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.

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.

The first generation of personalized CAR-T therapies made big waves in the treatment of lymphoma for their stunning efficacy. Nkarta is hoping its off-the-shelf natural killer cell approach will stand out on safety — while keeping some of those impressive numbers on responses.

In a new update from its Phase I dose escalation study, the South San Francisco-based biotech reported that seven out of 10 patients treated with the highest doses of its NK cell therapy, NKX019, achieved a complete response, translating to a complete response rate of 70%.

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.