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Seaport Therapeutics Presents Phase 1 Clinical Data for GlyphAgo
Seaport Therapeutics announced the presentation of Phase 1 clinical data for GlyphAgo at the 39th European College of Neuropsychopharmacology Congress, taking place October 10-13, 2026, in Munich, Germany. The poster represents the first scientific presentation of data from the GlyphAgo Phase 1 program and provides detailed pharmacokinetic analyses supporting previously reported topline results and reinforcing GlyphAgo's differentiated profile. GlyphAgo is a novel, "Glyphed" oral prodrug of agomelatine designed to enhance lymphatic absorption and bypass first-pass liver metabolism. In the Phase 1 program, GlyphAgo demonstrated a statistically significant 6.8-fold increase in bioavailability of agomelatine compared to unmodified agomelatine and showed significantly lower PK variability. GlyphAgo achieved therapeutically relevant exposure of agomelatine at substantially lower doses that are designed to reduce liver exposure. Seaport believes this approach has the potential to reduce the risk of liver enzyme elevations and reduce the need for routine liver function monitoring that has historically limited agomelatine's clinical use. The completed multi-part Phase 1 proof-of-concept trial evaluated the safety, tolerability and pharmacokinetics of GlyphAgo in 174 healthy volunteers. The newly presented results include data from the multiple-ascending dose portion and analyses supporting the absence of a food effect with GlyphAgo. The single- and multiple-ascending dose portions of the trial demonstrated dose-dependent increases in agomelatine exposure and showed no accumulation of exposure over seven days of dosing, supporting a consistent profile with repeat dosing. Additional analyses presented in the poster further characterize the substantially reduced PK variability observed with GlyphAgo, with variability in both AUC0-24 and Cmax substantially lower than with unmodified agomelatine. Specifically, in the SAD portion, PK variability observed in participants dosed with GlyphAgo ranged from 12.9% to 26.6% for AUC0-24 and from 17.1% to 50.5% for Cmax, compared with 200% and 217%, respectively, for unmodified agomelatine. In the crossover portion, PK variability in participants dosed with GlyphAgo ranged from 22.6% to 29.7% for AUC0-24 and from 26.5% to 44.0% for Cmax, compared with ranges of 234.6% to 350.1% and 303.7% to 500.9%, respectively, for unmodified agomelatine. As previously noted, the data showed no effect of estrogen-containing oral contraceptives on agomelatine exposure following GlyphAgo dosing, further supporting the ability of GlyphAgo to bypass first-pass hepatic metabolism and avoid drug-drug interactions that occur in the liver. Seaport has initiated a Phase 2a clinical trial evaluating GlyphAgo in adults with generalized anxiety disorder and sleep disturbance, with topline results expected in early 2028. The Company also plans to initiate a Phase 2/3 clinical trial evaluating the efficacy and safety of GlyphAgo in patients with GAD in the first half of 2027.
Seaport Therapeutics Doses First Patient in GlyphAgo Phase 2a Trial
Seaport Therapeutics announced that the first patient has been dosed in a Phase 2a clinical trial in Australia evaluating GlyphAgo, in adults with generalized anxiety disorder and sleep disturbance. Agomelatine has demonstrated statistically significant separation from placebo in four third-party placebo-controlled studies in GAD1.
Seaport Therapeutics Reports Positive Phase 1 Results for GlyphAllo
Seaport Therapeutics announced positive topline results from the Phase 1 Driving Simulation Trial of GlyphAllo, a novel, Glyphed oral prodrug of allopregnanolone, in healthy volunteers. The trial evaluated the 375 mg dose of GlyphAllo, the highest dose currently being investigated in the Phase 2b BUOY-1 trial, as well as a 250 mg dose. The trial met its primary endpoint demonstrating that evening dosing of GlyphAllo at 375 mg did not impair next-morning driving performance compared to placebo on Day 5, following multiple-day dosing. The key secondary endpoint was also met, showing that a single 250 mg dose of GlyphAllo did not impair next-morning driving performance compared to placebo on Day 2. "We are very pleased by the results which showed no next-morning driving impairment at either dose evaluated. The trial used a validated driving simulator and trial design with an evening dosing regimen consistent with the Phase 2b BUOY-1 trial and GlyphAllo's intended clinical use," said Daphne Zohar, Co-founder and Chief Executive Officer of Seaport Therapeutics. "We believe that GlyphAllo has the potential to deliver the benefits of allopregnanolone without next-morning effects on driving."
Seaport Therapeutics Completes IPO and Reports Positive Phase 1 Trial Results for GlyphAgo
"The second quarter of 2026 was marked by two major milestones for Seaport - positive results from our Phase 1 proof-of-concept trial of GlyphAgo and the successful completion of our IPO," said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics. "We believe the GlyphAgo Phase 1 data package significantly derisks future clinical development of this program, and we expect to initiate Phase 2 development of GlyphAgo in generalized anxiety disorder in the second half of this year."
SpaceX Files for IPO Aiming to Raise $80 Billion
SpaceX and OpenAI are moving toward blockbuster public debuts, with SpaceX formally filing its Form S 1 to list on Nasdaq under the ticker "SPCX" in what could become the largest IPO in history. Meanwhile, OpenAI is reportedly preparing to submit its own draft prospectus as early as this week for a potential September listing.LATEST IPOS AND DIRECT LISTINGS:Conexeu Sciencesopened on May 21 at $13.50 after a Nasdaq direct listing. The preclinical developer of a regenerative tissue device for wound care and aesthetics filed a resale prospectus with the SEC stating that it expected its common stock to begin trading on the Nasdaq on or about Thursday, May 21, in connection with its direct listing. The company registered 9.5M shares that may be sold by the Registered Securityholders identified in the prospectus. Conexeu Sciences will not raise new capital in its listing. The stock opened for trading earlier at a price of $13.50 per share.Lincoln Internationalopened on May 20 at $22.51. The company priced 21.05M shares at $20.00, at the top end of the $18.00-$20.00 target range. Lincoln International is an investment banking advisor whose services include mergers and acquisitions advisory, private funds and capital markets advisory, and valuations and fairness opinions.Amass Brandsopened on May 20 at $17 after a Nasdaq direct listing. The premium, multi-category beverage platform spanning non-alcohol, functional, and alcohol 2.0 products saw its common stock begin trading earlier on the Nasdaq Capital Market under the stock ticker symbol "AMSS". The direct listing did not involve the issuance of new common stock by the company, it noted.Optimi Healthopened on May 20 at $5.50 after a Nasdaq uplisting. The commercial-stage pharmaceutical company focused on manufacturing and distributing finished psychedelic drug products announced the pricing of its underwritten public offering in connection with the uplisting of its common shares to the Nasdaq Capital Market. The company offered 2.4M common shares at a public offering price of $6.25 per share.RECENT SPAC IPOS:Peace Acquisitionopened on May 22 at $10.01. The blank check company intends to focus its search on businesses throughout Asia. "However, the Company will not undertake an initial business combination with any entity based in or with its principal business operations in Mainland China, Hong Kong or Macau," it added.Aperture ACopened on May 21 at $10.01. The blank check company was formed for the purpose of effecting a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses.Research Alliance Corporation IIIopened on May 20 at $10.21. The blank check company intends to focus its search on a target business in the healthcare or healthcare-related industries.Amanat Acquisitionopened on May 19 at $10.15. While the company may pursue an initial business combination target in any business or industry, it intends to focus on opportunities in healthcare or healthcare-related industries.PERFORMANCE:Prices as of 10:15 am ET on Monday, May 26 -Conexeu Sciences – down about 5% at $13.70;Lincoln International – down more than 2% at $23.52;Amass Brands – down almost 11% at $3.85;Optimi Health – down about 5% at $5.57.RECENT IPOS TO WATCH:Pershing Square Inc., Pershing Square USA, Avalyn Pharma, Hemab Therapeuticsand Seaport Therapeuticsare already seeing coverage roll out, while Silver Bow Miningis among stocks that could see new coverage this week as the quiet periods for banks that underwrote the companies' IPOs expire.UPCOMING IPOS:Upcoming IPO and direct listings expected include SpaceX, Sunshine Silver Mining & Refining, Innio, Inspire Brands, and Tarsier Pharma.Clickto see upcoming IPO calendar on TipRanks.SpaceXofficially submitted its Form S-1 with the SEC to list its Class A common stock on the Nasdaq under the ticker symbol SPCX. Expected to be the largest IPO in history, the company targets raising up to $80B at a valuation exceeding $2T.Sunshine Silver Mining & Refining Companyannounced the launch of its initial public offering of 20M shares of its common stock. In connection with the offering, Sunshine expects to grant the underwriters a 30-day option to purchase up to 3,000,000 shares of common stock. The IPO price is expected to be between $13.50-$16.50 per share. Sunshine's common stock has been approved for listing, subject to official notice of issuance, under the ticker symbol "SSMR" on the New York Stock Exchange.Innioannounces that it has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of its common shares. The timing of the offering, number of shares to be offered and the price range for the proposed offering have not yet been determined. Innio has applied to list its common shares on the Nasdaq Global Select Market under the ticker symbol "INIO." Innio designs, manufactures and services power systems under its Jenbacher and Waukesha brands. The company delivers power for applications including data centers, microgrids, grid stabilization, industrial energy and gas compression.Inspire Brandsannounced that it has confidentially submitted a draft registration statement on Form S-1 with the Securities and Exchange Commission relating to the proposed initial public offering of its common stock. Inspire Brands expects to use the net proceeds of the proposed offering to repay outstanding indebtedness under its existing term loan facility and pay offering fees and expenses.Tarsier Pharma Ltd.filed for an initial public offering of its ordinary shares and applied to list its ordinary shares on the NYSE American under the symbol "TARX". The prospectus stated: "Tarsier Pharma is developing TRS01 and TRS02, novel product candidates based on dazdotuftide, a new molecule with a new mechanism of action for uveitis and uveitic glaucoma. We are attempting to address a significant, underserved market opportunity and have engaged closely with the FDA on our clinical development strategy, including a Special Protocol Assessment agreement for our planned pivotal trial."OTHER IPO NEWS:OpenAI is preparing to file for a public listing as early as this week, with the AI lab aiming for a blockbuster initial public offering as soon as September, Financial Times' George Hammond. The company has been laying the groundwork for an offering expected to value it at north of $1T, working with bankers at Morgan Stanleyand Goldman Sachsand lawyers at Cooley over the past few months, according to people familiar with the matter. The group could file a draft IPO prospectus as early as Friday, starting the timer on a public listing for the autumn, they added. That timing could shift depending on the market and on the performance of Elon Musk's SpaceX, which is expected to go public next month in the biggest listing of all time, the author notes.Opening Day" is The Fly's recurring series of stories on the latest initial public offerings, their performance, and upcoming IPOs.
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