→ Ul­tragenyx’s Crysvi­ta has scored its sec­ond FDA ap­proval, earn­ing the nod to treat bone soft­en­ing in pa­tients with the ul­tra-rare dis­ease known as tu­mor-in­duced os­teo­ma­la­cia. First ap­proved in 2018 for a dif­fer­ent ul­tra-rare in­di­ca­tion, x-linked hy­pophos­phatemia, Crysvi­ta quick­ly earned watch­dog scorn for its $200,000 per year price tag. De­spite hopes, though, that the price would bring block­buster sales, it earned on­ly $87.3 mil­lion last year and $28.8 mil­lion in Q1 2020. The drug is al­so mar­ket­ed by Japan­ese biotech Ky­owa Kirin.

→ Sanofi and Re­gen­eron’s IL-3/IL-14 block­buster Dupix­ent has been ap­proved in Chi­na for atopic der­mati­tis. CEO Paul Hud­son said that as part of the gov­ern­ment’s Healthy Chi­na 2030 ini­tia­tive, the French phar­ma will seek 25 new ap­provals by 2025.

→ Sagimet Bio­sciences re­leased pos­i­tive Phase II da­ta for its NASH drug TVB-2640. Al­though the field has strug­gled de­spite great in­vestor and in­dus­try promise, most re­cent­ly with the fail­ure of Gen­Fit’s close­ly-watched Phase III tri­al, a steady pipeline of ear­li­er stage drugs con­tin­ue to march along. Sagimet, known as 3-V Bio­sciences un­til last Au­gust, said the drug’s high dose had a 61% re­sponse rate across 30 pa­tients and led to a mean liv­er fat re­duc­tion of 28.2%.

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.

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

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.