Is­raeli biotech Sol-Gel Tech­nolo­gies an­nounced Fri­day that it got its hands on a rare dis­ease drug can­di­date from Pelle­Pharm for al­most $75 mil­lion, amid claims that the drug has the po­ten­tial to reach a $300 mil­lion mar­ket.

Ex­ecs said on a con­fer­ence call Fri­day morn­ing that patideg­ib, a hedge­hog sig­nal­ing path­way block­er, is be­ing in­ves­ti­gat­ed to treat Gor­lin syn­drome, a rare ge­net­ic dis­or­der that in­creas­es the risk of de­vel­op­ing cer­tain kinds of can­cer such as basal cell skin can­cer and medul­loblas­toma, a type of brain can­cer. The dis­ease af­fects around one in every 31,000 peo­ple, and an es­ti­mat­ed 70,000 peo­ple world­wide.

The biotech said that it will be pay­ing Pelle­Pharm $4.7 mil­lion up­front with an ad­di­tion­al $70 mil­lion in de­vel­op­ment, NDA and com­mer­cial mile­stones, plus sin­gle-dig­it roy­al­ties. The deal is ex­pect­ed to close on Jan. 30.

Sol-Gel, which al­ready has two FDA-ap­proved der­ma­tol­ogy treat­ments with part­ner Gal­der­ma, said that this new ac­qui­si­tion re­flects a shift in fo­cus for the com­pa­ny. Per board chair­man Mori Arkin Fri­day morn­ing, the com­pa­ny is piv­ot­ing from der­ma­to­log­i­cal prod­ucts in a “very crowd­ed mar­ket” to in­stead push­ing “for more unique prod­ucts, for more lu­cra­tive prod­ucts that cater to rare dis­ease and to re­al prob­lems.”

“This will be al­so our strat­e­gy for the fu­ture,” Arkin re­it­er­at­ed.

A query to Sol-Gel by End­points News was not im­me­di­ate­ly re­turned.

Pelle­Pharm is a Bridge­Bio com­pa­ny that has been qui­et in re­cent years, with its last press re­lease hav­ing been pub­lished in Oc­to­ber of 2020. Back in 2018, Leo Phar­ma took a mi­nor­i­ty stake in Pelle­Pharm, agree­ing to pro­vide R&D sup­port to the com­pa­ny that was plan­ning on test­ing patideg­ib in a Phase III.

Ac­cord­ing to the com­pa­ny’s LinkedIn page, on­ly five em­ploy­ees re­main at Pelle­Pharm.

Sol-Gel is plan­ning its own Phase III tri­al, which will in­clude se­lect­ing pa­tients that have a spe­cif­ic mu­ta­tion. Sol-Gel’s study is ex­pect­ed to be­gin in the sec­ond half of this year, with re­sults ex­pect­ed by the end of 2025.

Sol-Gel added that the drug, al­ready hav­ing or­phan drug des­ig­na­tion from both the FDA and EMA, on top of FDA’s break­through ther­a­py des­ig­na­tion, may have enough sup­port for ap­proval from a sin­gle piv­otal tri­al, ac­cord­ing to the agen­cies.

Sol-Gel al­so is­sued a sec­ond press re­lease Fri­day, where it an­nounced it was rais­ing $22.8 mil­lion via con­cur­rent di­rect and pri­vate place­ment of­fer­ings. In­vestors in­clud­ed Armistice Cap­i­tal and M. Arkin Der­ma­tol­ogy Ltd., an en­ti­ty whol­ly-owned by Arkin.

“I’m very hap­py to pro­vide my own cap­i­tal to this project, and to con­tin­ue to sup­port the com­pa­ny all the way un­til the suc­cess of this project,” Arkin added on the con­fer­ence call.

Shares of Sol-Gel $SLGL went down slight­ly af­ter the mar­ket opened Fri­day.

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.