In­vestors on board for KalVista’s roller coast­er ride of stock swings are in for some new dra­ma. Two months af­ter the biotech re­port­ed pos­i­tive Phase II re­sults for its lead drug de­signed to pre­vent the ef­fects of the rare ge­net­ic dis­or­der hered­i­tary an­gioede­ma, the FDA has slapped a hold on their Phase II study of their oral drug to pre­vent HAE.

The biotech hur­ried to as­sure in­vestors that no new da­ta would be need­ed to start the Phase II, but not­ed:

The FDA let­ter re­quests fur­ther in­for­ma­tion and analy­sis re­lat­ed to cer­tain pre­clin­i­cal stud­ies of KVD824 sub­mit­ted to sup­port the planned Phase 2 tri­al. Re­fine­ments were al­so pro­posed to the in­tend­ed KVD824 Phase 2 study pro­to­col.

Shares of KalVista dropped 10% by mid-morn­ing.

An­drew Crock­ett

A lit­tle over a year ago Mer­ck dropped out of their deal to part­ner with KalVista af­ter their Phase II study for a di­a­bet­ic mac­u­lar ede­ma drug failed.

“We in­tend to ful­ly com­ply with the re­quests and rec­om­men­da­tions pro­vid­ed by the FDA,” said An­drew Crock­ett, the CEO of KalVista. “Al­though we no longer can con­firm that the KVD824 Phase 2 tri­al will ini­ti­ate this quar­ter, we are work­ing to re­solve their con­cerns in a time­ly fash­ion. Im­por­tant­ly, this let­ter re­lates sole­ly to KVD824, and does not im­pact our ac­tiv­i­ties or ex­pec­ta­tions with re­gard to KVD900, for which we con­tin­ue to pre­pare for an End of Phase 2 FDA meet­ing and com­mence­ment of our Phase 3 ef­fi­ca­cy tri­al.”

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.