→ Kala Phar­ma­ceu­ti­cals, one of the pletho­ra of biotechs that trace their roots to the pro­lif­ic lab at MIT led by Bob Langer, on Thurs­day dis­closed that its ex­per­i­men­tal drug for short-term dry eye re­lief did not pass muster with the FDA. Last year, the com­pa­ny post­ed mixed da­ta from two stud­ies — STRIDE 1 and STRIDE 2. Kala $KALA is now bank­ing on the on­go­ing STRIDE 3 study to re­verse its for­tunes. It ex­pects STRIDE 3 to read out by the end of the year, and to re­sub­mit its mar­ket­ing ap­pli­ca­tion the first half of 2020.

While dis­ap­point­ing, the CRL is not com­plete­ly un­ex­pect­ed, COO Todd Baze­more said. The com­pa­ny had ini­ti­at­ed STRIDE 3 last year at the ad­vice of the FDA, and is con­fi­dent that they have now got­ten the in­clu­sion/ex­clu­sion cri­te­ria right by screen­ing out pa­tients with un­sta­ble symp­toms. Once they have the da­ta, he added, they can re­file an NDA un­der a type 2 sub­mis­sion, which en­tails a 6-month in­stead of 12-month re­view.

Point­ing to No­var­tis‘ re­cent $5.3 bil­lion pur­chase of Shire’s Xi­idra — whose ap­proval process in­spired Kala to take its chances the first time — Baze­more em­pha­sized the po­ten­tial of KPI-121: “There’s so few prod­ucts in this cat­e­go­ry, it’s a huge un­tapped cat­e­go­ry in which on­ly about a mil­lion and a half of the 30 mil­lion pa­tients are cur­rent­ly be­ing treat­ed with a pre­scrip­tion prod­uct.”

→ Em­bat­tled In­sys, en­gulfed in lit­i­ga­tion and fi­nan­cial­ly starved, has found a buy­er for its unit-dose nasal and sub­lin­gual spray man­u­fac­tur­ing equip­ment, as well as two pipeline prod­ucts — nalox­one nasal spray and ep­i­neph­rine nasal spray — in UK-based Hik­ma. “Hik­ma is the largest sup­pli­er of gener­ic nasal sprays in the US and we have been look­ing for ways to build up­on our strong man­u­fac­tur­ing plat­form and ex­pand our prod­uct port­fo­lio,” said Hik­ma’s pres­i­dent of gener­ics Bri­an Hoff­mann in a state­ment.

→ Los An­ge­les biotech BioVie, which in April post­ed pos­i­tive da­ta from a small study test­ing its in­fu­sion ther­a­py for se­ri­ous com­pli­ca­tion of ad­vanced liv­er cir­rho­sis, on Thurs­day amend­ed the terms of its im­pend­ing IPO. The com­pa­ny now plans to raise $15 mil­lion by of­fer­ing 1.3 mil­lion shares for $11.44/share, the as-con­vert­ed last close of its shares on the over-the-counter mar­ket. The com­pa­ny, which plans to list un­der the sym­bol BIVI, had pre­vi­ous­ly filed to of­fer 1.3 mil­lion priced at $11.88/share.

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.