fda-and-biotech News

Janux Surges on $850M Cancer Therapy Deal with Bristol Myers Squibb
FDA & Biotech
2w ago

Janux Surges on $850M Cancer Therapy Deal with Bristol Myers Squibb

The collaboration to develop a next-generation solid tumor treatment provides major validation for Janux's TRACTr technology platform, sending shares soaring.

Erasca Shares Fall After Upsized $225 Million Stock Offering
FDA & Biotech
2w ago

Erasca Shares Fall After Upsized $225 Million Stock Offering

The clinical-stage oncology company is capitalizing on a recent share price surge to fund its drug pipeline, a move that dilutes existing shareholders.

Amylyx Surges 16% on New Pipeline Drug, CEO Option Exercise
FDA & Biotech
2w ago

Amylyx Surges 16% on New Pipeline Drug, CEO Option Exercise

Shares rally as company unveils new candidate for hypoglycemia, building a franchise beyond its past ALS drug setback and signaling a strategic pivot.

enGene Secures $125M Debt Facility to Advance Gene Therapy Pipeline
FDA & Biotech
2w ago

enGene Secures $125M Debt Facility to Advance Gene Therapy Pipeline

Financing from Hercules Capital provides non-dilutive capital to extend the clinical-stage biotech's operational runway as it develops its novel genetic medicines.

Mesoblast Surges After FDA Signals Clear Path for Back Pain Drug
FDA & Biotech
2w ago

Mesoblast Surges After FDA Signals Clear Path for Back Pain Drug

Regulator acknowledges efficacy of rexlemestrocel-L and opens door to a coveted opioid-sparing label, boosting prospects in a multi-billion dollar market.

Tiziana Life Sciences Soars as $8.8M Funding Eclipses Dilution Fears
FDA & Biotech
3w ago

Tiziana Life Sciences Soars as $8.8M Funding Eclipses Dilution Fears

Shares jumped over 13% as strong insider participation in the capital raise signals confidence in the company's clinical pipeline, outweighing shareholder dilution concerns.

Telix Advances Key Prostate Cancer Diagnostic to Phase 3 in U.S.
FDA & Biotech
3w ago

Telix Advances Key Prostate Cancer Diagnostic to Phase 3 in U.S.

Company doses first American patient in its BiPASS study, a pivotal trial aimed at improving diagnostic accuracy and reducing unnecessary biopsies.

Teva Shares Climb on Positive AJOVY Data in Prominent Medical Journal
FDA & Biotech
3w ago

Teva Shares Climb on Positive AJOVY Data in Prominent Medical Journal

Publication in the New England Journal of Medicine reinforces the migraine drug's clinical profile, bolstering its position in a competitive market.