It’s been a record year for biotech IPOs, and the ex­ecs at Nas­daq would like noth­ing bet­ter than to see that mo­men­tum con­tin­ue in­to the first half of next year.

Since Jan­u­ary, 72 biotech and bio­phar­ma com­pa­nies have hit Wall Street, ac­cord­ing to Nas­daq head of health­care list­ings Jor­dan Saxe, to­geth­er rais­ing $13.2 bil­lion.

Jor­dan Saxe

The lat­est is Flag­ship’s Foghorn Ther­a­peu­tics, which priced its shares last night at $16 apiece, the mid­point of a $15 to $17 range. The Cam­bridge, MA-based biotech — which ini­tial­ly filed for a $100 mil­lion raise on Oct. 2 — is net­ting $120 mil­lion from a 7.5 mil­lion-share of­fer­ing. The pro­ceeds will go right in­to its gene traf­fic con­trol plat­form, in­clud­ing two lead pre­clin­i­cal on­col­o­gy can­di­dates.

Foghorn was found­ed in 2016 by Dana-Far­ber re­searcher Cigall Kadoch, and has since blown through $123 mil­lion, ac­cord­ing to its S-1/A fil­ing. When Bris­tol My­ers Squibb vet Carl De­ci­c­co joined as CSO in 2018, one of his first or­ders of busi­ness was pick­ing the pro­grams to prep for clin­i­cal tri­als, with a goal of hit­ting the clin­ic by 2020.

Cigall Kadoch

Foghorn is fo­cused on drug­ging tar­gets in the chro­matin reg­u­la­to­ry sys­tem — the sys­tem that con­trols the move­ment of mol­e­cules that turn genes “on” and “off,” ac­cord­ing to the com­pa­ny. An IND could be com­ing for its lead can­di­date, an al­losteric AT­Pase in­hibitor dubbed FHD-286, in AML and uveal melanoma lat­er this year, ac­cord­ing to the S-1/A. About $35 mil­lion from the IPO raise will sup­port that pro­gram.

An­oth­er $20 mil­lion is go­ing in­to the biotech’s hema­to­log­ic can­cer and sol­id tu­mors can­di­date, FHD-609, for which it ex­pects to sub­mit an IND in the first half of 2021.

Flag­ship owns 35.09% of Foghorn’s shares, ac­cord­ing to the S-1/A. Kadoch holds 11.09% of shares, and CEO Adri­an Gottschalk has a 2.56% slice of the pie.

Carl De­ci­c­co

Back in Ju­ly, Mer­ck inked a $425 mil­lion deal to es­sen­tial­ly li­cense one of the fac­tors Foghorn had just be­gun test­ing, buy­ing ex­clu­siv­i­ty on any po­ten­tial drugs that emerge to tar­get it. “I think this bi­ol­o­gy has been un­ex­plored and un­ex­ploit­ed as a drug, and I think the time is right,” Gottschalk said at the time.

This year’s biotech IPO tal­ly far sur­pass­es the 47 tracked last year by Brad Lon­car. Saxe told End­points News last month that a va­ri­ety of fac­tors, in­clud­ing the Covid-19 pan­dem­ic, have cre­at­ed the “per­fect storm” for an IPO boom. He and his team have been in talks with mul­ti­ple com­pa­nies prep­ping for an IPO at the end of this year or ear­ly next year, he said.

Round­ing out the year with 75 IPOs and just un­der $14 bil­lion in pro­ceeds would be a “fair es­ti­mate,” he said on Fri­day.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.