A biotech in Chi­na re­ports to­day that it will be scoop­ing up a string of pre­clin­i­cal siR­NA pro­grams from Sanofi as the multi­na­tion­al play­er lat­er­als a dor­mant de­vel­op­ment plat­form to the Lil­ly-backed group in Shang­hai.

De­tails are sparse, but Rona Ther­a­peu­tics — which scored a $33 mil­lion launch round in April from Lil­ly Asia Ven­tures, CMB In­ter­na­tion­al, Pla­tanus, Fontus Cap­i­tal and Lant­i­ng Cap­i­tal — says it gained world­wide ex­clu­sive rights to Sanofi’s siR­NA plat­form.

The deal in­cludes new drugs for neu­ro and mus­cu­lar dis­eases, and Sanofi is hang­ing on to op­tions in those ar­eas for ex-Chi­na rights to any­thing that makes its way to an ap­proval.

There was an up­front in the deal, but no one is say­ing for how much.

Sanofi has had a star-crossed jour­ney in the RNA field, ini­tial­ly scor­ing a ma­jor al­liance with Al­ny­lam, then ex­it­ing with fi­tusir­an in the pipeline for he­mo­phil­ia. Safe­ty is­sues forced a re­vamp of that late-stage pro­gram, and just days ago the phar­ma­cy gi­ant flagged a fail­ure for its mi­croR­NA drug lademirsen, part­nered with Reg­u­lus.

But this deal has noth­ing di­rect­ly to do with those pro­grams. A spokesper­son for Sanofi tells me that the com­pa­ny is spin­ning out an in­ter­nal­ly de­vel­oped siR­NA plat­form, which they put on the shelf back in 2019. Sanofi is al­so keep­ing the deal terms here qui­et.

“Rona plans to quick­ly ad­vance the de­vel­op­ment of these pro­grams in meta­bol­ic, neu­ro­log­i­cal and oc­u­lar dis­eases to un­lock the po­ten­tial of siR­NA ther­a­peu­tics,” said Stel­la Shi, the CEO of Rona Ther­a­peu­tics.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sarepta’s research agreement with the Broad Institute is taking the next step Monday.

The biotech will license a new group of adeno-associated viruses from the institute for an undisclosed upfront payment and milestone promises, the pair announced Monday morning. Under the agreement, Sarepta will have the rights to five neuromuscular and cardiac indications, including Duchenne muscular dystrophy, where it’s already well-versed.