Replimune's sec­ond com­plete re­sponse let­ter for its can­cer ther­a­py last week is al­ready lead­ing to mul­ti­ple rounds of lay­offs and ex­is­ten­tial ques­tions about the com­pa­ny's fu­ture un­less it can fig­ure out a path for­ward with the FDA, CEO Sushil Pa­tel told End­points News in an ex­clu­sive in­ter­view.

The on­colyt­ic virus ther­a­py RP1 is in­tend­ed to treat ad­vanced melanoma and is the on­ly ad­vanced drug in Mass­a­chu­setts-based Replimune's pipeline. Pa­tel con­ced­ed that both CRLs, the first of which was is­sued in Ju­ly, were large­ly the same. They raised ques­tions about the piv­otal tri­al's de­sign and the ex­tent to which Bris­tol My­ers Squib­b's Op­di­vo helped the ex­per­i­men­tal ther­a­py. But he ques­tioned the agen­cy's rea­son­ing and point­ed to po­ten­tial po­lit­i­cal in­volve­ment in the lat­est de­ci­sion.

The FDA is con­cerned that Eli Lil­ly's new­ly ap­proved obe­si­ty pill Foun­dayo might come with a risk for ma­jor car­dio­vas­cu­lar events and liv­er dam­age, and has asked the com­pa­ny to pro­vide da­ta from an on­go­ing tri­al to as­sess the risks.

In its ap­proval let­ter for Foun­dayo, the agency stat­ed that it was seek­ing more in­for­ma­tion on “an un­ex­pect­ed se­ri­ous risk for ma­jor ad­verse car­dio­vas­cu­lar events (MACE), drug-in­duced liv­er in­jury (DILI), and ex­po­sure to or­for­glipron dur­ing lac­ta­tion.” Or­for­glipron is Foun­dayo’s gener­ic name.

Ac­cord­ing to the let­ter, the agency had de­ter­mined that “on­ly a clin­i­cal tri­al (rather than a non­clin­i­cal or ob­ser­va­tion­al study) will be suf­fi­cient” to as­sess these risks. It asked that one of Lil­ly’s on­go­ing tri­als, which is de­signed to pro­vide da­ta on MACE rates, al­so look at oc­cur­rences of DILI.

Click Ther­a­peu­tics cut more than a quar­ter of its work­force short­ly af­ter rais­ing Se­ries D fund­ing, End­points News has learned.

The dig­i­tal ther­a­peu­tics start­up, which on Thurs­day raised $50 mil­lion from phar­ma­ceu­ti­cal gi­ant Boehringer In­gel­heim, let go of 25 em­ploy­ees out of a staff of 93, ac­cord­ing to a per­son fa­mil­iar with the mat­ter. In a state­ment to End­points, Click con­firmed the lay­offs.   

"We are at a nat­ur­al tran­si­tion point. Af­ter years of suc­cess­ful R&D, we are now re­tool­ing Click to fo­cus on the com­mer­cial launch of our val­i­dat­ed ther­a­pies," Click­'s chief strat­e­gy of­fi­cer Austin Speier said in a state­ment. "While we are in­cred­i­bly ex­cit­ed about the po­ten­tial of CT-155, that shift means mak­ing hard changes to our team to match our new com­mer­cial mis­sion."

John­son & John­son ex­ec­u­tives be­lieve the worst of the biosim­i­lar pres­sure fac­ing Ste­lara is be­hind them, and feel con­fi­dent enough to pre­dict sig­nif­i­cant growth through the end of the 2020s.

But Wall Street may need con­vinc­ing.

On Tues­day morn­ing's first-quar­ter earn­ings call, J&J lead­ers re­peat­ed­ly and ea­ger­ly trum­pet­ed the re­cent ap­proval of Ico­tyde as a game-chang­ing mo­ment for the com­pa­ny. CEO Joaquin Du­a­to even made the bold claim that plaque pso­ri­a­sis pill Ico­tyde “has the po­ten­tial to be one of our largest prod­ucts ever.”

In ad­di­tion, con­tin­ued strong sales of the im­munol­o­gy drug Trem­fya and the can­cer ther­a­py Darza­lex, as well as oth­er new­er ap­provals for In­lex­zo and Ry­bre­vant in on­col­o­gy, col­ored Tues­day’s call with a clear sense of op­ti­mism. It’s a de­par­ture for the nor­mal­ly tight-lipped com­pa­ny, which usu­al­ly prefers to let peo­ple read be­tween the lines.

The FDA ex­pand­ed the la­bel for Filspari on Mon­day to add an­oth­er kid­ney con­di­tion. The drug is now the first ther­a­py ap­proved in the US for fo­cal seg­men­tal glomeru­loscle­ro­sis (FS­GS).

The pill may be tak­en by pa­tients aged eight years and old­er who do not have nephrot­ic syn­drome, a pos­si­ble con­se­quence of FS­GS. Tra­vere said that the new ap­proval would mean the drug could reach over 30,000 more pa­tients.

The ap­proval fol­lows a three-month reg­u­la­to­ry de­lay. Tra­vere said the agency ex­tend­ed its re­view time­line to ad­dress new in­for­ma­tion sub­mit­ted by the com­pa­ny about Filspar­i's clin­i­cal ben­e­fit.