FDA puts Gilead Sciences blood cancer drug studies on hold

 Gilead Sciences said on Monday the U.S. health regulator placed a clinical hold on studies of its blood cancer drug, just a month after the company scrapped a late-stage trial due to efficacy concerns.

The company gained access to the drug, magrolimab, with its $4.9 billion buyout of Forty Seven Inc in March 2020.

The company said the U.S. Food and Drug Administration (FDA) had paused screening and enrollment of new study participants, while the patients already under the studies may continue to receive treatment.

Studies of magrolimab in solid tumors also to continue without any impact from the FDA action, said the company.

The company was studying the drug in combination with a type of chemotherapy called azacitidine for the treatment of patients with a higher risk of myelodysplastic syndromes — a rare group of bone marrow failure disorders.

https://finance.yahoo.com/news/1-us-fda-puts-gilead-125523659.html

Phathom Submits Data in Support of Erosive GERD New Drug Application

 

• Six-month stability data remain more than 10x below the acceptable intake limit set by the U.S. Food and Drug Administration (FDA) and continue to support the requested product shelf life
  
  

• Submission of six-month stability data satisfies Phathom's stability data submission requirements for Erosive GERD New Drug Application (NDA) for vonoprazan with a Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023

https://finance.yahoo.com/news/phathom-pharmaceuticals-announces-submission-six-120000988.html

Amgen's Lumakras facing FDA advisory panel for full approval

 The US FDA will hold an advisory committee meeting to discuss converting the accelerated approval of Amgen's (NASDAQ:AMGN Lumakras in non-small cell lung cancer.

https://seekingalpha.com/news/4004750-amgen-lumakras-facing-fda-advisory-panel-full-approval

Hutchmed: Phase III Study Met Its Primary Endpoint in Primary Immune Thrombocytopenia in China

  Randomized, double-blind, controlled trial met primary endpoint of durable response rate and all secondary endpoints —

— Overall safety consistent with sovleplenib known profile —

— Plans for regulatory submission underway in China, where it was designated a Breakthrough Therapy —

— Results to be submitted to an upcoming medical meeting —

https://finance.yahoo.com/news/hutchmed-announces-sovleplenib-phase-iii-000000766.html

Goldman sees US shutdown over spending 'more likely than not'

 The U.S. government looks "more likely than not" to shut down later this year due to political differences on spending that could temporarily hit economic growth, Goldman Sachs analysts said in a research note.

The Goldman economics analysts said prior shutdowns - which occur if Congress fails to pass annual spending bills - have stemmed either from disagreement on the level or distribution of spending, or a dispute over other issues that one party wants to address in spending legislation.

"At the moment, both types of risks are in play," Goldman said in the note.

A broad government shutdown stands to directly reduce growth by around 0.15 percentage points for each week it lasts, while the reduction could be 0.2 percentage points a week when including a modest impact in the private sector, according to Goldman.

However, the analysts said, in the quarter following the government reopening, growth would rise by the same amount.

Markets have not had strong reactions to three past shutdowns, in 1995-1996, 2013, and 2018-2019, according to the note.

Equity markets were flat or up at the end of those shutdowns, "though in each instance equity prices were lower at some point in the days following the start of the shutdown than when it began," the analysts wrote, while the 10-year Treasury yield declined "more consistently" after the start of the shutdowns.

The Goldman analysts said a shutdown "is not a foregone conclusion," pointing to support for a temporary extension after the end of the fiscal year on Sep. 30.

They also noted that compared to the severe macroeconomic impact of a failure to raise the U.S. debt limit, the less dramatic economic effect of a shutdown "also makes it more likely that Congress fails to act in time."

https://finance.yahoo.com/news/goldman-sees-us-shutdown-over-152754780.html

Goldman Looks To Exit Another Solomon-Driven Mass-Market Business-Line

 In yet another sign of Goldman's retrenchment back to its core competency - and away from profiteering off subprime consumers - the recently-embattled Wall St. legend is reportedly weighing the sale of a part of its wealth business catering to high net worth clients (shifting its focus back to serving the ultra-rich).

The FT reports that the Wall Street firm said on Monday it was “currently evaluating alternatives” for its personal financial management business, which encompasses Goldman’s registered investment adviser operations and supervises about $29bn in assets.

“We are currently evaluating alternatives for that business as we determine where to invest our resources and where we see the greatest opportunity,” the New York-based bank said in an emailed statement Monday.

The business grew out of United Capital, a California-based investment adviser that Goldman acquired for $750mn in 2019.

The deal came as Goldman was pushing to serve a broader array of customers.

“We expect to find an outcome that benefits both our clients and our advisers,” the bank said of the personal financial management business.

While it’s a small part of Goldman’s wealth business, it's symbolic of the strategic shift away from CEO David Solomon's ill-fated push to manage money for a broader set of customers.

In fact this is the second time in recent months that the bank seeks to unwind a deal that current Solomon executed (the bank this year put up for sale the online lending business GreenSky, acquired in 2021).

Having already noted problems at their Marcus unit (retail/credit) - paring back its business as charge-offs accelerate - it appears Solomon's decision to move away from the super-rich (so-called ultra-high net worth clients - whose wealth is at least in the tens of millions of dollars) is an unmitigated disaster.

As we note previously, it should be no surprise why Goldman is trying to dump its consumer finance division fast...

Worst!

Worst-er!

The bank said that it plans to grow its core wealth business serving ultra-high net worth clients, reiterating aspirations from its investor day in late February.

The question is - will Solomon be spinning the discs at the helm of this ship as they return to core competence?

https://www.zerohedge.com/markets/goldman-looks-exit-another-solomon-driven-mass-market-business-line

J&J says Kenvue tender offer oversubscribed, sees 23.8% of tendered shares exchanged

 Johnson & Johnson (JNJ) said Monday that 802.7 million shares of its common stock were validly tendered and not validly withdrawn in a Kenvue Inc. tender offer that expired at midnight Friday. The tender offer was oversubscribed, as expected, and J&J intends to accept about 191 million of the tendered shares in exchange for the 1.53 billion shares of Kenvue's common stock that it owned. J&J spun out Kenvue, which houses brands like Tylenol and Listerine, earlier this year. The company is "accepting only a portion of the shares of its common stock that were validly tendered and not validly withdrawn, on a pro rata basis in proportion to the number of shares tendered," though shareholders who had fewer than 100 shares of J&J's common stock and who validly tendered all their shares won't be subject to proration. J&J expects that about 23.8% of the tendered J&J shares will be exchanged. The company will retain about 9.5% of the outstanding shares of Kenvue after the exchange offer is complete. J&J shares were off 2% in Monday morning trading while Kenvue shares were ahead by roughly the same amount.

https://www.morningstar.com/news/marketwatch/20230821149/jj-says-kenvue-tender-offer-was-oversubscribed-expects-238-of-tendered-shares-will-be-exchanged