Wednesday, November 4
The deal gives NewcelX upfront cash and equity plus up to $55 million in milestones as it narrows focus to its cell-therapy pipeline for Type 1 diabetes.
SEC filing
The company said the FDA agreed to a single, approximately 280-patient pivotal trial for its brain metastases imaging agent, with dosing expected to begin in the first half of 2027.
SEC filing (2)
The company reported preclinical data at the 2026 American Thyroid Association meeting and plans to start a Phase 1 trial in the first quarter of 2027.
SEC filing
The company agreed to sell over 7.4 million shares at $10.77 apiece to institutional investors, with closing expected November 4, 2026.
SEC filing
WAKIX net revenue reached $269 million in the quarter, and the company said it remains on track to meet full-year guidance of $1.0 billion to $1.04 billion.
SEC filing (2)
The company secured new technology transfer and development-phase projects while disclosing a pending merger agreement and a third-quarter net loss of $40.1 million.
SEC filing
The company got FDA approval for ORLADEYO oral pellets in patients 12 and older and lifted its full-year total revenue outlook to $715 million to $730 million.
SEC filing
Viridian Therapeutics posted third-quarter 2026 results showing early Lumvoa uptake, an on-track elegrobart filing, and upcoming VRDN-292 and VRDN-008 milestones, alongside $955.2 million in cash.
SEC filing
Nuvectis says FDA talks on ciprocopan for PNH are underway with an update expected by year-end, as it plans US IND filings for both lead oncology and complement assets.
SEC filing
The FDA set a PDUFA target action date of May 1, 2027 for ifezuntirgene inilparvovec, as uniQure reported third-quarter 2026 results and detailed confirmatory study plans.
SEC filing
Processa announced leadership appointments on November 4, 2026, as the company advances its BTK inhibitor VT-7208 following its July 2026 acquisition of Vidya Therapeutics.
SEC filing
The company cited new biomarker support for its ulcerative colitis drug and completed IND-enabling work for a second program, with cash seen lasting into the second half of 2028.
SEC filing
Q32 Bio cited 36-week and 16-week off-drug results from SIGNAL-AA Part B and said it holds $289.6 million in cash as of September 30, 2026.
SEC filing
The company filed for accelerated approval in October and says a $4.0 million September offering should fund operations into mid-first quarter 2027.
SEC filing
Mineralys says commercialization plans remain on track ahead of its FDA decision date, with new blood pressure data and a terminated Tanabe license already behind it.
SEC filing (2)
Arrowhead Pharmaceuticals replaced its existing debt with a new $400 million term loan priced at SOFR plus 5.50%, cutting its interest rate from 15% and extending maturity to November 2031.
SEC filing
ACI-7104 cleared FDA IND review and earned Fast Track status while posting strong week-100 antibody response data, as AC Immune said cash lasts into Q1 2028.
SEC filing
The company also dosed its first patient in a Phase 3 trial of OCU410 for geographic atrophy and said cash on hand extends its runway into 2028.
SEC filing
The contract research firm reported 4.7% organic revenue growth in the quarter ended September 26, 2026, and lifted its full-year revenue and earnings outlook.
SEC filing
Tuesday, November 3
Phase 2, Phase 3, and long-term extension studies of the antisense drug apazunersen were all terminated, with records updated November 3, 2026.
ClinicalTrials.gov (3)
Sanofi told Nurix it is stopping development of SAR448272 and shutting down the program, cutting off related milestone and royalty payments to Nurix.
SEC filing
GeoVax Labs seeks net proceeds of about $4.6 million in a Nasdaq offering tied to a Phase 3 GEO-MVA trial, while Xbrane's ranibizumab approval remains unchanged.
Drugs@FDA, SEC filing (2)
The deal, expected to close mid-2027, would add Vantive's concentrates, machines, and Medolla, Italy manufacturing campus to Rockwell's portfolio.
SEC filing
The company finished enrolling its Phase 3 trial of tenapanor for chronic idiopathic constipation ahead of schedule and posted 19% product revenue growth to $125.5 million for the quarter.
SEC filing
The Swiss biopharma agreed to acquire Accure Therapeutics' rights to lead candidate Privosegtor and expanded its at-the-market share sale facility to $125 million.
SEC filing
The board unanimously elected Guegan, who had served as interim finance chief since August, to the role with a $1.3 million base salary.
SEC filing
PRF would license and ultimately sell its GridFeed energy platform to Dotz for $1.0 million while taking an equity stake, allowing PRF to focus on its drug pipeline.
SEC filing
The board approved the payout on November 3, 2026, with payment set for mid-December to shareholders on record in late November.
SEC filing
The company also disclosed a $200 million private placement and pro forma cash of $343 million, as it moves ANB033 toward registrational studies.
SEC filing
Tarsus reported third-quarter 2026 XDEMVY sales up about 64% year-over-year and outlined 2027-2029 milestones across TP-04, TP-05, IRX-101, and gildeuretinol.
SEC filing
The company agreed to sell 260,001 shares at $2.50 apiece, with the deal expected to close on or about November 20, 2026.
SEC filing
QuidelOrtho reported a 12% revenue decline in the third quarter and said a new cost transformation plan should deliver over $80 million in annual savings in 2027.
SEC filing
The Toronto-based heart disease drug developer will use proceeds to support CardiolRx development for pericarditis and CRD-38's clinical program.
SEC filing
Contineum said its Phase 2 IPF trial of PIPE-791 now spans more than 100 sites in 16 countries, with cash runway projected through mid-2029.
SEC filing
Green Dragon exercised over 517,000 advisory warrants in a cashless transaction on October 29, 2026, under its fee arrangement with Lite Strategy.
SEC filing
The company reported third-quarter 2026 results alongside an update on Anaphylm's regulatory path, ex-U.S. filings and the AQST-108 program.
SEC filing
Denali reported Q3 2026 results showing AVLAYAH's second full commercial quarter alongside progress on five TransportVehicle pipeline programs expected to yield data in 2027.
SEC filing
Spyre also dropped SPY072 from rheumatic disease development, started a new HS trial, and reported pro forma cash of $1.5 billion with runway into the second half of 2029.
SEC filing
Emil Kuriakose and Michael Vasconcelles join as independent directors effective October 30, 2026, expanding the board to eleven members.
SEC filing
Mirum launched ATEBRIOZ in FOP and posted positive results across ATEBRIOZ, LIVMARLI and brelovitug studies while lifting full-year product sales guidance.
SEC filing
InMed shareholders vote November 4 on the proposed merger with Mentari Therapeutics, while InMed works to resolve a Nasdaq equity shortfall and says cash lasts only into mid-November.
SEC filing
Oculis Holding AG amended its sales agreement with Leerink Partners on November 3, 2026, expanding its at-the-market program above the original $100 million cap.
SEC filing
Bio-Techne's board approved an $0.08 per share payout that will only go forward if the company's pending acquisition by Merck KGaA has not closed by the record date.
SEC filing