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Tuesday, February 15, 2022

Biden administration eyes $30 billion for COVID-19 funding in talks with Congress

 The Biden administration signaled it will request $30 billion in supplemental COVID-19 funding during discussions with Congress on Tuesday, including money for vaccines, testing and treatment. 

The discussions come ahead of a March 11 deadline for a government funding package, which could serve as a vehicle for more COVID-19 funds. 

Sen. Roy Blunt (R-Mo.) told reporters he spoke to Health and Human Services Secretary Xavier Becerra on Tuesday and is expecting a $30 billion request. 

"I talked to Secretary Becerra today, and I think they're going to be proposing a $30 billion supplemental," Blunt said, according to audio provided by his office.

He noted that he had previously questioned if money already provided was still available but said: "Frankly in the categories they're asking for money, the other money has all been spent or committed to the purposes it was appropriated for."

An HHS spokesperson confirmed the discussions, saying agency leaders "discussed the status of COVID response funds as well as the need for additional resources to support securing more life-saving treatments and vaccines, sustaining testing capacity, and investing in research and development of next-generation vaccines."

"These resources would help us continue expanding the tools the country needs to stay ahead of the virus and help us move toward the time when COVID-19 will not disrupt our daily lives," the statement added. 

The statement made no mention of additional funding for global vaccinations, an area where Democratic lawmakers have been pushing for more action. 

The Congressional Progressive Caucus, as well as other Democratic lawmakers, has been pushing for $17 billion for global vaccinations.

Asked about the COVID-19 funding talks in general on Tuesday, White House Press Secretary Jen Psaki said "what we're trying to do now is stay ahead" of the virus.

Some congressional Republicans have expressed opposition to more funding, though, pointing to the billions already allocated.

"It is ridiculous to think that Congress should go along with such a request," Rep. Jason Smith (Mo.), the top Republican on the House Budget Committee, wrote in a Fox News op-ed last week. "The Administration’s own trail of inflationary fueled spending over the last year has hardly emboldened Americans’ confidence that government is a good steward of their tax dollars."

https://thehill.com/policy/healthcare/594380-biden-administration-eyes-30-billion-for-covid-19-funding-in-talks-with

Alcon Reports Fourth Quarter and Full Year 2021 Results

 

  • Fourth Quarter 2021 sales of $2.1 billion, up 11% or 13% constant currency

  • Full Year 2021 sales of $8.2 billion, up 22% or 20% constant currency

  • Above-market growth in both Surgical and Vision Care; sales momentum from key products, new product launches and commercial execution

  • Full Year 2021 cash from operations of $1.3 billion, free cash flow of $645 million

  • 2022 guidance reflects continued sales and earnings growth

2022 outlook

The Company provided its full year 2022 outlook as follows. This outlook assumes that markets grow over 2021 in line with historical averages; that the impact from inflation moderates in the second half of the year; and that exchange rates as of mid-January 2022 prevail through year-end.

2022 outlook

Change vs. 2021
actuals (cc)(2)

Net sales

$8.7 to $8.9 billion

+7% to +9%

Core operating margin(1)

18% to 19%

Interest expense and Other financial income & expense

$180 to $190 million

Core effective tax rate(5)

17% to 19%

Core diluted EPS(1)

$2.35 to $2.45

+13% to +18%

Webcast and Conference Call Instructions

The Company will host a conference call on February 16 at 2:00 p.m. Central European Time / 8:00 a.m. Eastern Time to discuss its fourth quarter and full year 2021 earnings results. The webcast can be accessed online through Alcon's Investor Relations website, investor.alcon.com. Listeners should log on approximately 10 minutes in advance. A replay will be available online within 24 hours after the event.

https://finance.yahoo.com/news/alcon-reports-fourth-quarter-full-213000718.html

HOOKIPA, Gilead Amend Agreement to Develop Immunotherapies Against HIV

 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced it has entered into an amended and restated collaboration and license agreement with Gilead to advance the development of a novel arenaviral immunotherapy as a component of a potential functional curative regimen for human immunodeficiency virus (HIV).

In April 2018, Gilead licensed exclusive rights to HOOKIPA’s versatile arenaviral platform to develop immunotherapies for HIV and hepatitis B virus (HBV). Under those terms, the companies agreed to collaborate through a joint research phase, after which time Gilead had rights for further development. Under the amended and restated agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial, with funding from Gilead via an upfront payment and equity purchases. At the completion of the Phase 1b trial, Gilead has the exclusive right to assume further development of the program. The HBV portion of the agreement remains unchanged.

“We are pleased to enter into this amended agreement with Gilead which includes provisions that we believe benefit both parties, and we hope ultimately the HIV community,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Gilead is helping to advance our novel arenaviral platform technology, which has the potential to complement Gilead’s overall research strategies for cures of HIV and HBV.”

Hookipa earned a one-time $4 million preclinical milestone payment under the original 2018 collaboration and license agreement. Upon signing of the amended agreement, Hookipa will receive a payment of $15 million. In addition, Gilead will make a $5 million equity investment in HOOKIPA at a premium to the current market price, and up to an additional $30 million of equity financing that can be drawn at HOOKIPA’s discretion by December 31, 2023.


Sensus Healthcare Records Over 150% Jump In Q4 Sales

 Sensus Healthcare Inc's 

 Q4 FY21 sales increased 156% to $13 million, primarily driven by a higher number of units sold as the market continued to reopen, beating the consensus of $11.7 million.

  • The gross profit margin improved to 68% of revenues, compared with $3.2 million, or 63.4% of revenues.
  • The Company shipped a record 35 systems, including three SRT-100 systems, to China.
  • "Record revenues for the fourth quarter were significantly higher than for any quarter in the company's history," said Joe Sardano, Chairman & CEO. 
  • "We are comfortable that this momentum will continue through 2022 as so many of our initiatives are being very well-executed.
  • "We were delighted to receive a license renewal from China's Ministry of Health to market the SRT-100 system. This new license runs through December 2026 and covers the sale of our superficial radiation therapy to treat non-melanoma skin cancer and keloids," added Joe Sardano.
  • The Company reported Q4 EPS of $0.32 compared to $0.06 a year ago, surpassing the consensus of $0.15.
  • Adjusted EBITDA was $5.6 million, compared with $1.3 million for the fourth quarter of 2020. 
  • Cash and investments were $14.5 million.

Why AstraZeneca Shares Are Trading Higher

 Adding AstraZeneca Plc's 

 (Get Free Alerts for AZN) Lynparza to Johnson & Johnson's  (Get Free Alerts for JNJ) Zytiga (abiraterone) extended the time to live without disease progression in patients with newly diagnosed metastatic, castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.

  • The Lynparza combination pared down that risk by 34% over Zytiga alone, according to phase 3 data released at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). 
  • The Lynparza combo added more than eight months to patients' time to disease progression or death, reaching a median of 24.8 months versus 16.6 months for the control group.
  • AZ and Merck designed the 796-patient phase 3 PROpel trial for all patients independent of HRR status.
  • Results also showed a favorable trend towards improved overall survival (OS) with Lynparza plus abiraterone versus abiraterone alone. 
  • However, the difference did not reach statistical significance at this data cut-off (analysis at 29% data maturity). The trial will continue to assess OS as a key secondary endpoint.
  • In July 2017, AstraZeneca and Merck & Co Inc (NYSE: MRK) announced an oncology collaboration to co-develop and co-commercialize Lynparza and Koselugo (selumetinib) for multiple cancer types.

AC Immune-Janssen Alzheimer's Vaccine Shows Tau-Specific Antibodies In Early-Stage Trial

 AC Immune SA 

 (Get Free Alerts for ACIU) and partner Janssen, a unit of Johnson & Johnson  (Get Free Alerts for JNJ), have found that an early-stage Alzheimer's vaccine spurs induction of antibodies that attack a type of tau, a protein in the brain that contributes to the disease.

  • The interim data for ACI-35.030 come from the high-dose group in Phase 1b/2a trial of patients with early Alzheimer's
  • AC Immune and the Johnson & Johnson unit are studying the safety and immunogenicity of the tau vaccine candidate.
  • With these new data, AC Immune has the evidence needed to "support plans for further late-stage development," according to the press release.
  • The companies previously reported data from the low- and mid-dose cohorts.
  • The study had already been expanded to include 24 patients in the mid-dose cohort to collect more information on immunogenicity and safety.
  • Assessed at Week 10 after a second dose, patients had levels of antibodies that were reactive to pathological tau. No safety signals were flagged in the study.

Amgen Posts Latest Batch of Lumakras Data In Pancreatic Cancer

 Amgen Inc 

 (Get Free Alerts for AMGN) announced the presentation of efficacy and safety data from the CodeBreaK 100 Phase 1/2 trial in KRAS G12C-mutated advanced pancreatic cancer patients who received Lumakras (sotorasib). 

  • The data will be presented at the American Society of Clinical Oncology (ASCO) Plenary Series. 
  • Data show encouraging and clinically meaningful anticancer activity and a favorable benefit-risk profile.
  • The Company posted a new Lumakras data, spotlighting a 21% objective response rate among 38 patients. 
  • Researchers tracked a median progression-free survival rate of 4 months with a median overall survival rate that neared seven months.
  • Eight of the 38 patients achieved a confirmed partial response (PR). Two of the eight patients with PR have ongoing responses. 
  • The median duration of response was 5.7 months, with a median follow-up of 16.8 months. 
  • No new safety signals were identified.