Investment

Regulatory Science

PharmAla Biotech licenses ALA-002 U.S. rights to Jupiter Neurosciences

PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Roche and Nurix strike $2.3bn BTK degrader deal for bexobrutideg

Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
The Biotech Times Editorial Team  · 
Regulatory Science

Crossject closes €15m equity raise to advance ZEPIZURE EUA process

The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.
The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Alpha Tau and Tolmar partner to commercialise Alpha DaRT in U.S.

Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
The Biotech Times Editorial Team  · 
Regulatory Science

Attralus wins FDA orphan drug status for AL amyloidosis candidate AT-02

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
The Biotech Times Editorial Team  · 
Biotech

Ona Therapeutics raises $86.6m Series B to bring ADCs into clinic

The Barcelona biotech closed an oversubscribed round to advance its lead ADC, ONA-255, toward clinical proof of concept in breast cancer.
The Barcelona biotech closed an oversubscribed round to advance its lead ADC, ONA-255, toward clinical proof of concept in breast cancer.
The Biotech Times Editorial Team  · 
Bioinformatics
Diagnostics
Digital Health

Alzai Health files IPO prospectus on TSXV to raise up to C$4m

The Toronto-based AI Alzheimer's screening company plans to list on the TSX Venture Exchange in May, raising up to C$4 million at
The Toronto-based AI Alzheimer's screening company plans to list on the TSX Venture Exchange in May, raising up to C$4 million at
The Biotech Times Editorial Team  · 
Regulatory Science
Biotech

BridgeBio wins ANVISA approval for acoramidis in ATTR-CM

BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
The Biotech Times Editorial Team  · 
Medical Devices
Biotech

Bioventus posts 7% Q1 revenue rise and raises 2026 earnings guidance

The Durham-based medical-technology company reported Q1 net sales of $132.1m and lifted its full-year adjusted EPS and cash-flow forecasts.
The Durham-based medical-technology company reported Q1 net sales of $132.1m and lifted its full-year adjusted EPS and cash-flow forecasts.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science

EyePoint targets mid-2026 wet AMD readout as losses widen

EyePoint said its DURAVYU Phase 3 wet AMD trials remain on track for topline data from mid-2026, backed by $223m in cash extending into
EyePoint said its DURAVYU Phase 3 wet AMD trials remain on track for topline data from mid-2026, backed by $223m in cash extending into
The Biotech Times Editorial Team  · 
Biotech

Hemab Therapeutics prices upsized IPO at $18 per share on Nasdaq

The coagulation-disorder biotech raised approximately $301.5m gross, listing under ticker COAG with two clinical-stage antibody programmes in its pipeline.
The coagulation-disorder biotech raised approximately $301.5m gross, listing under ticker COAG with two clinical-stage antibody programmes in its pipeline.
The Biotech Times Editorial Team  · 
Biotech

InflaRx prices $150m share offering to fund complement pipeline

The Jena-based biopharmaceutical company sold 75 million ordinary shares at $2.00 each, attracting a broad syndicate of healthcare-focused institutional investors.
The Jena-based biopharmaceutical company sold 75 million ordinary shares at $2.00 each, attracting a broad syndicate of healthcare-focused institutional investors.
The Biotech Times Editorial Team  · 
Biotech

Integra LifeSciences posts Q1 revenue of $391.9m amid leadership change

The medical technology group beat its adjusted EPS guidance and named Stuart Essig as CEO as its Tissue Reconstruction unit led organic growth.
The medical technology group beat its adjusted EPS guidance and named Stuart Essig as CEO as its Tissue Reconstruction unit led organic growth.
The Biotech Times Editorial Team  · 
Medical Devices

LeMaitre Vascular posts 11% Q1 sales growth on Artegraft expansion

The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%

Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
The Biotech Times Editorial Team  · 
Bioprocessing

Medline posts 10.7% Q1 sales growth but profits squeezed by tariffs

Medline raised its full-year organic sales guidance to 8.5–9.5% despite a 25.8% drop in net income driven by tariff costs
Medline raised its full-year organic sales guidance to 8.5–9.5% despite a 25.8% drop in net income driven by tariff costs
The Biotech Times Editorial Team  · 
Regulatory Science

Orchestra BioMed receives $15m Ligand tranche, totalling $40m

Orchestra BioMed has drawn a scheduled $15m royalty-financing tranche from Ligand, bringing total Ligand capital to $40m to fund two pivotal cardiovascular device trials.
Orchestra BioMed has drawn a scheduled $15m royalty-financing tranche from Ligand, bringing total Ligand capital to $40m to fund two pivotal cardiovascular device trials.
The Biotech Times Editorial Team  · 
Regulatory Science

Picard Medical prices $5m offering to clear debt and fund operations

The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.
The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Addex Therapeutics posts CHF 6.7m net loss as cash falls to CHF 1.6m

The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
The Biotech Times Editorial Team  · 
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