Things are not look­ing up for the French biotech Ery­tech Phar­ma.

The com­pa­ny is knock­ing off its plan to get FDA ap­proval for its drug Gras­pa in hy­per­sen­si­tive acute lym­phoblas­tic leukemia (ALL), fol­low­ing feed­back from the reg­u­la­tors, it said in a press re­lease Wednes­day af­ter­noon. ALL is the com­mon type of child­hood can­cer di­ag­nosed in ap­prox­i­mate­ly 5,000 new cas­es each year in the Unit­ed States.

“We are ob­vi­ous­ly dis­ap­point­ed to stop the process of seek­ing ap­proval for Gras­pa in ALL af­ter all the work done and clin­i­cal promise ob­served in this in­di­ca­tion,” Ery­tech CEO Gil Beyen said in a press state­ment.

The com­pa­ny’s stocks $ERYP plunged more than 20% fol­low­ing the news.

Af­ter pos­i­tive re­sults of a Phase II tri­al, Ery­tech had been in dis­cus­sions with the FDA for the ap­proval of Gras­pa to treat ALL pa­tients who had pre­vi­ous­ly ex­pe­ri­enced hy­per­sen­si­tiv­i­ty re­ac­tions to pe­gy­lat­ed as­parag­i­nase ther­a­py.

How­ev­er, the chang­ing com­pet­i­tive land­scape and the FDA’s re­quest for more clin­i­cal da­ta made it too dif­fi­cult for Ery­tech, lead­ing to its de­ci­sion to with­draw its ap­pli­ca­tion, ac­cord­ing to the com­pa­ny’s press state­ment.

In 2017, the FDA ap­proved Kym­ri­ah (ti­s­agen­le­cleu­cel) — a CAR-T ther­a­py for cer­tain pe­di­atric and young adult pa­tients with a form of ALL that has be­come one of the go-to ther­a­pies for the con­di­tion.

Near­ly four years ago, Ery­tech cel­e­brat­ed its im­pres­sive Phase IIb da­ta for sec­ond-line metasta­t­ic pan­cre­at­ic can­cer, but that hype died when the drug failed the Phase III piv­otal tri­al. That led the stock to fall 28%.

Gras­pa is Ery­tech’s lead prod­uct can­di­date. It con­tains a chemother­a­peu­tic agent L-as­parag­i­nase en­cap­su­lat­ed in­side a donor-de­rived red blood cell. By en­cap­su­lat­ing the L-as­parag­i­nase in­to red blood cells, Gras­pa aims to en­large its ther­a­peu­tic win­dow.

Mean­while, the com­pa­ny has been un­der­go­ing a “strate­gic re­view” since at least April. Ery­tech sold its com­mer­cial-scale cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty in Prince­ton, NJ to Catal­ent for $44.5 mil­lion, and 40 peo­ple from Ery­tech’s New Jer­sey lo­ca­tion would be of­fered em­ploy­ment at Catal­ent.

For now, the com­pa­ny will fo­cus on its oth­er pre­clin­i­cal pro­grams, “while pur­su­ing strate­gic part­ner­ing op­tions to max­i­mize val­ue for our share­hold­ers and em­ploy­ees,” Beyen said.

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.