Core Viewpoint - The company received a complete response letter from the FDA regarding bitopertin, indicating that while there is evidence of its effectiveness in lowering protoporphyrin IX (PPIX), there is uncertainty about whether this reduction can predict clinical benefits [3]. Group 1: Regulatory Update - The FDA's complete response letter highlights sufficient evidence that bitopertin significantly lowers PPIX levels [3]. - However, the FDA expressed uncertainty regarding the correlation between PPIX reduction and actual clinical benefits [3].

Halozyme Therapeutics, Inc. 1 Forward-Looking Statements In addition to historical information, the statements set forth in this presentation include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance and growth rates (including the Company's 2026 financial guidance and longer term financial outlook through 2028 and the assumptions used in deriving such guidance and longer term financial outlook) including expectations for futu ...

Core Viewpoint - A class action lawsuit has been filed against Mereo BioPharma Group plc, alleging securities fraud and unlawful business practices by the company and certain officers and/or directors [2]. Group 1: Lawsuit Details - Investors are encouraged to contact Pomerantz LLP for participation in the class action, with a deadline to apply as Lead Plaintiff by April 6, 2026 [2]. - A copy of the Complaint related to the class action can be accessed at Pomerantz's website [2]. Group 2: Company Performance and Stock Impact - On July 9, 2025, Mereo and Ultragenyx Pharmaceutical Inc. announced that the Phase 3 Orbit study was progressing towards a final analysis, leading to a significant drop in Mereo's ADR price by $1.25, or 42.52%, closing at $1.69 on July 10, 2025 [4]. - On December 29, 2025, Mereo reported that neither the Orbit nor the Cosmic Phase 3 studies achieved statistical significance, resulting in a drastic decline in ADR price by $2.02, or 87.7%, closing at $0.29 [5].

Washington, D.C. 20549 FORM S-1 As filed with the Securities and Exchange Commission on February 17, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aspire Biopharma Holdings, Inc. (Exact name of registrant as specified in its charter) (State or jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 33-3467744 (I.R.S. Employer Identification No.) 23150 Fashion Dr ...

Core Insights - The conference call was held to discuss the positive topline results from the SOL-1 Phase III clinical trial of AXPAXLI (OTX-TKI) for wet AMD [2][3]. Group 1: Company Overview - Ocular Therapeutix is presenting topline data from its Phase III clinical trial, indicating a significant advancement in its product pipeline [2]. - The call features remarks from key executives and clinical researchers involved in the SOL program, highlighting the collaborative effort in the trial [3]. Group 2: Clinical Trial Details - The SOL-1 trial results are positioned as a pivotal moment for Ocular Therapeutix, potentially impacting the treatment landscape for wet AMD [2]. - The involvement of prominent figures in the ophthalmology field, such as Dr. Arshad Khanani and Dr. Darius Moshfeghi, underscores the credibility and importance of the trial results [3].

Core Viewpoint - Coherus Oncology, Inc. has successfully closed a public offering of 28,600,000 shares at a price of $1.75 per share, raising approximately $50.1 million to support its clinical development and commercialization efforts [1][3][4]. Group 1: Offering Details - The public offering was led by healthcare-focused investors including Janus Henderson Investors, HBM Healthcare Investments, and Samsara BioCapital [2]. - The gross proceeds from the offering were approximately $50.1 million, with a 30-day option for underwriters to purchase an additional 4,290,000 shares [1][4]. - The offering was conducted under an effective shelf registration statement previously filed with the SEC [5]. Group 2: Company Strategy and Use of Proceeds - Coherus aims to utilize the net proceeds from the offering to support the commercialization of LOQTORZI (toripalimab-tpzi), continue clinical development of its product candidates, and for general corporate purposes [4]. - The company has significantly improved its financial position by reducing debt by over 80% and transitioning from a biosimilar company to a clinical-stage biotech focused on innovative oncology [3]. Group 3: Product Pipeline - Coherus has an approved next-generation PD-1 inhibitor, LOQTORZI, and a pipeline that includes mid-stage clinical candidates targeting various cancers [7]. - The innovative oncology pipeline includes multiple antibody immunotherapy candidates designed to enhance immune responses against tumors [8].

Core Viewpoint - Immunic, Inc. has successfully closed an oversubscribed private placement financing, raising an upfront total of USD 200 million, with the potential for an additional USD 200 million, aimed at funding clinical trials and transitioning into a commercial organization [1] Financing Details - The financing was led by BVF Partners L.P. and included participation from various institutional investors [1] - Immunic issued 229,076,000 pre-funded warrants at a price of USD 0.873 per warrant, resulting in upfront gross proceeds of USD 200 million [1] - Additional warrants for the purchase of up to 229,076,000 shares at the same exercise price could generate up to another USD 200 million [1] Use of Proceeds - The net proceeds from the offering will be utilized to fund clinical trials, operations, and general corporate purposes [1] - The combined funds from this private placement and existing cash reserves are expected to support operations into late 2027 [1] Clinical Development Programs - Immunic's lead program, vidofludimus calcium (IMU-838), is in Phase 3 trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [1] - The company is also initiating a Phase 3 trial for primary progressive multiple sclerosis [1] - Other development programs include IMU-856, targeting gastrointestinal diseases, and IMU-381, currently in preclinical testing [1]

HALOZYME REPORTS FULL YEAR 2025 RECORD REVENUE OF $1.4 BILLION AND REITERATES STRONG 2026 FINANCIAL GUIDANCE [Accessibility Statement] Skip NavigationFull Year 2025 Total Revenue Increased 38% YOY to Record $1.397 billionFull Year 2025 Royalty Revenue Increased 52% YOY to Record $868 millionCompleted Acquisitions of Elektrofi's Hyperconâ"¢ Technology and Surf Bio's Hyperconcentration TechnologyReiterating 2026 Financial Guidance Ranges:Total Revenue of $1.710 - $1.810 billion, YOY Growth of 22% - 30%Adjuste ...

Summary of Coya Therapeutics Update - February 17, 2026 Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of targeted therapies for ALS (Amyotrophic Lateral Sclerosis) Key Industry Insights - **ALS Treatment Landscape**: The approval of tofersen for SOD1 ALS has marked a significant development, indicating that targeted therapies can have a substantial impact on the disease's biology, potentially slowing, halting, or even reversing progression for a small subset of patients [3][4] - **Current Therapies**: Existing therapies show only modest benefits due to a lack of focus and understanding of the disease's biology. The industry is shifting towards more biologically informed clinical trials [5][6] Core Scientific Insights - **Neuroinflammation**: Neuroinflammation is identified as a critical factor in ALS pathology. The understanding of its role has evolved, with a focus on specific biological processes rather than broad observations [6][12] - **Regulatory T Cells (Tregs)**: Tregs are crucial for neuroprotection but are dysfunctional in ALS patients. Enhancing Treg function is a potential therapeutic target [13][14] Combination Therapy Rationale - **Combination of Low-Dose IL-2 and CTLA-4**: The rationale for this combination therapy is based on the need to enhance Treg function while suppressing inflammatory responses from activated macrophages. This dual approach aims to prevent Treg dysfunction and improve therapeutic outcomes [16][18][19] Clinical Trial Insights - **Initial Study Results**: A small study involving four ALS patients showed promising results, with some patients experiencing slowed progression and improved biomarkers related to inflammation and oxidative stress [24][25][26] - **ALSTARS Phase 2 Trial**: The upcoming trial aims to enroll 120 patients, with a design that includes a placebo group and two different dosing regimens for the combination therapy. The trial will measure clinical outcomes and biomarkers over six months [40][41][42] Safety and Tolerability - **Safety Profile**: Previous studies indicate that both IL-2 and CTLA-4 have favorable safety profiles, with no significant increase in infection rates observed. The low-dose IL-2 specifically activates Tregs without causing pro-inflammatory responses [56][59] Future Considerations - **Potential for FDA Approval**: If the trial meets its primary efficacy endpoint, Coya plans to submit an application for FDA approval. The strength of the data will be crucial for this process [65][66] - **Long-Term Outcomes**: There is optimism that slowing disease progression could correlate with improved survival rates, although ongoing monitoring of inflammation levels will be essential [62][64] Conclusion Coya Therapeutics is at the forefront of developing targeted therapies for ALS, with a strong focus on understanding the underlying biology of the disease. The upcoming ALSTARS trial represents a significant step towards validating the efficacy of combination therapies aimed at neuroinflammation and Treg dysfunction.

NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Vistagen Therapeutics, Inc. (“Vistagen” or the “Company”) (NASDAQ: VTGN).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.  The class action concerns whether Vistagen and cer ...