Xencor and Adlai Nortye add new oncology data as ESMO roundup widens
Xencor reported Phase 1 XmAb819 results in kidney cancer and Adlai Nortye set an AN4035 presentation, joining earlier Nanobiotix, NovaBridge and Eikon ESMO updates.
SEC filing (5)
Latest
Wednesday, October 28
Benitec reports positive interim high-dose BB-301 results, durable low-dose benefit in OPMD trial
Benitec Biopharma announced October 28, 2026 interim Phase 1b/2a data showing all nine treated OPMD patients across both BB-301 doses are formal responders, with high dose showing greater gains at three months.
SEC filing
Novo Nordisk: BARI-STEP semaglutide trial results posted; two new Phase 1 studies registered
FDA accepts Palvella's NDA for QTORIN rapamycin, grants priority review
The agency set a February 28, 2027 PDUFA date for the microcystic lymphatic malformations treatment, which would be the first FDA-approved therapy for the rare disease.
SEC filing
Enanta CEO Jay Luly to retire in 2027, Tara Kieffer named COO
Luly plans to step down as president and CEO by February 1, 2027 after 23 years leading the company; Kieffer takes on a newly created operating role.
SEC filing
Wave Life Sciences details Q3 2026 progress on WVE-006, WVE-007, WVE-008 pipeline
The company said it has FDA alignment on a registrational path for AATD drug WVE-006 and reported $431.0 million in cash as of September 30, 2026.
SEC filing (7)
22nd Century Group adds Clear Street as sales agent for $18.8 million stock program
The company amended its at-the-market sales agreement to bring on a second agent, as its stock traded below 11 cents a share.
SEC filing (4)
Amarin posts first profitable quarter in two years as VAZKEPA growth accelerates in Europe
Amarin reported Q3 2026 net income of $0.2 million as Recordati-driven European demand for VAZKEPA rose 68% and an investigator-led Phase 3 trial pointed to a possible new use for the drug in colorectal cancer.
SEC filing
Replimune reports early TUDRIQEV launch progress, $307.8 million cash as of Sept. 30, 2026
The company said more than 15 institutions have prescribed its melanoma therapy since first patient delivery on October 6, while its confirmatory Phase 3 trial continues enrolling.
SEC filing
Tuesday, October 27
Innate Pharma pushes PACIFIC-9 data readout to first half of 2027
AstraZeneca delayed the Phase 3 trial's high-level data readout by roughly six months, citing the study's event-driven design.
SEC filing
Enhertu wins EU approval for adjuvant HER2-positive early breast cancer
The approval, announced October 27, 2026, triggers a $75 million milestone payment from AstraZeneca to Daiichi Sankyo and marks Enhertu's first EU nod in curative-intent early breast cancer.
SEC filing
Aclaris prices $50 million stock offering after positive ATI-052 Phase 1b readouts
The biotech paired upbeat atopic dermatitis and asthma data for its bispecific ATI-052 with a public offering of shares and pre-funded warrants priced October 27, 2026.
SEC filing (2)
Kiniksa raises 2026 ARCALYST sales guidance, confirms KPL-387 data timing
Kiniksa lifted its 2026 ARCALYST revenue outlook to $1.045-$1.050 billion and said pivotal Phase 3 data on KPL-387 are still expected in the second half of 2027.
SEC filing (6)
Oncolytics reports durability and survival data for pelareorep in anal cancer
The company said Cohort 4 of its GOBLET study showed about 15-month median duration of response, with all responders alive past one year.
SEC filing
Pfizer terminates TACTIVE-U Sub-Study C of vepdegestrant plus samuraciclib
Enrollment closed after 11 patients for strategic business reasons, not safety, with Phase 2 and drug interaction portions never started.
ClinicalTrials.gov
Clearmind finishes enrollment for first AUD cohort in CMND-100 trial
The company said patient recruitment is complete for the first segment of Part B of its Phase I/IIa study testing CMND-100 in alcohol use disorder patients.
SEC filing
Zentalis-supplied Phase 2 pancreatic trial of ZN-c3 plus gemcitabine ends early on toxicity
IQVIA raises 2026 outlook after record third-quarter bookings
IQVIA reported third-quarter revenue up 8.0% and its strongest clinical bookings since 2022, and raised full-year revenue, EBITDA and EPS guidance.
SEC filing
CDT Equity signs evaluation deal with Manoira for animal health uses of two compounds
CDT Equity will let Manoira Corporation test AZD1656 and AZD5904 in its upcoming animal health lineup, with possible licensing talks if the evaluation works out.
SEC filing
Munee M & A files Form D for $32 million offering tied to data center deal
The New York issuer, formerly MHR Acquisitions, is raising capital for an AI data center project that involves buying a natural gas company and a building.
SEC filing
NRC Health posts 11% revenue growth in Q3 2026, declares $0.16 dividend
Revenue reached $38.4 million and recurring contract value rose 9% as a large customer went live on schedule, the company said.
SEC filing
Repligen posts record Q3 revenue, raises 2026 guidance after closing BioLife deal
The bioprocessing company reported $209 million in third-quarter revenue and lifted its full-year revenue outlook to $844-$852 million following the October close of its BioLife Solutions acquisition.
SEC filing
Zura Bio reports Q3 2026 results, tibulizumab trials fully enrolled
Both Phase 2 studies of tibulizumab are fully enrolled with topline data on track for Q4 2026 and H1 2027, while cash of $187.7 million is expected to fund operations through at least 2028.
SEC filing
Bayer completes Phase 1 drug interaction study of sevabertinib with metformin
Conexeu Sciences discloses private placement, special warrants and share issuances in 8-K
Filing covers a $3.00-per-Unit raise, Canadian special warrants, consultant stock grants, and warrant exercises from mid-September through mid-October 2026.
SEC filing (3)
Senti Biosciences director Edward Mathers resigns from board
The resignation, effective immediately, comes days after Senti closed a merger and set a record date for a contingent value rights distribution.
SEC filing
Revolution Medicines' daraxonrasib appears in two new pancreatic cancer trial registrations
Lifeward names Ronen Tsimerman as Chief Financial Officer
The Israeli company's board appointed Tsimerman effective November 1, 2026, following prior finance leadership roles at IceCure Medical and Scopio Labs.
SEC filing
Tango registers Phase 1/2 trial pairing vopimetostat with Erasca's ERAS-0015
ICON reports Q3 2026 results, raises buyback authorization to $750 million
Revenue fell 2.9% year over year to $2,024.8 million as the CRO narrowed full-year guidance and expanded its share repurchase program.
SEC filing
Spero Therapeutics COO Timothy Keutzer to retire effective December 31, 2026
Spero disclosed in an SEC filing that its chief operating officer will step down at year end and remain as a paid consultant into early 2027.
SEC filing
Aclaris prices stock and warrant offering, expects $46.7 million net proceeds
The company will sell shares and pre-funded warrants at $3.50 and $3.49999 respectively, with closing expected October 28, 2026.
SEC filing
GeoVax enters $1 million revolving loan deal, replaces five board members
Bowery Consulting Group's loan brought three new directors to GeoVax's board as five departing members resigned, with source documents giving differing dates for the agreement.
SEC filing
Helus Pharma co-founders step down from executive roles, stay on board
Eric So and Paul Glavine exit executive posts as Mark Lawson becomes independent board chair, the company said on October 27, 2026.
SEC filing
Bionano Genomics files S-1 to register 1.3 million warrant shares
The San Diego genomics company registered shares underlying four outstanding warrant series after its prior Form S-3 shelf nears expiration on November 6, 2026.
SEC filing
Entera Bio and Altimmune both add directors in late-October board moves
Entera named a women's-health focused clinical executive to its board as a longtime director departs, while Altimmune added two biopharma executives ahead of three planned retirements.
SEC filing (2)
VolitionRx prepays $500,000 on Lind convertible note, pauses conversion rights
The epigenetics company cut the note's balance to $706,667 and secured a deferral of conversion rights until January 2027 unless its stock hits $0.275.
SEC filing
Valion Bio closes new tranches of Series B and Series C preferred stock sales
3i, LP and other investors bought additional preferred shares and warrants on October 26, 2026 under existing purchase agreements.
SEC filing
Faeth Therapeutics adds Zymeworks R&D chief Adam Schayowitz to board
The company expanded its board to seven members and named Schayowitz a Class III director effective October 23, 2026.
SEC filing
Artiva Biotherapeutics halts AlloNK development, cuts staff by 94%
The company stopped work on its lead NK cell therapy after two patient deaths and weak durability data, and is now reviewing strategic options including a possible sale or dissolution.
SEC filing (4)
Atrium doses first patient in Corventis trial of ATR 1072 for PRKAG2 syndrome
Monday, October 26
FDA approves efficacy supplement for Pfizer's Talzenna
The agency cleared a priority-review supplemental application for the PARP inhibitor talazoparib tosylate, according to FDA records.
Drugs@FDA
Supernus terminates UBS credit line ahead of Indivior merger close
Supernus Pharmaceuticals ended its uncommitted revolving credit facility with UBS Bank USA on October 20, 2026, citing its pending combination with Indivior Pharmaceuticals.
SEC filing
Onconetix sets second 1-for-10 reverse stock split, effective November 6
The move completes a previously authorized split program, cutting share count to about 589,000 shares outstanding.
SEC filing
Mirum reports positive Cohort 2 data for ATEBRIOZ in younger FOP patients
Mirum plans an sNDA in the first half of 2027 to expand ATEBRIOZ's label to children aged 6 to under 12 with fibrodysplasia ossificans progressiva.
SEC filing
Longeveron reports MACE benefit in ELPIS II trial despite missed primary endpoint
Longeveron said a secondary analysis of its Phase 2b HLHS trial found fewer major cardiac events with laromestrocel, though the study still missed its primary heart-function goal.
SEC filing
Arcus Phase 2 EDGE-Gastric trial in upper GI cancers completed, 332 enrolled
Equillium doses first subject in Phase 1 trial of EQ504, triggers $20M milestone financing
Cumberland Pharmaceuticals plans NDA filing for ifetroban in DMD heart disease
The company said it will submit a New Drug Application after a fall pre-NDA meeting with the FDA, using Phase 2 and natural history data rather than a new Phase 3 trial.
SEC filing
Amgen adds former Yum! Brands CEO David Gibbs to board
Gibbs joins Amgen's Audit and Compensation and Management Development committees effective immediately, expanding the board to 13 directors.
SEC filing