Larimar completes rolling BLA for nomlabofusp in Friedreich's ataxia
The company seeks accelerated approval using skin frataxin as a surrogate endpoint, with FDA review and a possible launch targeted for 2027.
SEC filing
Latest
Yesterday
Eugia US recalls one lot of vancomycin injection over particulate matter
The company is pulling lot 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL from hospitals and healthcare facilities nationwide.
FDA
Vir's elebsiran-tobevibart hits primary endpoint in Phase 3 hepatitis delta trial
ECLIPSE 1 topline data show 44% achieved undetectable virus plus ALT normalization at Week 48, versus 0% in delayed treatment, Vir disclosed November 8, 2026.
SEC filing
Viridian reports positive phase 1 data for VRDN-008, an FcRn inhibitor
The company said the subcutaneous therapy showed deep IgG reduction and an extended half-life, supporting plans for a pivotal myasthenia gravis trial in mid-2027.
SEC filing
Artiva details wind-down cost estimates after scrapping AlloNK program
The company now pegs total charges from its workforce cut and trial shutdown at $27 million to $35 million, with most costs expected in Q4 2026.
SEC filing
Corvus Capital floats $2.00/share offer to take CDT Equity private
CDT Equity's board plans a special committee to review a non-binding buyout proposal delivered by a letter tied to the company's former CEO.
SEC filing
Mentari Therapeutics closes merger with InMed, begins Nasdaq trading as MTRI
The combined migraine-focused biotech closed $490 million in financing alongside the merger and started trading under a new ticker on November 9, 2026.
SEC filing
CorMedix to acquire nearly all of Heron Therapeutics' assets in cash-and-stock deal
The deal brings four commercial drugs into CorMedix's hospital business for $145 million cash plus stock, with Heron staying public to pursue new ventures.
SEC filing (2)
FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer
The FDA's announcement confirms full approval for dostarlimab-gxly in mismatch repair deficient endometrial cancer, as of the posted record.
FDA (2)
FDA clears zenocutuzumab-zbco under accelerated pathway for two tumor types
The agency's accelerated approval covers both non-small cell lung cancer and pancreatic adenocarcinoma, according to an FDA posting.
FDA
argenx reports positive Phase 3 ALKIVIA data in autoimmune myositis
The trial hit its primary and key secondary endpoints in combined IMNM and DM patients, with argenx planning an FDA filing for IMNM by year-end 2026.
SEC filing
Can-Fite says liver cancer patient from Phase II Namodenoson trial hits ten-year survival
The company reported the patient remains cancer-free, as its Phase III HCC trial continues with survival data running ahead of design assumptions.
SEC filing
Xenon submits azetukalner NDA for focal seizures, reports Q3 2026 results
Company says it has $1.2 billion in cash and runway into 2029 as it awaits December MDD data and plans new epilepsy and pain studies.
SEC filing
Surrozen doses first DUET patient, expands Phase 2a to 150 patients in DME study
Surrozen reported the first patient dosed in its SZN-8141 Phase 1b/2a trial and a planned Phase 2a enrollment increase, alongside added capital extending cash runway into 2029.
SEC filing
LifeVantage reports first quarter fiscal 2027 revenue down 22% as CEO outlines new strategy
The Salt Lake City company posted a net loss of $0.2 million for the quarter ended September 30, 2026, citing lower active accounts and softer sales of its MindBody GLP-1 System.
SEC filing
Zai Lab discloses $249.9 million private securities offering in SEC Form D
The filing shows all shares already sold to 25 investors, with Leerink Partners serving as placement agent.
SEC filing
Immunome posts Q3 2026 update with varegacestat PDUFA date and new ADC trial clearance
Immunome reaffirmed an April 2027 FDA decision date for varegacestat and said IND clearance for IM-1340 sets up a fourth clinical-stage program by year-end.
SEC filing
Spruce Biosciences keeps December BLA target for Sanfilippo therapy, spins off CRHX-101
Spruce reported third quarter 2026 results, reaffirmed a December BLA submission for TA-ERT, amended its Avenue loan, and separated CRHX-101 into a new subsidiary, Adrenyx Biosciences.
SEC filing
Zymeworks raises 2026 guidance after $250M Ziihera milestone, posts Roche deal for ZW209
Zymeworks reported third-quarter 2026 results, raised full-year revenue and EBITDA guidance, and detailed a new Roche collaboration on ZW209 pending antitrust clearance.
SEC filing
AN2 Therapeutics reports Q3 2026 results, PV trial cleared in all planned jurisdictions
AN2 said its global Phase 2 epetraborole study in polycythemia vera has clearance to proceed everywhere planned and expects enrollment to start by year-end 2026.
SEC filing
Immuneering appoints Grant C. Bogle to board as Class III Director
The Cambridge biotech added Bogle to its board effective November 9, 2026, with no committee assignment yet disclosed.
SEC filing
Trevi reports Q3 2026 results, three chronic cough trials now recruiting
Trevi Therapeutics said its Phase 3 OCEAN-2 trial opened in the third quarter and all three active trials are enrolling, with cash into 2030.
SEC filing
AbCellera reports Q3 2026 results, highlights ABCL635 Phase 2 and $200M raise
Positive Phase 2 data for menopause drug ABCL635 and a $200 million share offering anchor the quarter, alongside Phase 1 results for ABCL575 that will not advance past that stage.
SEC filing
Tango reports pancreatic cancer combo data, plans Phase 3 start in 1H 2027
Tango Therapeutics said its vopimetostat-daraxonrasib combination hit an 82% response rate in pancreatic cancer and reported $977.5 million in cash as of September 30, 2026.
SEC filing (2)
iSpecimen closes $400,000 Series D preferred stock private placement
The Woburn, Massachusetts-based specimen marketplace sold 500 shares of newly created Series D Convertible Preferred Stock to accredited investors, with E.F. Hutton as placement agent.
SEC filing
Maze Therapeutics completes HORIZON enrollment, reports Q3 2026 results
Maze finished enrolling its Phase 2 HORIZON trial of MZE829 with more than 50 patients and said full data are expected in early 2027, while cash stood at $477 million.
SEC filing
Ocular Therapeutix adds Riad Sherif to board, Hong to resign
The company named the Oculis Holding chief executive to a Class I board seat effective November 6, 2026, as director Seung Suh Hong plans to step down at year end.
SEC filing
Septerna reports Q3 2026 results, SEP-204 named lead TSHR candidate
Phase 1 data for hypoparathyroidism candidate SEP-479 are expected in Q1 2027, the same quarter Septerna plans to start a Phase 1 trial of new candidate SEP-204.
SEC filing
Kala Bio narrows net loss sharply in preliminary third-quarter 2026 results
The company cut its quarterly net loss by about 90% year over year while continuing to build out its AI platform business alongside its biologics pipeline.
SEC filing
Tonix posts $15 million in TONMYA sales for Q3, cites pipeline progress
Tonix Pharmaceuticals reported third-quarter 2026 TONMYA net sales of about $15 million, up 37% from the prior quarter, alongside updates on its MDD, Lyme and transplant programs.
SEC filing
VistaGen gets FDA feedback on Phase 3 path for fasedienol in social anxiety disorder
After a Type C meeting, FDA offered input on using the LSAS as the primary endpoint and on tracking longer-term functional benefit, VistaGen said November 9, 2026.
SEC filing
Whitehawk reports Q3 2026 results, starts Phase 1 trial of HWK-206 with Fast Track tag
The company began dosing in a new Phase 1 study of its third ADC candidate and said cash on hand should fund operations into the second half of 2028.
SEC filing
Rani Therapeutics gets FDA Emerging Technology Program acceptance, updates RT-114 enrollment
Rani reported third-quarter 2026 results, citing the FDA program acceptance and continued RT-114 expansion enrollment alongside a cash runway statement through at least the end of 2027.
SEC filing
SIGA gets $15M Canadian defense contract for oral TPOXX, discloses CSO retirement
SIGA Technologies reported financial results for the third quarter and first nine months of 2026 on November 9, 2026, alongside operational updates on its smallpox antiviral TPOXX.
SEC filing
ImageneBio reports Q3 2026 results, reaffirms olevaprubart trial timelines
The company said its Phase 2b atopic dermatitis trial remains on track for topline data in Q4 2027 and a new alopecia areata study is set to start by year end 2026.
SEC filing
Definium reports positive Phase 3 results for DT120 ODT in GAD, FDA breakthrough status in MDD
The company posted two positive Phase 3 anxiety studies, an MDD breakthrough designation, and roughly $1.05 billion in cash as of September 30, 2026.
SEC filing
NewcelX prices $1.55 million private placement at premium to market
NewcelX will sell shares and warrants at a 20% premium to its November 6, 2026 closing price, with proceeds aimed at advancing its type 1 diabetes cell therapy program.
SEC filing
Atea reports Phase 3 HCV win, HEV progress, and new Hercules credit line
Atea's C-BEYOND trial hit its endpoints for BEM/RZR in hepatitis C, while a new $200 million Hercules Capital facility backs a planned US launch.
SEC filing
Bicara reaches substantial enrollment in HPV-negative head and neck cancer trial
The company said topline interim results from its pivotal FORTIFI-HN01 study are expected in mid-2027, while cash on hand is projected to fund operations into the first half of 2029.
SEC filing (10)
CervoMed reports Q3 2026 results and neflamapimod pipeline progress across four programs
The company detailed data, regulatory steps, and a new dosing regimen across dementia with Lewy bodies, FTD, ALS, and stroke recovery programs, while cash stood at $19.6 million.
SEC filing
Atea Pharmaceuticals secures up to $200 million term loan from Hercules Capital
The November 6, 2026 agreement ties additional funding tranches to progress on Atea's Phase 3 trial of bemnifosbuvir and ruzasvir and other drug milestones.
SEC filing
Inovio prices $80.5 million stock offering, expects close on Nov. 9
Inovio entered an underwriting agreement for shares and pre-funded warrants priced November 5, 2026, with closing anticipated on or about November 9.
SEC filing
Mereo BioPharma gives Q3 2026 update on setrusumab and alvelestat regulatory talks
Mereo reported cash of $26.1 million as of September 30, 2026, with runway into late 2027, as it continues regulatory discussions on setrusumab and alvelestat.
SEC filing
Attovia reports Phase 1b itch drug topline data, plans Phase 2 starts in 1H 2027
ATTO-1310 hit week-12 itch and skin endpoints in chronic pruritus and atopic dermatitis patients, with two Phase 2 trials targeted to begin in the first half of 2027.
SEC filing
Azora Therapeutics adds three directors, four board members resign
The company, formerly Adial Pharmaceuticals, reconstituted its board and committees effective November 3, 2026, while also disclosing conversion of preferred stock tied to its Azora acquisition.
SEC filing
NBO Pharma Inc. files Form D for $7 million private offering
The Delaware pharmaceutical company has sold $238,000 toward a $7 million equity and warrant offering as of a November 9, 2026 filing with the SEC.
SEC filing
Immunovant's IMVT-1402 hits primary endpoint in difficult-to-treat rheumatoid arthritis trial
The company reports ACR20 response of 92.5% versus 75.6% for placebo at Week 28, with FDA discussions planned for later this year to chart a registrational path.
SEC filing
Annexon posts Q3 2026 results, flags tanruprubart BLA and ARCHER II readout timing
The company said its U.S. BLA for tanruprubart is expected this quarter and the ARCHER II Month 15 primary endpoint assessment for vonaprument is on track for the fourth quarter of 2026.
SEC filing
Harrow posts record Q3 revenue, cuts 2026 Adjusted EBITDA outlook
Harrow reported record Q3 2026 revenue, mixed Phase 4 IHEEZO data, and a lowered full-year Adjusted EBITDA target tied to added spending on its G-MELT NDA and TYRVAYA integration.
SEC filing
ADC Therapeutics reports Q3 2026 results, restructuring extends cash runway into 2029
The company detailed a PIPE and debt amendment completed in October, ASH 2026 abstracts for ZYNLONTA, and a Japan filing by partner Tanabe Pharma.
SEC filing