Af­ter a harsh slap­down last fall, US reg­u­la­tors are now singing a dif­fer­ent tune on Su­per­nus Phar­ma­ceu­ti­cals’ “sprin­kleable” AD­HD drug.

The FDA on Fri­day ap­proved SPN-812 — now mar­ket­ed as Qel­bree — as a non-stim­u­lant treat­ment for AD­HD in kids 6 to 17 years old. And with new da­ta in hand for adult pa­tients, the com­pa­ny plans on fil­ing a sup­ple­men­tal NDA in the sec­ond half of this year.

Reg­u­la­tors ini­tial­ly re­ject­ed Su­per­nus’ ap­pli­ca­tion for Qel­bree back in No­vem­ber at the same time they is­sued an RTF for SPN-830, a con­tin­u­ous treat­ment pump meant for Parkin­son’s dis­ease.

Su­per­nus said Qel­bree’s re­jec­tion had to do with CMC is­sues af­ter the re­lo­ca­tion of an in-house lab that does an­a­lyt­ic test­ing raised ques­tions in the agency about qual­i­ty con­trol. At the time, the Rockville, MD-based biotech said it would clar­i­fy to the FDA that it doesn’t re­ly sole­ly on that fa­cil­i­ty for qual­i­ty con­trol and re­sub­mit.

The Fri­day ap­proval sent Su­per­nus’ stock $SUPN up 8.12% in pre-mar­ket trad­ing, with shares pric­ing at $28.89 ear­ly Mon­day morn­ing.

Su­per­nus bills Qel­bree as the first new non-stim­u­lant treat­ment for AD­HD in a decade. The agency based its de­ci­sion on da­ta from four Phase III tri­als that en­rolled more than 1,000 pe­di­atric pa­tients be­tween 6 and 17 years old, ac­cord­ing to the com­pa­ny.

An ear­ly cut of Phase III da­ta fell short of ex­pec­ta­tions back in 2018, af­ter Qel­bree failed to show a dose-de­pen­dent re­sponse in the high dose. Some in­vestors wor­ried that the drug may have not per­formed well enough to dif­fer­en­ti­ate it­self from ex­ist­ing AD­HD drugs such as Eli Lil­ly’s Strat­tera and Shire’s In­tu­niv.

Su­per­nus, how­ev­er, point­ed to Qel­bree’s swift on­set of ac­tion. Strat­tera, the first non-stim­u­lant med­ica­tion ap­proved for AD­HD, can take more than six weeks to start work­ing, while some pa­tients felt the ef­fects of Qel­bree in just one. Strat­tera reached $535 mil­lion in the US be­fore go­ing gener­ic, ac­cord­ing to Cowen’s Ken Cac­cia­tore.

“AD­HD is one of the most com­mon men­tal health is­sues in the US,” said An­drew Cut­ler, SUNY Up­state Med­ical Uni­ver­si­ty as­so­ciate pro­fes­sor and Neu­ro­science Ed­u­ca­tion In­sti­tute CMO. “The right treat­ment is key for chil­dren and ado­les­cents, as they grow and nav­i­gate school and so­cial re­la­tion­ships. This ap­proval of­fers a nov­el once a day sprin­kleable non-stim­u­lant that can be a great op­tion for chil­dren and ado­les­cents with AD­HD.”

In De­cem­ber, Su­per­nus read out topline Phase III da­ta show­ing that Qel­bree sig­nif­i­cant­ly im­proved adult pa­tients’ re­sults on the AD­HD In­ves­ti­ga­tor Symp­tom Rat­ing Scale (AISRS) com­pared to place­bo. At the end of six weeks, those in the Qel­bree group saw a change of -15.5 from base­line in AISRS scores com­pared to -11.7 in the con­trol arm, with a p-val­ue of 0.0040, ac­cord­ing to Su­per­nus. The sta­tis­ti­cal sig­nif­i­cance was con­firmed lat­er by a sen­si­tiv­i­ty analy­sis show­ing a p-val­ue of 0.0085.

Qel­bree’s ap­proval in chil­dren 6 to 17 years old came with a warn­ing: “In clin­i­cal tri­als, high­er rates of sui­ci­dal thoughts and be­hav­ior were re­port­ed in pe­di­atric pa­tients treat­ed with Qel­bree than in pa­tients treat­ed with place­bo,” the la­bel states. “Close­ly mon­i­tor for wors­en­ing and emer­gence of sui­ci­dal thoughts and be­hav­iors.”

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The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

There’s another unicorn in biotech land, as Benchling and its leading R&D cloud platform pull in a $200 million Series E to help scientists accelerate drug development. In doing so, the company hit a lofty $4 billion valuation — nearly five times what it was worth around this time last year, according to Forbes.

Despite the fact that drug development is becoming significantly more complex, the industry continues to run on paper, emails and spreadsheets, co-founder and CEO Sajith Wickramasekara said in a video on Benchling’s website. The MIT grad sought to change that by creating software that allows scientists to better track, model and forecast their work.

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

Amylyx is one of several companies looking to break through in the tough ALS field, and Wednesday they announced they’re moving forward with regulatory plans.

The Cambridge, MA-based biotech said they’re submitting a marketing application to the EMA for their AMX0035 program by the end of 2021. Wednesday’s news comes a few weeks after they revealed similar plans to move forward with Canadian health regulators by June 30.

The US Court of Appeals for the Fifth Circuit on Tuesday upheld the Federal Trade Commission’s ruling that generic drugmaker Impax Laboratories should be charged with antitrust violations for accepting payments worth about $100 million to delay the entry of a generic opioid for more than two years.

The court’s opinion upheld the FTC’s anticompetitive findings on the deal between Impax (now owned by Amneal Pharmaceuticals) and Endo Pharmaceuticals, under which Endo committed to not market an authorized generic, which increased Impax’s projected profits by $24.5 million. Endo agreed to pay Impax credits for the shrunken market that Impax would inherit if, as expected, Endo made a successful hop to a reformulated Opana ER.