Sign inEnlivex is winding down non-clinical R&D and cutting its workforce by about 60% to focus funding on reaching six-month topline data from its Phase 2b trial by mid-2027.
SEC filing
Alector plans an October 13 webinar on its anti-Abeta, tau, and alpha-synuclein programs following its $100 million upfront Genentech license and updated cash guidance into 2029.
SEC filing (5)
The settlement, signed October 19, 2026, lets Navinta sell a generic triheptanoin product starting in 2033, with other ANDA litigation still ongoing.
SEC filing
The company filed a patent application on October 19, 2026 covering use of its ALS drug candidate PrimeC in concussion, blast injury, and CTE, with potential protection through 2047.
SEC filing
Study '304' hit all primary and secondary endpoints, with VDPHL01 beating placebo on hair count and patient-reported improvement at Month 6.
SEC filing
The company plans to resubmit an FDA application by the end of 2026 after the trial met both co-primary endpoints and all secondary endpoints.
SEC filing
Clene said it filed for accelerated approval earlier in October based on neurofilament light chain biomarker data and clinical outcomes, as it prepares a confirmatory Phase 3 trial.
SEC filing
The clinical-stage retinal disease drug developer moved its listing from the Nasdaq Capital Market, with trading on the new tier starting October 19, 2026.
SEC filing
BrainsWay said the partnership includes a multisystem order of its Deep TMS devices for installation at IPMG clinics, with joint research projects also planned.
SEC filing
The agency set a first-quarter 2027 PDUFA date for the antifungal's new prophylaxis use, based on the Phase III ReSPECT trial.
SEC filing
The Atlanta biopharmaceutical company will issue shares to its largest shareholder as it prepares for Phase 3 work on pain drug Halneuron ahead of November 2026 Phase 2b data.
SEC filing
NRC Health's board appointed Trent Green, already serving as CEO, to also act as interim principal financial officer effective October 14, 2026.
SEC filing
The FDA approved a supplemental efficacy application for phentolamine mesylate ophthalmic solution Ryzumvi on October 16, 2026.
Drugs@FDA
The phase 1 SURVEYOR trial testing MOON101 is suspended under a clinical hold, according to a registry update posted October 16, 2026.
ClinicalTrials.gov
The FDA recorded approval of a standard-priority efficacy supplement for avapritinib tablets under NDA212608 on October 16, 2026.
Drugs@FDA
The company said topline data from the placebo-controlled study in mild Alzheimer's disease are expected in the first quarter of 2027.
SEC filing (2)
The agency cleared the Type 3 new dosage form application on October 16, 2026, adding a liquid option for the anticoagulant.
Drugs@FDA
The agency cleared the solution under a new drug application on October 16, 2026, as a new formulation rather than a novel active ingredient.
Drugs@FDA
The phase II study, sponsored by MD Anderson with NCI and Genentech as collaborators, was terminated after failing to reach enrollment targets, according to its ClinicalTrials.gov record.
ClinicalTrials.gov
Sanjay Nayak notified the company of his resignation effective October 16, 2026, to take the CEO role at a privately-held firm.
SEC filing
The company filled resulting committee vacancies with existing directors Stephen Biggar and R. Keith Woods.
SEC filing
The board elevated Chief Commercial Officer Tammi Gaskins to CEO and to a board seat effective January 1, 2027, as McCourt retires after 17 years at the company.
SEC filing
Quantum Cyber N.V. named Maj. Gen. (Ret.) Alberto C. Rosende a director effective October 12, 2026, the same day Peter O'Rourke stepped down from the board and his post at subsidiary Quantum Drones Corporation.
SEC filing
The Nasdaq-listed company said Weisblum, CEO of Silo Pharma, will join its board and all three key committees effective October 12, 2026.
SEC filing
Kenneth T. Mills will leave the REGENXBIO board effective October 21, 2026, and the company named George Migausky as the new Chairman.
SEC filing
Nasdaq told Lucid Diagnostics on October 12, 2026 that its stock has traded below $1 for 30 straight business days, triggering a compliance deadline.
SEC filing
The departure, disclosed in an October 16, 2026 filing, takes effect once the company submits its quarterly report for the period ended September 30, 2026.
SEC filing
The neurodegeneration-focused biotech priced an underwritten offering of 36.6 million shares, with closing expected October 19, 2026.
SEC filing
The Delaware biotechnology company reported $612,503 raised from six investors as of a filing dated October 16, 2026.
SEC filing
Maze exchanged nearly 2.8 million common shares held by Frazier Life Sciences funds for pre-funded warrants under an agreement dated October 15, 2026.
SEC filing
The Nasdaq-listed biotech tapped its existing revolving facility again on October 9, 2026, citing general corporate purposes.
SEC filing
Lindahl steps down as principal financial officer December 31, 2026, advises through March 31, 2027, as Vargo takes over January 1, 2027.
SEC filing
The company said the move is tied to a restructuring of leadership duties around its RAS-targeting drug programs.
SEC filing