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Zacks News
Are Medical Stocks Lagging Acrivon Therapeutics, Inc. (ACRV) This Year?
by Zacks Equity Research
Here is how Acrivon Therapeutics, Inc. (ACRV) and Akebia Therapeutics (AKBA) have performed compared to their sector so far this year.
Verastem (VSTM) Begins Dosing in Solid Tumors Study in China
by Zacks Equity Research
Verastem (VSTM) doses the first patient in a phase I/II study conducted by GenFleet Therapeutics, evaluating KRAS G12D inhibitor, GFH375/VS-7375 in solid tumors. Shares rise.
AbbVie (ABBV) Files for Rinvoq in Giant Cell Arteritis in US & EU
by Zacks Equity Research
AbbVie (ABBV) files regulatory applications to the FDA and the EMA, seeking approval for a new indication of Rinvoq, giant cell arteritis.
SpringWorks (SWTX) Rises More Than 40% in a Year: Here's Why
by Zacks Equity Research
SpringWorks' (SWTX) Ogsiveo is the first drug approved by the FDA to treat desmoid tumors. The company's efforts to develop its pipeline candidate, mirdametinib, for treating NF1-PN also hold promise.
Athira (ATHA) Completes Dosing in Alzheimer's Study, Stock Up
by Zacks Equity Research
Athira (ATHA) completes dosing the last patient in the phase II/III LIFT-AD study on fosgonimeton for treating people with mild-to-moderate Alzheimer's disease. Stock gains.
Mirum (MIRM) Gets EC Approval for Livmarli Label Expansion
by Zacks Equity Research
The European Commission approves Mirum's (MIRM) Livmarli for the treatment of progressive familial intrahepatic cholestasis in patients three months of age and older.
HilleVax (HLVX) Tanks as Norovirus Vaccine Study in Infants Fails
by Zacks Equity Research
HilleVax's (HLVX) phase IIb NEST-IN1 study evaluating HIL-214 for preventing acute gastroenteritis caused by norovirus infection in infants fails to meet its primary efficacy endpoint. Stock falls.
Mirum (MIRM) Rises More Than 30% in Past 3 Months: Here's Why
by Zacks Equity Research
The recent label expansion of Mirum's (MIRM) lead drug, Livmarli, is expected to drive sales in the upcoming quarters. The company's efforts to build its pipeline beyond Livmarli also hold promise.
AstraZeneca's (AZN) Tagrisso Gets EU Nod for First-Line NSCLC
by Zacks Equity Research
The European Commission approves AstraZeneca's (AZN) Tagrisso in combination with chemotherapy for first-line treatment of advanced EGFR-mutated NSCLC based on data from the phase III FLAURA2 study.
Vertex (VRTX) NDA for Vanza Triple Therapy Accepted by FDA
by Zacks Equity Research
The FDA accepts Vertex's (VRTX) new drug application for vanza triple therapy for people living with cystic fibrosis aged six years and above. A decision is due on Jan 2, 2025.
SpringWorks (SWTX) Completes NDA Submission for Mirdametinib
by Zacks Equity Research
SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with neurofibromatosis type 1- associated plexiform neurofibromas.
AstraZeneca (AZN) Imfinzi Combo Gets CHMP Nod for Expanded Use
by Zacks Equity Research
The CHMP recommends approval of AstraZeneca's (AZN) Imfinzi plus Lynparza for treating primary advanced or recurrent endometrial cancer based on data from the phase III DUO-E study.
Beam Therapeutics (BEAM) Begins Dosing in Phase I/II AATD Study
by Zacks Equity Research
Beam Therapeutics (BEAM) doses the first patient in a phase I/II study, evaluating in vivo base editor BEAM-302 for treating alpha-1 antitrypsin deficiency.
Corcept (CORT) Shares Rise 20% in Three Months: Here's Why
by Zacks Equity Research
Corcept's (CORT) pipeline progress has been encouraging with relacorilant currently under evaluation for Cushing's syndrome. The NDA for relacorilant is expected to be filed in the third quarter.
GSK's Filing for Expanded Use of Jemperli Gets EMA Acceptance
by Zacks Equity Research
The European Medicines Agency accepts GSK's application for the expanded use of Jemperli plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer.
Is Acrivon Therapeutics, Inc. (ACRV) Stock Outpacing Its Medical Peers This Year?
by Zacks Equity Research
Here is how Acrivon Therapeutics, Inc. (ACRV) and Hims & Hers Health, Inc. (HIMS) have performed compared to their sector so far this year.
AstraZeneca's (AZN) Truqap Gets EU Nod for Breast Cancer
by Zacks Equity Research
The European Commission approves AstraZeneca's (AZN) Truqap in combination with Faslodex for ER-positive, HER2-negative advanced or metastatic breast cancer.
Zentalis (ZNTL) Tanks After FDA Puts 3 Cancer Studies on Hold
by Zacks Equity Research
Zentalis' (ZNTL) three studies evaluating azenosertib for three different cancer indications face the FDA's partial clinical hold following the death of two patients.
Mirum (MIRM) Soars on Interim Data From Liver Disease Studies
by Zacks Equity Research
Mirum (MIRM) posts positive interim data from two phase IIb studies evaluating volixibat in patients with primary biliary cholangitis and primary sclerosing cholangitis. Stock rises.
AstraZeneca's (AZN) Truqap Misses Endpoints in TNBC Study
by Zacks Equity Research
AstraZeneca's (AZN) phase III CAPItello-290 study evaluating Truqap plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer fails to meet the dual primary endpoints.
AstraZeneca's (AZN) Imfinzi Gets FDA Nod in Expanded Use
by Zacks Equity Research
The FDA approves AstraZeneca's (AZN) Imfinzi in combination with chemotherapy for treating mismatch repair deficient advanced/recurrent endometrial cancer based on data from the phase III DUO-E study.
Intellia (NTLA) Banks on Genome Editing Pipeline Amid Rivalry
by Zacks Equity Research
Intellia's (NTLA) lead genome-editing candidate, NTLA-2001 being developed to treat transthyretin (ATTR) amyloidosis, holds promise. Other pipeline candidates are also progressing well.
Repligen (RGEN) Promotes CCO, Shares Fall on Leadership Change
by Zacks Equity Research
Repligen (RGEN) appoints Olivier Loeillot as the company's new president and chief executive officer, effective from Sep 1, 2024. Stock falls on the news.
Ultragenyx (RARE) to Seek Accelerated Nod for Rare Disease Drug
by Zacks Equity Research
Following a fruitful meeting with the FDA, Ultragenyx (RARE) plans to seek accelerated approval for UX111 for the treatment of Sanfilippo syndrome type A.
Ultragenyx (RARE) Posts New Data From Bone Disease Study
by Zacks Equity Research
Ultragenyx's (RARE) pipeline candidate setrusumab shows sustained reductions in fracture rates in patients with osteogenesis imperfecta in new data from the Orbit study.