Walensky: US has not yet seen omicron peak

Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), said on Friday that she does not think the U.S. has yet reached the peak of the omicron surge. 

With the seven-day average of COVID-19 cases almost doubling from last week, Walensky told NBC's “Today” that she does not think the U.S. is experiencing what South Africa saw when concluding it “may have passed the peak.”

“The way it has peaked in other countries — in South Africa, it has come down rapidly as well,” she said. “But I don’t believe we’ve seen that peak here in the United States.”

Walensky reported on Wednesday that the average daily cases reached 491,700 infections, after reaching a high of nearly 1 million cases confirmed on Monday. 

In her “Today” interview, she noted that COVID-19 hospitalizations and deaths are climbing at a slower rate than cases, but “we’re now starting to see the number of hospitalizations rise as well.”

Hospitalizations reached a seven-day average of about 14,800 per day in a 63 percent increase from the previous week, Walensky said on Wednesday. Deaths rose 5 percent to approximately 1,200 per day. 

But hospitals across the country are filled with unvaccinated patients who are 17 times more likely to be admitted and 20 times more likely to die than boosted individuals, the CDC director told “Today.”

“So there’s a lot we can do right now in this moment getting vaccinated, getting boosted,” she said. “We have 99 percent of our counties in high transmission. Wear your mask in public indoor settings.”

https://thehill.com/policy/healthcare/588724-walensky-us-has-not-yet-seen-omicron-peak

Appeals court grapples over next steps in Texas abortion law case

 A federal appeals court on Friday grappled with how to proceed with a legal challenge against the controversial Texas abortion law known as SB 8 after the Supreme Court declined to strike it down but allowed lawsuits against it to move forward.

During a hearing, a three-judge panel for the Fifth Circuit Court of Appeals heard arguments from lawyers for the state and abortion providers challenging the law, who disagree on procedural issues over the next steps for the case.

Two of the three judges, both appointed by Republican presidents, appeared sympathetic towards Texas's argument that the case should be sent to the state's supreme court for further litigation over the law. Abortion providers argue that the case should be returned to the federal district court and have even asked the Supreme Court to intervene to prevent the Fifth Circuit from stalling the case.

"Any further delay would be inconsistent with how the Supreme Court has handled this case," Marc Hearron, an attorney for the plaintiffs, said during Friday's hearing.

Judge Kyle Duncan responded by saying that the Supreme Court did not outline how the case should proceed.

"I really question that premise Mr. Hearron, because the Supreme Court had multiple opportunities to grant an injunction against SB 8, to send it directly to the district court, and it didn't do any of that," said Duncan, who was appointed by former President Trump.

The issue now before the Fifth Circuit involves extremely technical procedural issues, but how it's decided could determine the pace of the remaining legal challenges.

SB 8 bans abortion procedures after six weeks into a pregnancy, which many legal scholars say flies in the face of previous Supreme Court precedent. But the law was designed to frustrate judicial review with a provision that leaves enforcement entirely to private individuals filing civil suits against medical personnel or anyone else who facilitates the banned procedures.

In December, the Supreme Court narrowed the abortion providers' suit, but allowed it to proceed against certain Texas licensing officials, while dismissing a legal challenge from the Biden administration.

The high court remanded the case to the Fifth Circuit, which abortion providers believe is disinclined to handle the lawsuit with the appropriate urgency.

Lawyers for the reproductive clinics took the extraordinary step this week of asking the Supreme Court to step in and order the circuit court to dispatch the case to the district court level where the next steps can be litigated.

"Absent intervention by the Court, the Fifth Circuit is poised to entertain questions already decided by the Court in direct violation of this Court’s mandate, and delay further resolution of this case in the district court by at least weeks, and potentially months or more," Hearron wrote in a Supreme Court brief on Monday. "Therefore, Petitioners have no recourse in any other court."

It's unclear when the Fifth Circuit or the Supreme Court will rule in the case.

https://thehill.com/regulation/court-battles/588743-appeals-court-grapples-over-next-steps-in-texas-abortion-law-case

Personalis upped to Buy from Neutral by B of A

 Target to $23 from $27

https://finviz.com/quote.ashx?t=psnl&ty=c&ta=1&p=d

Supreme Court To Weigh Biden Vaccine Mandate

 The Supreme Court on Friday is scheduled to hear at least two hours of arguments beginning at 10 a.m. EST after GOP state officials and business groups filed requests to block President Joe Biden's vaccine mandate for employers who have more than 100 workers, as well as a similar requirement for healthcare facilities.

Justice Sonia Sotomayor has chosen to participate in the arguments from her chambers, and two arguing attorneys, the solicitors general of Ohio and Louisiana, will also participate remotely by telephone, a court spokeswoman said.

The justices spent most of the pandemic working remotely but returned to in-person arguments in October. All nine are fully vaccinated, the court said. The court remains closed to the public due to the pandemic. -Reuters

The plaintiffs have argued that the Biden administration exceeded its authority by imposing requirements that were never authorized by Congress, and that it f ailed to follow the proper administrative rules for issuing emergency regulations. 

Of note - and possible relevance to the argument; in July, Biden explicitly stated that people who take the vaccine will not get COVID-19, a statement we know (and knew at the time) was false.

Under one of the Biden policies, OSHA required that businesses employing more than 100 employees need to require vaccinations or weekly testing - which would apply to more than 80 million workers nationwide.

Taking the lead in trying to block the mandate is the state of Ohio and the National Federation of Independent Business. Meanwhile, several religious groups, including the Southern Baptist Theological Seminary, have filed similar cases.

The second policy under consideration by the Supreme Court requires that approximately 10.3 million workers across 76,000 healthcare facilities receive the vaccine.

https://www.zerohedge.com/medical/live-supreme-court-weigh-biden-vaccine-mandate

Amylyx Pharmaceuticals Announces Pricing of Upsized IPO

 Amylyx Pharmaceuticals, Inc. (“Amylyx”), a clinical-stage pharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the pricing of its upsized initial public offering of 10,000,000 shares of common stock pursuant to registration statements on Form S-1 filed with the U.S. Securities and Exchange Commission (“SEC”) at an initial public offering price of $19.00 per share.

All of the shares of common stock are being offered by Amylyx. Amylyx has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The gross proceeds to Amylyx from this offering are expected to be $190 million, before deducting underwriting discounts and commissions and offering expenses and excluding any exercise of the underwriters' option to purchase additional shares.

Amylyx' common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "AMLX" on January 7, 2022. The offering is expected to close on or about January 11, 2022, subject to the satisfaction of customary closing conditions.

Goldman Sachs & Co. LLC, SVB Leerink, and Evercore ISI are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

https://www.businesswire.com/news/home/20220106005955/en/Amylyx-Pharmaceuticals-Announces-Pricing-of-Upsized-Initial-Public-Offering-of-Common-Stock

Mersana 2022 Strategic Priorities and Milestones

 UPLIFT, a single-arm registrational trial of UpRi in platinum-resistant ovarian cancer, expected to complete enrollment in Q3 2022

UP-NEXT, a Phase 3 trial of UpRi monotherapy maintenance in platinum-sensitive ovarian cancer, expected to initiate in Q2 2022

Interim data from UPGRADE dose escalation umbrella trial of UpRi in combination with platinum planned for 2H 2022

Phase 1 dose escalation studies for two first-in-class candidates, XMT-1660, a Dolasynthen B7-H4 targeted ADC and XMT-2056, an Immunosynthen STING-agonist ADC targeting HER2, both expected to initiate in mid-2022

 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today provided its strategic priorities and anticipated milestones for 2022. Anna Protopapas, President and CEO of Mersana Therapeutics, Inc. will provide a business update at the upcoming virtual 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022.

https://finance.yahoo.com/news/mersana-therapeutics-announces-2022-strategic-130000188.html

Absci Announces Research Collaboration with Merck

 Absci Corporation (Nasdaq: ABSI), the drug and target discovery company harnessing deep learning AI and synthetic biology to expand the therapeutic potential of proteins, today announced that it has entered into a research collaboration with Merck (known as MSD outside the United States and Canada), using Absci’s AI-powered Integrated Drug Creation™ Platform.

Under the collaboration, Absci will deploy its Bionic Protein™ non-standard amino acid technology to produce enzymes tailored to Merck’s biomanufacturing applications and receive an upfront and certain other milestone payments. In addition, Merck has the option to nominate up to three targets and enter into a drug discovery collaboration agreement, and Absci would then be eligible to receive up to $610 million in upfront fees and milestone payments for all three targets, as well as research funding and tiered royalties on sales.

https://finance.yahoo.com/news/absci-announces-research-collaboration-merck-100000531.html