Durect’s shares are crash­ing again.

Two years af­ter a No­var­tis-part­nered Phase III flop sent them in­to pen­ny stock ter­ri­to­ry, Durect has failed an­oth­er tri­al for a top can­di­date. This time, though, the biotech may have bet­ter fall­back op­tions.

DUR-928, the lead drug in Durect’s epi­ge­net­ic reg­u­la­tor pro­gram, was test­ed in 28 plaque pso­ri­a­sis pa­tients. Each pa­tient served as their own con­trol, with the drug ad­min­is­tered to one arm and the place­bo ad­min­is­tered to the oth­er. The good news was that there was no mean­ing­ful dif­fer­ence in ad­verse ef­fects be­tween the two arms. The bad news was there didn’t seem to be much of a dif­fer­ence at all, as DUR-928 “did not demon­strate a ben­e­fit over ve­hi­cle (place­bo)” and missed all pri­ma­ry and sec­ondary end­points.

Durect’s shares $DR­RX, which had been ris­ing for months, fell 34% to $2.50.

Durect an­nounced it is dis­con­tin­u­ing the top­i­cal pso­ri­a­sis pro­gram, but that is on­ly one of the three in­di­ca­tions in which the biotech is test­ing DUR-928. They al­so have an in­jectable form of the drug in Phase II for al­co­holic he­pati­tis and an oral form in Phase I for non­al­co­holic steato­hep­ati­tis, bet­ter known as NASH. Pos­i­tive re­sults came out for the al­co­holic he­pati­tis pro­gram in No­vem­ber; pa­tients in the treat­ment arm saw a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in biliru­bin, the yel­low sub­stance in bile that gives pa­tients the well-known jaun­diced look.

The tri­al fail­ure comes as the biotech pre­pares for a key reg­u­la­to­ry date for the No­var­tis-part­nered drug, a post-op­er­a­tion non-opi­oid pain drug now called Posimir. The drug has had a rocky his­to­ry, in­clud­ing a 2012 tri­al fail­ure, a 2014 CRL from the FDA, and a 2016 re­quest from the agency to change their tri­al de­sign, help­ing lead to the 2017 fail­ure.

Durect re­spond­ed to the CRL this past June, repack­ag­ing their orig­i­nal sub­mis­sion to fo­cus on six tri­als. It’s not yet clear what the FDA will say, but the new sub­mis­sion con­vinced the agency to de­lay an ear­ly PDU­FA date of De­cem­ber 27 and give the biotech an ad­comm meet­ing for lat­er this month.

The Durect pro­gram with the most po­ten­tial, though, may end up be­ing their long-act­ing in­jectable HIV can­di­date, part of their SABER plat­form. Gilead paid $25 mil­lion up­front and promised mil­lions more in mile­stones to latch on­to that plat­form. They op­tioned the HIV drug in Sep­tem­ber for a $10 mil­lion pay­ment.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.