Tuesday, August 4
VEPPANU won FDA approval and was licensed to Rigel Pharmaceuticals, while Arvinas outlined data timelines for three Phase 1 programs and cash runway into second-half 2028.
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Revuforj and Niktimvo both posted double-digit year-over-year net revenue growth as Syndax laid out new trial timelines for its expanded pipeline.
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The company says the rolling NDA submission stays on track for the second half of 2026, with a U.S. launch planned for early 2027 if approved.
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OnKure Therapeutics said it is no longer subject to a rule limiting how much stock it can sell under its existing $100 million at-the-market program with Leerink Partners.
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Larimar says FDA aligned on a rolling BLA path for nomlabofusp in Friedreich's ataxia and expects to start a global confirmatory Phase 3 study in the third quarter of 2026.
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Arrowhead reported topline Phase 3 results for plozasiran in severe hypertriglyceridemia and disclosed a PNPLA3 licensing deal with Madrigal worth up to $975 million in milestones.
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WAKIX net revenue rose 30% to $261.3 million in Q2 2026 as Harmony released single ascending dose data for orexin-2 agonist BP-205 and reaffirmed full-year guidance.
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OptimUM-02 met its progression-free survival goal in metastatic uveal melanoma as IDEAYA files an NDA under FDA's real-time review program, backed by $1.24 billion in cash.
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Pfizer lifted the midpoint of its full-year revenue guidance while reaffirming adjusted EPS guidance, which factors in costs tied to its Innovent Biologics licensing deal.
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FILSPARI's FSGS launch and IgAN demand drove sales growth as pegtibatinase enrollment continues and civorebrutinib joins the pipeline.
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The Nasdaq-listed vector-borne disease drugmaker sold shares and warrants at $1.74 per share, with H.C. Wainwright as placement agent.
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Cumberland Pharmaceuticals reported new Phase 2 results for ifetroban in Duchenne muscular dystrophy and cancer metastasis prevention alongside second-quarter 2026 results following its $100 million Apotex transaction.
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At its August 3, 2026 annual meeting, Theriva Biologics shareholders approved six proposals, including an increase in shares available under its 2020 Stock Incentive Plan.
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The clinical-stage biotech hired the former Eli Lilly insulin executive effective July 31, 2026, and granted her 430,000 inducement stock options.
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The company said its Phase 2 trial of PIKTOR in endometrial cancer remains on track for year-end topline results, with breast cancer data expected in 2027.
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Dianthus disclosed a 75% response rate in an interim look at Part A of its Phase 3 CIDP trial and said its Phase 3 gMG trial began in June, alongside second-quarter results dated August 4, 2026.
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Amgen widened its MariTide Phase 3 program, dropped AMG 513, and continued its fight with the FDA over pulling TAVNEOS, while reporting second-quarter results.
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All six director nominees were reelected and shareholders backed a 200,000-share expansion of the company's incentive plan, per an August 4 8-K filing.
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Seres registered 103,520 shares for BMR-Sidney at $4.83 each, worth $500,001.60, as partial payment for ending its Sidney Research Campus lease.
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The company reported second-quarter 2026 results alongside progress on its AATD, PKU, and sickle cell programs, with $1.2 billion in cash guided to last into mid-2029.
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OnKure said OKI-355 and OKI-345 remain in IND-enabling work with FDA submissions planned for the first half of 2027, and cash of $176.4 million is expected to fund operations into 2029.
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The oncology and hematology company licensed the PROTAC breast cancer drug from Arvinas and Pfizer and expects U.S. launch in mid-August, while its R289 MDS trial stays on track for second-half 2026 dose selection.
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Richard E. Uihlein swapped notes across five credit lines for 34,376,167 shares, cutting Galectin's debt load and lifting his voting stake to about 49.3%.
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Pacira closed its iovera° divestiture on July 31, advanced its PCRX-201 gene therapy program, and trimmed full-year revenue guidance to reflect the sale.
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Nuvectis says partner Haisco's China approval of ciprocopan for untreated PNH patients validates the drug as it plans a U.S. IND submission in the fourth quarter.
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The appointment took effect July 31, 2026, elevating a longtime executive who has been with the company since 2017.
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The company raised its 2026 revenue and EPS guidance ranges after second quarter results driven by CAG Diagnostics gains and IDEXX inVue Dx placements.
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A $6.8 billion acquisition drove a GAAP loss per share of $0.54, while Merck lifted its 2026 sales guidance and reported new approvals and trial data across oncology, HIV and cardiometabolic programs.
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Lipocine plans an FDA guidance meeting in the third quarter of 2026 and has started a new placebo-controlled trial for LPCN 1154 after a post hoc analysis flagged one site's data.
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The company reaffirmed full-year 2026 revenue guidance and flagged upcoming FDA decisions for DTX401 and UX111 alongside pivotal Phase 3 data for GTX-102 in Angelman syndrome.
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The company reported its eighth straight quarter of sequential product revenue growth and disclosed new regulatory and supply milestones for ANKTIVA.
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Second-quarter net revenue of $53.1 million drove net income of $20.1 million, and the company said cash on hand plus product sales should carry it to cash flow break-even by year-end 2026.
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The Cambridge biotech will use the proceeds to advance CMP-002, its SYNGAP1-related disorder therapy, following Australian clearance to begin a Phase 1/2 trial.
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A Form D filed August 4, 2026 shows Jasper Therapeutics sold $131,999,611 in equity securities to 40 investors under a Rule 506(b) exemption.
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Tyra says initial SURF302 data are expected in September 2026, while a BEACH301 achondroplasia readout slips to end of Q1 2027 as a fifth dose level is added.
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Tyra amended its sales agreement with TD Cowen on August 4, 2026, after fully using a prior $150 million facility, raising the ceiling on shares it can sell through the program.
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Spyre says both antibodies hit primary and secondary endpoints in ulcerative colitis, while three SKYWAY sub-studies finished enrollment ahead of schedule.
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The company posted a GAAP diluted loss of $8.45 per share tied to acquisition charges while raising full-year product sales guidance.
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The company also completed Phase 2 enrollment in its remlifanserin Alzheimer's psychosis program and won FDA Fast Track designation, with topline data expected in September to October 2026.
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The company said Phase 2a monotherapy data on OD-001 will be presented in October, with a combination trial and a Phase 2b trial slated to start later in 2026, backed by $433.1 million in cash.
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