The FDA be­stowed good tid­ings up­on Arde­lyx’s ex­per­i­men­tal chron­ic kid­ney dis­ease drug Thurs­day morn­ing.

Reg­u­la­tors told the biotech they would hear an ap­peal to its com­plete re­sponse let­ter, po­ten­tial­ly set­ting Arde­lyx up for an ap­proval re­sub­mis­sion in the first half of next year. The move fol­lows a post-CRL ad­vi­so­ry com­mit­tee meet­ing last month in which the FDA’s Car­dio­vas­cu­lar and Re­nal Drugs pan­elists vot­ed in fa­vor of both monother­a­py and com­bi­na­tion reg­i­men ap­provals.

“To say I’m ex­cit­ed would be an un­der­state­ment,” pres­i­dent and CEO Mike Raab said on an an­a­lyst call Thurs­day morn­ing. In­vestors didn’t feel the same, how­ev­er, as Arde­lyx shares $ARDX fell about 8%.

Arde­lyx al­so won’t have to sub­mit new da­ta, Raab said. Some of the analy­ses sub­mit­ted for the ad­vi­so­ry com­mit­tee “may very well be part of what they would want us to sub­mit,” he said. “But that’s da­ta that they al­ready have as part of the” drug ap­pli­ca­tion.

The news pro­vides new mo­men­tum for Arde­lyx’s roller-coast­er at­tempt to get its drug, known as tena­panor, across the fin­ish line. FDA orig­i­nal­ly re­ject­ed the drug back in Ju­ly 2021 de­spite three pos­i­tive Phase III read­outs. An­a­lysts at the time de­clared an ap­proval “all but cer­tain.”

Arde­lyx orig­i­nal­ly had fo­cused on treat­ing chron­ic kid­ney dis­ease writ large, but nar­rowed that aim to a sub­set of pa­tients with an over­abun­dance of phos­phate in the blood af­ter ear­li­er, broad­er stud­ies flopped. That con­di­tion, called hy­per­phos­phatemia, oc­curs in about 80% of pa­tients with end-stage kid­ney dis­ease on main­te­nance dial­y­sis.

The FDA wasn’t con­vinced, and Arde­lyx’s stock lost more than 70% of its val­ue, and the com­pa­ny made rounds of job cuts. As the ap­peal and ad­vi­so­ry com­mit­tee process­es played out, reg­u­la­tors even­tu­al­ly said “the mag­ni­tude of the treat­ment ef­fect is un­clear.”

When tena­panor was first re­ject­ed, the im­pli­ca­tion of the FDA’s re­sponse was that the agency want­ed Arde­lyx to con­duct a new study look­ing at clin­i­cal out­comes, Raab told End­points News Thurs­day. That wasn’t some­thing the biotech was will­ing to do, he said: “Giv­en the com­plex­i­ty of the dis­ease, the mori­bund na­ture and the speed at which they die of many things, makes an out­come study near­ly im­pos­si­ble.”

Now, the com­pa­ny will fo­cus on dis­cus­sions with the FDA, which will like­ly start with a Type A meet­ing, Raab added. Arde­lyx is be­ing in­clud­ed in dis­cus­sions for the drug’s po­ten­tial la­bel, and is ex­pect­ed to be brand­ed as Xphozah.

If the FDA ul­ti­mate­ly re­vers­es course and ap­proves tena­panor here, it will be the drug’s sec­ond green light af­ter a 2019 thumbs-up for ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion in adults.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.

Republican members of Congress want FDA Commissioner Robert Califf and his agency to provide more information on the research FDA has funded that manipulates certain viruses like the SARS-CoV-2 virus — after the FDA confirmed that certain studies it funded involved viral manipulation, but in standard ways that are common in molecular biology.

The three-page letter, signed Monday by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chairs Brett Guthrie (R-KY) and Morgan Griffith (R-VA), kicked things off by saying that the committee was looking into FDA’s oversight of “FDA-funded research that may pose significant biosafety or biosecurity risks.”

The FDA has scheduled or planned for three advisory committee meetings in May: one for an over-the-counter birth control pill, one for a nasal spray version of the EpiPen, and another for  Intarcia Therapeutics, which has all but completely folded already as a company.

Perrigo will bring its daily contraceptive, Opill, to the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on May 9 and 10 for its over-the-counter birth control application.