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 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.

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We often think a person’s transition from a healthy to a diseased state is binary. But that’s often not the case. In reality, the onset of a disease is not something that occurs overnight, and the majority lie on a continuum that is impacted by a multitude of factors. Some of these factors are in a patient’s control. Others are not.

This is the case in nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), two of the most complex diseases that “live” on this proverbial continuum. The clinical onset of NAFLD — and ultimately NASH — is a complex process that is closely related to obesity, insulin resistance and impaired adipose tissue metabolism.