→ 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.

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.