Search This Blog

Monday, June 5, 2023

"Bad For America" - Mid- & Big-Banks May Face 20% Jump In Capital Requirements

 U.S. regulators are preparing to force large banks to shore up their financial footing, moves they say will help boost the resilience of the system after a spate of midsize bank failures this year.

The Wall Street Journal reports, citing people familiar with the plans, the changes, which regulators are on track to propose as early as this month, could raise overall capital requirements by roughly 20% at larger banks on average.

Banks with at least $100 billion in assets may have to adhere to new requirements, lower than the existing $250 billion threshold, for which regulators have reserved their most stringent rules, according to the Journal.

Banks that are heavily dependent on fee income - such as that from investment banking or wealth management - could also face large capital increases.

Fed Vice Chair for Supervision Michael Barr signaled to House lawmakers in May that he believes capital requirements should be higher.

The banking system might need additional capital to be more resilient precisely because we don’t know the nature of the kinds of ways we might experience shocks to the system, as has happened with these recent bank failures."

Barr has previously said that US officials are reviewing bank capital requirements and committed to putting in place strictures that align with Basel III.

Bloomberg reports that the biggest banks have argued that their steadiness in the recent turmoil showed their strength and that they already have more than enough capital. The six biggest US firms have added more than $200 billion to their capital reserves in the last decade, and JPMorgan said last month that its total loss-absorbing capacity now exceeds the loan losses that all US banks had during the financial crisis.

“Higher capital requirements are unwarranted,” said Kevin Fromer, the chief executive of the Financial Services Forum, which represents the largest U.S. banks.

“Additional requirements would mainly serve to burden businesses and borrowers, hampering the economy at the wrong time.”

JPMorgan CEO Jamie Dimon has been among critics blasting more cumbersome capital requirements, calling the upcoming increase “bad for America” last year ahead of a pair of congressional hearings.

The coming proposal is the last piece of capital rules that global policy makers agreed to implement after the 2007-09 financial crisis. The overhaul forced banks around the world to boost their capital cushions in hopes of making them better prepared to weather downturns without taxpayer bailouts.

Nathan Dean, Bloomberg's senior government analyst noted that:

“The last remaining piece of Basel III, known informally as the Basel III endgame, would alter capital levels for US banks as regulators recalibrate risk-weighting of assets and restrict internal models used to calculate both credit and operational risk.”

All three agencies (The Fed, OCC, and FDIC) are expected to seek comment on the proposed capital rules.

They would have to vote again to complete the changes, likely implementing them over the coming years.

However, JPMorgan said at its investor day that while the final pieces of Basel III capital rules - which some investors have referred to as Basel IV because they could be so extensive - may be proposed soon, they’re unlikely to be implemented before early 2025.

https://www.zerohedge.com/markets/bad-america-big-banks-face-20-jump-capital-requirements

PDS Biotechnology Post-ASCO Conference Call Tomorrow, June 6, at 8 a.m. ET

 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that the Company will be hosting a conference call and webcast tomorrow, June 6, 2023, to discuss the promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), presented at the 2023 American Society for Clinical Oncology (ASCO) meeting.

During the call, management will provide an in-depth review of the 2023 ASCO interim data.

Conference Call Information:
PDS Biotech will host a conference call on Tuesday, June 6, at 8:00 a.m. ET to discuss the interim data being presented at the ASCO 2023 Annual Meeting. A live webcast of the event will be available online at PDS Biotech Post-ASCO Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

Additionally, interested participants and investors may access the conference call by dialing either 877-407-3088 (US) or 201-389-0927 (International).

https://finance.yahoo.com/news/pds-biotechnology-post-asco-conference-185200795.html

Seres, Nestlé Health VOWST for C. diff.. Commercially Available in US

 – VOWST is now available by prescription in the U.S. for adult patients following antibiotic treatment for recurrent CDI –

– VOWST Voyage™ Support Program to help reduce out-of-pocket patient costs for eligible patients and facilitate treatment start –

Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced that VOWST™ (fecal microbiota spores, live-brpk) is now commercially available for patients. VOWST, formerly called SER-109, is the first and only U.S. Food and Drug Administration (FDA)-approved orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is not indicated for the treatment of CDI.

https://finance.yahoo.com/news/seres-therapeutics-nestl-health-science-110000909.html

HTG Molecular Diagnostics Halted, News Pending

 “Partnering discussions have been initiated with global biopharmaceutical companies around the Company's portfolio of drug candidate molecules in oncology and neurodegenerative disease indications. In addition, HTG has initiated partnering conversations regarding the use of HTG's drug discovery engine within the partners' portfolios of drug assets.”

https://stocktwits.com/ZACHSPIZZA

ASCO: AstraZeneca, Daiichi's Enhertu delivers 'very compelling' pan-tumor activity

 AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. Now, the companies are positioning the HER2 antibody-drug conjugate (ADC) for expansion into other tumor types with data that researchers view as very compelling.

Enhertu shrank tumors in 37.1% of patients with various types of HER2-expressing solid tumors, according to an investigator assessment of a phase 2 trial called DESTINY-PanTumor02. The responses to treatment lasted a median 11.8 months. The data will be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting.

The early data are “really compelling” and represent “a shift in how we think about cancer care,” Bradley McGregor, M.D., from the Dana-Farber Cancer Institute and an ASCO expert, said during a press briefing. At the same event, Funda Meric-Bernstam, M.D., from the MD Anderson Cancer Center and the lead investigator of the study, also called Enhertu’s anti-tumor activity “very compelling.”

The data could open Enhertu for a tumor-agnostic approval in HER2-positive tumors regardless of their location, although Daiichi Sankyo’s head of global oncology clinical development, Mark Rutstein, M.D., declined to comment on the company’s regulatory submission plan.

Speaking about the principles of a tumor-agnostic indication in an interview with Fierce Pharma, Rutstein said the response rates and the durability of response are clinically meaningful and meet the bar for a pan-tumor indication based on precedent.

But a couple uncertainties could affect a potential tumor-agnostic application for Enhertu.

For one, Enhertu only achieved a 4% tumor response rate in patients with pancreatic cancer in the trial. The trial also included biliary tract, bladder, cervical, endometrial, ovarian and other cancers, which recorded response rates at 22%, 39%, 50%, 57.5%, 45% and 12%, respectively.

Patients with breast cancer, stomach cancer, colorectal cancer and non-small cell lung cancer, where Enhertu or other HER2 agents are approved, were excluded.

For pretreated patients with pancreatic cancer, Meric-Bernstam said the 12% response rate by central review and a 68% stable disease rate by investigator analysis were “quite favorable."

In addition, compared to patients with HER2 expression at immunohistochemistry (IHC) 2+ expression, Enhertu’s benefit looks more compelling in high HER2-expressers whose tumors had IHC 3+. In those patients, the overall response rate reached 61.3%, with a median duration of 22.1 months.

Rutstein said there's a high unmet need among these patients. The DESTINY-PanTumor02 study enrolled patients who have either failed existing standard of care or have no treatment available. Rutstein said he’s “very confident” that Enhertu “would have the capability to meet a clear unmet medical need” regardless of whether tumors are IHC 2+ or 3+.

“This is an opportunity for Enhertu to really see if we can help more patients at a very basic level,” Rutstein said.

The data are strong enough in some of the tumor types for drug developers to start thinking about running studies to examine Enhertu in earlier lines of treatment, Meric-Bernstam said.

Enhertu recently opened a new category in breast cancer treatment, winning an FDA approval to treat HER2-low cases. Patients in the DESTINY-PanTumor02 trial didn’t fit in the HER2-low category.

AZ and Daiichi are generally interested in lower-expressing populations but currently have no specific plans to study Enhertu in a HER2-low pan-tumor setting, Rutstein said.

Enhertu’s HER2-low breast cancer indication cuts the patient eligibility criteria at IHC 1 and in a post-chemotherapy setting. The phase 3 DESTINY-Breast06 study is testing the ADC in a pre-chemo setting and in patients with even lower HER2 expression. A readout is expected this year.

https://www.fiercepharma.com/pharma/astrazeneca-daiichis-enhertu-delivers-very-compelling-pan-tumor-activity-say-experts

FDA rejects Clovis' long-shot bid for approval of Rubraca

 Six months after filing for bankruptcy, Clovis Oncology was hoping for a last gasp win for fading cancer drug Rubraca. But the FDA has rejected the company’s bid for approval of the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients who have responded to a round of chemotherapy.

The Colorado-based biopharma was hit with a complete response letter from the U.S. regulator May 26, according (PDF) to a Securities and Exchange Commission (SEC) filing. The FDA said it needed to see survival data from a phase 3 study before considering the application.

Last year, the regulator warned Clovis that applying for the approval without presenting the survival data would hinder its chance for success. The company added (PDF) in an SEC filing that those results would not be available until 2024.

The problem for Clovis is that the company itself may no longer exist by then. Clovis was clinging to hope for an approval, which would have triggered a milestone fee from Pharma& Schweiz GmbH, Clovis said in its most recent filing. Two months ago, the Swiss company purchased Rubraca for $70 million, with an additional $50 million available in potential regulatory milestone payments.

With Rubraca as its lone commercial asset, 14-year-old Clovis had little chance to survive, triggering the Chapter 11 claim and the sale. The drug was originally approved in 2016 but, last June, because of death risk fears, the company withdrew its nod as a third-line treatment.

Sales of Rubraca peaked in 2020 at $164 million. Then the pandemic reduced the number of women being diagnosed with ovarian cancer, the company said, which it said impacted sales. AstraZeneca and Merck's Lynparza is the most successful PARP inhibitor, bringing in sales of $2.6 billion in 2022. 

Last year, as part of its bankruptcy procedure, Clovis also revealed that it sold cancer candidate FAP-2286 to Novartis for $50 million, with an additional $334 million due if milestones are hit and $297 million if certain sales goals are reached.

In its bankruptcy filing, Clovis revealed assets of $319 million compared to $754 million in debt. The company secured a $75 million loan to fund its operations during the procedure.

https://www.fiercepharma.com/pharma/fda-rejects-clovis-long-shot-bid-approval-rubraca

PDS: Discussion of Interim VERSATILE-002 Data at 2023 American Society of Clinical Oncology

 Date: June 5, 2023

Time: 4:30 PM-6:00 PM CDT
Session Title: Head and Neck Cancer
Discussant: Erminia Massarelli, MD, PhD, City of Hope Comprehensive Cancer Center