May 29, 8:22 AM EDT
Replimune surges on plans to resubmit lead drug for FDA review
REPL
Replimune ( REPL ) shares climbed more than 60% in the premarket on Friday after the company announced plans to resubmit a marketing application for its lead asset RP1 in the U.S., following its second FDA rejection in April. The Massachusetts-based biotech
May 29, 7:53 AM EDT
Agios to discontinue candidate for myelodysplastic syndromes
AGIO
Hailshadow/iStock via Getty Images Agios Pharmaceuticals ( AGIO ) lost ~6% in the premarket on Friday after the company announced plans to discontinue studies for a treatment targeting myelodysplastic syndromes, a group of blood cancers marked by abnormal bloo…
May 29, 5:00 AM EDT
FDA panel backs XFG strain for 2026-27 COVID vaccine update
MRNAPFE
Grandbrothers/iStock Editorial via Getty Images An FDA advisory panel voted 8-0, with one abstention, to recommend updating COVID-19 vaccines for the 2026-27 season to target the dominant XFG variant, despite concerns from some members about limited data on cu…
May 29, 2:56 AM EDT
Pfizer signs up to $10.5B oncology deal with China’s Innovent
PFEIVBIYBMY
JHVEPhoto/iStock Editorial via Getty Images Pfizer ( PFE ) and Innovent Biologics ( IVBIY ) ( IVBXF ) have entered into a global oncology partnership worth up to $10.5B, underscoring growing demand among multinational drugmakers for innovative therapies develo…
May 28, 5:29 PM EDT
Allogene Therapeutics names Zachary Roberts CEO in planned succession
ALLO
Allogene Therapeutics ( ALLO ) said on Thursday that CEO David Chang will step down effective June 30 after eight years leading the company and will remain on its board of directors. The company named Zachary Roberts, currently executive vice president of rese…
May 28, 5:16 PM EDT
Regeneron, Gilead therapies eyed as potential Ebola treatments by WHO
REGNGILDMRK
Saulo Angelo/iStock via Getty Images The World Health Organization has given the green light to examine Regeneron Pharmaceuticals' ( REGN ) antibody maftivimab as a potential treatment for the current Ebola outbreak. Maftivimab is one of the antibodies include…
May 28, 4:11 PM EDT
Outlook Therapeutics prices $5M registered direct offering
OTLK
Outlook Therapeutics ( Nasdaq: OTLK ) on Thursday said it priced a registered direct offering of about 8.54 million shares of common stock at $0.5855 per share to GMS Ventures and Investments, its largest shareholder. The offering is expected to generate gross
May 28, 9:12 AM EDT
Cogent Bio granted FDA priority review for lead asset in tumor indication
COGTPFE
Cogent Biosciences ( COGT ) is poised for two product launches later this year after the FDA granted priority review for its marketing application for its lead candidate, bezuclastini, for a rare form of cancer. The company’s New Drug Application targets the
May 28, 9:12 AM EDT
Sunshine Biopharma down after announcing 1-for-10 reverse stock split
SBFMSBFMW
Sunshine Biopharma ( SBFM ) on Thursday announced a one-for-ten reverse split of its common stock, effective at market open on June 1, 2026. SBFM down 13.7% to $0.37. The reverse stock split was undertaken to regain compliance with Nasdaq's minimum bid price r…
May 28, 7:12 AM EDT
GSK, Ionis mark late-stage trial win for chronic hepatitis B therapy
GSKIONS
ALENA DZIHILEVICH GSK ( GSK ) announced on Thursday that its antisense oligonucleotide bepirovirsen, developed with Ionis Pharma ( IONS ), reached the main goals in two late-stage trials for patients with chronic hepatitis B, a long-standing viral infection li…