Just weeks af­ter Astel­las agreed to pay Aquinox Phar­ma­ceu­ti­cals $25 mil­lion up­front for Asian rights to their lead drug rosip­tor, the lit­tle biotech says their Phase III tri­al was a com­plete dis­as­ter, leav­ing noth­ing to sal­vage.

David Main

CEO David Main didn’t sug­ar­coat it. No mat­ter how hard they stud­ied the da­ta, the in­ter­sti­tial cys­ti­tis drug clear­ly couldn’t beat a place­bo. He said:

We have con­duct­ed a num­ber of sen­si­tiv­i­ty, sub­pop­u­la­tion, and sec­ondary end­point analy­ses and none demon­strate a ben­e­fit of rosip­tor over place­bo.

In­vestors bet­ting on a key suc­cess here clear­ly weren’t hap­py. Aquinox’s shares $AQXP were swift­ly dec­i­mat­ed, div­ing 85%.

The Van­cou­ver-based biotech had hoped for bet­ter, re­cruit­ing 433 pa­tients suf­fer­ing from in­ter­sti­tial cys­ti­tis/blad­der pain syn­drome for the study, which had the same de­sign as Phase II.

Af­ter bury­ing the drug pro­gram, and watch­ing its mar­ket cap shriv­el, Main says it’s time to study what kind of strate­gic al­ter­na­tives re­mains open. There is a mid-stage study un­der­way for the same drug — a small mol­e­cule ac­ti­va­tor of SHIP1 — in chron­ic pro­sta­ti­tis/chron­ic pelvic pain syn­drome. But vir­tu­al­ly all of its eggs were in the one drug bas­ket.

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.