Praxis Precision Medicines, Inc. SEC Filings

Praxis Precision Medicines (PRAX) reported positive topline Phase 3 results for ulixacaltamide in essential tremor. In Study 1, the placebo-controlled parallel study, ulixacaltamide produced a statistically significant and clinically meaningful improvement in the mADL11 primary endpoint at Week 8 (p<0.0001), with effects evident from Week 2 and sustained through 12 weeks. All key secondary endpoints in Study 1 reached statistical significance.

In Study 2, a randomized withdrawal design, 55% of patients continuing ulixacaltamide maintained response versus 33% on placebo (p=0.0369; OR=2.7). The first key secondary endpoint (rate of disease improvement) was significant; PGI-C and CGI-S favored ulixacaltamide numerically. Ulixacaltamide was generally well tolerated, with no deaths and no drug-related serious adverse events; common adverse events included dizziness and brain fog. The company has requested a pre-NDA meeting with the FDA and plans to submit an NDA by early 2026, upon agreement with the agency.

Praxis Precision Medicines launched a primary offering of common stock and is also offering pre-funded warrants, with an underwriters’ 30‑day option to buy additional shares. The pre-funded warrants carry a $0.0001 per‑share exercise price and are subject to ownership limits. Proceeds are earmarked for R&D, late‑stage commercialization preparation, earlier‑stage programs, working capital and general corporate purposes.

The company reported positive topline Phase 3 Essential3 results for ulixacaltamide in essential tremor. In Study 1, the primary endpoint showed a 4.3‑point mean improvement in mADL11 at Week 8 (p<0.0001), sustained through 12 weeks, with all key secondary endpoints statistically significant. In Study 2, 55% maintained response on ulixacaltamide vs 33% on placebo (p=0.0369; OR=2.7).

Safety was generally consistent with prior experience: most common adverse events included constipation, dizziness, euphoric mood, brain fog, headache, paraesthesia and insomnia; there were no deaths and no drug‑related serious adverse events. Praxis has submitted a pre‑NDA meeting request to the FDA and plans to submit the NDA by early 2026.

Mitchell Dean J, a director of Praxis Precision Medicines, Inc. (PRAX), reported multiple option exercises and resulting share holdings on 09/24/2025. He acquired 1,932 shares via exercise at $14.36, 8,566 shares at $44.25 and 1,753 shares at $44.04, increasing his direct beneficial ownership to 17,251 shares. The related options have varying vesting histories: the $14.36 option fully vested 06/12/2024, the $44.25 option fully vested 06/05/2025, and the $44.04 option vests monthly over one year starting 06/26/2025. The reported transactions were filed by an attorney-in-fact on 09/25/2025.

Praxis Precision Medicines, Inc. is reshaping its at-the-market equity financing. The company terminated its 2024 Open Market Sale Agreement with Jefferies, under which it had sold 1,368,176 shares of common stock for aggregate gross proceeds of approximately $86.2 million, with no termination penalties. As a result, no further shares will be sold under that 2024 ATM program.

The company has entered into a new 2025 Sales Agreement with TD Securities (USA) LLC (TD Cowen) to sell up to $250 million of common stock from time to time through an at-the-market offering. Praxis will set sale parameters and pay TD Cowen a commission of up to 3.0% of gross proceeds, and sales will be made under its effective shelf registration statement and related prospectus supplement.

Praxis Precision Medicines, Inc. filed a prospectus supplement for an "at the market" offering to sell up to $250,000,000 of common stock through TD Securities (USA) LLC (TD Cowen) as sales agent. The offering may be conducted from time to time on Nasdaq under ticker PRAX; the prospectus cites a last reported sale price of $44.94 per share on September 2, 2025. TD Cowen may receive commissions up to 3.0% of gross sales and will be treated as an underwriter for Securities Act purposes. The filing discloses 21,049,585 shares outstanding as of August 31, 2025 and illustrates an example issuance of 5,562,972 shares (assumed) resulting in up to 26,612,557 post-offering shares. Net tangible book value was $404.2 million ($19.21/share) as of June 30, 2025 and would be $646.4 million ($24.30/share) after the assumed sale, implying $20.64 per-share dilution to new investors. Proceeds are for research and clinical development, working capital and general corporate purposes. The prospectus emphasizes material risks, broad managerial discretion over proceeds, potential dilution, and incorporation by reference of SEC filings.

Adage Capital Management and two principals report beneficial ownership of 2,374,085 shares of Praxis Precision Medicines, Inc. (PRAX), representing 11.28% of the 21,045,781 shares outstanding as of July 31, 2025. The filing is a Schedule 13G/A indicating the stake is held in the ordinary course of business and not to influence control. The reported holdings are held directly by Adage Capital Partners, L.P. and are disclosed by Adage Capital Management, L.P., Robert Atchinson and Phillip Gross, each showing shared voting and dispositive power over 2,374,085 shares and no sole voting or dispositive power. The filing cites the issuers principal executive office in Boston and uses the CUSIP 74006W207.

Adage Capital Management, L.P. reported an initial Section 16 filing for Praxis Precision Medicines, Inc. (PRAX) disclosing 2,374,085 shares beneficially owned indirectly. The filing states these shares are held directly by Adage Capital Partners, L.P. (ACP) and that Adage Capital Management, L.P. (ACM) serves as ACP's investment manager with discretionary authority over the portfolio. Robert Atchinson and Phillip Gross are identified as managing members of related Adage entities. The reporting persons are listed as Directors and as a 10% owner relationship to the issuer. The filing includes standard Section 16 disclaimers that each reporting person disclaims beneficial ownership except for any pecuniary interest, and it is signed by Adage and the two individuals on 08/19/2025.

Point72-associated entities and Steven A. Cohen report collective beneficial ownership of Praxis Precision Medicines (PRAX) common stock totaling 1,531,038 shares, representing 7.3% of the outstanding class as of June 30, 2025. The filing shows 1,465,105 shares reported by Point72 Asset Management/Point72 Capital Advisors (7.0%) and 65,933 shares held by related entities (0.3%). The total includes 511,030 shares issuable upon exercise of warrants, which are counted in the denominator used for the percent calculation. The report states these holdings are not intended to change or influence control of the issuer.

Cormorant Asset Management, LP and Bihua Chen report beneficial ownership of 1,625,000 shares of Praxis Precision Medicines common stock, representing 7.72% of the outstanding class. The shares are held through Cormorant-managed funds (the "Cormorant Funds") and the filing attributes voting and dispositive authority as shared rather than sole power.

The filing notes that the Cormorant Funds have the economic rights to dividends or sale proceeds and identifies Cormorant Global Healthcare Master Fund, LP as a fund with rights to more than 5% of the reported shares. The statement clarifies it is filed on behalf of both reporting persons and disclaims that the filing alone establishes beneficial ownership for purposes of Section 13.