Clinical News

Latest clinical news and updates for US-listed public companies.

📣 Get clinical alerts and analysis

Plus Therapeutics Presents Positive CNSide CSF Assay Platform Results at the 2025 SNO/ASCO CNS Metastases Conference

CNSide® can quantify leptomeningeal metastases (LM) over time and monitor changes in the expression of multiple targetable mutations

What are the risks if subsequent validation studies do not confirm the assay's performance? Could the assay's ability to monitor multiple targetable mutations lead to broader applications beyond leptomeningeal metastases? What are the potential reimbursement challenges for the CNSide assay in key markets?
Symbol: PLST
7 days ago
Read more globenewswire

Solid Biosciences Reports Second Quarter 2025 Financial Results and Provides Business Updates

- Duchenne (SGT-003): 15 participants dosed in the Phase 1/2 INSPIRE DUCHENNE trial and dosing remains ongoing; On track to discuss regulatory pathways with U.S. FDA in Q4 2025 -

How might the sentiment score of 45 be interpreted by the market and what short‑term price implications could arise? Are there any partnership or licensing opportunities on the horizon that could provide additional funding or de‑risk the program? What is the probability of achieving Breakthrough Therapy designation based on current data and how would that affect valuation?
Symbol: SBIO
8 days ago
Read more globenewswire

Lyra Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

– Positive ENLIGHTEN 2 Phase 3 results announced in June 2025 propel business activities in manufacturing, regulatory strategy and ENLIGHTEN clinical dataset analysis to advance path forward for LY...

What are the potential upside or downside scenarios if regulatory feedback on LYR-210 is delayed or requires additional studies? How does the Phase 3 success impact the risk profile and discount rate used in DCF models for Lyra Therapeutics? Are there any upcoming catalyst events (e.g., FDA meetings, data releases, partnership announcements) that could drive short‑term stock movement?
Symbol: LYR
8 days ago
Read more globenewswire

Cognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer’s Disease

- Cognition and FDA align on enriched population, study design, and endpoints -

How does the sentiment score of 70 reflect market perception, and could it shift after further trial updates? Will the alignment on endpoints influence the choice of biomarkers and impact trial costs? What is the expected market size for an approved Alzheimer’s disease treatment and how could Cognition capture share?
Symbol: CTOT
8 days ago
Read more globenewswire

ADC Therapeutics Reports Second Quarter 2025 Financial Results and Provides Operational Update

ZYNLONTA® in combination with glofitamab (COLUMVI®) demonstrated overall response rate (ORR) of 93.3% and a complete response (CR) rate of 86.7% in LOTIS-7 across 30 efficacy evaluable patients Exp...

How does this trial’s data influence the valuation of ADCT relative to its peers (e.g., Juno, Bristol‑Myers, etc.)? What is the expected market size for ZYNLONTA® in combination therapy for r/r DLBFS, and how might market share be captured? How will the expansion to 100 patients affect the company’s burn rate and need for additional financing?
Symbol: ADCT
9 days ago
Read more prnewswire

Veru Announces Selection of Novel Modified Release Oral Enobosarm Formulation for Chronic Weight Loss Management Following Pharmacokinetic Clinical Study

MIAMI, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic ...

What implications does this have for Veru’s overall pipeline prioritization and allocation of R&D resources? Are there any upcoming FDA meetings, advisory committee reviews, or regulatory milestones tied to this formulation? How might the announcement affect Veru’s cash burn rate and the need for additional financing or equity raises?
Symbol: VERU
9 days ago
Read more globenewswire

Annexon Selected by EMA to Participate in Product Development Coordinator Pilot for Vonaprument (ANX007) for Dry Age-Related Macular Degeneration with Geographic Atrophy

New Pilot Appoints Designated Product Development Coordinator to Navigate Regulatory Interactions, Respond to Ad-hoc Queries, and Support Evidence Planning

How does the sentiment score of 65 reflect market optimism, and should traders adjust their positions accordingly? Will the EMA's pilot potentially expedite market entry for Vonaprument, and how could that affect revenue forecasts? What risks remain for Annexon despite the EMA's support in navigating regulatory interactions and evidence planning?
Symbol: ANNX
13 days ago
Read more globenewswire

CytomX Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update

- May 12, 2025 announcement of positive interim data from ongoing Phase 1 study of CX-2051 (EpCAM Antibody Drug Conjugate) in patients with advanced colorectal cancer (CRC) -

What is the current institutional and insider ownership, and are there any notable changes following the announcement? How does CYTX’s valuation (e.g., market cap, price‑to‑sales multiple) compare to peers developing oncology ADCs? What risk factors (e.g., trial enrollment, safety concerns, competitive landscape) could negatively affect the stock’s upside?
Symbol: CYTX
13 days ago
Read more globenewswire

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2025 Financial Results

Soquelitinib data from cohort 3 of atopic dermatitis Phase 1 clinical trial demonstrates earlier and deeper responses compared to cohorts 1-2 along with clinically meaningful reduction in itch as e...

How could the market react to the sentiment score of 65 in the context of broader sector sentiment? What risks remain for the drug's development despite the encouraging cohort 3 results? How might this data influence partnership or licensing opportunities with larger pharmaceutical companies?
Symbol: CRVS
13 days ago
Read more globenewswire