A child plays Akili's FDA-approved EndeavorRx video game to treat ADHD.

Ak­ili cuts about 30% of staff in ef­fort to be 'ex­treme­ly lean'

Ak­ili In­ter­ac­tive is ax­ing about a third of its work­force, the com­pa­ny re­vealed last week, while re­or­ga­niz­ing the pipeline around its FDA-cleared video game for at­ten­tion deficit hy­per ac­tiv­i­ty dis­or­der (AD­HD).

Ed­die Mar­tuc­ci

CEO Ed­die Mar­tuc­ci said in an in­ter­nal mes­sage to em­ploy­ees on Jan. 12 that Ak­ili’s ex­ec­u­tive team has come to the “nec­es­sary but dif­fi­cult de­ci­sion” to say good­bye to 46 staffers. Those af­fect­ed have been no­ti­fied, and all lay­offs will take place by the end of the quar­ter, ac­cord­ing to an SEC fil­ing.

“I wish that we had a more ef­fi­cient foot­print so that this ac­tion would be less dra­mat­ic, but the truth is that we are just not as lean as we can be, and for that I apol­o­gize,” he wrote.

In 2020, En­deav­or­Rx be­came the first video game to win FDA au­tho­riza­tion as a men­tal health treat­ment. The game is cleared for kids 8 to 12 years old, and is de­signed to im­prove pa­tients’ at­ten­tion as they zoom through icy wa­ters and tar­get fly­ing crea­tures on the plan­et Frigidus. How­ev­er, in­sur­ers have been slow to cov­er En­deav­or­Rx and oth­er dig­i­tal ther­a­peu­tics.

In ad­di­tion to the cuts, Ak­ili is hold­ing off on a hand­ful of pro­grams be­yond AD­HD, such as at­ten­tion in autism spec­trum dis­or­der and cog­ni­tive dys­func­tion as­so­ci­at­ed with mul­ti­ple scle­ro­sis and ma­jor de­pres­sive dis­or­der, ac­cord­ing to the fil­ing. The com­pa­ny will con­tin­ue with in­ves­ti­ga­tor-ini­ti­at­ed stud­ies, and is “as­sess­ing var­i­ous po­ten­tial ways” to pur­sue those oth­er in­di­ca­tions, in­clud­ing part­ner­ships.

Two “Covid Fog” stud­ies be­ing con­duct­ed by out­side in­sti­tu­tions should pro­duce topline da­ta in the first half of this year, the com­pa­ny added.

As for AD­HD, Ak­ili will look to add more pa­tient groups to En­deav­or­Rx’s la­bel, in­clud­ing kids 13 to 17 years old, for which an FDA sub­mis­sion is ex­pect­ed this year. In adults, Ak­ili is stop­ping en­roll­ment ear­ly and an­a­lyz­ing da­ta ahead of sched­ule, af­ter re­cruit­ment was pro­gress­ing “more slow­ly than an­tic­i­pat­ed,” the fil­ing stat­ed.

Mar­tuc­ci said af­fect­ed em­ploy­ees will be of­fered at least two months’ salary and “ad­di­tion­al com­pen­sa­tion in recog­ni­tion of em­ploy­ee con­tri­bu­tions,” cost­ing the com­pa­ny a to­tal of $1.5 to $2.5 mil­lion, ac­cord­ing to the fil­ing. The changes are ex­pect­ed to ex­tend the com­pa­ny’s cash run­way to 2025.

“In re­cent months, the eco­nom­ic en­vi­ron­ment has dra­mat­i­cal­ly shift­ed. As a re­sult, there is pres­sure on all com­pa­nies (no mat­ter where they are in their stage of growth) to be ex­treme­ly lean and op­er­ate as ef­fi­cient­ly as pos­si­ble to­ward prof­itable growth. While En­deav­or­Rx is gain­ing trac­tion, we still must re­duce our spend­ing in re­sponse to the new re­al­i­ties of the world around us,” Mar­tuc­ci wrote.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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