Sign inData presented at SITC 2026 found neoantigen-specific T cells detectable directly ex vivo and a strong statistical link between AI-Immunology predictions and actual T-cell responses.
SEC filing, Drugs@FDA (9)
The company detailed response rates and safety from its Phase 1 dose-escalation study of the FLT3xCD3 T cell engager as it prepares four posters and plans for ASH 2026.
SEC filing, FDA (4)
Peer-reviewed Phase 1 results support safety and dosing seen earlier, as InflaRx proceeds toward 2027 Phase 2 trials with peak sales estimated at $1.5-2.0 billion.
SEC filing (3)
Zenas ended its prior at-the-market stock sale and filed a new $200 million offering under the same sales agreement, while reporting Q3 results and pipeline progress toward a May 2027 PDUFA date.
SEC filing (2)
The exchange and subscription transactions closed November 6, 2026, converting most tendered 2028 notes and leaving $143.2 million of old notes outstanding.
SEC filing (2)
The deal gives Foldlab 53.6% of iSpecimen's outstanding stock, and the Nasdaq company gained an AI protein-discovery agent and a disease-trend prediction model.
SEC filing
The approval covers adults with recurrent or metastatic HNSCC that progressed after platinum chemotherapy and an anti-PD-(L)1 antibody, based on tumor response data.
FDA press release, FDA, Drugs@FDA (10)
The company reported Q3 net product revenue of $24 million and pro forma cash of $422.8 million as it advances Phase 3 trials and a KRAS G12D inhibitor program.
SEC filing
ANI disclosed a $676 million bridge facility and a recommended public cash offer for Swedish drugmaker Egetis valued at roughly $559.9 million.
SEC filing
The company said VY7523 tau PET data remain on track for Q4 2026 and VY1706 dosing should begin within months, pending enrollment.
SEC filing
The company terminated its 2023 term loan with a $23.3 million payoff and moved forward with a workforce reduction tied to halting its sabirnetug program.
SEC filing
Sample technologies and genomics drove sales growth, but Qiagen withheld 2026 guidance because of the pending EQT Private Equity acquisition.
SEC filing (2)
Corvus says its Phase 3 PTCL and Phase 2 atopic dermatitis trials remain on track, with hidradenitis suppurativa and asthma studies advancing and cash runway extended into second quarter 2028.
SEC filing
The company ended its prior arrangement with Jefferies and replaced it with a new at-the-market agreement on November 5, 2026.
SEC filing
The regenerative medicine company reported a $29.6 million net loss for the quarter and now expects 2026 revenue of $179.4 million to $200.0 million, down from prior guidance.
SEC filing
Caribou is discontinuing clinical development of vispa-cel and CB-011 and cutting its workforce while it reviews options including a possible sale, merger or dissolution.
SEC filing
Rezolute said the FDA recommended it file a Biologics License Application for congenital hyperinsulinism, while topline results from its Phase 3 upLIFT study in tumor HI are expected by mid-December 2026.
SEC filing
The clinical-stage cell therapy company replaced its prior arrangement with Jefferies with a new at-the-market offering through Leerink Partners dated November 5, 2026.
SEC filing
Yong Ben, M.D., M.B.A. gave notice on October 30, 2026 that he will step down as Chief Medical and Development Officer, with the resignation effective January 8, 2027.
SEC filing
aTyr will seek partners to fund the Phase 3 study after aligning with FDA on using FVC as the primary endpoint, while reporting $50.3 million in cash.
SEC filing
The company tapped its Chief Strategy Officer to serve as principal executive officer and disclosed a $250,000 note and new consulting share issuance.
SEC filing
Cogent says it is ready to launch bezuclastinib in GIST pending a November 30, 2026 FDA decision, with two more PDUFA dates and $791.1 million in cash into late 2028.
SEC filing
BioAge dosed its first diabetic macular edema patient in September, completed enrollment in its cardiovascular trial, and said cash runs through 2029.
SEC filing
Revelation says cash runs into Q2 2027 as it readies a CRO-backed study of Gemini in acute kidney injury and touts a $94 billion total addressable market assessment.
SEC filing
The amendment adjusts ownership terms tied to a net cash threshold and extends the deal's closing deadline by several months.
SEC filing
The company said enrollment in its Phase 3 NOVA-2 trial of LB-102 is progressing and topline data remain on track for the first half of 2027, with cash expected to last beyond the second quarter of 2029.
SEC filing
Ungaro stepped down from Longeveron's board and all its committees on November 1, 2026, citing personal health reasons.
SEC filing
Cryoport now supports a record 788 clinical trials and 23 commercial cell and gene therapies, and lifted its full-year revenue outlook to $197-199 million.
SEC filing
Elutia said a GLP rabbit study of its drug-coated surgical matrix hit its performance goals, supporting a fourth-quarter 2026 FDA filing, while it reported $26 million in new non-dilutive funding.
SEC filing
IN8bio named Oxana Polyakova as SVP of Research & Development and said it remains on schedule to report preclinical animal data for its INB-619 T cell engager by the end of 2026.
SEC filing
Rigel reported third-quarter net income of $13.2 million and raised total revenue guidance to $290 to $295 million for 2026, a range that includes early VEPPANU sales.
SEC filing
vTv reported third-quarter 2026 results alongside completed enrollment in its T1D trial and FDA orphan drug designation for its sickle cell disease candidate HPPD.
SEC filing
FDA approval of MIMRYLO triggered $275 million in payments to Protagonist, and the company plans a Phase 2b psoriasis study of PN-881 for early Q1 2027.
SEC filing
Sana said it continues moving toward starting trials for two cell therapy candidates while reporting $121.7 million in cash as of September 30, 2026.
SEC filing
Vera posted $10.3 million in TRUTAKNA net product revenue and said about 700 Patient Start Forms have come in since the drug's July accelerated approval.
SEC filing
Tempest received a Nasdaq deficiency letter on November 4, 2026 after its shares closed below $1.00 for 30 straight business days, starting a 180-day clock to fix it.
SEC filing