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 Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.

The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.

The pandemic stock market has proven fruitful for virtually any type of biotech. Now a 7-year-old cell therapy startup will see how much it can yield for a company that specializes in fighting viruses.

AlloVir, a company that until 2019 largely lived off grant money, has filed for a $100 million IPO to back its line of off-the-shelf, virus-fighting T cells. Although in normal circumstances, $100 million could be a solid return for a biotech that got its first major round of funding only last year, we’ll have to wait to see how much the company ultimately earns. As Covid-19 has sent investor money scurrying to almost anyone in drug development, every single biotech to go public this year has prized above their midpoint or upsized their offering, according to Renaissance Capital, sometimes dramatically so.