→ As­traZeneca has won a pri­or­i­ty re­view for its an­ti-CD22 ther­a­py mox­e­tu­momab for hairy cell leukemia. The phar­ma gi­ant can now ex­pect a de­ci­sion on third-line use in the third quar­ter, mark­ing an­oth­er prospec­tive ad­vance for its crit­i­cal­ly im­por­tant on­col­o­gy pipeline.

→ With ma­jor help from Fra­zier Health­care Part­ners, a stealthy gene ther­a­py com­pa­ny from the Uni­ver­si­ty of Penn­syl­va­nia has se­cured $9.29 mil­lion in in­vest­ment. Gene ther­a­py pi­o­neer James Wil­son co-reg­is­tered the com­pa­ny in 2016, the Philadel­phia In­quir­er notes, but has since been re­placed on the board by Penn med­ical school vice dean Kevin Ma­honey. Kr­ish­na Polu, a for­mer Cy­tomX chief med­ical of­fi­cer who joined Fra­zier as an en­tre­pre­neur in res­i­dence, is the CEO. Sev­er­al Fra­zier ex­ecs, in­clud­ing Patrick Heron and Tadata­ka Tama­da, are al­so on the board.

→ Switzer­land’s Glycemi­con an­nounced to­day that af­ter a sec­ond clos­ing, it has raised a to­tal of $5.28 mil­lion (CHF 5.05 mil­lion) to ad­vance cat and hu­man stud­ies of its neu­traceu­ti­cals. The biotech is de­vel­op­ing a pipeline of nov­el food prod­ucts that man­ages pre­di­a­betes, the “gray area” be­tween nor­mal blood sug­ar lev­els and di­a­betes, as well as weight.

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.