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biotechs: Archive
Biotech Stock Roundup: CORT Up on Study Data, Updates From AXSM, BMY, EXEL & More
by Ekta Bagri
CORT and AXSM are in the spotlight this week following the announcement of study data.
BMYNegative Net Change EXELNegative Net Change CORTNegative Net Change BLUENegative Net Change AXSMNegative Net Change
biotechnology biotechs medical pharmaceuticals
GRI Stock Down on Public Offering Despite Encouraging IPF Study Data
by Zacks Equity Research
GRI stock plunges on the pricing of its public offering, paring the gains witnessed following positive IPF study results.
FOLDNegative Net Change ANIPNegative Net Change GRINegative Net Change
biotechnology biotechs medical pharmaceuticals
AXSM Stock Down on Top-Line Data From Depression Study on Solriamfetol
by Zacks Equity Research
Axsome's phase III PARADIGM study evaluating solriamfetol in major depressive disorder fails to show a statistically significant change in the primary endpoint.
DVAXNegative Net Change JAZZNegative Net Change AXSMNegative Net Change KRYSNegative Net Change
biotechs
LXRX Stock Moves Up 30% in a Week: What is Driving This Rally?
by Zacks Equity Research
The upside comes after Lexicon lands a deal worth $1 billion for its experimental obesity drug with Novo Nordisk.
NVONo Net Change LXRXPositive Net Change ANIPNegative Net Change ETNBPositive Net Change
biotechs medical pharmaceuticals
Alkermes Begins Idiopathic Hypersomnia Study on ALKS 2680
by Zacks Equity Research
ALKS' phase II Vibrance-3 study investigates the safety and efficacy of ALKS 2680 versus placebo for treating adults with idiopathic hypersomnia.
ALKSNegative Net Change JAZZNegative Net Change AXSMNegative Net Change KRYSNegative Net Change
biotechs
APLS' Empaveli sNDA for 2 Rare Kidney Diseases Gets FDA Priority Tag
by Zacks Equity Research
The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.
NVSPositive Net Change BAYRYPositive Net Change CORTNegative Net Change APLSNegative Net Change
biotechnology biotechs medical pharmaceuticals
PFE Secures EU Nod for Expanded Use of RSV Vaccine Abrysvo
by Zacks Equity Research
The latest decision makes Pfizer's Abrysvo the first RSV vaccine approved for use in non-pregnant adults under 50 years of age in the EU.
GSKPositive Net Change PFENegative Net Change MRNANegative Net Change
biotechs medical pharmaceuticals vaccines
CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo
by Zacks Equity Research
BMY obtains CHMP recommendation for Opdivo for perioperative regimen of neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo for resectable non-small cell lung cancer.
BMYNegative Net Change FOLDNegative Net Change ANIPNegative Net Change
biotechnology biotechs medical pharmaceuticals
VRTX Provides Mixed Updates for Type 1 Diabetes Pipeline Candidates
by Zacks Equity Research
Vertex plans to submit regulatory filings seeking approval for zimislecel in type 1 diabetes in 2026. However, it is likely to stop further development of VX-264.
DVAXNegative Net Change VRTXNegative Net Change JAZZNegative Net Change KRYSNegative Net Change
biotechs
SNY Gets FDA Nod for First Ever Hemophilia Drug in the United States
by Zacks Equity Research
The FDA approves Sanofi's Qfitlia as the first therapy in the United States to treat hemophilia A or B with or without inhibitors.
SNYPositive Net Change ALNYPositive Net Change BAYRYPositive Net Change CORTNegative Net Change
biotechnology biotechs medical pharmaceuticals
AstraZeneca's Imfinzi Gets FDA Nod for Bladder Cancer Indication
by Zacks Equity Research
The FDA approves AZN's sBLA seeking the expanded use of Imfinzi for adult patients with muscle-invasive bladder cancer.
AZNNegative Net Change DVAXNegative Net Change BAYRYPositive Net Change CORTNegative Net Change
biotechnology biotechs immuno-therapy medical pharmaceuticals
Biotech Stocks Fall After Top FDA Official Quits Over Clash With RFK Jr.
by Sundeep Ganoria
The decline in biotech stocks comes after FDA official Peter Marks' resignation, citing irreconcilable differences with the new HHS Secretary.
MRNANegative Net Change NVAXNegative Net Change SRPTPositive Net Change CRSPNegative Net Change PCVXNegative Net Change
biotechs gene-editing gene-therapy medical messenger-rna vaccines
Intellia Focuses on Pipeline Development Amid Stiff Competition
by Zacks Equity Research
Studies on NTLA's gene-edited therapy, nex-z, are progressing well while other pipelines are picking up pace. Stiff competition in the target market is a woe.
REGNNegative Net Change VRTXNegative Net Change NTLANegative Net Change CRSPNegative Net Change
biotechs
Is the Future Bleak for SAVA Stock Following Another Setback?
by Zacks Equity Research
The failure of yet another late-stage study on its Alzheimer's disease candidate puts Cassava Sciences in a pickle with uncertain growth prospects.
BIIBNegative Net Change LLYNegative Net Change SAVANegative Net Change
biotechnology biotechs medical pharmaceuticals
JNJ's Rybrevant-Lazcluze Combo Outshines AZN's Tagrisso in Lung Cancer
by Zacks Equity Research
Study investigators expect that J&J's combo drug can extend overall survival by at least a year over the current standard of care in certain NSCLC patients.
AZNNegative Net Change NVSPositive Net Change JNJNegative Net Change
biotechs medical pharmaceuticals
RDY & Bio-Thera Ink Deal for JNJ's Stelara/Simponi Biosimilar
by Zacks Equity Research
Dr. Reddy's inks collaboration deal with Bio-Thera to develop and commercialize proposed biosimilar candidates of J&J's Stelara and Simponi in Southeast Asia.
RDYNegative Net Change JNJNegative Net Change AMGNNegative Net Change ALVOPositive Net Change
biotechnology biotechs medical pharmaceuticals
FDA Accepts Merck's Filing for Subcutaneous Version of Keytruda
by Zacks Equity Research
The filing is based on late-stage data, which shows that treatment with the subcutaneous version of MRK's Keytruda is at least as effective as the IV version.
MRKNegative Net Change ANIPNegative Net Change CTMXNegative Net Change ETNBPositive Net Change
biotechs medical pharmaceuticals
Kodiak Q4 Loss Narrower Than Expected, Pipeline Development in Focus
by Zacks Equity Research
KOD reports a narrower-than-expected loss for the fourth quarter of 2024. The company provides updates regarding its pipeline development plans.
DVAXNegative Net Change BAYRYPositive Net Change CORTNegative Net Change KODNegative Net Change
biotechnology biotechs earnings medical pharmaceuticals
Promising Genomics & Synthetic Biology Stocks to Consider in 2025
by Ekta Bagri
Investors interested in the Genomics and Synthetic Biology theme should consider these stocks: Twist Bioscience Corporation, Wave Life Sciences, and CRISPR Therapeutics AG.
ILMNNegative Net Change BEAMNegative Net Change WVENegative Net Change NTLANegative Net Change CRSPNegative Net Change TWSTNegative Net Change
biotechnology biotechs gene-editing gene-therapy genetic-testing genomics medical
BEAM's IND for BEAM-302 in Genetic Disorder Study Gets FDA Clearance
by Zacks Equity Research
The FDA clears Beam Therapeutics' investigational new drug application for BEAM-302 for the treatment of alpha-1 antitrypsin deficiency in the United States.
DVAXNegative Net Change JAZZNegative Net Change BEAMNegative Net Change KRYSNegative Net Change
biotechs
FDA Expands Exelixis Cabometyx Label for Neuroendocrine Tumors
by Zacks Equity Research
Exelixis obtains FDA nod for label expansion of lead drug Cabometyx for neuroendocrine tumors.
BMYNegative Net Change NVONo Net Change BAYRYPositive Net Change EXELNegative Net Change
biotechnology biotechs medical pharmaceuticals
Bayer Licenses PRMT5 inhibitor From Suzhou Puhe BioPharma
by Zacks Equity Research
Bayer obtains an exclusive worldwide license for MTA-cooperative PRMT5 inhibitor from Suzhou Puhe BioPharma for selective targeting of MTAP-deleted tumors.
DVAXNegative Net Change NVONo Net Change BAYRYPositive Net Change
biotechnology biotechs medical pharmaceuticals
NTLA Genome-Editing Therapy Gets FDA's RMAT Tag for New Indication
by Zacks Equity Research
The FDA bestows a Regenerative Medicine Advanced Therapy tag to Intellia's nex-z for treating transthyretin amyloidosis with cardiomyopathy.
REGNNegative Net Change JAZZNegative Net Change NTLANegative Net Change KRYSNegative Net Change
biotechs
PLRX Stock Plunges 89% in 3 Months: Here's What Investors Should Know
by Zacks Equity Research
Pliant stock crashes 89% in three months following setbacks in the mid-stage study of its lead candidate, bexotegrast, for idiopathic pulmonary fibrosis.
DVAXNegative Net Change BAYRYPositive Net Change CORTNegative Net Change PLRXNegative Net Change
biotechnology biotechs medical pharmaceuticals
SLNO Stock Rallies on FDA Approval of Prader-Willi Syndrome Drug
by Zacks Equity Research
Soleno's shares soar in the premarket hours following the FDA approval of Vykat XR (diazoxide choline) for treating hyperphagia in PWS patients.
BAYRYPositive Net Change CORTNegative Net Change ACADPositive Net Change SLNONegative Net Change
biotechnology biotechs medical pharmaceuticals