Ru­mors of bad news can flick­er around the BioTwit­ter world in a heart­beat. And the im­pact can be dev­as­tat­ing.

On Tues­day the tar­get was In­tra-Cel­lu­lar Ther­a­pies $IT­CI, and the ru­mor was pegged to an up­date on the FDA’s web­page that not­ed the agency was can­cel­ing the Psy­chophar­ma­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee meet­ing for Ju­ly 31 and the re­view planned for the biotech’s schiz­o­phre­nia drug, lu­mate­per­one to­sy­late cap­sules.

For the le­gions of in­vestors look­ing for some­thing, any­thing, on the in­ter­net to bet on with what might be an in­side clue to a cat­a­lyst, it was pure gold. Had reg­u­la­tors al­ready de­cid­ed against the drug? What could it mean? It had to be bad, right?

Dis­as­ter!

The com­pa­ny’s stock was shred­ded, drop­ping more than 30% on the spec­u­la­tion. More than $150 mil­lion in mar­ket cap was gone in a snap as word of the move spread.

Then, af­ter the mar­ket closed, In­tra-Cel­lu­lar tried to staunch the flow of red. The biotech put out a state­ment say­ing that they had sup­plied ad­di­tion­al in­for­ma­tion on their drug that the agency want­ed ex­tra time to study — hence the de­ci­sion to strike the ad­comm.

The FDA can­celled the Ad­vi­so­ry Com­mit­tee meet­ing to al­low suf­fi­cient time to re­view this new and any forth­com­ing in­for­ma­tion as they con­tin­ue the NDA re­view.  This in­for­ma­tion may re­sult in an ex­ten­sion of the Sep­tem­ber 27, 2019 Pre­scrip­tion Drug User Fee Act (PDU­FA) tar­get ac­tion date for the lu­mate­per­one NDA.

That was good for a 9% re­bound af­ter the bell on Tues­day.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.