Thursday, October 8
The FDA approved a Type 5 new formulation or manufacturer submission for Breztri Aerosphere on October 8, 2026.
Drugs@FDA
The agency's approval covers adjuvant use of the immunotherapy alongside chemotherapy in patients as young as two.
Drugs@FDA, FDA (2)
The company cleared regulatory and ethics requirements in Australia to start its first-in-human study of the gene-editing therapy for high cholesterol, with initial safety data expected in early 2027.
SEC filing
The deal, announced October 8, 2026, values Pacira's equity at $1.65 billion and would add the non-opioid pain drugs EXPAREL and ZILRETTA to Viatris's portfolio.
SEC filing (2)
The single-site study, sponsored by MD Anderson with Amgen as collaborator, was suspended at the principal investigator's request, per a clinicaltrials.gov update posted October 8, 2026.
ClinicalTrials.gov
The agency cleared the new application on October 8, 2026, covering three dosage strengths for the antipsychotic formulation.
Drugs@FDA
The agency cleared an efficacy supplement for the atezolizumab injection under priority review, with a status date of October 8, 2026.
Drugs@FDA
The company finalized terms for its common stock and convertible note offerings on October 6, 2026, raising roughly $960 million combined after the OPUS-1 readout.
SEC filing (5)
The designation covers adult patients with locally advanced unresectable or metastatic FAP-positive solitary fibrous tumors, a rare cancer with limited treatment options.
SEC filing
The Dallas-based biotechnology company filed a Form D with the SEC showing sales under a 506(b) exemption toward a $15 million target.
SEC filing
The Miramar, Florida biotech sold all $1.5 million offered to a single investor under a Rule 506(b) exemption, with no commissions paid.
SEC filing
ICON plc said it will post Q3 2026 results after market close on October 27, 2026, with a call and webcast the next morning.
SEC filing
The San Antonio biotech raised $50,000 in a new closing under its existing preferred stock financing arrangement with 3i, LP.
SEC filing
Aardvark named David Zhang, who led biometrics work behind CAMZYOS and Abivax's ulcerative colitis trials, as an independent director effective October 7, 2026.
SEC filing
The new loan replaces X4's prior Hercules facility and is intended to help fund mavorixafor's potential commercial launch in chronic neutropenia.
SEC filing
The Memphis-based biotechnology company reported selling the full amount to 62 investors under a Regulation D exemption.
SEC filing
The PSMA-targeted T-cell engager, co-developed with Astellas, now has Fast Track status for late-line metastatic castration-resistant prostate cancer as Phase 3 plans target 2027.
SEC filing
Grant & Eisenhofer named lead counsel in the newly merged class action, as Quantum BioPharma's own direct suit against the banks proceeds alongside it.
SEC filing
The company agreed to sell 8,000,000 Class A ordinary shares at $1.50 each with accompanying warrants, expecting the deal to close around October 9, 2026.
SEC filing
Rami Aviram withdrew from the CFO role before his November 1 start date, leaving Josh Hexter to continue covering both top executive posts at Lifeward.
SEC filing (2)
Li's departure comes as the Nasdaq-listed company, trading as CHGA, positions itself for a possible deal in the drone defense sector.
SEC filing
Wednesday, October 7
The trial was terminated after enrollment declined and remaining participants had already been on study for more than three years, the registry record states.
ClinicalTrials.gov
Verity Pharmaceuticals, Lipocine's North American licensing partner, plans to launch the oral testosterone capsule in Canada by the end of 2026.
SEC filing
The buyer will pay in cash at closing, with a fifth of the proceeds owed to NIH under a 2018 license agreement, per Ultragenyx's 8-K.
SEC filing
The agency cleared tucatinib with trastuzumab and pertuzumab as a maintenance therapy following induction treatment, the FDA said.
Drugs@FDA, FDA (2)
The company disclosed an October 7, 2026 agreement granting Oster options, restricted stock units, and performance shares tied to 2027 and 2028 EBITDA-per-share thresholds, pending stockholder approval.
SEC filing
Genmab shareholders approved 2026 board remuneration on October 7, 2026, resulting in 5,300 restricted stock units granted to board members.
SEC filing
An 8-K filed October 7, 2026 shows GridAI made a third loan of $536,000 to Pronghorn Resources on October 1, 2026, bringing the aggregate principal to $3,500,000.
SEC filing
The shares back warrants issued to Armistice Capital after a September 22 inducement exercise, with the placement closing September 23 and the company flagging going-concern doubt.
SEC filing
The Delaware biotech, based in Monrovia, Maryland, reported selling $25,000 in securities to a single investor under a Regulation D exemption.
SEC filing