Dafinchi AI

ARVN

Healthcare

1w

Progress in PROTAC Clinical Pipeline and Data Milestones

Enrollment in 3 Phase I trials across neuro and oncology portfolios, including KRAS G12D degrader ARV-806.
Presentation of first-in-human data for ARV-102, LRRK2 degrader, demonstrating deep-brain penetration and target engagement.
Preclinical data for ARV-393 (BCL6 degrader) and ARV-806 (KRAS G12D degrader) supporting upcoming clinical results.
Anticipated clinical data from ARV-102 in Parkinson's disease and PSP in 2026.
Progress of ARV-393 in preclinical models of non-Hodgkin lymphoma and combination strategies.

Amylyx Pharmaceuticals, Inc.

AMLX

Healthcare

1w

Advancement of Avexitide and Market Potential for PBH

Amylyx's lead asset, Avexitide, is an investigational GLP-1 receptor antagonist with FDA breakthrough therapy designation for postbariatric hypoglycemia (PBH).
The company has initiated a pivotal Phase III LUCIDITY trial, with recruitment expected to complete by year-end and top-line data anticipated in the first half of 2026.
Market research and prevalence models suggest approximately 160,000 Americans suffer from medically important PBH, with around 119,000 experiencing recurrent, severe episodes that require medical attention.
Amylyx is preparing for a potential commercial launch in 2027, focusing on building market access strategies and educating healthcare providers and patients.
The company’s collaboration with Gubra aims to develop long-acting GLP-1 receptor antagonists, with promising early proof of concept data indicating extended half-lives and potency.

Schrödinger, Inc.

SDGR

Healthcare

1w

Progress and Strategic Opportunities for SGR-1505 MALT1 Inhibitor

Initial Phase I data for SGR-1505 showed a well-tolerated profile with responses in heavily pretreated CLL and Waldenstrom's macroglobulinemia patients, with 3 of 17 CLL patients responding and all 5 Waldenstrom's patients responding.
The program has received FDA Fast Track designation, highlighting its potential as a promising therapeutic in refractory hematologic cancers.
Schrodinger is exploring strategic opportunities to accelerate clinical development and maximize the potential of SGR-1505, rather than pursuing independent late-stage trials.
The company plans to provide further updates on dose escalation, translational data, and regulatory feedback later this year.
The emerging profile of SGR-1505 suggests best-in-class potential, with early evidence supporting its use in refractory disease, especially in patients previously exposed to BTK and BCL2 inhibitors.

LIVN

Healthcare

1w

Clinical Milestones in Epilepsy and Impact on Market Position

LivaNova announced long-term results from the CORE-VNS study, the largest real-world evidence study of VNS therapy to date.
The data shows durable, clinically meaningful seizure reduction, with a median of 80% in focal seizures and 95% in focal to bilateral tonic-clonic seizures over 36 months.
The results are well received by the clinical community and are expected to strengthen the epilepsy franchise.
Management plans to leverage this data for publications, regulatory discussions, and expanding market access.

Mirum Pharmaceuticals, Inc.

MIRM

Healthcare

1w

Pipeline Progress and Key Study Readouts in 2025-2026

Mirum's pipeline is advancing rapidly, with three pivotal studies expected to read out over the next 24 months, including the VISTAS Phase IIb study in PSC, with topline data expected in Q2 2026.
The VISTAS study is on track to complete enrollment this quarter, with interim analysis last year providing confidence in IBAT inhibition's potential in PSC.
Additional studies, VANTAGE in PBC and EXPAND in cholestatic pruritus, are progressing well, with enrollment expected to complete in 2026.
The company is also initiating a Phase II study of MRM-3379 for Fragile X syndrome, with FDA feedback received and enrollment planned to start by year-end.

Apellis Pharmaceuticals, Inc.

APLS

Healthcare

2w

FDA Label Expansion for EMPAVELI in C3G and Primary IC-MPGN

FDA approved a label expansion for EMPAVELI for patients 12 years and older with C3 myelopathy and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
This is the company's third FDA approval in 4 years, highlighting scientific strength and regulatory success.
The approval enables treatment with a C3-targeting therapy that achieves outcomes across proteinuria reduction, eGFR stabilization, and C3 deposit clearance.
Launch is underway, expanding into rare nephrology and underserved populations, including pediatric patients and post-transplant recurrence.

ACADIA Pharmaceuticals Inc.

ACAD

Healthcare

1w

ACADIA's Pipeline Milestones and Upcoming Data Readouts

ACADIA showcased nine disclosed pipeline programs during its R&D Day, with five Phase II or III data readouts expected through 2027.
Key upcoming milestones include initiating a Phase II study of ACP-204 in Lewy body dementia psychosis in Q3 2025 and top-line results from the COMPASS PWS Phase III study in Q4 2025.
The company plans to start a Phase III study of trofinetide in Rett syndrome in Japan in Q3 2025 and a first-in-human study of ACP-271 before year-end.
Progress in the pipeline underscores ACADIA's strategic focus on expanding indications and leveraging novel biology, with multiple data readouts potentially transforming its market position.

Revolution Medicines, Inc.

RVMD

Healthcare

1w

Advancement of RAS(ON) Inhibitors and Pipeline Progress

Revolution Medicines has a pipeline of three clinical-stage RAS(ON) inhibitors: daraxonrasib, elironrasib, and zoldonrasib, with recent publications highlighting their innovative chemistry and mechanism of action.
Daraxonrasib received Breakthrough Therapy designation from the FDA for metastatic pancreatic cancer with KRAS G12 mutations, emphasizing its potential to address a large unmet medical need.
The company is progressing towards multiple registrational trials, including a Phase III in second-line pancreatic cancer (RASolute 302), and plans to initiate first-line and adjuvant trials later in 2025.
Elironrasib and zoldonrasib are showing promising clinical data, with elironrasib granted Breakthrough Therapy designation for KRAS G12C NSCLC, and ongoing studies for G12D mutations and combination therapies.

Inovio Pharmaceuticals, Inc.

INO

Healthcare

5d

Regulatory Progress and BLA Submission Strategy for INO-3107

Inovio remains on track to submit its BLA for INO-3107 in the second half of 2025, with a goal of file acceptance by year-end.
The company has completed the design verification testing of the CELLECTRA 5PSP device, a key regulatory milestone.
Inovio has requested a rolling submission of its BLA under breakthrough therapy designation, aiming for a 6-month review period and a potential PDUFA date around mid-2026.
The company successfully completed an FDA inspection of its clinical trial operations, an important step in regulatory compliance.
Differences in trial design and technology, such as DNA medicine versus viral vectors, distinguish INO-3107 from competitors' programs.

Relmada Therapeutics, Inc.

RLMD

Healthcare

1w

Progress and Milestones for NDV-01 in Bladder Cancer

Relmada reported impressive 6-month follow-up data for NDV-01, with a 91% response rate in high-grade non-muscle invasive bladder cancer (NMIBC).
The 6-month disease-free status was achieved by 90% of evaluable patients, indicating durable efficacy.
NDV-01 is a sustained-release formulation of gemcitabine and docetaxel, designed to improve safety, convenience, and efficacy over traditional therapies.
The company plans to initiate a Phase III trial in the first half of 2026, with preparations underway including FDA interactions and manufacturing scale-up.
The 6-month data showed no treatment-related adverse events greater than grade 3, supporting safety and tolerability.
The focus is on positioning NDV-01 as a potential first-in-class bladder-sparing therapy, especially for BCG-unresponsive patients.

BIIB

Healthcare

2w

Biogen's Pipeline Advancements in Neurodegenerative and Autoimmune Diseases

Initiation of all Phase III studies for felzartamab, including microvascular inflammation in kidney transplants, with a readout expected in 2028.
Presentation of long-term data on LEQEMBI showing benefits over 4 years, and bioequivalence data for subcutaneous lecanemab.
Exciting interim Phase Ib data for salanersen in SMA, demonstrating motor function improvements and neurofilament reduction, with potential to transform SMA treatment.
Progress in lupus pipeline with positive Phase III dapi study showing improvements in fatigue and disease activity, with data expected in 2027-2028.
Expansion of felzartamab into a new indication for late microvascular inflammation, targeting a high unmet need in kidney transplant rejection.