Pharming Group, the Netherlands-based rare disease specialist best known for RUCONEST — its recombinant C1 esterase inhibitor for hereditary angioedema — issued full-year 2026 revenue guidance of $405 million to $425 million on Friday, a range that straddled analyst consensus of $411.9 million but …
Atara Biotherapeutics received perhaps the most consequential piece of regulatory clarity in its corporate history on Friday, as the US Food and Drug Administration confirmed — following a Type A meeting — that a single-arm study supported by an appropriate historical control could serve …
Entrada Therapeutics reported what it described as a statistically significant and potentially differentiated improvement versus placebo in Time to Rise velocity from its Phase 1/2 ELEVATE-44-201 trial of ENTR-601-44 in patients with Duchenne muscular dystrophy carrying exon 44-amenable mutations — and watched its shares …
EDAP TMS delivered a first-quarter performance that demonstrated the commercial momentum of its Focal One robotic high-intensity focused ultrasound platform in convincing terms, reporting record HIFU revenues of $11.6 million — a 78% year-over-year increase — alongside compelling clinical data from the HIFI-2 study. …
AIM ImmunoTech reported Phase 2 topline data for Ampligen (rintatolimod) in recurrent ovarian cancer that, on their face, represent some of the most clinically striking results the company has generated in its long and often turbulent history. A 50% objective response rate, a 79% …
enGene Therapeutics delivered a data readout on Friday that the market received as a decisive disappointment, sending shares down 81% to close at $1.72 after the company reported six-month complete response rates from the LEGEND Phase 2 pivotal cohort evaluating detalimogene voraplasmid in patients …
Ernexa Therapeutics unveiled preclinical data on Friday that demonstrated complete tumour elimination and 100% long-term survival when its lead cell therapy candidate, ERNA-101, was combined with PD-1 blockade in syngeneic ovarian cancer models. Shares closed up 29% at $7.82 — a substantive move for …
KALA BIO's announcement of a 1-for-50 reverse stock split — one of the most aggressive ratio consolidations seen in the small-cap biotech space in recent memory — is the kind of corporate action that speaks volumes without requiring elaboration. When a company must consolidate …
Akebia Therapeutics reported first-quarter 2026 net product revenue of $15.8 million for Vafseo (vadadustat), its oral hypoxia-inducibleFactorprolyl hydroxylase inhibitor for the treatment of anaemia associated with chronic kidney disease, alongside a 60% sequential increase in patient numbers. The commercial metrics represent genuine early momentum. …
Apyx Medical delivered a first-quarter performance that combined revenue outperformance,Marginimprovement, and guidance upgrade — the trifecta most likely to drive a meaningful re-rating in a small-cap medical technology company. Shares closed up 22% at $3.56, a move that reflects the market's positive reassessment of …