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FSD Pharma Inc. (HUGE) is a biopharmaceutical innovator advancing cannabinoid-based therapies and pharmaceutical-grade cannabis production. This news hub provides investors and industry professionals with essential updates on clinical developments, strategic partnerships, and regulatory milestones.
Access timely press releases covering clinical trial progress for neurodegenerative treatments, product commercialization efforts including alcohol misuse solutions, and research collaborations shaping the future of medical cannabis. Our curated updates ensure you stay informed about developments impacting FSD Pharma's position in biotech innovation.
Key coverage areas: Phase trial results for Lucid-MS multiple sclerosis treatment, unbuzzd™ market expansion, intellectual property updates, and manufacturing capacity enhancements. All content is verified through primary sources to maintain accuracy.
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The Concerned Shareholders of FSD Pharma (NASDAQ: HUGE) announced a court ruling that moves the annual shareholders' meeting to May 14, 2021, allowing for timely resolutions of shareholder issues. The court ordered that Dr. Raza Bokhari cannot chair the meeting and that shares issued since January 4, 2021, will not count in votes. The Concerned Shareholders criticized the board's actions, citing the issuance of over 13 million Class B shares that devalued stock, and proposed replacement directors with extensive industry experience to improve governance.
FSD Pharma Inc. (Nasdaq:HUGE) has entered into an Equity Distribution Agreement to sell Class B Subordinate Voting Shares, allowing potential sales of up to US$20 million. The sales will occur on Nasdaq at market prices, with proceeds intended for growth opportunities, including R&D for FSD201, aimed at treating COVID-19's inflammatory response. The offering is detailed in a prospectus supplement filed with the SEC and Canadian securities commissions. This press release emphasizes that it does not constitute an offer to sell or a solicitation of securities.
FSD Pharma Inc. (Nasdaq: HUGE) announces updates including progress on its Phase 2 clinical trial of ultramicronized PEA for treating COVID-19. The trial aims to randomize 352 patients, but recruitment challenges may delay completion. The company has a cash balance of C$22 million and seeks additional financing for future studies and potential acquisitions. FSD Pharma also terminated its President, Zeeshan Saeed, for cause, and faces a contested shareholders meeting on June 29, 2021, where certain shareholders seek board changes.
FSD Pharma Inc. (Nasdaq:HUGE) will hold its annual shareholder meeting on June 29, 2021. Key agenda items include the presentation of audited financial statements and a shareholder-requisitioned proposal to reduce the board size and replace six directors. This consolidated approach aims to minimize costs and distractions for shareholders. Shareholders will receive detailed information in early June. FSD Pharma focuses on developing FSD201 for anti-inflammatory treatments, aiming to combat severe COVID-19 symptoms by reducing cytokine storms.
FSD Pharma (Nasdaq: HUGE) has initiated dosing for its Phase 2a clinical trial of FSD201, an ultramicronized palmitoylethanolamide treatment for COVID-19 in hospitalized patients. This randomized, double-blind study involves 352 patients, assessing the drug's efficacy and safety at doses of 600mg and 1200mg, combined with standard care (SOC). The primary endpoint is evaluating clinical improvement within 28 days, with secondary objectives including duration of fever normalization and hospitalization. FSD Pharma emphasizes no claims regarding the ability to cure or contain COVID-19 at this stage.
FSD Pharma Inc. (Nasdaq: HUGE) reported its financial results for Q3 2020, highlighting gross proceeds of $19.5 million from direct offerings and total assets of $56.2 million CAD with liabilities of $13.6 million CAD. The company filed an IND application and received FDA approval for a Phase 2 clinical trial for FSD201 to treat COVID-19. However, it faces a $5.5 million CAD settlement in ongoing litigation. Operating expenses rose by 57% year-over-year to $17.5 million, leading to a net loss of $18 million, an increase of 6% compared to last year.
FSD Pharma Inc. (Nasdaq: HUGE) has announced a direct offering of 4,318,179 Class B Subordinate Voting Shares and warrants for 3,454,543 Shares at $2.20 each. The offering is expected to close around October 20, 2020. A.G.P./Alliance Global Partners is the sole placement agent and holds an option for an additional $10 million in Securities within 30 days. This offering is conducted under an effective shelf registration statement filed with the SEC. Investors are advised to consult the prospectus for complete information.
FSD Pharma Inc. (Nasdaq: HUGE) has received FDA authorization to initiate a Phase 2 study for FSD201, an ultramicronized palmitoylethanolamide, to treat COVID-19. The trial aims to enroll 352 patients to evaluate the efficacy and safety of FSD201 alongside standard care. Treatment is set to begin in October 2020, with a focus on addressing the inflammatory response in COVID-19 patients. The trial will assess various clinical outcomes over a 28-day period. Additionally, FSD Pharma announced the departure of board member David Urban effective October 31, 2020.
FSD Pharma has received FDA authorization to initiate a Phase 2 clinical trial involving 352 patients using FSD201 (ultramicronized PEA) to treat hospitalized COVID-19 patients. The trial aims to assess the efficacy of FSD201 in improving clinical outcomes alongside standard of care treatments. Dosing is set to begin in October 2020, with primary endpoints measured 28 days post-treatment. The company has also announced the departure of board member David Urban, effective October 31, 2020. FSD Pharma emphasizes that there are no guarantees regarding the trial outcomes or financial returns.
FSD Pharma has submitted an Investigational New Drug Application (IND) to the FDA for FSD201, aimed at treating COVID-19. The proposed Phase 2 trial will take place at 25-30 hospitals in North America, testing FSD201 alongside standard care in hospitalized patients. The trial design includes a randomized, controlled, double-blind approach. Additionally, the company authorized the issuance of share-based compensation for its CEO, Dr. Raza Bokhari, who now controls about 23% of voting rights. The company does not expect near-term revenues from this initiative.