fda-and-biotech News

Novo Nordisk Rallies on Oral Wegovy's Cardiovascular Benefits
FDA & Biotech
3mo ago

Novo Nordisk Rallies on Oral Wegovy's Cardiovascular Benefits

New data from ObesityWeek 2025 shows the pill version of its blockbuster drug reduces key heart risk factors, boosting its competitive stance against rivals.

Vera Shares Drop Despite Positive Kidney Drug Trial Data
FDA & Biotech
3mo ago

Vera Shares Drop Despite Positive Kidney Drug Trial Data

Atacicept meets Phase 3 goals and earns NEJM publication, but faces competitive pressure from a rival with stronger results, muting investor reaction.

UroGen Pharma Surges on Positive Bladder Cancer Drug Data
FDA & Biotech
3mo ago

UroGen Pharma Surges on Positive Bladder Cancer Drug Data

Phase 3 trial shows a 77.8% response rate for its UGN-103 treatment, with the FDA greenlighting a clear path for a New Drug Application.

Relmada Therapeutics Shares Fall After $100M Capital Raise
FDA & Biotech
3mo ago

Relmada Therapeutics Shares Fall After $100M Capital Raise

The financing provides a crucial lifeline for the biotech firm, which is seeking a new strategic path after its lead depression drug failed in late-stage trials last year.

4DMT Prices $100M Stock Offering to Fund Gene Therapy Trials
FDA & Biotech
3mo ago

4DMT Prices $100M Stock Offering to Fund Gene Therapy Trials

Capital raise follows positive long-term data for its lead wet AMD drug candidate, 4D-150, as the company prepares for pivotal Phase 3 studies.

BillionToOne Raises $273M in Upsized IPO Amid Strong Investor Demand
FDA & Biotech
3mo ago

BillionToOne Raises $273M in Upsized IPO Amid Strong Investor Demand

The molecular diagnostics firm priced its offering at $60 per share, signaling robust appetite for specialized biotech companies in a selective market.

Lexeo Tumbles 9% Despite Positive FDA Update on Heart Gene Therapy
FDA & Biotech
3mo ago

Lexeo Tumbles 9% Despite Positive FDA Update on Heart Gene Therapy

Investors weigh promising clinical pathway and manufacturing green light for LX2006 against the company's Q3 net loss and ongoing cash burn.

MoonLake Raises $75M in Offering to Fund Pipeline After Stock Plunge
FDA & Biotech
3mo ago

MoonLake Raises $75M in Offering to Fund Pipeline After Stock Plunge

The clinical-stage biotech is shoring up its balance sheet to advance its lead drug candidate following a steep sell-off tied to mixed clinical trial data.