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Affinia Therapeutics Receives European Medicines Agency Orphan Drug Designation for AFTX-201 in BAG3-Associated Dilated Cardiomyopathy (DCM)

Affinia Therapeutics Receives European Medicines Agency Orphan Drug Designation for AFTX-201 in BAG3-Associated Dilated Cardiomyopathy (DCM)

✨ Onyx Summary Affinia Therapeutics said the European Medicines Agency has granted Orphan Drug designation to AFTX-201, its investigational AAV gene therapy for BAG3-associated dilated cardiomyopathy, following the FDA’s acceptance of its IND. The designation adds regulatory incentives and market-exclusivity potential in the EU as Affinia advances a one-time intravenous

Verily Pre is Now “Awardable” in DoW’s Tradewinds Solutions Marketplace

Verily Pre is Now “Awardable” in DoW’s Tradewinds Solutions Marketplace

✨ Onyx Summary Verily says its Verily Pre precision health AI platform has achieved “Awardable” status on the Department of War CDAO’s Tradewinds Solutions Marketplace, positioning it as a readily awardable option for DoW agencies. The designation is intended to streamline federal procurement and expands Verily’s path from existing

Recursion Reports Grant of Inducement Awards as Permitted by the Nasdaq Listing Rules

Recursion Reports Grant of Inducement Awards as Permitted by the Nasdaq Listing Rules

✨ Onyx Summary Recursion’s board compensation committee approved inducement RSU awards covering 820,431 shares to 17 new employees under its 2024 Inducement Equity Incentive Plan, with quarterly vesting beginning after a one-year anniversary milestone and continuing until fully vested, contingent on continued employment. The grants, issued under Nasdaq Rule

Ocugen Appoints Rita Johnson-Greene to Chief Financial Officer

Ocugen Appoints Rita Johnson-Greene to Chief Financial Officer

✨ Onyx Summary Ocugen appointed Rita Johnson-Greene as chief financial officer, citing her leadership experience across regenerative medicine and gene therapy organizations including ARM, bluebird bio (Genetix Biotherapeutics), Spark Therapeutics, and AstraZeneca. The hire comes as Ocugen prepares to submit the first of three planned biologics license applications this year, aligning

Phathom Pharmaceuticals to Present at the Guggenheim Emerging Outlook Biotech Summit 2026

Phathom Pharmaceuticals to Present at the Guggenheim Emerging Outlook Biotech Summit 2026

✨ Onyx Summary Phathom Pharmaceuticals announced that its management team will participate in a fireside chat at the Guggenheim Emerging Outlook Biotech Summit 2026 on February 12, alongside one-on-one investor meetings during the conference. The appearance underscores the company’s ongoing investor engagement as it advances and commercializes its gastrointestinal disease

SpyGlass Pharma Announces Pricing of Initial Public Offering

SpyGlass Pharma Announces Pricing of Initial Public Offering

✨ Onyx Summary SpyGlass Pharma priced its initial public offering of 9.4 million shares at $16.00 per share, raising approximately $150 million in gross proceeds ahead of its Nasdaq Global Select Market debut under the ticker “SGP.” The IPO provides capital to advance the company’s late-stage, long-acting drug

Seer to Report Fourth Quarter and Full Year 2025 Financial Results on February 26, 2026

Seer to Report Fourth Quarter and Full Year 2025 Financial Results on February 26, 2026

✨ Onyx Summary Seer, Inc. announced it will report fourth-quarter and full-year 2025 financial results on February 26, 2026, followed by a webcasted conference call with management later that day. REDWOOD CITY, Calif., Feb. 05, 2026 – Seer, Inc. (Nasdaq: SEER), the pioneer and trusted partner for deep, unbiased proteomic insights, today

enGene to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

enGene to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

✨ Onyx Summary enGene Holdings announced that CEO Ron Cooper will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11. The presentation highlights continued investor engagement as the company advances its non-viral genetic medicine platform and lead program for non-muscle invasive bladder cancer. BOSTON

Affinia Therapeutics Announces FDA Acceptance of IND Application to Advance AFTX-201 to a Phase 1/2 Trial for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM)

Affinia Therapeutics Announces FDA Acceptance of IND Application to Advance AFTX-201 to a Phase 1/2 Trial for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM)

✨ Onyx Summary Affinia Therapeutics said the U.S. Food and Drug Administration has accepted its IND application for AFTX-201, clearing the company to initiate a Phase 1/2 clinical trial in adults with genetically confirmed BAG3-associated dilated cardiomyopathy. The decision advances a first-in-class gene therapy program targeting a severe inherited

MassBio Applauds Passage of Appropriations Bill, $400 Million Increase in NIH Funding

MassBio Applauds Passage of Appropriations Bill, $400 Million Increase in NIH Funding

✨ Onyx Summary MassBio praised the enactment of the FY2026 appropriations bill, which includes a $400 million funding increase for the National Institutes of Health along with provisions advancing PBM reform and reauthorizing the Rare Pediatric Disease Priority Review Voucher program. The measure reinforces bipartisan support for federal biomedical research, which

Guardant Health to Participate in Upcoming Investor Conferences

Guardant Health to Participate in Upcoming Investor Conferences

✨ Onyx Summary Guardant Health announced its participation in several upcoming investor conferences in February and March, including events hosted by BTIG, TD Cowen, Leerink Partners, and Barclays. Management will conduct one-on-one meetings and fireside chats, with live and archived webcasts available through the company’s investor website. PALO ALTO, Calif.

Cellares to Expand Automated Manufacturing to Gene-Edited Stem Cell Therapies

Cellares to Expand Automated Manufacturing to Gene-Edited Stem Cell Therapies

✨ Onyx Summary Cellares announced a collaboration with Stanford Medicine to automate manufacturing and release testing for gene-edited hematopoietic stem cell therapies, extending its automation platforms beyond T cell therapies into a new cell modality. The effort aims to establish a standardized, scalable manufacturing foundation that can reduce variability and accelerate