Biotech news for Monday, June 29, 2026, ranked by our 5-dimension investment framework — regulatory, technology, commercial, manufacturing, and narrative.
designer491 Acadia Pharmaceuticals ( ACAD ) added ~13% on Friday after an expert panel of the EU drug regulator, the European Medicines Agency, endorsed granting marketing authorization for Daybu, a treatment for a rare genetic neurodevelopmental disorder call…
Grandbrothers The Trump administration has narrowed its list of potential FDA commissioners down to three. The finalists are senior Pentagon health official Stephen Ferrara; Jeffrey Vacirca, an oncologist; and Heidi Overton, an MD who has served as Deputy Assi…
An expert panel of the EU drug regulator, the European Medicines Agency, endorsed six new medicines and 11 label expansions for approval this week, benefiting drugmakers including Eli Lilly ( LLY ), Incyte ( INCY ), and CSL Limited ( CSLLY ) ( CMXHF ). Eli Lil…
Capricor Therapeutics ( CAPR ) lost ~12% on Friday after the U.S. FDA scheduled an advisory committee meeting to discuss the company’s marketing application for Deramiocel, a treatment targeting Duchenne muscular dystrophy. According to a federal notice on Fri…
LIXTE Biotechnology Holdings ( LIXT ) on Friday announced its inclusion in the Russell Microcap Index, effective after the close of the U.S . equity markets on June 26, 2026, as part of the annual Russell U.S . Indexes reconstitution. The reconstituted indexes…
FibroBiologics ( NASDAQ: FBLG ) said on Friday it priced a private placement of 4.08M shares and accompanying warrants at $0.735 per share, with potential gross proceeds of up to $9M. The offering is expected to generate about $3M in gross proceeds initially,…
Replimune ( REPL ) shares slipped in the premarket on Friday after the company announced that the FDA will convene an advisory committee to review its lead drug, RP1, following the regulator's acceptance of its resubmitted marketing application. The Massachuse…
Shares of Quantum Cyber ( QUCY ) surged nearly 32% in premarket trading on Friday after the defense technology company said its board approved the engagement of investment banking professionals to facilitate the acquisition of an equity stake in Space Explorat…
Avalo Therapeutics ( AVTX ) is set to join the small-cap Russell 2000 Index and the broad-market Russell 3000 Index. The addition is effective after the close of U.S. equity markets on June 26, 2026. More on Avalo Therapeutics Avalo Therapeutics: Sell-Off Coul…
JHVEPhoto/iStock Editorial via Getty Images Amgen ( AMGN ) is facing a possible withdrawal of its rare-disorder therapy, Tavneos, in the EU after an expert panel of the European Medicines Agency recommended its marketing authorization be revoked due to data in…
HJBC The European Commission has opened a formal antitrust investigation to assess whether Sanofi ( SNY ) has breached EU competition rules by carrying out a communication campaign that disparages the only rival flu vaccine recommended for vulnerable patients…