AHA: J&J's Invokana chases AZ's Farxiga and Lilly's Jardiance with phase 3 heart failure win

 

 Chasing rivals from AstraZeneca and Eli Lilly/Boehringer Ingelheim, Johnson & Johnson's Invokana is vying for a piece of the lucrative heart failure market.

J&J's Type 2 diabetes med helped improve patients' heart failure symptoms regardless of whether they had diabetes, phase 3 data presented at the American Heart Association's virtual Scientific Sessions 2021 showed.

With positive late-stage data in hand, Invokana could become the latest sodium-glucose co-transporter 2 (SGLT2) inhibitor to make the jump from Type 2 diabetes to heart failure, following in the footsteps of AstraZeneca's Farxiga and Eli Lilly and Boehringer Ingelheim's Jardiance.

Patients on Invokana reported "significantly greater improvement" in their heart failure symptoms versus placebo, investigators said. Benefits were seen within two weeks and lasted throughout the entire three-month trial period.

Improvements were observed in both heart failure patients with preserved ejection fraction (HFpEF), when the lower left portion of the heart doesn't fill with blood properly, as well as those with reduced ejection fraction (rEF), when the same section of the heart fails to pump blood properly.

The 476-patient study enrolled 285 patients with HFpEF, while the rest had HFrEF. A total of 133 patients had Type 2 diabetes. Researchers looked at patients' symptom reports at two, four, six and 12 weeks. The team ran the trial virtually because of the pandemic.

Patients self-reported their symptoms on smartphones using the Kansas City Cardiomyopathy Questionnaire, which measures patients' perception of their health. The descriptions of their symptoms are converted into a Total Symptom Score that ranges from zero, indicating most severe, to 100, which suggests they've had no symptoms for the past two weeks.

“Demonstrating the success of a decentralized clinical trial opens opportunities for applying this approach to the testing of other cardiovascular therapies that focus on health status," John Spertus, M.D., lead author of the study, said in a statement.

If approved in heart failure, Invokana would be jockeying for space alongside diabetes rivals Farxiga and Jardiance. AZ's Farxiga won its green light in HFrEF in 2020, while Lilly and Boehringer's Jardiance scored a nod in the same indication in August.

Meanwhile, Invokana was the first-ever FDA approved SGLT2 inhibitor. It hit the scene in Type 2 diabetes way back in 2013 and snared $795 million in global sales last year.

https://www.fiercepharma.com/pharma/j-j-s-invokana-chases-az-s-farxiga-and-lilly-s-jardiance-phase-3-heart-failure-win

Talkspace cut to Neutral at 3 sell siders

 

Nov-16-21 Downgrade SVB Leerink Outperform → Mkt Perform Nov-16-21 Downgrade Robert W. Baird Outperform → Neutral $10 → $3 Nov-16-21 Downgrade Citigroup Buy → Neutral $3.50

https://finviz.com/quote.ashx?t=talk

Reddit biotech stocks in focus

 

Progenity, Inc. (NASDAQ:PROG)

Number of Hedge Fund Holders: 6

Progenity, Inc. (NASDAQ:PROG) makes and sells molecular testing products. The stock has surged in the past weeks, returning 38% to investors in the past month as the firm announced that it had been granted patents related to a new ingestible therapeutics technology it was developing. The new technology will help deliver drugs being developed by drug giants like Pfizer, a key growth catalyst highlighted by Redditors.

HC Wainwright analyst Joseph Pantginis recently initiated coverage of Progenity, Inc. (NASDAQ:PROG) stock with a Buy rating and a price target of $4, noting the “differentiated” drug pipeline of the firm.

At the end of the second quarter of 2021, 6 hedge funds in the database of Insider Monkey held stakes worth $34 million in Progenity, Inc. (NASDAQ:PROG), down from 9 in the previous quarter worth $17 million.

Cassava Sciences, Inc. (NASDAQ:SAVA)

Number of Hedge Fund Holders: 13

Cassava Sciences, Inc. (NASDAQ:SAVA) is a biotech firm that focuses on the development of drugs for the treatment of neurodegenerative diseases. Even though the short interest on the stock is very high, at over 30%, Redditors have been busy highlighting a recent report in a medical journal that there was no evidence of data manipulation in an article published by Cassava in the journal earlier to highlight efficacy of an Alzheimer's drug under development.

On September 23, investment advisory B Riley maintained a Buy rating on Cassava Sciences, Inc. (NASDAQ:SAVA) stock with a price target of $108. Mayank Mamtani, an analyst at the advisory, issued the ratings update.

Among the hedge funds being tracked by Insider Monkey, Chicago-based investment firm Citadel Investment Group is a leading shareholder in Cassava Sciences, Inc. (NASDAQ:SAVA) with 311,538 shares worth more than $26 million.

https://finance.yahoo.com/news/10-reddit-stocks-buy-november-163336835.html

GeoVax Gets Notice of Allowance for Cancer Vaccine Patent

 GeoVax Intellectual Property Portfolio Includes More than 70 Granted/Pending Patent Applications

GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 16/068,527 entitled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.” In general, the claims to be granted in the patent cover GeoVax’s vector platform for expressing tumor associated antigens in virus-like particles (VLPs) from a Modified Vaccinia Ankara (MVA) viral vector and encompass GeoVax’s Mucin 1 (MUC1) tumor-associated antigen immunotherapy candidate.

GeoVax’s initial results with its MVA-VLP-MUC1 immunotherapy candidates have been encouraging. The Company uses its MVA-VLP vaccine platform to express abnormal, aberrantly glycosylated forms of the cell surface-associated MUC1 protein that is associated with a wide range of cancers, including breast, colon, ovarian, prostate, pancreatic, and lung.

https://finance.yahoo.com/news/geovax-receives-notice-allowance-cancer-140000519.html

12 states sue to block Biden vaccine mandate on health care workers

 A group of 12 states is suing the Biden administration to block its vaccine mandate for health care workers, contending that the requirement is unconstitutional and violates a number of federal laws.

The lawsuit, filed on Monday, argues the vaccine mandate for health care workers, issued by the Centers for Medicare and Medicaid Services, exceeds the agency’s statutory authority and breaches the Social Security Act’s ban on regulations that control the hiring and firing of health care workers.

“The Biden Administration is playing statutory shell games with the courts, straining to justify an unjustifiable and unprecedented attempt to federalize public health policy and diminish the sovereign States’ constitutional powers,” the lawsuit reads.

The plaintiffs are also alleging that the mandate violates the Spending Clause, the Anti-Commandeering Doctrine, the 10th Amendment, which protects state's rights, and a number of federal laws.

The attorneys general of Alabama, Arizona, Georgia, Idaho, Indiana, Louisiana, Mississippi, Montana, Oklahoma, South Carolina, Utah, West Virginia are all listed as plaintiffs in the lawsuit.

Last week, 10 other states filed a lawsuit against the administration’s requirement, calling it “unconstitutional and unlawful.”

The latest suit names as defendants the Department of Health and Human Services and its secretary, Xavier Becerra, and the Centers for Medicare and Medicaid Services and its administrator, Chiquita Brooks-Lasure.

Workers at health facilities that receive federal funding from Medicare or Medicaid, including hospitals and nursing homes, must be fully vaccinated against COVID-19 by Jan. 4, according to the emergency rule released by the Biden administration earlier this month.

Unlike the mandate for businesses with more than 100 employees, there is not option for healthcare workers to submit to regular testing for the virus. 

Montana Attorney General Austin Knudsen (R), who is leading the lawsuit, said the decision of whether or not to get vaccinated should be up to the health care workers themselves.

“The federal mandates are not about health — they are about forced compliance. Healthcare workers should be allowed to make their own decisions about their health — not President Biden,” Knudsen said in a statement.

“If his unprecedented overreach is not stopped, healthcare workers will lose their jobs threatening access to medical care that Montanans need,” he added.

https://thehill.com/policy/healthcare/581702-12-states-sue-to-block-biden-vaccine-mandate-on-health-care-workers

Pfizer testing antiviral COVID-19 pill in Russia

 Pfizer has begun conducting clinical trials for its anti-viral COVID-19 pill in Russia.

A state registry of medicines on Tuesday showed that Russia has granted the vaccine company approval to conduct trials of the experimental pill, according to Reuters.

During the trials, which began on Nov. 12, will take place with a group of 90 people who have been subjected to someone who is symptomatic of COVID-19 in home-like conditions, the news outlet noted.

The trials are expected to continue through March of 2023, the registry website stated.

arlier this month, Pfizer said that with the pill hospitalizations and deaths connected to COVID-19 could be decreased by 89 percent.

"These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” Pfizer CEO and Chairman Albert Bourla said at the time.

Pfizer noted that it hopes to make the pill, brand named Paxlovid, available globally as soon as possible, Reuters reported.

https://thehill.com/policy/healthcare/public-global-health/581692-pfizer-testing-antiviral-covid-19-pill-in-russia

NYC sanitation workers suspended amid probe into fake vaccine cards

 A group of several dozen sanitation workers in New York City has been suspended without pay as officials investigate whether the employees used counterfeit vaccine cards in order to circumvent the city's vaccine mandate, according to a report from ABC 7. 

Spokesperson Diane Struzzi told the television station, "[The Department of Investigations] is aware of allegations involving the issuance of bogus vaccination cards and declines further comment."

According to ABC's report, the employees allegedly submitted authentic vaccine cards that listed that they were vaccinated at a CVS Pharmacy with the singe-dose Johnson & Johnson COVID-19 vaccine, however, CVS has not administered J&J shots in half a year. 

The officials are looking into the reports to see if there was any payment in exchange for these falsified and said that the department is taking these allegations seriously, reports ABC 7.

"These are very concerning allegations and we take them very seriously — getting vaccinated is important to public health, and we do not tolerate anyone faking something that is a requirement of city employment," spokesman Joshua Goodman said, according to the news outlet.

Municipal employees for the City of New York were required to have at least one dose of a COVID-19 vaccine by October 29 and the test-out option was eliminated for city employees. 

According to The New York Times, The Department of Sanitation workers in New York City took its vaccine rate from 67 percent to 76 percent swiftly as the mandate was enacted, however, the possibility that some of those vaccinations in that near-ten percent leap could have been fraudulent has rattled the department.

A spokesman for New York City Mayor Bill de Blasio (D) touted the mandate's apparent success for the Department of Sanitation on Twitter. 

According to the Times, over 87 percent of sanitation workers in New York have gotten at least one dose of a COVID-19 vaccine.

https://thehill.com/homenews/state-watch/581695-new-york-sanitation-workers-suspended-amid-probe-into-fake-vaccine-cards