Thursday, October 22
The company said it reached agreement with FDA on patient selection, dose, duration, and endpoints for a registrational study in dementia with Lewy bodies.
SEC filing
AstraZeneca's Alexion unit said Ultomiris is now the first C5 complement inhibitor cleared in the US to cut proteinuria in adults with the rare kidney disease.
Drugs@FDA, SEC filing (2)
Arbutus Biopharma said it can resume U.S. clinical development of AB-101, its oral PD-L1 inhibitor for chronic hepatitis B, after the FDA removed the hold.
SEC filing, Drugs@FDA (2)
The agency approved submission number 2 under BLA761382 for Enzeevu, Sandoz's aflibercept-abzv injection, on October 22, 2026.
Drugs@FDA
The agency approved a standard-review efficacy supplement for the pembrolizumab and berahyaluronidase alfa-pmph combination product under BLA761467, effective October 16, 2026.
FDA, Drugs@FDA (2)
An independent monitoring committee found no reason to stop the Phase 2b IPF trial early, with topline results still expected in mid-2027.
SEC filing
The company reported that izicopan reduced kidney injury markers in two hamster models and described structural data distinguishing it from avacopan.
SEC filing
FDA's drug database shows a second original BLA approval for Pavblu, with the agency's approval letter dated October 23, 2026.
Drugs@FDA
The company stopped the dose-ranging study for a business reason after enrolling 170 participants across 117 sites in 24 countries.
ClinicalTrials.gov (2)
The agency approved a second original application covering a new injectable dosage form of the aflibercept biosimilar Ahzantive.
Drugs@FDA (2)
The company sold 15,000 shares of newly created Series C Convertible Preferred Stock to accredited investors, closing October 21, 2026.
SEC filing
The Minnesota biotechnology company has sold $550,000 of a planned $20 million round to three investors as of October 22, 2026.
SEC filing
The low nicotine cigarette maker reported revenue up 66% from the prior quarter and said full results are due by November 13, 2026.
SEC filing
The company disclosed terms for Ying Luo and Thomas Eastling, including base salaries, bonus targets, and change-of-control severance provisions.
SEC filing
The Nasdaq-listed company said Wong will start as VP and principal accounting officer on November 2, 2026, with a base salary of $360,000.
SEC filing
GlucoTrack will combine shares 1-for-2 on October 26 and closed a $2 million private placement of notes and warrants on October 22, 2026.
SEC filing (2)
The board compensation committee acted October 17, 2026, with Moat's pay set to rise in 2027 and no change to his reporting line.
SEC filing
The company said the new authorization, good through October 21, 2027, adds to a prior buyback effort still underway.
SEC filing
The Carmel, Indiana-based company set board size at eight following the appointment, effective October 20, 2026.
SEC filing
Dean Zikria's first-month review sets three priorities: advancing Entolimod, building Velocity Bioworks' CDMO customer base, and exploring strategic options for the manufacturing unit.
SEC filing
The agency assigned a first-quarter 2027 PDUFA date and plans an advisory committee meeting before deciding on the drug, Biohaven said.
SEC filing
The company said it is preparing a year-end IMNM filing for VYVGART Hytrulo and expects Phase 3 MMN data for empasiprubart in December 2026.
SEC filing
The company said it will not contest a Nasdaq delisting determination and plans to withdraw its stock from the exchange after reporting a stockholders' deficit of over $9 million.
SEC filing
Wednesday, October 21
The study, which enrolled just 3 of a planned 20 patients, was stopped for strategic reasons, according to its ClinicalTrials.gov record updated October 21, 2026.
ClinicalTrials.gov
The company said its HLP003 Phase 3 data remain on track for Q4 2026, while a new HLP004 Phase 2 monotherapy study for generalized anxiety disorder is expected to start in Q1 2027.
SEC filing
The CRO posted $716.0 million in quarterly revenue and 23.8% backlog conversion, while its board swapped a $527.0 million repurchase program for a new $1.0 billion authorization running through 2028.
SEC filing
The company and investors ended the right to buy up to $12 million in additional shares and warrants from the October 8, 2026 offering.
SEC filing
The company estimated about $694.0 million in cash, cash equivalents and marketable securities as of September 30, 2026, pending completion of its financial closing process.
SEC filing
China's NMPA granted the designation for lisaftoclax combined with acalabrutinib in treatment-naive patients, ahead of a Phase III readout from the GLORA-2 trial.
SEC filing
Ashwath Jayagopal is leaving his post at Opus Genetics effective October 19, 2026, and will serve as a paid consultant for six months.
SEC filing
The San Diego-based company has sold $5.1 million of the equity offering to 37 investors so far, according to an SEC filing.
SEC filing
Eloxx Pharmaceuticals expanded its board and named a new chief medical officer while detailing its global Phase 2 EXPRESS trial for exaluren in nonsense-mutation ADPKD.
SEC filing
Four SEC filings detail bridge note and equity raises by the private biotechnology company dating back to 2010, with proceeds ranging from under $1 million to nearly $23 million.
SEC filing (4)