Bristol Myers Squibb wins FDA accelerated approval for Zenbexus/CELMoD in multiple myeloma
FDA grants accelerated approval to BMS's first-in-class CELMoD therapy Zenbexus (iberdomide) in combination for relapsed/refractory multiple myeloma, supporting
Sahm · +12 outlets
Capricor shares surge 67% after FDA signals openness to revised Deramiocel filing for Duchenne MD
Capricor plans to amend its BLA for deramiocel after an adcomm setback, with the FDA indicating flexibility, sending shares sharply higher.
finance.biggo.com · +5 outlets
Replimune raises $150M, rehires commercial team to fund TUDRIQEV launch after FDA reversal
Replimune raises $150 million to support the launch of its approved melanoma therapy TUDRIQEV and a required confirmatory trial after an FDA reversal.
The Business Journals · +2 outlets
Moderna secures US FDA approval for mRNA flu vaccine, revenue not expected before 2027
Moderna receives FDA approval for its mRNA-based influenza vaccine, though the company does not anticipate meaningful revenue until 2027.
TechStock² · +14 outlets
Compass Pathways achieves primary endpoint in Phase 3 treatment-resistant depression trial, shares rise 23%
COMPASS Pathways' psilocybin therapy meets its primary endpoint in a Phase 3 trial for treatment-resistant depression, boosting investor sentiment and drawing c
Stocktwits · +14 outlets
GLP-1 drug competition: Eli Lilly vs Novo Nordisk and the impact on patients
Ongoing competitive dynamics between Eli Lilly and Novo Nordisk in the GLP-1 weight loss drug market intensify, with implications for drug pricing, working capi
International Business Times, Singapore · +14 outlets
ABBV wins FDA approval for rare blood cancer drug
AbbVie receives FDA approval for a new drug targeting a rare blood cancer, adding to its oncology portfolio.
Stocktwits · +14 outlets
FDA approves palbociclib for HR+, HER2+ breast cancer maintenance therapy
Pfizer's Ibrance (palbociclib) wins an expanded FDA approval for maintenance treatment in HR-positive, HER2-positive metastatic breast cancer.
The American Journal of Managed Care · +14 outlets
MNKD jumps on FDA approval of Afrezza for children with diabetes
MannKind receives FDA approval to expand inhaled insulin Afrezza to pediatric diabetes patients, driving a stock surge.
Stocktwits · +5 outlets
PepGen's DM1 program placed on FDA hold amid dilution fears
The FDA places PepGen's myotonic dystrophy type 1 program on clinical hold, triggering dilution concerns among investors.
Finimize
Selas Life Sciences shares hit 3-year high as AML drug trial nears final readout, CEO involved in EU policy talks
Sellas Life Sciences stock climbs to a multi-year high as the company approaches a final data readout for its AML drug REGAL Phase 3 trial, with added attention
Stocktwits · +1 outlets
Inovio stock jumps as Jefferies upgrade bets on FDA decision
Jefferies upgrades Inovio, citing confidence in an upcoming FDA decision, sending shares higher.
StocksToTrade · +1 outlets
Natera highlights record Signatera volumes, raises outlook at Canaccord conference
Natera reports record testing volumes for its Signatera liquid biopsy assay and raises its financial outlook at a healthcare conference.
TradingView · +1 outlets
Celcuity shares rise after Revtopik wins FDA approval and NCCN Category 1 status
Celcuity's breast cancer drug Revtopik receives FDA approval and achieves NCCN Category 1 recommendation, strengthening the bull case for the stock.
simplywall.st · +1 outlets
Eton Pharmaceuticals surges 32% after Q2 earnings beat and raised 2026 outlook
Eton Pharmaceuticals shares spike on strong Q2 results and an upwardly revised full-year 2026 guidance.
simplywall.st · +3 outlets
ABVX stock suffers worst day ever on malignancy signal for drug candidates
ABVX shares plummet after a malignancy signal is detected in its drug program, drawing commentary from Martin Shkreli about GLP-1 safety comparisons.
Stocktwits
IONS shares jump 4% after-hours as Goldman Sachs raises target on Tryngolza approval
Goldman Sachs lifts its price target on Ionis Pharmaceuticals following the FDA approval of Tryngolza, sending shares up in after-hours trading.
Stocktwits
PFE stock drops as lung cancer trial disappointment overshadows Ibrance win
Pfizer shares decline after a lung cancer trial miss outweighs positive news from an expanded Ibrance approval.
Stocktwits