Rani Ther­a­peu­tics has tapped the ven­ture well again, this time rais­ing a sweet $69 mil­lion for its push to make in­jectable med­i­cines go down in a more de­light­ful way.

The San Jose, CA-based biotech is work­ing on a ro­bot­ic pill — dubbed the Ra­niP­ill — that’s de­signed to re­place in­jectable drugs like in­sulin. Rani says the Se­ries E round, which brings its to­tal raise to $211 mil­lion, will go straight in­to clin­i­cal de­vel­op­ment and man­u­fac­tur­ing for the can­di­date.

The idea of trans­form­ing in­jecta­bles in­to pills isn’t a new one. But a string of ef­forts to evade the en­zymes that break down an oral drug be­fore it can be ab­sorbed have large­ly hit a wall. Rani’s can­di­date has an en­teric coat­ing that pro­tects it from the acidic am­bi­ence of the stom­ach, then dis­solves as the pill moves in­to the in­tes­tine and pH lev­els rise. A chem­i­cal re­ac­tion in­flates a bal­loon, and the pres­sure push­es a dis­solv­able mi­cronee­dle in­to the in­testi­nal wall.

The in­jec­tion is pain-free, a Rani spokesper­son said. And be­cause the tech­nol­o­gy is ag­nos­tic to the pay­load, Rani be­lieves it could be used to de­liv­er pep­tides, pro­teins and an­ti­bod­ies.

So far the No­var­tis and Take­da-part­nered com­pa­ny has test­ed 9 mol­e­cules in pre­clin­i­cal stud­ies, and con­duct­ed clin­i­cal tri­als with adal­i­mum­ab, GLP-1 and oc­treotide — a mon­o­clon­al an­ti­body, meta­bol­ic drug and pep­tide, re­spec­tive­ly.

Back in Jan­u­ary, Rani said it got the re­sults it was look­ing for in an ear­ly-stage tri­al with oc­treotide. A to­tal of 58 vol­un­teers were en­rolled, 52 of whom got the Ra­niP­ill ver­sion, and 6 of whom got an in­tra­venous in­jec­tion with an iden­ti­cal dose. Rani CEO Mir Im­ran told End­points News at the time that the com­pa­ny proved its hy­poth­e­sis: The pa­tients didn’t feel a thing.

“And then the sec­ond end­point was bioavail­abil­i­ty, which turned out to be greater than 70%. Which is what ex­act­ly we had seen in our pre­clin­i­cal test­ing,” he said, adding that Rani would con­duct a head-to-head study to prove equiv­a­lence or non-in­fe­ri­or­i­ty to the in­jectable ver­sion.

Im­ran al­so said in Jan­u­ary that an IPO was a “dis­tinct pos­si­bil­i­ty” in about a year — which would be just about any time now. When asked on Fri­day if an IPO is in the near fu­ture, the com­pa­ny didn’t say yes. But they didn’t ex­act­ly say no, ei­ther.

“Right now we are fo­cused on ad­vanc­ing the clin­i­cal tri­als of our in­ter­nal pipeline of drugs, and our in-house man­u­fac­tur­ing of the Ra­niP­ill,” a spokesper­son said. “We do not com­ment on fu­ture fi­nanc­ing plans.”

Last year, a team of MIT and No­vo Nordisk sci­en­tists re­port­ed pos­i­tive an­i­mal re­sults from their own stab at a ro­bot­ic pill. Their can­di­date con­sists of a nee­dle in­side a cap­sule made of com­pressed freeze-dried in­sulin. Up­on con­tact with the wet in­ner lin­ing of the stom­ach, a sug­ar disk hold­ing the nee­dle in place dis­solves.

The pill de­liv­ered enough in­sulin to low­er an­i­mals’ blood sug­ar to lev­els sim­i­lar to in­jec­tions, ac­cord­ing to the re­searchers, who said they were still a few years away from the clin­ic.

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.