Bob Langer, Cred­it: Chem­i­cal Her­itage Foun­da­tion, CC BY-SA 3.0

Kala Phar­ma­ceu­ti­cals has now joined the ranks of this year’s biotech IPO class, hit­ting the range and rais­ing $90 mil­lion af­ter pric­ing shares at $15.

Mar­ck Iwic­ki, Kala CEO

That cash will now help fund the fi­nal leg of two Phase III stud­ies for two dif­fer­ent dos­es of KPI-121 and the first round of com­mer­cial­iza­tion work that the biotech hopes lies ahead. Their lead drug is be­ing stud­ied for in­flam­ma­tion and pain fol­low­ing oc­u­lar surgery as well as the tem­po­rary re­lief of the signs and symp­toms of dry eye dis­ease.

Back in ear­ly 2016 MIT pro­fes­sor Bob Langer told me that Kala had moved through pre­clin­i­cal work and in­to late-stage test­ing in just three years, a ma­jor ac­com­plish­ment for the com­pa­ny. The group, which was in­spired by work done by Langer and some of his stu­dents at MIT, can now add a suc­cess­ful IPO as they plan an NDA be­fore the end of this year. One of Langer’s for­mer stu­dents, Hong­ming Chen, is the CSO at Kala. Mark Iwic­ki is CEO.

Hong­ming Chen, Kala CSO

The Waltham, MA-based biotech will trade as $KALA. The biotech raised $68 mil­lion in ear­ly 2016 from Lon­gi­tude Cap­i­tal, Or­biMed, Vi­vo Cap­i­tal, CAM Cap­i­tal, RA Cap­i­tal Man­age­ment, Welling­ton Man­age­ment Com­pa­ny LLP, Po­laris Part­ners, and Lux Cap­i­tal.

J.P. Mor­gan, Bo­fA Mer­rill Lynch and Wells Far­go Se­cu­ri­ties are act­ing as joint bookrun­ners for the of­fer­ing. Wed­bush Pac­Grow is act­ing as a co-man­ag­er for the of­fer­ing.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.