AlchemicalVoyager13
6月前
Georgie, how is the open gap to fill coming along? A trade might be profitable but when the stock has historically hit $7 twice then, well, I hope you bought back shares and retained them. Especially with news like EMA providing special guidance, 1 of only 20 companies selected. At times a hold is the best action. Go for dollars, not dimes profit.
georgie18
7月前
ANNX...$5.06...🥳...Off my $4.50 Alert...All out for now...Probably go higher but Taking quicker profit with this market...especially with 2 open gap ...
georgie18
Member Level
Re: georgie18 post# 400946
Thursday, November 20, 2025 9:49:36 AM
Post#
400949
of 400954
ANNX...$4.80...🥳...Off my $4.50 Alert...
georgie18
Member Level
Re: georgie18 post# 11
Thursday, November 20, 2025 8:35:36 AM
Post#
12
of 13
ANNX...$4.58...🥳...Gapper...
georgie18
Member Level
Re: None
Thursday, November 20, 2025 8:06:00 AM
Post#
400942
of 400945
ANNX...$4.50...🥳..Another Gap Up...following the offering...Watching for possible entry...bidding the open gaps...
tw0122
7月前
Above warrant price..25 million shares at $2.60On November 12, 2025, Annexon, Inc. (the “Company’) entered into an underwriting agreement (the “Underwriting Agreement”) with Goldman Sachs & Co. LLC, TD Securities (USA) LLC and Wells Fargo Securities, LLC, as representatives of the several underwriters listed therein (collectively, the “Underwriters”), to issue and sell 25,096,153 shares (the “Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”) at a price to the public of $2.60 per share and pre-funded warrants (the “Pre-Funded Warrants”) to purchase 3,750,000 shares of Common Stock at a price to the public of $2.599 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $0.001 exercise price of each Pre-Funded Warrant (the “Offering”). The Offering was made pursuant to an effective registration statement on Form S-3 (File No. 333-278246) and related prospectus and prospectus supplement, in each case filed with the Securities and Exchange Commission (the “SEC”). All of the Shares and the Pre-Funded Warrants were sold by the Company. Pursuant to the Underwriting Agreement, the Company has also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 4,326,922 shares of Common Stock at the public offering price, which was exercised in full by the Underwriters on November 13, 2025. The net proceeds from the Offering were approximately $80.4 million after deducting underwriting discounts and commissions and estimated offering expenses. The Offering closed on November 14, 2025. The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage to a percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company. The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the “Securities Act”), other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. A copy of the Underwriting Agreement and the form of Pre-Funded Warrant are filed as Exhibits 1.1 and 4.1, respectively, and are incorporated herein by reference. The foregoing descriptions of the Underwriting Agreement and the Pre-Funded Warrants do not purport to be complete and are qualified in their entirety by reference to such exhibits. A copy of the opinion of Cooley LLP relating to the legality of the securities issued and sold in the Offering is filed herewith as Exhibit 5.1. On November 12, 2025, the Company issued a press release announcing the pricing of the Offering, a copy of which is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. On November 14, 2025, the Company issued a press release announcing the closing of the Offering, a copy of which is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. ...
tw0122
2年前
Item?8.01.
Other Events.
On June 4, 2024, Annexon announced positive topline results from a randomized placebo-controlled pivotal Phase 3 clinical trial in patients with GBS. The Phase 3 trial met its primary endpoint, with a single infusion of ANX005 30 mg/kg achieving a statistically significant 2.4-fold improvement on the GBS-disability scale (“GBS-DS”) (proportional odds analysis, week 8, p = 0.0058). ANX005 30 mg/kg treatment also demonstrated improvements versus placebo on key secondary endpoints, including early gains in muscle strength (day 8, p < 0.0001* and week 8, p = 0.0351*) and a median of 28 fewer days on artificial ventilation (through week 26, p = 0.0356*). Additionally, ANX005 30 mg/kg demonstrated an early reduction in the prespecified analysis of serum levels of neurofilament light chain, a biomarker of nerve damage (11.2% reduction relative to placebo between weeks 2–4, p = 0.03*) and a 31-day reduction in the median time to walk independently (week 26, p = 0.0211*), each of which are important clinical care outcomes. (* nominal)
The randomized, placebo-controlled Phase 3 trial, which enrolled 241 subjects in Bangladesh and the Philippines, evaluated two doses of ANX005, 30 mg/kg and 75 mg/kg, which both delivered rapid and complete suppression of complement activity but differed in duration of C1q inhibition. The 30 mg/kg dose lasted one week and the 75 mg/kg dose lasted two to three weeks. ANX005 75 mg/kg outperformed placebo on multiple endpoints, however, it was not statistically significant on the primary endpoint of GBS-DS at week 8 (p = 0.5548). The two dose levels were evaluated based on findings in the earlier Phase 1b proof-of-concept study, which showed efficacy in pooled analysis of both shorter and longer duration of ANX005 C1q inhibition. Because classical complement drives tissue damage in the early phase of disease, while facilitating nerve repair after acute nerve injury, the strong positive Phase 3 results with the 30 mg/kg dose resulting in one week of C1q inhibition appeared to define the optimal treatment window.
The clinical safety and tolerability findings of ANX005 at both doses in the Phase 3 study support a generally well-tolerated profile with no new safety signals. The majority of adverse events were mild Grade 1 to moderate Grade 2 events. The most common treatment-related adverse events were infusion related reactions (30.4%) that were mostly mild transient rashes. There were no autoimmune related adverse events and no drug-related deaths or serious infections observed.
The GBS Phase 3 study was conducted in Bangladesh and Philippines due to the high prevalence of GBS and limited access to standard of care intravenous immunoglobulin. Based on feedback from the U.S. Food and Drug Administration (“FDA”), Annexon has initiated a real-world evidence (“RWE”) protocol with International Guillain-Barré Syndrome Outcomes Study to establish comparability between Phase 3 participants and Western patients. RWE data and a potential biologics license application submission with the FDA are expected in the first half of 2025. Annexon plans to present the Phase 3 data at the 2024 Peripheral Nerve Society Annual Meeting on June 25, 2024.
GBS is a rapid and acute neurological disease with a narrow therapeutic window that results in the hospitalization of over 22,000 people annually in the U.S. and Europe. The significant and long-term disease burden associated with GBS on patients, caregivers, hospitals and payers has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system. Currently, there are no approved treatments for GBS by the FDA.
Item?9.01.
Financial Statements and Exhibits.
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