Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

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.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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