Al­most a year ago, As­traZeneca’s triple-drug com­bi­na­tion for chron­ic ob­struc­tive pul­monary dis­ease was shot down with an FDA com­plete re­sponse let­ter. But on Fri­day, it fi­nal­ly re­ceived the green light.

The UK phar­ma gi­ant has re­ceived ap­proval for its Breztri Aeros­phere, for­mer­ly dubbed PT010, cul­mi­nat­ing the drug’s bumpy reg­u­la­to­ry jour­ney in a win. Now, As­traZeneca can chal­lenge the leader in the area — Glax­o­SmithK­line’s Trel­e­gy — with­out ob­sta­cle.

Orig­i­nal­ly, Breztri Aeros­phere faced con­cerns from the re­sults of its KRO­NOS tri­al. De­spite demon­strat­ing pos­i­tive topline re­sults, the in­haler drug failed to sig­nif­i­cant­ly dis­tin­guish it­self from two of As­traZeneca’s oth­er dual-com­bo ther­a­pies in the rate of mod­er­ate or se­vere COPD ex­ac­er­ba­tions.

But As­traZeneca re­turned to reg­u­la­tors with re­sults from the more re­cent ETHOS study, which had not been com­plet­ed when the phar­ma orig­i­nal­ly sub­mit­ted the NDA. That ex­ac­er­ba­tion rate served as ETHOS’ pri­ma­ry end­point as op­posed to KRO­NOS, which mea­sured lung func­tion pa­ra­me­ters.

“Pre­vent­ing ex­ac­er­ba­tions is cen­tral to the man­age­ment of chron­ic ob­struc­tive pul­monary dis­ease,” said Fer­nan­do Mar­tinez, lead in­ves­ti­ga­tor of the ETHOS tri­al, in a state­ment. “Even a sin­gle ex­ac­er­ba­tion can have a neg­a­tive im­pact on a pa­tient’s lung func­tion and qual­i­ty of life, and it can in­crease the risk of death.”

Full re­sults from ETHOS, re­leased last Au­gust, in­di­cat­ed that both stan­dard and half dos­es of the ther­a­py’s budes­onide agent re­sult­ed in sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in those COPD ex­ac­er­ba­tions. Ad­di­tion­al­ly, ETHOS was a 52-week tri­al where­as KRO­NOS was 24 weeks.

Breztri Aeros­phere had pre­vi­ous­ly re­ceived a reg­u­la­to­ry OK in Japan with num­bers from the KRO­NOS study, but the FDA was not sat­is­fied.

The ther­a­py it­self com­bines its pre­vi­ous dual-com­bi­na­tion treat­ments in­to what As­traZeneca has said is a bet­ter way for pa­tients to in­di­vid­u­al­ly cal­i­brate their dosage lev­els. In ad­di­tion to the in­haled cor­ti­cos­teroid budes­onide, Breztri Aeros­phere uti­lizes a LAMA (gly­copy­rro­ni­um) and a LA­BA (for­moterol fu­marate).

Giv­en the ap­proval, GSK could face some stiffer com­pe­ti­tion in the COPD mar­ket. Trel­e­gy is al­so a triple-com­bo ther­a­py and raked in about $660 mil­lion in 2019 sales, with al­most three-quar­ters of that amount com­ing from US pur­chas­es. As the res­pi­ra­to­ry field shifts to­ward triple-drug com­bi­na­tions and away from dual- and monother­a­py treat­ments, As­traZeneca is look­ing to take a chunk of that pie.

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.