Agomab reports positive OLE data for ontunisertib in Crohn's bowel strictures
The company said results from the 48-week extension study support starting a global Phase 2b trial, NOV-ERA, in the coming months.
SEC filing
Latest
Thursday, October 1
Cullinan and Taiho start FDA review of zipalertinib combo for first-line lung cancer
An NDA submission under the FDA's Real-Time Oncology Review program began October 1, 2026, backed by Phase 3 REZILIENT3 progression-free survival data.
SEC filing (2)
Monte Rosa reports Phase 1 data for MRT-8102 in cardiovascular risk study
The company said its NEK7 degrader lowered multiple inflammatory markers tied to atherosclerosis and plans three Phase 2 trials starting as early as late 2026.
SEC filing
Azitra clears safety review, moves ATR-04 trial to Cohort 2
The Phase 1/2 study of ATR04-484 for EGFR inhibitor-associated skin rash advances after a safety panel review of six Cohort 1 patients.
SEC filing
Foghorn and Lilly halt FHD-909 program, company cuts 40% of workforce
Foghorn Therapeutics said it will not advance FHD-909 with Eli Lilly into expansion after Phase 1 data, and is reducing staff to focus on its own pipeline.
SEC filing
Oncolytics reports faster enrollment in REO 033 colorectal cancer study
Nearly all Part A sites are active, an interim update is expected by year-end 2026, and the FDA has aligned on a possible accelerated approval route.
ClinicalTrials.gov, SEC filing (3)
Kyntra Bio adds Andrew Singer to board, Maykin Ho departs after eight years
The biopharma company also renewed CEO Thane Wettig's change-in-control and severance agreement for another three years.
SEC filing
Pyxis Oncology prices $110 million stock and warrant offering for MICVO trial
The company finalized terms on September 29, 2026 for an offering of 36 million shares plus warrants, with proceeds aimed at funding a planned Phase 3 trial in head and neck cancer.
SEC filing (2)
Janssen posts Phase 3 ExPEC9V vaccine results; registers two guselkumab IBD studies
HUTCHMED's HMPL-A830 trial registry posted, detailing 147-participant Phase I/IIa design
BMS registers Phase 1 CAR T cell trial in kidney cancer; adds mavacamten real-world study
Wednesday, September 30
Phase 1b indibulin-capecitabine trial ended early after no dose-limiting toxicity seen
A Phase 1b trial testing indibulin combined with capecitabine in patients with advanced solid tumors was terminated, according to its registry record on ClinicalTrials.gov (NCT00726687, sponsor study ID IBL1005).
ClinicalTrials.gov
Q32 Bio reports Part B data for bempikibart in alopecia areata at EADV 2026
The company said 36-week and off-drug follow-up results support moving bempikibart into a registration-directed program targeted for the first half of 2027.
SEC filing
Alaunos Therapeutics trial of darinaparsin in blood cancers ended early, record updated
The phase 2 study of ZIO-101 (darinaparsin) in hematologic malignancies was stopped after enrolling 50 of a planned 70 patients, according to the registry record.
ClinicalTrials.gov
Standard BioTools switches mass cytometry buyer to GMT Venture unit, ends Multiplex Bio deal
Standard BioTools terminated its Multiplex Bio sale and signed a new $5.5 million deal with Element Biosystems, a GMT Venture affiliate, after finding the offer superior.
SEC filing
Connect Biopharma reports positive Phase 2 topline data for rademikibart in COPD
The company said rademikibart cut treatment failure by 81% and new exacerbations by 85% versus placebo in the Seabreeze STAT COPD trial, and plans to seek FDA alignment on Phase 3.
SEC filing
FDA approves Camzyos for children with obstructive hypertrophic cardiomyopathy
The agency's approval marks the first drug cleared to improve functional capacity and symptoms in children with the inherited heart condition.
Drugs@FDA, FDA (2)
Alaunos Therapeutics trial of darinaparsin in liver cancer ends after first stage
The Phase 2 study of ZIO-101 in advanced hepatocellular carcinoma was closed after 15 of a planned 40 patients were treated, with the registry citing a lack of treatment response.
ClinicalTrials.gov
Eupraxia reports 52-week data from highest dose cohort of EP-104GI in RESOLVE trial
The company said 9 of 14 patients across cohorts 5-9 remained in clinical remission at 52 weeks after a single dose, with no treatment-related serious adverse events reported.
SEC filing
Alaunos Therapeutics trial of palifosfamide plus doxorubicin in sarcoma ended early after interim an
The phase 2 PICASSO study stopped enrollment at 67 of a planned 100 patients after an interim look showed the primary progression-free survival endpoint had been met.
ClinicalTrials.gov
Mirati's SAPPHIRE trial in NSCLC terminated, results posted on ClinicalTrials.gov
The sitravatinib-nivolumab combination missed its goal against docetaxel, with overall survival data posted for the terminated phase 3 study.
ClinicalTrials.gov
Rafael Holdings' Phase 3 NPC trial misses primary endpoint, subgroup hits significance
Trappsol Cyclo showed a directionally favorable but not statistically significant effect on the primary endpoint, while a prespecified subgroup analysis reached significance; Rafael still plans an NDA filing in Q4 2026.
SEC filing
BioMarin and Ascendis sign settlement and license agreement over CNP patents
The September 24, 2026 agreement resolves patent litigation and grants Ascendis a non-exclusive license to BioMarin patents covering TransCon CNP, with royalties running through May 2030.
SEC filing
Sagimet Biosciences prices $107.5 million stock offering
The company plans to use proceeds to fund a Phase 3 acne trial for denifanstat and advance other pipeline programs.
SEC filing
Oculis board member Lionel Carnot resigns after nearly a decade
The resignation, effective September 30, 2026, leaves Oculis with an eight-member board and triggers a Remuneration Committee leadership change.
SEC filing
Neurocrine registers Phase 2 trial of NBIP-01435 in classic congenital adrenal hyperplasia
Indaptus extends outside date for $24 million private placement to October 16
A Form 8-K filed September 30, 2026 reports that Indaptus and its purchasers agreed on September 29, 2026 to extend the closing deadline for a stock sale.
SEC filing
Immix Biopharma prices $125 million stock offering alongside NEXICART-2 data update
The company priced 11,363,637 shares at $11.00 each, with the offering expected to close September 30, 2026, as it disclosed new CAR-T trial results.
SEC filing (2)
Tiziana Life Sciences seeks FDA orphan drug status for foralumab in MSA
The company filed an Orphan Drug Designation request on September 30, 2026 for intranasal foralumab in multiple system atrophy, a rare disease with no approved disease-modifying treatments.
SEC filing
Satellos completes enrollment in BASECAMP Phase 2 trial of forazapadin for Duchenne
The company said topline data from the trial will now come in the first quarter of 2027 after adjusting its prior data release plan.
SEC filing
CalciMedica files prospectus supplement for up to $25 million stock sale
The company disclosed the filing in an 8-K dated September 30, 2026, tied to its existing at-the-market agreement with H.C. Wainwright & Co.
SEC filing
Takeda posts results for TAK-881 vs HYQVIA pharmacokinetic study in PIDD patients
AEON gets FDA Type 2b feedback on ABP-450 biosimilar pathway for BOTOX
FDA meeting minutes support a potentially narrower clinical program, with an IND for a pharmacodynamic study planned for the fourth quarter of 2026.
SEC filing
RedHill reports H1 2026 results after Rebyota, Clenpiq deal and Talicia exit
RedHill said it funded a $12 million Rebyota and Clenpiq acquisition from Ferring using proceeds from its Talicia divestment, while advancing opaganib, RHB-204 and RHB-102 programs.
SEC filing
Kardigan names Kristin Reinke to board, Giordano departs
The cardiovascular-focused biotech added a Google finance executive to chair its Audit Committee as a founding director stepped down.
SEC filing
CRISPR Therapeutics registers Phase 1/2 trial of CTX460 for AATD-related emphysema
MoonLake submits BLA for sonelokimab in hidradenitis suppurativa
The company filed its application with the FDA on September 30, 2026, and expects to hear on acceptance within about two months.
SEC filing
Corcept's miricorilant MASLD Phase 1 study completed, University of Missouri site
Peking University registers finerenone-semaglutide trial for obesity kidney disease
TScan Therapeutics sets separation terms for outgoing CFO and CMO
The company's Form 8-K, with earliest event reported September 24, 2026, details severance terms for Jason Amello and Chrystal Louis.
SEC filing
Lantern Pharma prices $4 million offering of stock and pre-funded warrants at $1.09
The Dallas biotech is selling 1,469,725 shares at $1.09 each alongside pre-funded warrants priced at $1.0899, with net proceeds earmarked for working capital.
SEC filing
bioAffinity and AvMEDICAL bring CyPath Lung test to VA conference
The companies presented their new federal distribution partnership for the noninvasive lung cancer test to VA leaders and physicians in Arlington, Virginia.
SEC filing
Adlai Nortye names Christopher Liu head of investor and public relations
The clinical-stage oncology company said Liu, a former equity research analyst, will join as of September 30, 2026 to lead its IR and PR efforts.
SEC filing
Halozyme adds James Daly to board of directors
Halozyme Therapeutics disclosed the September 28, 2026 election in an 8-K filed with the SEC.
SEC filing
Regeneron grants long-term PSUs to co-founders, forms new subsidiary
An 8-K filed September 30, 2026 details a 10-year performance award for CEO Leonard Schleifer and CSO George Yancopoulos and discloses equity stakes in a newly formed subsidiary.
SEC filing
Moderna creates COO role, brings back Juan Andres as Jerh Collins retires
Moderna named Juan Andres Chief Operating Officer effective October 5, 2026, as the company said it prepares for a possible launch of its cancer therapy intismeran autogene and expands its vaccine lineup.
SEC filing
CalciMedica files for up to $25 million at-the-market stock offering
The clinical-stage biotech filed a prospectus supplement on September 30, 2026 to sell shares through H.C. Wainwright & Co. under an existing sales agreement.
SEC filing
Lantern Pharma closes $4 million registered direct offering
The Dallas oncology company priced shares at $1.09 and pre-funded warrants at $1.0899, with a concurrent private placement of matching purchase warrants.
SEC filing
Nomad Power Solutions raises $6.0 million via secured note, with Lixte as guarantor subsidiary
SEC filing indexed under Lixte Biotechnology Holdings actually names Nomad Power Solutions, Inc. as the registrant entering the financing.
SEC filing