Últimas noticias sobre IGC Pharma (AMEX:IGC) Bolsa

IGC Pharma

IGC Pharma Inc develops advanced cannabinoid-based formulations for treating diseases and conditions, including, but not limited to, Alzheimer's disease, period cramps, premenstrual syndrome and chronic pain. The company has two investigational drug assets targeting Alzheimer's disease, IGC-AD1 and TGR-63, which have demonstrated in Alzheimer's cell lines the potential to be effective in suppressing or ameliorating key hallmarks of Alzheimer's disease, such as plaques or tangles. IGC-AD1 is a low-dose tetrahydrocannabinol-based formulation that is in a 146-person Phase 2 clinical trial for agitation in dementia due to Alzheimer's. IGC also markets a wellness brand, Holief, that targets women experiencing premenstrual syndrome and menstrual cramps.

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<h3>Gainers</h3>
<ul>
<li>Azitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) stock rose 35.0% to $0.41 during Thursday's after-market session. The company's market cap stands at $6.1 million. </li>
<li>Alector (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALEC#NASDAQ">ALEC</a>) shares moved upwards by 9.11% to $1.28. The company's market cap stands at $126.5 million. </li>
<li>Xtant Medical Hldgs (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/XTNT#AMEX">XTNT</a>) stock rose 8.33% to $0.52. The market value of their outstanding shares is at $72.4 million. </li>
<li>Mobile-health Network (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNDR#NASDAQ">MNDR</a>) shares rose 7.63% to $1.55. The market value of their outstanding shares is at $6.7 million. </li>
<li>Penumbra (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PEN#NYSE">PEN</a>) shares rose 6.75% to $318.4. The market value of their outstanding shares is at $12.3 billion. The company's, Q1 earnings came out yesterday. </li>
<li>Ovid Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OVID#NASDAQ">OVID</a>) shares increased by 6.59% to $0.36. The market value of their outstanding shares is at $25.5 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>SenesTech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNES#NASDAQ">SNES</a>) shares declined by 8.3% to $2.0 during Thursday's after-market session. The market value of their outstanding shares is at $3.4 million. </li>
<li>IGC Pharma (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/IGC#AMEX">IGC</a>) shares decreased by 7.59% to $0.29. The company's market cap stands at $23.1 million. </li>
<li>Processa Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PCSA#NASDAQ">PCSA</a>) shares fell 7.04% to $0.22. The company's market cap stands at $1.1 million. </li>
<li>Senti Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNTI#NASDAQ">SNTI</a>) shares declined by 6.52% to $4.59. The market value of their outstanding shares is at $119.3 million. </li>
<li>CNS Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNSP#NASDAQ">CNSP</a>) stock decreased by 5.96% to $0.98. The market value of their outstanding shares is at $2.8 million. </li>
<li>VolitionRX (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/VNRX#AMEX">VNRX</a>) stock declined by 5.92% to $0.46. The market value of their outstanding shares is at $45.3 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Thursday's After-Market Session

<a href="https://www.marijuanamoment.net/bipartisan-congressional-lawmakers-file-bill-to-end-federal-marijuana-prohibition-in-legal-states-in-line-with-trumps-stance/" title="https://www.marijuanamoment.net/bipartisan-congressional-lawmakers-file-bill-to-end-federal-marijuana-prohibition-in-legal-states-in-line-with-trumps-stance/">https://www.marijuanamoment.net/bipartisan-congressional-lawmakers-file-bill-to-end-federal-marijuana-prohibition-in-legal-states-in-line-with-trumps-stance/</a>

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'Bipartisan Congressional Lawmakers File Bill To End Federal Marijuana Prohibition In Legal States In Line With Trump's Stance' - Marijuana Moment

IGC Pharma Expands Phase 2 CALMA Trial With Site At Butler Hospital's Memory and Aging Program

<a href="https://www.marijuanamoment.net/marijuana-rescheduling-isnt-on-the-white-houses-new-list-of-top-drug-policy-priorities-under-the-trump-administration/" title="https://www.marijuanamoment.net/marijuana-rescheduling-isnt-on-the-white-houses-new-list-of-top-drug-policy-priorities-under-the-trump-administration/">https://www.marijuanamoment.net/marijuana-rescheduling-isnt-on-the-white-houses-new-list-of-top-drug-policy-priorities-under-the-trump-administration/</a>

'Marijuana Rescheduling Isn't On The White House's New List Of Top Drug Policy Priorities Under The Trump Administration' - Marijuana Moment

IGC Pharma Expands CALMA Phase 2 Trial with Miami Jewish Health Addition

IGC Pharma, Inc. ("IGC", or the "Company") (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IGC#NYSE">IGC</a>) today announced the expansion of its ongoing Phase 2 CALMA trial for IGC-AD1 with the addition of a new clinical site at Hamilton Health Sciences (HHS) in Ontario, Canada. This expansion marks a key milestone in IGC Pharma's strategy to advance IGC-AD1 toward commercialization, accelerating patient enrollment and expanding the Company's clinical footprint.
Hamilton Health Sciences is one of Canada's leading academic and research hospitals. The CALMA trial at HHS will be led by Dr. Alexandra Papaioannou, a distinguished geriatrician and Executive Director of HHS' <a href="https://pr.report/8ht1">Geras Centre for Aging Research</a>, whose expertise in aging, frailty, and dementia will play a critical role in the trial's success.

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IGC Pharma Announces CALMA Phase 2 Trial Expansion With The Addition Of Canadian Hamilton Health Sciences In Ontario, Canada

Alliance Global Partners analyst James Molloy reiterates IGC Pharma (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/IGC#AMEX">IGC</a>) with a Buy and maintains $3.5 price target.

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Alliance Global Partners Reiterates Buy on IGC Pharma, Maintains $3.5 Price Target

<a href="https://www.marijuanamoment.net/senator-john-fetterman-circulates-petition-to-legalize-marijuana-at-the-federal-level/" title="https://www.marijuanamoment.net/senator-john-fetterman-circulates-petition-to-legalize-marijuana-at-the-federal-level/">https://www.marijuanamoment.net/senator-john-fetterman-circulates-petition-to-legalize-marijuana-at-the-federal-level/</a>

'Senator John Fetterman Circulates Petition To Legalize Marijuana At The Federal Level' - Marijuana Moment

Ascendiant Capital analyst Edward Woo maintains IGC Pharma (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/IGC#AMEX">IGC</a>) with a Buy and raises the price target from $4 to $4.25.

Ascendiant Capital Maintains Buy on IGC Pharma, Raises Price Target to $4.25

<a href="https://themarijuanaherald.com/2025/02/dea-official-says-marijuana-rescheduling-is-delayed-but-certainly-not-dead/" title="https://themarijuanaherald.com/2025/02/dea-official-says-marijuana-rescheduling-is-delayed-but-certainly-not-dead/">https://themarijuanaherald.com/2025/02/dea-official-says-marijuana-rescheduling-is-delayed-but-certainly-not-dead/</a>

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"DEA Official Says Marijuana Rescheduling Is 'Delayed, But Certainly Not Dead'" - The Marijuana Herald

Management

IGC Pharma Appoints Former VA Governor Terry McAuliffe As A Strategic Advisor

IGC Pharma Names Alzheimer's Agitation Phase 2 Trial "CALMA" And Expands Recruitment With Geofencing Technology, Targeting Completion In 2H 2025 After Achieving 200%-300% Enrollment Boost At Select Sites

Ascendiant Capital analyst Edward Woo maintains IGC Pharma (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/IGC#AMEX">IGC</a>) with a Buy and raises the price target from $3.75 to $4.

Ascendiant Capital Maintains Buy on IGC Pharma, Raises Price Target to $4

IGC Pharma Initiates New Trials To Evaluate IGC-AD1 As A Potential Alzheimer's Therapy

<a href="https://www.marijuanamoment.net/dea-judge-wont-remove-agency-from-marijuana-rescheduling-hearing-but-raises-concerns-about-alleged-unlawful-contact-with-prohibitionists/">https://www.marijuanamoment.net/dea-judge-wont-remove-agency-from-marijuana-rescheduling-hearing-but-raises-concerns-about-alleged-unlawful-contact-with-prohibitionists/</a>
A Drug Enforcement Administration (DEA) judge has denied a motion to remove the agency from its role in an upcoming marijuana rescheduling hearing—though he sharply criticized responses from DEA and a prohibitionist group over an allegation that they unlawfully communicated during the cannabis rulemaking process.
With <a href="https://www.marijuanamoment.net/dea-posts-details-on-next-weeks-marijuana-rescheduling-hearing-including-live-stream-and-documents-portal/">the initial rescheduling hearing set for next week</a>, DEA Administrative Law Judge (ALJ) John Mulrooney has been addressing multiple motions from interested parties, largely centering around witness participation in the proceedings.
But one motion from two designated participants—Hemp for Victory and Village Farms International—made an especially bold assertion: It alleged DEA effectively conspired with Smart Approaches to Marijuana (SAM), an anti-cannabis group that was selected to serve as a witness. And that alleged ex parte communication, coupled with DEA's apparent indecision over the proposed rule, should be grounds to remove the agency as the designated "proponent" of the rescheduling rule.
Mulrooney had already indicated that it's statutorily beyond ALJ authority to take that action, and he formally denied the motion on Wednesday.
"There is no question that the allegations raised by the [ex parte motion (EPM)] are distasteful and arguably unhelpful to the public's perception that the proceedings will be transparent," the order says. "That said, this tribunal is without authority to grant the supplementation and removal relief sought (the only relief sought) by the Movants."
But the judge also took the opportunity to more substantively address the allegations of unlawful communications between DEA and SAM, rebuking both parties' <a href="https://www.marijuanamoment.net/dea-says-it-didnt-conspire-with-anti-marijuana-group-dismissing-allegedly-illegal-talks-as-gossip/">response briefs that categorically denied the claims of misconduct</a>.
He said that, "in view of the nature of the allegations, the denial of the EPM does not finish the job."
After describing ex parte statutes in the Administrative Procedures Act (APA) and Controlled Substances Act (CSA), Mulrooney challenged DEA's "bold declarations" that it was innocent of violating the rules. He wrote that "these seemingly courageous proclamations are quickly all but eviscerated by the Government's surprising qualification that this proclamation of innocence extends only to the ‘DEA counsel of record.'"
That is, DEA denied the improper contacts, but only for its counsel of record in the hearing, whereas the motion that raised the allegations were not limited to only those officials.
"Thus, the Government defended against an allegation that was never actually leveled, and never dealt with the true gravamen of the factual allegations of the EPM," the order says. "Stated differently, the Government responded to an allegation that it created, not the one that was in issue."
"As discussed, supra, the applicable APA provisions are not so slender or lacking in common sense as to limit their applicability to a Government trial team who was never alleged to have made the communication in the first place. In its peculiar, semi-blanket denial, the Government did not happen to address staff members who actually may have made the purported communication, or those who may have been advising the Administrator at the time she was making decisions about whether there would be a rescheduling action, and who (if anyone) would sign the [notice of proposed rulemaking]."
The judge also noted that there's "no indication in its [DEA's response] that the Government has made even the mildest attempt to ascertain the truth and disclose it to the public and this tribunal."
Mulrooney further took SAM to task over its separate response to the allegations. The prohibitionist group maintained, for example, that any ex parte communications would have had to occur after the notice of proposed rulemaking was published, signaling that SAM President Kevin Sabet's talks with confidential sources at DEA that he posted about on social media ahead of the notice would not qualify as unlawful under the statute.
"This argument misleadingly omits from its analysis that portion of the relevant APA section that incorporates the critical qualifier ‘unless the person responsible for the communication has knowledge that it will be noticed, in which case the prohibitions shall apply beginning at the time of his acquisition of such knowledge,'" the order says.
The judge said "it would defy reason to suggest that Dr. Sabet and whoever in the DEA he may have spoken to were not aware that decisions in this matter were imminent."
"Such decisions would include not only whether the DEA Administrator intended to sign and support the goal of the NPRM, but also, who would be ultimately identified as a Designated Participant (or at least, what criteria would be used in reaching that determination)," he said.
"By SAM's reckoning even if a prospective party to a rulemaking proceeding were to spend hours advocating its position to the decider on the day before publication in the Federal Register, that public servant (who would clearly have had knowledge of the publication) would have no obligation to reveal that to a soul; not to the public, not to the parties who were not invited, not to the administrative record, and certainly not to any reviewing courts. This indeed would be a very restrictive view of the ethical obligations of a public servant, and perhaps less transparency than the public might expect from its government."
SAM also contended that there's no evidence that the alleged communications with DEA concerned the merits of the rescheduling proposal, so they could not therefore be considered ex parte.
Mulrooney agreed that merit is a key component of the statute at play, but "as is often the case with secret communications, by design the act of shielding the contents from others inhibits the ability to discover their contents."
"There is no context as to the conversation surrounding Dr. Sabet's social media announcements regarding his ‘two confidential sources inside [the] DEA,' or why those sources would be close enough to the Administrator to render their obvious violations of her confidence to be deemed reliable," he said.
"It is also challenging to interpret the comments Dr. Sabet allegedly posted as a status check. Likewise requiring some level of creativity is reconciling SAM's argument that rescheduling proceedings had not commenced with its current position that Dr. Sabet was performing a status check. Stated differently, if there were no proceedings yet in existence, what would Dr. Sabet have been checking the status of?"
"SAM dismisses the allegation essentially on the basis that others (including some who publicly favor the NPRM) were equally loquacious on social media," the order says. "An inescapable point here is that (unlike SAM) none of those others are DPs in this case, and based on the motion practice to date, many of those not selected to participate do not seem to have an understanding as to why that is true."
In light of all this, the ALJ said his job was then to determine whether the allegation of illegal communications justified an order to have the government and SAM prove their ex parte innocence.
"As unappetizing as this whole misadventure appears, the remedy test for improper ex parte communications is whether the communication materially affected or will affect the way a given case is or has yet been decided," he said.
"Dr. Sabet (for whatever his reasons were) elected to alert the world through social media that he was receiving privileged information from those close to Agency leadership. When he told the world, he also told the Movants. The Movants knew about Dr. Sabet's online bragging before these proceedings began. At this juncture, this question hinges on ‘whether, as a result of improper ex parte communications, the agency's decisionmaking process [has been or would be] irrevocably tainted so as to make the ultimate judgment of the agency unfair, either to an innocent party or to the public interest that the agency [is] obligated to protect.'"
"Here, because I have concluded that, at least based on the papers I have, there is insufficient basis to support such a conclusion, even if every fact alleged in the EPM were assumed arguendo to be accurate, no order to show cause will issue," he said.
That is, without an "ultimate judgment" being rendered in the rescheduling proceedings at this stage, the judge said he could not order DEA or SAM to further establish that they didn't engage in the alleged conduct.
Meanwhile, in a prehearing statement submitted to Mulrooney on Tuesday, <a href="https://www.marijuanamoment.net/federal-health-officials-rejected-deas-request-to-testify-at-marijuana-rescheduling-hearing-agency-tells-judge/">DEA previewed the testimony its own witnesses plan to provide</a>&nbsp;at the upcoming hearing—without clarifying where it stands on the rescheduling proposal.
The agency also said that the U.S. Department of Health and Human Services (HHS)—which carried out a scientific review that informed the proposal to move cannabis to Schedule III—"rejected" its request to provide witnesses.
While the initial preliminary hearing is scheduled for December 2, the merit-based proceedings were delayed until at least early 2025 after Mulrooney notified DEA that it provided insufficient information about&nbsp;<a href="https://www.marijuanamoment.net/dea-judge-issues-order-approving-and-denying-witnesses-for-marijuana-rescheduling-hearing-and-laying-out-next-steps/">the 25 selected witnesses that DEA Administrator Ann Milgram submitted</a>.
Separately, the judge last week&nbsp;<a href="https://www.marijuanamoment.net/researcher-asks-dea-judge-to-postpone-marijuana-rescheduling-hearing-until-after-trump-takes-over/">denied a request from a cannabis and psychedelics researcher</a>&nbsp;to postpone the upcoming rescheduling hearing over the agency's alleged "improper blocking" of witnesses, while arguing that the process should be halted at least until President-elect Donald Trump's administration comes into power so it can review the rulemaking.
Mulrooney also&nbsp;<a href="https://www.marijuanamoment.net/dea-judge-rejects-veterans-groups-petition-to-participate-in-marijuana-rescheduling-hearing/">rejected a veterans group's petition to participate in the rescheduling hearing</a>, which the organization called a "travesty of justice" that excludes key voices that would be affected by the potential policy change.
For what it's worth, Vice President Kamala Harris said recently that part of the reason for the delay in the administration's marijuana rescheduling effort is&nbsp;<a href="https://www.marijuanamoment.net/kamala-harris-blames-marijuana-rescheduling-delay-on-dea-bureaucracy-while-defending-her-own-prosecutorial-record/">federal bureaucracy that "slows things down," including at DEA.</a>
In March, Harris also expressed some frustration with the bureaucratic process of rescheduling marijuana, prior to DOJ's formal recommendation,&nbsp;<a href="https://www.marijuanamoment.net/watch-live-vp-harris-talks-marijuana-ahead-of-white-house-meeting-with-cannabis-pardon-recipients/">calling on DEA to expediently finish the job</a>.
While the Biden–Harris administration facilitated the review that led to the DOJ rescheduling proposal, Trump has also voiced support for the reform.
In Congress, numerous lawmakers have shared their own perspectives on the proposed reform with DEA and DOJ since the Schedule III announcement was made.
In August, for example, Sen. Chuck Grassley (R-IA)&nbsp;<a href="https://www.marijuanamoment.net/gop-senator-demands-answers-on-rush-to-reschedule-marijuana-from-top-biden-administration-officials/">raised concerns about the Biden administration's justification</a>&nbsp;for recommending marijuana rescheduling, demanding answers to questions from federal agencies about how they arrived at that decision in what he described as a rushed and unconventional administrative process.
A week earlier, top Democratic senators—including&nbsp; Senate Majority Leader Chuck Schumer (D-NY)—sent a separate letter to DOJ's Garland and DEA's Milgram urging the agencies to&nbsp;<a href="https://www.marijuanamoment.net/schumer-booker-and-other-senators-push-dea-to-promptly-finalize-marijuana-rescheduling/">"promptly finalize" the rule to reschedule marijuana</a>.
While rescheduling would remove certain research barriers and free up state-licensed cannabis business to take federal tax deductions under the Internal Revenue Service (IRS) code known as 280E, it would not federally legalize marijuana, as the&nbsp;<a href="https://www.marijuanamoment.net/marijuana-businesses-could-advertise-in-newspapers-and-magazines-if-rescheduling-is-approved-congressional-researchers-say/">Congressional Research Service (CRS) has made known in multiple recent reports</a>.
Meanwhile, two additional congressional lawmakers have joined the ranks of GOP members who are challenging what they say is&nbsp;<a href="https://www.marijuanamoment.net/gop-lawmakers-demand-answers-from-biden-administration-about-unusual-marijuana-review-process-behind-rescheduling-push/">the "unusual" process that led the Biden administration to propose rescheduling marijuana</a>, expressing concern about how the review was carried out and demanding answers.
Rep. Doug LaMalfa (R-CA)&nbsp;<a href="https://www.marijuanamoment.net/gop-congressman-says-marijuana-rescheduling-and-banking-reform-would-prop-up-an-immoral-industry/">condemned the Biden administration's push to reclassify marijuana</a>, as well as legislative efforts to enact bipartisan cannabis banking reform, because he says the policy changes would "prop up this immoral industry" and give a "green light to the evil that comes from drug use."
Sen. Bill Cassidy (R-LA) also blasted the Biden administration over what he described as&nbsp;<a href="https://www.marijuanamoment.net/gop-senator-condemns-lack-of-transparency-in-marijuana-rescheduling-process/">repeated refusals from federal agencies to brief Congress</a>&nbsp;on its plans and justification for rescheduling marijuana, which he argues fuels speculation that the proposed policy change is politically motivated.
Similarly, 25 GOP congressional lawmakers sent a public comment letter in July opposing the administration's planned rescheduling of marijuana, specifically alleging&nbsp;<a href="https://www.marijuanamoment.net/gop-lawmakers-push-justice-department-to-reverse-course-on-marijuana-rescheduling/">the government's recommendation was based on politics rather than science</a>.

'DEA Judge Won't Remove Agency From Marijuana Rescheduling Hearing, But Raises Concerns About Alleged Unlawful Contact With Prohibitionists' - Marijuana Moment

<a href="https://www.dea.gov/stories/2024/2024-11/2024-11-26/dea-hold-hearing-rescheduling-marijuana#:~:text=WASHINGTON%20%E2%80%93%20Formal%20hearing%20proceedings%20regarding,Navy%20Drive%2C%20Arlington%2C%20VA" title="https://www.dea.gov/stories/2024/2024-11/2024-11-26/dea-hold-hearing-rescheduling-marijuana#:~:text=WASHINGTON%20%E2%80%93%20Formal%20hearing%20proceedings%20regarding,Navy%20Drive%2C%20Arlington%2C%20VA">https://www.dea.gov/stories/2024/2024-11/2024-11-26/dea-hold-hearing-rescheduling-marijuana#:~:text=WASHINGTON%20%E2%80%93%20Formal%20hearing%20proceedings%20regarding,Navy%20Drive%2C%20Arlington%2C%20VA</a>.

DEA Says Formal Hearing Proceedings Regarding Proposed Rescheduling Of Marijuana Will Begin On Dec 2 At 9:30 a.m. ET

<a href="https://www.marijuanamoment.net/federal-health-officials-rejected-deas-request-to-testify-at-marijuana-rescheduling-hearing-agency-tells-judge/" title="https://www.marijuanamoment.net/federal-health-officials-rejected-deas-request-to-testify-at-marijuana-rescheduling-hearing-agency-tells-judge/">https://www.marijuanamoment.net/federal-health-officials-rejected-deas-request-to-testify-at-marijuana-rescheduling-hearing-agency-tells-judge/</a>

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'Federal Health Officials 'Rejected' DEA's Request To Testify At Marijuana Rescheduling Hearing, Agency Tells Judge' - Marijuana Moment

<a href="https://www.marijuanamoment.net/democratic-congressional-lawmakers-push-biden-to-issue-marijuana-executive-order-before-trump-takes-office/" title="https://www.marijuanamoment.net/democratic-congressional-lawmakers-push-biden-to-issue-marijuana-executive-order-before-trump-takes-office/">https://www.marijuanamoment.net/democratic-congressional-lawmakers-push-biden-to-issue-marijuana-executive-order-before-trump-takes-office/</a>

'Democratic Congressional Lawmakers Push Biden To Issue Marijuana Executive Order Before Trump Takes Office' - Marijuana Moment

IGC Pharma, Inc.(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IGC#NYSE">IGC</a>) reported additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1 for agitation in dementia associated with Alzheimer's disease. IGC-AD1 targets neuro-inflammation and CB1 receptor dysfunction,. The investigational drug contains THC as one of two active pharmaceutical agents. 
Interim data analysis reveals cognitive improvements in the active treatment group versus the placebo group, marking a meaningful step toward developing a therapy that may influence underlying disease progression.
These findings <a href="https://www.benzinga.com/general/biotech/24/04/38275005/igc-pharma-says-cannabinoid-based-drug-candidate-provides-fast-relief-with-fewer-side-effects-for" target="_blank" rel="noreferrer noopener">align with previously announced preclinical data</a>, which showed a reduction in amyloid plaque aggregation by approximately 20% and improved spatial memory by about 50% in Alzheimer&#8217;s cell lines and mouse models, respectively.
&#8220;The cognitive improvements observed in our interim results align with preclinical evidence of IGC-AD1&#8217;s active pharmaceutical ingredients&#8217; impact on amyloid plaques and spatial memory," stated Ram Mukunda, CEO of IGC Pharma. "While agitation remains the primary focus of the Phase 2 trial, these exploratory findings strengthen our confidence in IGC-AD1&#8217;s potential to address the broader pathology of Alzheimer&#8217;s disease. For patients and caregivers, this potentially represents hope for improved care, and for our investors, it signifies a compelling opportunity in a growing market.&#8221;
Read Also: <a target="_blank" href="https://www.benzinga.com/partner/biotech/24/05/38699585/6-7-million-americans-live-with-alzheimers-igc-pharma-believes-they-deserve-treatment-options-wit" rel="noreferrer noopener">6.7 Million Americans Live With Alzheimer&#8217;s – IGC Pharma Believes They Deserve Treatment Options Without Black Box Warnings</a>
Get Benzinga's exclusive analysis and the top news about the cannabis industry and markets daily in your inbox for free. Subscribe to our newsletter <a target="_blank" href="https://newsletteremail.benzinga.com/subscribe" rel="noreferrer noopener">here</a>. If you're serious about the business, you can't afford to miss out.
<h2 class="wp-block-heading">Cognitive Improvements&nbsp;&nbsp;</h2>
Cognitive decline in Alzheimer&#8217;s disease reflects the deterioration of memory, attention, language and reasoning due to underlying pathological changes, such as amyloid plaques and tau tangles. Interim results from the trial demonstrated that the active treatment group receiving IGC-AD1 twice daily for six weeks showed an average improvement of about 8% on the Mini-Mental State Examination, a validated clinical tool for assessing cognitive function. By contrast, the placebo group showed no improvement over the same period.
These results and the preclinical data provide a robust foundation for future trials focusing on cognition as the primary endpoint and exploring IGC-AD1&#8217;s disease-modifying potential.
<h2 class="wp-block-heading">Primary Outcome: Agitation Reduction in Alzheimer&#8217;s Patients</h2>
Agitation, a debilitating symptom affecting up to 76% of Alzheimer&#8217;s patients, accelerates disease progression, increases caregiver burden, and drives hospitalization rates. As previously disclosed, interim results showed that IGC-AD1 significantly reduced agitation compared to placebo, with improvements observed as early as two weeks. Unlike the existing therapy, which often takes up about 6–10 weeks to show results and carries a black box warning, IGC-AD1 offers rapid symptom relief with a favorable safety profile, making it a highly differentiated potential medication for managing agitation in Alzheimer&#8217;s.
Alzheimer&#8217;s disease affects 6.7 million Americans, with the global Alzheimer&#8217;s treatment market projected to exceed $50 billion by 2025.
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IGC shares closed Monday market session 5.34% higher at $0.38 per share.
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Health Care

Cannabinoid Drug For Agitation In Alzheimer's Yields Cognitive Improvements In Clinical Trial

<a href="https://www.marijuanamoment.net/dea-says-it-didnt-conspire-with-anti-marijuana-group-dismissing-allegedly-illegal-talks-as-gossip/">https://www.marijuanamoment.net/dea-says-it-didnt-conspire-with-anti-marijuana-group-dismissing-allegedly-illegal-talks-as-gossip/</a>
The Drug Enforcement Administration (DEA) and the prohibitionist group Smart Approaches to Marijuana (SAM) have categorically denied allegations that they illegally conspired together during the Biden administration's marijuana rescheduling process.
In a response to a motion seeking to remove DEA from the rescheduling proceedings over alleged ex parte communications with SAM, the agency on Monday said it "unequivocally denies" the charge and requested a dismissal of the motion from Hemp for Victory and Village Farms International.
"Movants' own evidence fails to demonstrate that any unlawful ex parte communication took place," DEA said in its brief with the administrative law judge (ALJ) overseeing the case. "The Movants would have this tribunal embark on a fishing expedition in search of evidence to support these sweeping, unsupported claims, which at best can be categorized as gossip, not ex parte communications."
The original filing included screenshots of social media posts where the group's president, Kevin Sabet, indicated he had private conversations with DEA officials about the rescheduling effort as SAM rallied opposition to the reform and urged the agency to keep marijuana in Schedule I.
One week prior to DOJ's publication of the proposed rule, Sabet posted on X that he could confirm DEA Administrator Anne Milgram wouldn't sign the notice, citing "two confidential sources inside DEA and another outside DEA with intimate knowledge."
The agency said that doesn't amount to ex parte communications, however.
"The tribunal correctly questions the seriousness of the remedies sought by the Movants and as such, should deny the motion," it said in the new filing, referring to comments from the judge last week. DEA added that the cannabis organizations behind the motion failed to "identify any precedent that would support removing an agency from its own rulemaking process."
"The only authority cited by the Movants on this point simply supports the notion that specific individuals may be removed from the proceeding under the appropriate circumstances," it said, pointing out that there is no accusation of any wrongdoing by DEA attorneys involved in the current proceedings on rescheduling. "In short, the Movants' arguments are completely without merit."
SAM also filed a response with the ALJ on Monday, arguing that the allegations "fail on their face to suggest any improper contacts between SAM and the DEA," and therefore they "can and should be quickly dispensed with by this Tribunal."
The organization asserted that, statutorily, unlawful ex parte communications would need to have occurred after the Justice Department posted its notice of proposed rulemaking, which is not explicitly alleged in the original motion.
"Standing alone, that deficiency itself is sufficient to dismiss Movants' speculation about supposed improper contacts," it said.
SAM also cited media reports from outlets including Marijuana Moment and The Wall Street Journal, as well as social media posts from supporters of the rescheduling effort, that contained information about the process that had not yet been made publicly available. It argued that such reporting undermined the allegation that Sabet's communications were uniquely improper.
"In short, the Motion is a transparent effort to smear both SAM and the DEA in an attempt to eliminate from this proceeding one of the strongest voices opposing rescheduling of marijuana," SAM said. "The Tribunal should deny Movants' invitation to create a sideshow requiring SAM and its counsel to expend more time and funds defending against unfounded attacks and instead should permit SAM to focus on the merits of these proceedings."
After the motion was filed with DEA ALJ John Mulrooney, <a href="https://www.marijuanamoment.net/dea-judge-gives-agency-one-week-to-address-allegations-of-illegal-talks-with-marijuana-opponents-amid-rescheduling-process/">the judge invited both the agency</a> <a href="https://www.marijuanamoment.net/dea-judge-invites-prohibitionist-group-to-explain-allegedly-unlawful-talks-with-agency-amid-marijuana-rescheduling-review/">and SAM to respond</a>, calling the nature of the alleged illegal communications "serious."
This comes just weeks before an initial December 2 hearing before the ALJ on the government's proposal to move marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA).
In a historic first, it was Attorney General Merrick Garland—and not DEA's Milgram—who signed the proposed rule to reschedule cannabis. The original motion said that fact, as well as DEA's apparent indecision on the proposed rule, warranted a change in the hearing structure.
The judge, in turn, said that the prospect of removing an agency head from rulemaking that it is responsible for overseeing would likely, "and correctly," be deemed beyond the ALJ office's jurisdiction.
Last week, Mulrooney officially ruled on <a href="https://www.marijuanamoment.net/dea-judge-issues-order-approving-and-denying-witnesses-for-marijuana-rescheduling-hearing-and-laying-out-next-steps/">which of the agency's 25 selected witnesses for the hearing will be able to participate</a>, while laying out the procedure for the administrative process—including how pro- and anti-reform speakers will be able to cross-examine one another.
Separately, the judge last week <a href="https://www.marijuanamoment.net/researcher-asks-dea-judge-to-postpone-marijuana-rescheduling-hearing-until-after-trump-takes-over/">denied a request from a cannabis and psychedelics researcher</a> to postpone the upcoming rescheduling hearing over the agency's alleged "improper blocking" of witnesses, while arguing that the process should be halted at least until President-elect Donald Trump's administration comes into power so it can review the rulemaking.
Mulrooney also <a href="https://www.marijuanamoment.net/dea-judge-rejects-veterans-groups-petition-to-participate-in-marijuana-rescheduling-hearing/">rejected a veterans group's petition to participate in the rescheduling hearing</a>, which the organization called a "travesty of justice" that excludes key voices that would be affected by the potential policy change.
For what it's worth, Vice President Kamala Harris said recently that part of the reason for the delay in the administration's marijuana rescheduling effort is&nbsp;<a href="https://www.marijuanamoment.net/kamala-harris-blames-marijuana-rescheduling-delay-on-dea-bureaucracy-while-defending-her-own-prosecutorial-record/">federal bureaucracy that "slows things down," including at DEA.</a>
In March, Harris also expressed some frustration with the bureaucratic process of rescheduling marijuana, prior to DOJ's formal recommendation,&nbsp;<a href="https://www.marijuanamoment.net/watch-live-vp-harris-talks-marijuana-ahead-of-white-house-meeting-with-cannabis-pardon-recipients/">calling on DEA to expediently finish the job</a>.
While the Biden–Harris administration facilitated the review that led to the DOJ rescheduling proposal, Trump has also voiced support for the reform.
In Congress, numerous lawmakers have shared their own perspectives on the proposed reform with DEA and DOJ since the Schedule III announcement was made.
In August, for example, Sen. Chuck Grassley (R-IA)&nbsp;<a href="https://www.marijuanamoment.net/gop-senator-demands-answers-on-rush-to-reschedule-marijuana-from-top-biden-administration-officials/">raised concerns about the Biden administration's justification</a>&nbsp;for recommending marijuana rescheduling, demanding answers to questions from federal agencies about how they arrived at that decision in what he described as a rushed and unconventional administrative process.
A week earlier, top Democratic senators—including&nbsp; Senate Majority Leader Chuck Schumer (D-NY)—sent a separate letter to DOJ's Garland and DEA's Milgram urging the agencies to&nbsp;<a href="https://www.marijuanamoment.net/schumer-booker-and-other-senators-push-dea-to-promptly-finalize-marijuana-rescheduling/">"promptly finalize" the rule to reschedule marijuana</a>.
While rescheduling would remove certain research barriers and free up state-licensed cannabis business to take federal tax deductions under the Internal Revenue Service (IRS) code known as 280E, it would not federally legalize marijuana, as the&nbsp;<a href="https://www.marijuanamoment.net/marijuana-businesses-could-advertise-in-newspapers-and-magazines-if-rescheduling-is-approved-congressional-researchers-say/">Congressional Research Service (CRS) has made known in multiple recent reports</a>.
Meanwhile, two additional congressional lawmakers have joined the ranks of GOP members who are challenging what they say is&nbsp;<a href="https://www.marijuanamoment.net/gop-lawmakers-demand-answers-from-biden-administration-about-unusual-marijuana-review-process-behind-rescheduling-push/">the "unusual" process that led the Biden administration to propose rescheduling marijuana</a>, expressing concern about how the review was carried out and demanding answers.
Rep. Doug LaMalfa (R-CA)&nbsp;<a href="https://www.marijuanamoment.net/gop-congressman-says-marijuana-rescheduling-and-banking-reform-would-prop-up-an-immoral-industry/">condemned the Biden administration's push to reclassify marijuana</a>, as well as legislative efforts to enact bipartisan cannabis banking reform, because he says the policy changes would "prop up this immoral industry" and give a "green light to the evil that comes from drug use."
Sen. Bill Cassidy (R-LA) also blasted the Biden administration over what he described as&nbsp;<a href="https://www.marijuanamoment.net/gop-senator-condemns-lack-of-transparency-in-marijuana-rescheduling-process/">repeated refusals from federal agencies to brief Congress</a>&nbsp;on its plans and justification for rescheduling marijuana, which he argues fuels speculation that the proposed policy change is politically motivated.
Similarly, 25 GOP congressional lawmakers sent a public comment letter in July opposing the administration's planned rescheduling of marijuana, specifically alleging&nbsp;<a href="https://www.marijuanamoment.net/gop-lawmakers-push-justice-department-to-reverse-course-on-marijuana-rescheduling/">the government's recommendation was based on politics rather than science</a>.

FLGC

Tom Angell Says "DEA says it is in the process of preparing public access to the cannabis rescheduling proceedings docket. For now, read Marijuana Moment's coverage of the latest significant filings:", 'DEA And Anti-Marijuana Group Deny Allegations They Conspired During Rescheduling Process' - Marijuana Moment

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