Moderna’s finance chief said it’s “too early to tell” whether the company’s goal of reaching break-even cash flow will be pushed back — once again — after the FDA declined to review its flu shot for adults 50 and older. The comments from Jamey Mock on Moderna’s earnings call Friday underscore the financial implications of the FDA’s refusal-to-file letter announced earlier this week . The agency argued that Moderna sped past recommendations to use a higher-dose flu shot as the comparator product

Lundbeck said its next-generation migraine prevention drug cleared the bar in a Phase 2b study, setting the company up for late-stage trials that could start this year. The Danish drugmaker said the IV-delivered medicine, bocunebart (Lu AG09222), was better than placebo at reducing the number of monthly migraine days that patients experienced during a 12-week review. The results were statistically significant. To be included in the trial, dubbed PROCEED , patients had to have failed one to four

Eli Lilly is continuing to stockpile its obesity pill orforglipron months ahead of its expected US launch. In a Thursday SEC filing , the drugmaker said it has $1.5 billion in “pre-launch inventories” as of Dec. 31, “primarily related” to orforglipron. Last February, Lilly said it had already stockpiled $548 million worth of the oral GLP-1 candidate, ready to be distributed as soon as the drug gains regulatory approval. Orforglipron is expected to be approved by the FDA in April. The Indianapoli

While biotechs were deterred from listing on the public markets last year due to a cold reception by investors, Agomab Therapeutics\' CEO \"sees the climate and the reception changing.\"\n Whisper it, but we may finally be seeing the IPO window reopening in 2026.Biotech listings saw their heyday in the middle of the COVID-19 pandemic, when an incredible 87 U.S.-based drug developers surfed a wave of goodwill from generalist investors onto the public markets in 2021. That interest subsided

Bioretec Ltd Inside information 13 February 2026 at 9.31 a.m. EET NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF CHINA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA OR THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. TAMPERE, Finland, Feb. 13, 2026 /PRNewswire/ -- The Board of Directors of Bioretec Ltd

Dexcom’s newest financial results show a strong fourth quarter for the company, which saw a 13% year-over-year revenue increase, reaching $1.260 billion. The company also beat analysts’ consensus for Q4 performance. Despite this revenue growth, following the earnings release the company saw a 1.1% decrease in its stock afterhours and Wells Fargo lowered its price target on DexCom from $93 to $85. JPMorgan Chase & Co. also reduced their target price on shares of DexCom from $90.00 to $75.00 and s

CE Mark certification enables commercialization across Europe and other CE-recognizing markets Clinical evidence from a 121-patient prospective study supports device safety and efficacy Certification obtained under EU Medical Device Regulation 2017/745 HERAKLION, Greece, Feb. 13, 2026 /PRNewswire/ -- EYE PCR announces that its fixOflex endocapsular device has received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745), enabling commercialization in Euro

PTC Therapeutics has pulled a US application for its Duchenne muscular dystrophy treatment, adding to a long history of regulatory setbacks for the protein restoration therapy. The biotech on Thursday said it withdrew its NDA resubmission for Translarna after the FDA said the data were unlikely to meet its bar for effectiveness. PTC added it was “disappointed that FDA approval cannot be achieved,” but didn’t share what it would do next. TD Cowen analysts wrote the same day that, while the announ

First SIRPα-IgG4 Fc Fusion Protein Granted Orphan Status in Gastric Cancer TAIPEI, SHANGHAI and SAN FRANCISCO, Feb. 13, 2026 /PRNewswire/ -- HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. The designation covers gastric cancer broadly, inclu

Creative Biolabs is accelerating CAR‑T innovation, driving breakthroughs in solid tumor targeting. SHIRLEY, NY, UNITED STATES, February 13, 2026 / EINPresswire.com / -- The global CAR‑T therapy landscape is entering a new phase of momentum, driven by rapid advances in cell engineering and a widening scope of therapeutic applications. While CAR‑T therapies are reshaping the treatment expectations for hematologic malignancies, researchers are now accelerating efforts to extend these benefits to so