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Monday, April 1, 2024

Idaho Bans Medicaid For Transgender Procedures

 by Naveen Athrappully via The Epoch Times (emphasis ours),

Idaho Governor Brad Little signed a bill Wednesday that prevents individuals enrolled in the state Medicaid program from being covered for transgender-related treatments.

House Bill 668 prohibits Idaho’s Medicaid program from reimbursing or offering coverage for gender transition procedures, applicable to both minors and adults. Such procedures include both surgical and medical interventions. The prohibition applies to other public funds as well. The bill was passed with 58–11 votes in the House of Representatives and the Senate by 26–8. On March 27, Mr. Little signed the bill into law, which will come into effect on July 1.

The bill is applicable to gender transition procedures used for altering an individual’s appearance in order to affirm the perception of their sex, which is “inconsistent with the individual’s biological sex.”

Medicare and public health funds can be used for gender transition under three conditions—(a) where such procedures are “necessary to the health of the person,” (b) when the purpose is to treat any infection, injury, disease, or disorder caused or worsened due to previous gender transition procedures, (c) if the procedure is performed on a person born with a “medically verifiable genetic disorder of sex development.”

During a debate on the Senate floor, state Sen. Ben Toews told lawmakers the bill will ensure that taxpayer dollars “are not used to pay for medically harmful treatments,” Idaho Capital Sun reported.

“Responding to the brokenness of the world requires humility, compassion, and wisdom. We don’t have enough of these things by ourselves. And it is only by the power of our Creator, that healing is truly enabled. The answer to our affliction will not be contrived because wholeness is given, not manufactured.”

State Sen. Melissa Wintrow accused House Bill 668 of being discriminatory, insisting that it is part of a series of bills “that clearly violates the 14th Amendment Equal Protection Clause.”

The bill prohibits any state property, facility, or building from being used to offer the banned gender transition procedures. Physicians and other health care professionals employed by state, county, or local governments are also not allowed to offer such procedures to individuals.

Any intentional violation of the provisions of this chapter by a public officer or public employee shall be considered a misuse of public moneys,” the bill states, warning that such people will be punished.

Protecting Minors

In addition to House Bill 668, Mr. Little has approved other measures to protect minors from gender transition procedures. In April last year, he signed House Bill 71 which states that any individual who knowingly provides such procedures to minors will be considered guilty of a felony.

“In signing this bill, I recognize our society plays a role in protecting minors from surgeries or treatments that can irreversibly damage their healthy bodies,” Mr. Little said at the time.

“However, as policymakers, we should take great caution whenever we consider allowing the government to interfere with loving parents and their decisions about what is best for their children.”

The law was supposed to come into effect on Jan. 1, 2024. However, a federal judge temporarily blocked the law in December. The U.S. Court of Appeals for the 9th Circuit later affirmed the decision.

In February, Idaho asked the U.S. Supreme Court to allow it to enforce the state ban. In its application, Idaho stated that rulings of the district and 9th Circuit courts “violate controlling precedent on the limits of equitable remedies. That violation matters because it harms non-parties, leaving vulnerable children subject to procedures that even [the] Plaintiffs’ experts agree are inappropriate for some of them.”

Every day Idaho’s law remains enjoined, exposes vulnerable children to risky and dangerous medical procedures and infringes Idaho’s sovereign power to enforce its democratically enacted law,” it stated.

In a statement to The Epoch Times, Idaho Attorney General Raul Labrador said that children suffering from gender dysphoria “deserve love, support, and medical care rooted in biological reality. Denying the basic truth that boys and girls are biologically different hurts our kid[s].”

On March 21, Mr. Little signed Senate Bill 1329 which recognizes that parents have a “fundamental right and duty” regarding the health care decisions of their minor children. Unless “otherwise provided by court order,” people are banned from offering or soliciting health care services to kids without obtaining the consent of their parents.

The law protects the parental right to access the health records of their minor children. Health care providers and government entities are prohibited from denying such records to parents when they make a request.

Alliance Defending Freedom praised the bill, with the group’s senior counsel Matt Sharp pointing out that there have been “instances nationwide of government officials actively seeking to replace parents as the ultimate determiners of what’s best for children.”

“We commend Idaho for safeguarding the vital role of parents to guide the medical care of their children … Now and always, a loving parent will always be the best advocate to ensure their child gets the care needed.”

https://www.zerohedge.com/medical/idaho-bans-medicaid-transgender-procedures

Biden Budget Shells Out $320 M On Border Walls... For Oman, Lebanon, Jordan, Egypt, Tunisia

 by Monica Showalter via American Thinker,

Is there anything Joe Biden can't do?

Get a load of what he funded in his latest bloated budget spending bill passed last week, according to Breitbart News, which opened the hood of that jalopy:

Slipped into a $1.2 trillion budget signed by Biden last weekend is about $380 million for “enhanced border security” projects in Egypt, Jordan, Lebanon, Oman, and Tunisia — about $150 million of which must go to border security in Jordan.

Meanwhile, the budget puts strict limitations on the Department of Homeland Security’s (DHS) ability to construct physical barriers along the U.S.-Mexico border to deter illegal immigration.

“The Biden administration wants nothing more than the ability to ‘manage’ an invasion here at home, all while helping nations abroad build walls,” RJ Hauman with the National Immigration Center for Enforcement (NICE) told Breitbart News. “Make it make sense.”

Why, exactly are we paying for some place like Tunisia's enhanced border security, which is a cost they can bear themselves, while failing to build a border wall amid millions of foreign invaders rolling into the U.S. from some of those very same countries?

The irony is incredible here. Biden knows that border security works, which is why he's taking cash from the U.S. taxpayer and handing it over to foreign countries to ensure that their borders stay secure from terrorists and other foreign invaders.

Meanwhile, he spends tremendous time, money and energy to ensure that our border wall is open as can be. He's fighting Texas through the courts all the way up to the Supreme Court to ensure that they can't defend their border from crime and terrorism from "newcomers" from more than 100 countries still rolling on in without papers.

The latest news is that he has a master plan for amnesty and free green cards for those who slipped through the border earlier, and plans to issue an executive order, making illegal immigration nothing more than stop on the express subway to U.S. citizenship and Democrat votes.

According to the Daily Caller:

President Joe Biden is currently considering granting amnesty to illegal migrants in a bid to act on the worsening immigration crisis, according to Politico. Biden and his administration are weighing several ideas to take a tougher stance on the southern border crisis and illegal immigration amid criticisms he has thus far failed to act on either. The administration could start dolling out green cards to illegal immigrants who have long stayed inside the United States, thereby giving them amnesty to stay in the country, three people familiar with the planning told Politico.

It's insane, given how unpopular the idea is, and it comes on the heels of this fund-everyone-else's border security buried within the budget, except for ours. Didn't we just get through a failed border bill that came about because of the public's demand for border security before handing Ukraine $60 billion for its border security? Joe doesn't care. He's not doing things to be popular anymore, he's doing things to reward big-money campaign donors and special interest groups with an interest in open borders.

It may go to show that he knows he's losing, so he's blowing up the border as much as he can on the way out. It's hard to see what the logic of his terrible moves and their terrible optics really are.

https://www.zerohedge.com/political/biden-budget-shells-out-320-million-border-walls-oman-lebanon-jordan-egypt-and-tunisia

Novavax Presents Data on Updated COVID Vax, Progress on COVID-Flu Combo Candidate

 Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, will showcase continued progress on data from its updated COVID-19 vaccine (NVX-CoV2601) and provide an overview of its influenza and COVID-19-Influenza Combination (CIC) vaccine candidates at the World Vaccine Congress 2024 (WVC) in Washington, DC, April 2 to 4, 2024.

New data from Novavax's ongoing research on its updated XBB.1.5 COVID-19 vaccine in participants who previously received an mRNA vaccine showed robust neutralizing antibody titers for the XBB.1.5 subvariant as well as for the currently circulating JN.1 subvariant. Data also showed that the vaccine's safety and reactogenicity profile was consistent with its prototype vaccine (NVX-CoV2373).

Differences observed in immunoglobulin (IgG) subclass responses and Fcγ-mediated effector functions following mRNA and protein-based COVID-19 vaccinations will be shared.

Novavax will also discuss its influenza and CIC vaccine candidates, including a recap of data to date and the timeline for the Phase 3 trial anticipated to start during the second half of 2024.

https://www.biospace.com/article/releases/novavax-presents-data-on-updated-covid-19-vaccine-and-progress-to-date-on-its-covid-19-influenza-combination-vaccine-candidate-at-world-vaccine-congress-2024/

Vistagen Initiates Phase 3 Study of Fasedienol for Social Anxiety Disorder

  VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that it has enrolled the first patient in its PALISADE-3 Phase 3 trial of fasedienol, an investigational pherine candidate in development for the acute treatment of social anxiety disorder (SAD).

“Initiating PALISADE-3 is another major milestone in our plan to develop and commercialize fasedienol as the first treatment of its kind for social anxiety disorder,” said Shawn Singh, Chief Executive Officer. “We look forward to initiating PALISADE-4 in the second half of this year and advancing our innovative pherine pipeline to deliver pioneering neuroscience to patients affected by mental health disorders and unsatisfied with current treatments.”

PALISADE-3, similar to PALISADE-2, is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in patients with SAD induced by a public speaking challenge conducted in a clinical setting. The primary outcome measure is the patient self-rated Subjective Units of Distress Scale (SUDS). The U.S. multi-center study is planned to randomize approximately 236 adults ages 18 through 65. Patients will be randomized in a 1:1 ratio to fasedienol or placebo. Patients who complete PALISADE-3 will have an option to enroll in an open-label extension. Vistagen plans to initiate PALISADE-4, which will be a replicate of PALISADE-3, during the second half of 2024.

About Fasedienol Nasal Spray

Vistagen’s fasedienol (PH94B) is a first-in-class, rapid-onset investigational pherine nasal spray with a novel proposed mechanism of action (MOA) that is differentiated from all currently approved anxiety medications, including the SSRIs and SNRI currently approved for the treatment of social anxiety disorder (SAD), as well as benzodiazepines prescribed off-label. Fasedienol’s proposed MOA regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system, without systemic distribution, potentiation of GABA-A receptors, or direct activity on neurons in the brain. Vistagen’s registration-directed PALISADE Phase 3 program for fasedienol is focused on the acute treatment of SAD. Fasedienol has not demonstrated any signals of abuse potential or physical dependence in any clinical trial conducted to date.

The U.S. FDA has granted Fast Track designation for the investigation of fasedienol for the acute treatment of SAD.

https://www.biospace.com/article/releases/vistagen-initiates-palisade-3-phase-3-study-of-fasedienol-for-the-acute-treatment-of-social-anxiety-disorder-following-positive-results-of-palisade-2/

NRx update

 Four potential near-term milestones, including data from two clinical trials, an NDA filing and an upcoming share dividend

-- 50% reduction in corporate overhead and 25% reduction in overall net loss in 2023, compared to 2024 with $0.20 per share improvement in negative earnings. Additions to working capital of $8 million in Q1 2024.

-- Company forecasts first commercial revenue in 2024 from sales of ketamine and related technologies. Company received advance of first milestone payments in 2024 for ongoing development of NRX-101 from Alvogen and Lotus Pharmaceuticals, Inc.  (1975.TW)

-- Company announces new partnership around the first drug to potentially modify the underlying cause of schizophrenia

-- Data lock this week and top-line data expected this month, after completed enrollment of the Phase 2b/3 trial of NRX-101 in Treatment Resistant Bipolar Depression (TRBD); trial demonstrated 94% rater concordance, far in excess of industry norms and exceeded industry norms in medication compliance

-- Two new Investigational New Drug applications (INDs) accepted by the US Food and Drug Administration (FDA) for NRX-101 in Chronic Pain and Complicated UTI.

-- Data lock expected this week in 200-person DOD-funded trial of D-cycloserine (DCS), the key component of NRX-101, to treat chronic pain, conducted by Northwestern University

-- Grant of Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review designations for NRX-101 in the treatment of Complicated Urinary Tract Infection (cUTI); Publication last week of QIDP-qualifying data in a peer-reviewed journal. NRx is reviewing partnership options

-- Established HOPE Therapeutics to develop and launch IV Ketamine together with related technologies with FDA New Drug Application to be submitted this year. In advance of FDA approval, HOPE is partnered with national 503b and 503a pharmacies to address the ketamine shortage declared by FDA. HOPE is planned to be spun out as a separate company to be owned by NRx, current NRx shareholders via a tax-free dividend, and new investors; Term Sheets received from prospective anchor investors for $60 million of new investment, once publicly listed

-- HOPE is presenting data from four randomized, prospective trials demonstrating safety and efficacy in 800 patients of IV Ketamine in treating severe and suicidal depression as the clinical basis for New Drug Application (NDA) for HTX-100 (IV Ketamine); expecting stability and CMC data sufficient for NDA filing by June 2024.

-- Added over $8 million in working capital, including an advance of a $5.1 million milestone payment from partners Alvogen, Inc. and Lotus Pharmaceuticals

-- Elected nationally recognized attorney in highly regulated industries, and healthcare specialist, Janet Rehnquist, Esq., to the Company's Board of Directors

-- Management has taken actions to address NASDAQ listing compliance and naked shorting of NRx securities

-- Management to host a conference call, April 1, 2024, at 8:30 AM ET

A live webcast of the conference call will be available on the Company's website at 8:30 a.m. ET today, at https://ir.nrxpharma.com/events. An archive of the webcast will be available on the Company's website for 30 days. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-877-704-4453 or internationally 1-201-389-0920.

https://www.biospace.com/article/releases/nrx-pharmaceuticals-nasdaq-nrxp-reports-fourth-quarter-and-full-year-2023-financial-results-and-provides-business-update/

BrainStorm corporate update

 

Conference call planned for early April 2024 to provide update on NurOwn program

"Brainstorm's priority for 2024 is to move forward with a confirmatory Phase 3b trial for NurOwn that will potentially support a new Biologics License Application," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We have been working closely with the FDA with the goal of agreeing on a Special Protocol Assessment (SPA) so that we are aligned on the study design. We believe that an SPA will substantially de-risk the regulatory aspects of our program. Our team is committed to this rigorous planning process, recognizing its critical importance in the potential success and validity of the trial outcomes. We continue to believe that, if approved, NurOwn has the potential to be a valuable treatment option for ALS patients in need. We look forward to providing a further update in the near future."

Stacy Lindborg, Ph.D., co-CEO BrainStorm commented, "We are acutely aware of the challenges faced by those afflicted with ALS. Our planned Phase 3b trial will be conducted with the highest standards of scientific excellence and integrity, driven by our commitment to the ALS community and our goal of expanding the treatment landscape."

BrainStorm management will host a conference call for the investment community in early April 2024 to discuss plans for NurOwn including an update on the SPA.  As described above, the Company is expecting to have a response from the US FDA very soon as we approach the 45-day SPA review cycle. Details on the conference call will be provided when available.   

https://www.biospace.com/article/releases/brainstorm-cell-therapeutics-announces-full-year-2023-financial-results-and-provides-corporate-update/

Fractyl Secures FDA OK for Weight Maintenance Study After Discontinuation of GLP-1s

 Fractyl Health, which went public in February 2024, got some good and bad news on Monday as it secured an Investigational Device Exemption from the FDA for its Revita endoscopy system designed to maintain weight loss, but posted a $19.2 million net loss in the company’s most recent quarter.

The FDA’s Investigational Device Exemption (IDE) clears the way for a pivotal study of Fractyl’s Revita system designed to maintain weight loss after patients have stopped taking GLP-1 drugs. An outpatient endoscopic procedure, Revita targets the duodenum—which is just below the stomach—and reverse the pathology in the duodenal lining that is a root cause of obesity and type 2 diabetes.

Fractyl said that in prior studies of the device conducted on patients with type 2 diabetes, the analyses of data showed evidence to support the potential for weight maintenance after a single procedure.  

With the IDE approved, Fractyl will begin the randomized, double blind Remain-1 study, a trial of Revita versus sham in patients who have lost at least 15% of their total body weight from taking tirzepatide. The trial is set to begin in the second half of this year.

The objectives of the study will be to demonstrate that Revita is superior to sham in the percent change in body weight from the baseline to week 24, and to show that a majority of Revita patients keep clinically significant weight loss after stopping tirzepatide.  

“The unmet need in obesity is shifting from ‘How do we help people lose weight?’ to ‘How do we help people keep the weight off?’” Christopher Thompson, director of endoscopy at Brigham and Women’s Hospital, said in a statement. “We now need new therapeutic strategies that can offer durable weight maintenance, and I am excited for the prospect of the Remain-1 pivotal study to hopefully address this massive challenge in obesity today.”

Despite the IDE approval, Fractyl also reported bad news on Monday. In its fourth quarter and full-year 2023 earnings report, the biotech posted a $19.2 net loss for the quarter. This is an increase from a net loss of $10.9 million from the same quarter in 2022.

Fractyl said the loss was due to a $6.8 million increase in the “fair value of the notes payable and warrants” and a $1.6 million increase in operating expenses. The company also reported that the revenue and leasing of its Revita system for 2023 was “insignificant,” bringing in $0.1 million last year.  

Still, CEO Harith Rajagopalan touted 2024 as a “transformational year” for the biotech as both its Rejuva and Revita platforms are approaching “key milestones as not only the Revita studies kick-off but Rejuva, its GLP-1 pancreatic gene therapy platform is “on track” to finish IND-enabling studies in the second half of the year as well. 

“Following our recent initial public offering, we are now well-capitalized and positioned to execute across multiple key upcoming milestones for both our Revita and Rejuva platforms,” Rajagopalan said in a statement. 

Fractyl joined the early wave of biotech IPOs at the beginning of 2024. The company completed its IPO in February which resulted in aggregate net proceeds of approximately $100 million, after deducting the underwriting discounts and other offering expenses. 

https://www.biospace.com/article/fractyl-secures-fda-approval-for-weight-maintenance-study-after-discontinuation-of-glp-1s-study/