Su­per­nus had a bad Mon­day.

Yes­ter­day, the Mary­land biotech an­nounced that two dif­fer­ent ther­a­pies had been shot back by the FDA. The agency re­ject­ed their ap­pli­ca­tion to ap­prove SPN-812, an ex­per­i­men­tal AD­HD med­ica­tion for kids and ado­les­cents. And they re­fused to even con­sid­er an ap­pli­ca­tion for SPN-830, a con­tin­u­ous treat­ment pump meant for Parkin­son’s dis­ease.

The re­jec­tion is a sig­nif­i­cant blow to Su­per­nus, which in­vest­ed in four clin­i­cal tri­als for the AD­HD med. The FDA doesn’t dis­close its rea­son­ing for re­ject­ing a drug, but the com­pa­ny said it had to do with CMC is­sues, rather than safe­ty or ef­fi­ca­cy con­cerns. An in-house lab that does an­a­lyt­ic test­ing re­cent­ly changed lo­ca­tions, they said, rais­ing ques­tions in the agency about qual­i­ty con­trol.

Su­per­nus said they plan to “clar­i­fy to the FDA” that they do “not re­ly sole­ly on this fa­cil­i­ty” for qual­i­ty con­trol and then dis­cuss how to re­sub­mit their ap­pli­ca­tion.

The com­pa­ny was less forth­com­ing on why the agency re­fused to file their Parkin­son’s ap­pli­ca­tion. “In the let­ter, the FDA re­quest­ed cer­tain doc­u­ments and re­ports to be sub­mit­ted in sup­port of the ap­pli­ca­tion,” the com­pa­ny said.

Su­per­nus stock $SUPN fell 18%  on the news pre-mar­ket, from 24.95 to 20.35.

Jack Khat­tar

Ex­pec­ta­tions around the AD­HD drug, how­ev­er, had al­ready be­gun to wane. Su­per­nus CEO Jack Khat­tar has billed SPN-812 as the “first tru­ly new ther­a­py” for AD­HD in a decade, but the re­sults in late-stage tri­als fell short of ex­pec­ta­tions.

Al­though pos­i­tive, their first cut of the Phase III study ap­peared to show an ef­fect size no greater than a ri­val Eli Lil­ly drug and failed to show a dose-de­pen­dent re­sponse in the high dose, wor­ry­ing in­vestors. The com­pa­ny has point­ed to da­ta sug­gest­ing their treat­ment can work faster, with pa­tients feel­ing the ef­fect af­ter one week as op­posed to sev­er­al weeks.

The SPN-830 Parkin­son’s pump was part of their $300 mil­lion buy­out of the Ken­tucky-based neu­ro­science com­pa­ny US WorldMeds. Su­per­nus en­vi­sioned it as an al­ter­na­tive to more in­va­sive pro­ce­dures for pa­tients strug­gling with symp­toms, such as the gas­tric tubes some­times used to pro­vide con­tin­u­ous dos­ing of L-Dopa.

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Neither Janet Woodcock nor Joshua Sharfstein is likely to be nominated as the permanent FDA commissioner, Steve Usdin at BioCentury reports.

The White House is looking for alternatives to Woodcock, the acting chief and longtime CDER director, after opposition from several Democratic senators who are calling on others to block her nomination if her name is put forth, according to Usdin. Sharfstein, the former principal deputy FDA commissioner and current Johns Hopkins professor, is out of the running altogether.