Sign inThe company said 71.4% of efficacy-evaluable patients achieved stable disease, with some patients progression-free at one year and no dose-limiting toxicities reported.
SEC filing
The company said 54% of evaluable patients hit DORIS remission at 12 months and plans to begin pivotal lupus nephritis trial start-up activities in the fourth quarter of 2026.
SEC filing
Kodiak Sciences said both retinal drugs met their primary endpoints in the wAMD study, with plans to file a BLA for Zenkuda in the fourth quarter of 2026.
SEC filing (2)
Keros Therapeutics said initial data from the open-label study are expected in the first half of 2027.
SEC filing
The state stem cell agency's CLIN2 award backs Fate's Phase 2 RECLAIM-LN study of off-the-shelf CAR T therapy FT819 in refractory lupus nephritis.
SEC filing
The company also amended existing Trust debt, added a director, and resolved a dispute with Helena Global Investment Opportunities in a Form 8-K covering events from September 18 through September 24, 2026.
SEC filing
The Board made the change effective September 28, 2026, after Keswani's departure was agreed on September 25.
SEC filing
The contract, signed September 25, 2026, funds a Phase 2 trial and could carry SCY-247 through NDA filing if all options are exercised.
SEC filing
The debt-for-equity swap reduced the outstanding balance of a 2021 secured note by $3.4 million, filings show.
SEC filing (2)
The San Diego biotech raised roughly $446.3 million in its Nasdaq offering alongside an $89.3 million concurrent stock purchase by AbbVie.
SEC filing
Both offerings closed September 25, 2026, after underwriters fully exercised their over-allotment options, following topline VK2735 maintenance dosing data.
SEC filing (5)
The company said topline results from the pivotal lanifibranor trial are expected in the fourth quarter of 2026, as it reports a comprehensive refinancing and updated cash runway.
SEC filing
Shareholders approved a 1,500,000-share increase to Phio's long-term incentive plan and elected six directors at the September 28, 2026 meeting.
SEC filing
The Nasdaq-listed medical cannabis company said the departure was for personal reasons and unrelated to any disagreement over operations.
SEC filing
The two life science executives join as Humacyte prepares its dialysis access launch of the ATEV, the company said.
SEC filing
The Brisbane biotech named Nancy Freda-Smith to its board and Constance Ames as CFO while signing a $5 million-a-year services pact with CEO-linked Factor Bioscience.
SEC filing
The FDA cleared supplement 43 to Gazyva's biologics license on September 25, 2026, though the agency's record does not detail the specific change.
Drugs@FDA
The new molecular entity application for tavapadon, submitted by AbbVie, received FDA approval dated September 25, 2026.
Drugs@FDA
Teva Pharmaceuticals, Inc. won approval for Degevma (denosumab-adet), a subcutaneous injectable, under BLA 761481.
Drugs@FDA
The September 24, 2026 agreement with an entity controlled by the company's own CEO was disclosed in an 8-K filed September 25, 2026.
SEC filing
New data from Phase 1 and Phase 1b trials show T-cell activation effects, and a safety committee cleared the first Phase 1b dose level for expansion.
SEC filing
The agency's approval letter for NDA218379 is dated September 29, 2026, with a submission status date of September 25, 2026.
Drugs@FDA
The FDA cleared a ninth supplemental application for Olumiant under a standard review, with the approval recorded on September 25, 2026.
Drugs@FDA
The FDA record shows approval of NDA 221198 for Atebrioz, an oral tablet containing zilurgisertib, sponsored by Incyte Corp.
Drugs@FDA
CDT Equity Inc. will combine every 25 shares into one to keep meeting Nasdaq's minimum bid-price rule, with adjusted trading starting September 29, 2026.
SEC filing
Biotricity said the departure, effective September 22, 2026, was unrelated to any disagreement with the company, and named a replacement to fill the resulting committee seat.
SEC filing
VolitionRx converted $525,000 of its senior secured note into common stock across two issuances in September 2026, per an 8-K filing.
SEC filing
The Delaware biotechnology company registered a new exempt securities notice with the SEC, reporting $10 million already raised from three investors.
SEC filing
Edward Kaye, M.D. stepped down as a Class III director, and Stoke's board named Alexander (Bo) Cumbo to fill the seat effective September 23, 2026.
SEC filing
ADARx Pharmaceuticals sold 26.25 million shares in its Nasdaq debut and will use proceeds to fund late-stage siRNA programs including a Phase 3 hereditary angioedema trial.
SEC filing
The Natick, Massachusetts biotechnology company reported selling $1.5 million in securities to 15 investors under a Regulation D exemption.
SEC filing
The efficacy-related application update for the oral cancer drug lenvatinib mesylate was approved with a standard review priority.
Drugs@FDA