AKRO
Phase 2b SYMMETRY study week 96 results expected to readout in February 2025
LEAP
Patient follow-up continuing in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer; data expected in late 2024 or early 2025
XLO
present initial data from its ongoing Phase 2 trial for vilastobart (XTX101), a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (ASCO GI) Cancers Symposium in San Francisco, California from January 23-25, 2025
SLNO
The new decision date for Soleno’s DCCR (diazoxide choline) extended-release tablets is set for 27 March 2025 – three months longer than the previous FDA extended review period.
BCAX
Data from a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab in second line (2L) or later squamous cancer of the anal canal is expected at a medical meeting in the first quarter of 2025.
RCUS
Multiple expansion cohorts of ARC-20 evaluating casdatifan in ccRCC as a monotherapy and in combination with cabozantinib in ccRCC are underway with additional data presentations expected in the next 12 months.
100mg (50mg twice daily (BID), capsules) and 50mg expansion cohorts: Updated data, including median PFS, are expected to be presented in the first quarter of 2025.
ALMS
ESK-001: Phase 2 OLE 52-week data update in psoriasis
PLRX
The Company has completed enrollment in the third of five cohorts in the Phase 1 open-label, dose-escalation trial. In this trial, PLN-101095 is being tested as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data is expected in early 2025.
TRVI
Last patient completed the Phase 2a RIVER trial in refractory chronic cough (RCC) in early January and topline results continue to be expected in the first quarter of 2025
SVRA
Updates Guidance on MOLBREEVI BLA Submission Completion Date to End of 1Q 2025 from 1H 2025 – Intends to Request Priority Review
SWTX
Secure FDA approval in adults and children with NF1-associated plexiform neurofibromas, or NF1-PN (PDUFA: February 28, 2025), and launch in the U.S.
AXSM
NDA resubmission for AXS-07 for the treatment of migraine accepted by the FDA with PDUFA goal date of January 31, 2025
Topline results of FOCUS Phase 3 trial of solriamfetol in ADHD anticipated 1Q 2025
Topline results of PARADIGM Phase 3 trial of solriamfetol in MDD anticipated 1Q 2025
LXEO
Completed enrollment of cohort 1 of LX2020 HEROIC-PKP2 Phase 1/2 trial; initial clinical data including safety and biodistribution on track for late Q1 / early Q2 2025
SCPH
In July 2024, scPharmaceuticals announced that the FDA has accepted for filing the Company’s sNDA seeking to expand the FUROSCIX indication to include treatment of edema due to fluid overload in patients with CKD. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025
CADL
On track to report updated overall survival data for CAN-2409 from phase 2a clinical trials in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC), expected in Q1 2025
ANL
Importantly, we remain highly focused on the advancement of our lead candidate, buparlisib, for the potential treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after prior anti-PD(L)1 treatment and remain on track to report the Phase 3 OS data in the first quarter of 2025
THTX
United States Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2025 to the Company’s recently submitted supplemental Biologics License Application for the F8 formulation of tesamorelin
IMMX
NXC-201 is the only one-time CAR-T therapy in development for AL Amyloidosis
Next program update Q1 2025
ARMP
Completed enrollment of Phase 1b/2a study ("diSArm") of intravenous AP-SA02 in patients with Staphylococcus aureus ("S. aureus") bacteremia.
Topline data expected in the first quarter of 2025
ALLK
Report randomized double-blind, placebo-controlled data on over 30 patients from the Phase 1 trial of AK006 in patients with CSU in early Q1 of 2025
TECX
Patient enrollment in the Phase 1b hemodynamic trial remains ahead of expectation, with topline results now expected in late Q1’2025 or early Q2’2025
RGLS
We expect to share preliminary topline data from a substantial number of patients from the fourth cohort in the Phase 1b MAD study of RGLS8429 in ADPKD in early 2025
PTGX
Top line results for JNJ-2113 Phase 2b ANTHEM clinical trial in moderate to severe ulcerative colitis expected in Q1 2025
Top line results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera expected in Q1 2025
GYRE
Last patient completed pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC with data expected in Q1 2025
PRAX
Study 1 of Essential3 program for ulixacaltamide in essential tremor (ET) on track for Q1 2025 interim analysis
ANNX
ANX1502 First Oral C1s Inhibitor On Track for Clinical Proof of Concept Data in 1Q 2025
AUTL
Obe-cel in autoimmune disease: initial data from SLE Phase 1 study
Q1 2025
FDMT
52-week interim data from Phase 2b cohort of the PRISM clinical trial to be presented at Angiogenesis, Exudation, and Degeneration 2025 on Saturday, February 8, 2025
GLUE
Initial clinical data from Phase 1 SAD/MAD study of VAV1-directed molecular glue degrader (MGD) MRT-6160 expected in Q1 2025
Additional clinical results from Phase 1/2 study of MRT-2359 in MYC-driven solid tumors, including biomarker and activity data, anticipated in Q1 2025
EWTX
Report initial CIRRUS-HCM 28-day data in the first quarter of 2025
CYBN
Topline efficacy data from Phase 2 Proof-of-Concept Study of CYB004 in Generalized Anxiety Disorder ("GAD") expected in Q1 2025
SLDB
Duchenne: Dosed four patients in INSPIRE DUCHENNE clinical trial; SGT-003 has been well tolerated in all patients with no SAEs observed; initial three patient data expected Q1 2025
CMPX
Top-line Phase 2/3 data readout for CTX-009, now named tovecimig (a DLL4 x VEGF-A bispecific), in patients with biliary tract cancer (BTC) is on track for end of Q1 2025
BDTX
Clinical updates of BDTX-1535 in EGFRm NSCLC and regulatory feedback expected in Q1 2025
MIST
PDUFA date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT)
CABA
Favorable safety profile observed across the first 10 patients dosed with rese-cel: 90% experienced either no CRS or grade 1 (fever) CRS and 90% experienced no ICANS; latest clinical and translational data to be presented at a scientific meeting in February 2025
STTK
DR3 Program Milestones Expected in 2025: Preclinical SL-325 data readout from GLP toxicology study in NHPs expected in the first quarter of 2025
COYA
Additional clinical data to be released in the Phase 2 LD IL-2 investigator-initiated trial (IIT) study in patients with AD
VERU
Topline data for primary endpoint of lean body mass expected January 2025
ADAG
today announced it will share updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA on Saturday, January 25, 2025
BLTE
Interim analysis from the pivotal global Phase 3 DRAGON trial of Tinlarebant in adolescent STGD1 subjects anticipated by end of 2024 or early 2025
WVE
Expect feedback from regulators and 48-week FORWARD-53 data for WVE-N531 in DMD in 1Q 2025
KURA
Topline results from registration-directed trial of ziftomenib in R/R NPM1-mutant AML expected in early 2025
ARVN
Topline data from the monotherapy Phase 3 VERITAC-2 trial of vepdegestrant anticipated in 1Q25
ANAB
Top-line Phase 2b data anticipated for rosnilimab, our PD-1 agonist, in rheumatoid arthritis (RA) in February 2025
RAPP
RAP-219 MAD-2 and PET trials ongoing; topline data expected in Q1 2025
CELC
The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025
THRD
THB335 Phase 1 SAD/MAD clinical trial on track to deliver clinical results in 1Q’25
DNLI
In addition to Breakthrough Therapy Designation, the FDA previously granted tividenofusp alfa Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation for development in the treatment of MPS II. Additional Phase 1/2 results have been accepted for oral presentation at the 2025 WORLDSymposium conference taking place February 3-7, 2025.
MGNX
The Company presented interim results from the TAMARACK study at the European Society for Medical Oncology (ESMO) Congress in September 2024 and expects to have mature median radiographic progression-free survival (rPFS) data in hand no later than early 2025
CRBP
The poster is titled Phase 1 Dose-Escalation Study of Next-Generation Nectin-4 Targeting Antibody-Drug Conjugate CRB-701 (SYS6002) in US And UK Patients with Urothelial Cancer and other Solid Tutors (Perez, et al) and will be presented on Friday February 14, 2025
VSTM
RAMP 205 trial in 1L metastatic pancreatic cancer continues to progress, with updated data expected in Q1 2025 to guide RP2D decision for trial expansion
ABOS
Expect to announce topline results of Phase 1 study to support subcutaneous administration of sabirnetug in the first quarter of 2025
MURA
Readouts for two late-stage, potentially registrational trials of nemvaleukin alfa expected in late Q1/early Q2 2025 for platinum-resistant ovarian cancer
CLGN
We are now one step closer to advancing our breast implant program into human studies, after developing a biocompatible commercial-sized, 3D-printed implant with a natural feel that has shown promising results in preclinical trials
We are looking forward to reporting additional results from this program in the first quarter of 2025
RVPH
Full data analysis of the OLE trial including long-term safety, tolerability and efficacy, as well as vocal and blood biomarker data expected in Q1 2025
