→ DBV Tech­nolo­gies $DB­VT, which with­drew its ap­pli­ca­tion to mar­ket its peanut al­ler­gy patch late last year, es­sen­tial­ly en­abling ri­val Aim­mune $AIMT to leapfrog it, on Fri­day an­nounced that the FDA has ac­cept­ed its lat­est BLA fil­ing. The agency is ex­pect­ed to make its de­ci­sion by Au­gust 5 — but will host an ad­vi­so­ry pan­el meet­ing to dis­cuss the im­munother­a­py.

→ Rit­ter Phar­ma­ceu­ti­cals $RT­TR did its best to make lemon­ade with the lemons it was dealt — by vault­ing its lac­tose in­tol­er­ance ther­a­py to­ward a con­fir­ma­to­ry tri­al, de­spite miss­ing the main goal in the pre­ced­ing Phase II/III study. Last month, the com­pa­ny re­port­ed its ther­a­py, RP-G28, failed not on­ly to se­cure a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment ver­sus place­bo in re­duc­ing lac­tose in­tol­er­ance symp­toms, but pa­tients in the place­bo group ac­tu­al­ly did bet­ter than the drug arm. Now, the LA-based com­pa­ny has ap­point­ed a fi­nan­cial ad­vi­sor to ex­plore strate­gic al­ter­na­tives.

→ As­traZeneca-part­nered French biotech, In­nate Phar­ma, which an­nounced plans for a US IPO worth up to $100 mil­lion a few weeks ago, said to­day that it plans to is­sue and sell about 10.7 mil­lion in an of­fer­ing, to de­vel­op their lead prod­uct, mon­al­izum­ab; fund their mid-stage tri­al of IPH4102 for pa­tients with Sézary syn­drome, MF and PT­CL; and the phase I/II de­vel­op­ment of IPH5401 for sol­id tu­mors, in­clud­ing NSCLC and HCC.

→ The FDA has green­light­ed Pfenex’s ap­pli­ca­tion to mar­ket PF708 to treat os­teo­poro­sis in cer­tain pa­tients at high risk of frac­ture. The ther­a­peu­tic is sim­i­lar to Am­gen’s $AMGN block­buster For­teo, which is made us­ing a type of parathy­roid hor­mone called teri­paratide.

Al­though the FDA plans to des­ig­nate cer­tain prod­ucts like in­sulins and hor­mones from drugs to bi­o­log­ics next year, teri­paratide is not on that list. There­fore, Pfenex sub­mit­ted a 505(b)(2) New Drug Ap­pli­ca­tion for PF708 rather than an ab­bre­vi­at­ed Bi­o­log­ics Li­cense Ap­pli­ca­tion. “We be­lieve PF708 has the po­ten­tial to sig­nif­i­cant­ly en­hance pa­tient ac­cess to an im­por­tant ther­a­py as a cost-ef­fec­tive al­ter­na­tive to For­teo, which had $1.6 bil­lion in glob­al sales in 2018,” said Eef Schim­melpen­nink, CEO of Pfenex. Pfenex is al­so con­duct­ing a sep­a­rate study with the goal of get­ting PF708 des­ig­nat­ed as ther­a­peu­ti­cal­ly equiv­a­lent to For­teo.

→ Adap­tive Phage Ther­a­peu­tics (APT), a com­pa­ny fo­cused on the de­vel­op­ment of ther­a­pies to com­bat the rise of mul­ti-drug re­sis­tant (MDR) path­o­gen­ic bac­te­ria, has closed its over­sub­scribed, non-bro­kered fi­nanc­ing — rais­ing about $7 mil­lion in pro­ceeds. In­vestors in­clud­ed Alexan­dria Ven­ture In­vest­ments. The com­pa­ny said that pro­ceeds will be used to­wards the sup­port of Phase II clin­i­cal stud­ies for its Phage­Bank ther­a­py for an­tibi­ot­ic-re­sis­tant bac­te­r­i­al in­fec­tions.

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.