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.

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.