AllSci News
Neovia Oncology and Creatv Bio collaborate on NEV-801 liquid biopsy studies for solid tumors
Neovia Oncology, a Bellevue, Washington-based clinical-stage company, has entered a research collaboration with Monmouth Junction, New Jersey-based Creatv...
Karyopharm's XPO1 plus JAK inhibitor regimen both hits and misses in Phase III myelofibrosis trial
Newton, Massachusetts-based Karyopharm Therapeutics (Nasdaq: KPTI) reported that selinexor (Xpovio) combined with ruxolitinib nearly doubled the spleen...
Praxis considering vormatrigine future after Phase II/III endpoint miss in focal onset seizures
Praxis Precision Medicines (Nasdaq: PRAX) reported that the Phase II/III POWER1 study of vormatrigine in adults with focal onset seizures did not meet its...
Immedica/PharmaMar’s Zepzelca plus atezolizumab adds EU approval for SCLC maintenance
The European Commission has granted marketing authorization for Zepzelca (lurbinectedin) in combination with atezolizumab as first-line maintenance treatment for adults with extensive-stage…
FDA’s post-Tazverik safety stance ends Fulcrum’s sickle cell ambitions
Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced the discontinuation of its PRC2 inhibitor pociredir program for sickle cell disease following FDA feedback indicating…
Amgen’s Imdylltra becomes first EU approved TCE for SCLC
The European Commission has granted marketing authorization for Imdylltra (tarlatamab), making Amgen (Nasdaq: AMGN) the first company to win approval for a…
NewLimit raises USD 435m Series C to advance aging reprogramming medicine toward human trials
South San Francisco-based NewLimit, a biotechnology company focused on longevity medicine, has closed a USD 435 million Series C funding round as it...
FDA issues CRL for Cingulate’s ADHD treatment citing CMC issues
Cingulate Inc., (NASDAQ: CING) disclosed that the US FDA issued a Complete Response Letter (CRL) for the New Drug Application for CTx-1301…
Abivax dismisses cancer fears as obefazimod meets primary endpoint in Phase III ulcerative colitis maintenance trial
Abivax SA (Euronext Paris: ABVX / Nasdaq: ABVX) reported that obefazimod, its oral once-daily miR-124 enhancer, met the primary endpoint and all key...
EU approval extended to AbbVie’s Aquipta for acute migraine
The European Commission has approved Aquipta (atogepant) for the acute treatment of migraine with or without aura in adults, expanding the oral…
BMS’s Opdivo with AVD nodded in EU for frontline cHL
The European Commission has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and adolescent patients aged 12…
UK immune profiling biotech IMU Bio closes Series A extension at over USD 53m
London-based IMU Biosciences has closed an oversubscribed extension to its Series A financing round, bringing the total raise to over USD 53 million (GBP 40...
Avenzo to gain Nasdaq listing via reverse merger with Rallybio, alongside USD 215m fund raise
Connecticut-based Rallybio Corporation (Nasdaq: RLYB) has agreed to acquire private San Diego-based Avenzo Therapeutics, Inc. in a reverse merger that will...
FDA sets November decision date for Vertex's povetacicept in IgA nephropathy
Vertex Pharmaceuticals (Nasdaq: VRTX) has received confirmation that the US FDA has accepted its Biologics License Application (BLA) for povetacicept, an...
Astellas terminates Phase I for KaliVir-licensed oncolytic vaccinia virus
Astellas Pharma Global Development, Inc. has terminated its Phase I clinical trial of ASP1012, an engineered oncolytic vaccinia virus, in adults with...
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