Sign inIn August 2026 filings, Radiopharm Theranostics reported dose escalation clearances for two radiotherapeutics and a scheduled FDA meeting for a diagnostic imaging agent.
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The agency signed off on submission 41 for NDA217806, with a corrected approval letter and label dated September 10, 2026.
Drugs@FDA
The board approved layoffs on August 6, 2026, to concentrate resources on PDS0301, and the company's COO departed the same week the cuts began.
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The approval triggers a $250 million milestone payment to Zymeworks from partner Jazz Pharmaceuticals, with more payments and royalties possible.
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Both doses hit statistical significance on some endpoints, but the effect size fell short of Spyre's bar to advance SPY072 as a standalone RA therapy.
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The company announced on August 20, 2026 that enrollment has begun for a first-in-human study of its brain tumor-targeting bispecific T cell engager, run at Duke.
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Jazz Pharmaceuticals said the agency cleared zanidatamab-hrii with and without tislelizumab plus chemotherapy for all HER2+ patients regardless of PD-L1 status.
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The dose-optimization study for the obstructive sleep apnea drug candidate follows earlier Phase 2 results and FDA Fast Track designation.
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The gene therapy company named an investment executive to its board while two longtime independent directors retired, effective August 25, 2026.
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The company issued an option for 307,814 shares outside its equity plans as an inducement for a new hire, per an 8-K filed for events on August 19, 2026.
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The clinical-stage biopharma named Craig L. Tendler, M.D., a former Johnson & Johnson oncology leader, as a new Class II director on August 22, 2026.
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The designation adds to earlier Fast Track and Orphan Drug status the drug already holds for two other autoimmune blood disorders.
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The clinical-stage biotech disclosed a shelf-based stock sale agreement dated August 21, 2026, alongside updated data on its lead osteosarcoma candidate OST-HER2.
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Vyome said it received FDA feedback on its pivotal trial strategy for VT-1953 and plans a Type C meeting, while ending the quarter with $7.9 million in cash.
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Anavex has moved completed Alzheimer's trial data to its FDA IND, sought an FDA meeting on Rett syndrome pediatric inclusion, and plans a Fragile X IND submission in September 2026.
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The GPCR-focused biotech's board appointed the physician-executive effective August 24, 2026, filling out its clinical leadership team.
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The company reported H1 2026 results, a new CD70 radio target for kidney cancer, and cash of CHF 67.9 million expected to last into late 2027.
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The Seattle biotech has sold $125,000 of a planned $2.5 million offering as of August 8, 2026, with two investors so far.
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The company said it plans to file a follow-on pre-submission this quarter, aiming toward a possible De Novo approval pathway for its Helix delivery catheter.
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MHLW cleared bepirovirsen on August 24, 2026, marking the drug's first global approval, backed by Phase III B-Well data.
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REGENXBIO said it does not expect to resubmit the RGX-121 BLA in the near term after asymptomatic spine MRI findings turned up in five trial participants.
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The company said the first patient received PBGENE-DMD at Arkansas Children's Hospital in August 2026, with initial safety data expected by year-end.
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Justin Trojanowski resigns as Tempest's principal financial officer effective September 1, 2026, with Nicholas Rossettos stepping into the top finance role the same day.
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The company revised pricing on its Hudson Global Ventures equity purchase agreement and separately raised $550,000 through discounted promissory notes to retire existing debt.
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The agency classified new HOPE-3 extension data as a major amendment, adding three months to its review of the Duchenne muscular dystrophy therapy.
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Two share issuances in August 2026 satisfied a combined $400,000 in conversion obligations tied to earlier convertible notes held by Lind Global Asset Management XII.
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The Huntsville biotech filed an S-1 on August 24, 2026 to cover potential stock sales under a new $25 million equity purchase agreement.
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The Houston biotech named the longtime athlete representative and brain health advocate a Class II director effective August 20, 2026.
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The Nasdaq-listed CNS drug developer plans to close the sale of 307,692 shares on or about August 24, 2026, with proceeds earmarked for working capital.
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Edwards, a former Arcutis and Incyte dermatology commercial leader, joined Oruka on August 24, 2026 with a base salary, bonus target, equity grants, and a signing bonus.
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The Switzerland-based biotech, previously known as NLS Pharmaceutics Ltd., reported completing an equity and warrant offering to five investors.
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The agreement, tied to Skye's planned acquisition of Redx Pharma, sets purchase terms and a warrant exercisable into 2030.
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The rare disease-focused drugmaker named a longtime AbbVie strategy executive to its board effective August 19, 2026, as a current director stepped down from the board while keeping his executive role.
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A newly published U.S. patent application covers combining MDMA with N-acylethanolamines like PEA, as FDA's new psychedelics guidance also names MDMA as a covered drug class.
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