de­rived from any donor sam­ples tak­en af­ter Dec. 1, 2019, but Finch said they were able to con­tin­ue tri­als with sam­ples banked be­fore that date. Be­gin­ning in ear­ly 2021, the com­pa­ny says it was able to start get­ting new donors again, first be­cause its con­tract man­u­fac­tur­er em­ployed SARS-CoV-2 screen­ing meth­ods and then be­cause it bought out some of the man­u­fac­tur­er’s tech­nol­o­gy and em­ployed the same screen­ing meth­ods.

In March 2022, though, the com­pa­ny said the agency raised ques­tions about those pro­ce­dures and paused en­roll­ment in a Phase III tri­al. Finch now says those con­cerns have been re­solved af­ter “a re­view of in­for­ma­tion Finch pro­vid­ed re­lat­ed to its SARS-CoV-2 screen­ing pro­ce­dures and as­so­ci­at­ed in­formed con­sent lan­guage.”

The hold couldn’t come soon­er for Finch. Al­though the com­pa­ny showed some of the first pos­i­tive re­sults in a ran­dom­ized mi­cro­bio­me tri­al in 2020, it has come on hard times as the larg­er biotech mar­ket has tak­en a down­turn.

Ear­li­er this month, the com­pa­ny laid off 37 em­ploy­ees, or 20% of its work­force. Its stock $FNCH has fall­en 85% over the past year, from $14.04 to $2.10 at the clos­ing bell Thurs­day. It is up $2.91 per mar­ket on the news.

It al­so side­lined a pro­gram in he­pati­tis B to re­serve cash.

The com­pa­ny’s fu­ture will de­pend on the Phase III re­sults from the tri­al, al­though that won’t get off the ground just yet. Al­though Finch says the agency has lift­ed the hold, it hasn’t done every­thing the FDA wants.

The com­pa­ny still needs to “com­plete cer­tain man­u­fac­tur­ing ac­tiv­i­ties and qual­i­ty sys­tem up­dates re­lat­ed to the re­cent­ly re­solved clin­i­cal hold,” it said. It al­so needs to sub­mit to the FDA a “val­i­da­tion pack­age” for one of its “re­lease tests” and it needs to change the al­go­rithms used to mon­i­tor whether a pa­tient has a re­cur­rent C. diff in­fec­tion.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”