A dozen De­mo­c­rat at­tor­neys gen­er­al are su­ing the FDA in fed­er­al court in the East­ern Dis­trict of Wash­ing­ton to re­move all re­stric­tions on mifepri­s­tone, a pill used in com­bi­na­tion with an­oth­er med­i­cine to end ear­ly preg­nan­cies.

The suit comes as a Trump-ap­point­ed Texas fed­er­al judge is ex­pect­ed to soon de­cide on whether the pill should be pulled from the mar­ket. Mifepri­s­tone is cur­rent­ly used in more than half of all US abor­tions, ac­cord­ing to the Guttmach­er In­sti­tute. De­mo­c­rat Sen­a­tors have urged US At­tor­ney Gen­er­al Mer­rick Gar­land to quick­ly pre­pare an ap­peal to the de­ci­sion.

State at­tor­neys gen­er­al from Wash­ing­ton, Ore­gon, Ari­zona, Col­orado, Con­necti­cut, Delaware, Illi­nois, Michi­gan, Neva­da, New Mex­i­co, Rhode Is­land and Ver­mont in­di­cat­ed in their suit that the FDA has sin­gled out mifepri­s­tone with an un­nec­es­sary warn­ing, or REMS, on its la­bel.

“This case is about whether it is im­prop­er and dis­crim­i­na­to­ry for FDA to rel­e­gate mifepri­s­tone—a med­ica­tion that has been used over 5 mil­lion times with very low rates of com­pli­ca­tions, very high rates of ef­fi­ca­cy, and which is crit­i­cal to the re­pro­duc­tive rights of the Plain­tiff States’ res­i­dents, as well as vis­i­tors who trav­el to the Plain­tiff States to seek abor­tion care—to the very lim­it­ed class of dan­ger­ous drugs that are sub­ject to a REMS,” the com­plaint reads.

The FDA has al­ready loos­ened some re­stric­tions around mifepri­s­tone since its ap­proval in 2000. In a ma­jor re­cent change, the FDA said it would al­low cer­tain cer­ti­fied phar­ma­cies to dis­pense mifepri­s­tone. Pa­tients still need a pre­scrip­tion to re­ceive the drug, though they aren’t re­quired to see a health­care provider in per­son to get one, the FDA spec­i­fied.

But the AGs main­tained that the FDA has con­tin­ued to ham­per ac­cess by sin­gling out mifepri­s­tone “for a unique set of re­stric­tions” with its REMS.

“FDA’s de­ci­sion to con­tin­ue these bur­den­some re­stric­tions in Jan­u­ary 2023 on a drug that has been on the mar­ket for more than two decades with on­ly ‘ex­ceed­ing­ly rare’ ad­verse events has no ba­sis in sci­ence,” the suit says. “It on­ly serves to make mifepri­s­tone hard­er for doc­tors to pre­scribe, hard­er for phar­ma­cies to fill, hard­er for pa­tients to ac­cess, and more bur­den­some for the Plain­tiff States and their health care providers to dis­pense.”

Two weeks ago, more than a dozen food and drug law ex­perts al­so ar­gued that if the Texas rul­ing hap­pens and mifepri­s­tone is pulled from the mar­ket, the en­tire drug ap­proval process could be ham­strung by pol­i­tics.

Their ar­gu­ments are in re­sponse to a No­vem­ber 2022 Texas law­suit filed by the Al­liance for Hip­po­crat­ic Med­i­cine chal­leng­ing the 2000 ap­proval of mifepri­s­tone. The FDA has al­ready urged the Trump-ap­point­ed Judge Matthew Kac­s­maryk, who is pre­sid­ing over the case, to re­ject a pre­lim­i­nary in­junc­tion filed by abor­tion op­po­nents to with­draw the ap­proval for the drug.

The FDA de­clined to com­ment.

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.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.