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biotechs: Archive

Zacks Equity Research

GSK Buys Flu, COVID mRNA Jab Rights From Partner CureVac

GSK revamps its existing collaboration deal with partner CureVac, converting it from a collaboration deal into a licensing agreement related to mRNA vaccine candidates for COVID-19 and influenza.

GSKPositive Net Change RAPTPositive Net Change ALGSNegative Net Change

Zacks Equity Research

Roche's (RHHBY) Combo Therapy Misses Lung Cancer Study Goals

Roche (RHHBY) announces that its mid to late-stage lung cancer study evaluating the tiragolumab combination therapy compared with Keytruda fails to meet primary endpoints.

RHHBYPositive Net Change MRKNegative Net Change CGENPositive Net Change ALXOPositive Net Change

Zacks Equity Research

Biotech Stock Roundup: GSK, CVAC Revise Agreement, Updates From MRNA, RNAC & More

GSK and CureVac (CVAC) are in the spotlight following a restructuring of their vaccine agreement.

GSKPositive Net Change MRNAPositive Net Change RCKTNegative Net Change RNACNegative Net Change

Sundeep Ganoria

NVO, LLY Slip After Study Links Obesity Drug Use to Vision Loss

A new study led by investigators of a Harvard-affiliated teaching hospital found that Novo Nordisk's (NVO) GLP-1 drugs Ozempic and Wegovy could be linked to rare cases of vision loss.

NVOPositive Net Change LLYNegative Net Change AMGNNegative Net Change VKTXPositive Net Change

Zacks Equity Research

Cartesian (RNAC) MG Study Meets Goals, Stock Down on Other Updates

Cartesian (RNAC) announced that the phase IIb study in MG patients has achieved its primary endpoints. However, the stock nosedives following an equity financing announcement.

NERVNegative Net Change ARGXPositive Net Change ALXOPositive Net Change RNACNegative Net Change

Zacks Equity Research

Moderna (MRNA) Secures BARDA Funding for Bird Flu Vaccine

Moderna (MRNA) expects this funding to help support the development of its mRNA-based pre-pandemic vaccine against the H5 influenza virus, which is responsible for causing avian influenza or bird flu.

MRNAPositive Net Change NVAXPositive Net Change

Zacks Equity Research

Vertex (VRTX) NDA for Vanza Triple Therapy Accepted by FDA

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.

VRTXPositive Net Change RAPTPositive Net Change ALGSNegative Net Change ACRVNegative Net Change

Zacks Equity Research

Annovis (ANVS) Up as Its Lead Candidate Meets Goals in PD Study

Annovis (ANVS) surges 76% on Jul 2 after meeting the primary and secondary goals with statistical significance in the late-stage PD study of its lead candidate, buntanetap.

CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change ALGSNegative Net Change

Zacks Equity Research

Regeneron (REGN), SNY Win EC Approval for Dupixent for COPD

Regeneron (REGN) and partner Sanofi get approval for their blockbuster drug Dupixent for the chronic obstructive pulmonary disease indication in the EU.

REGNPositive Net Change SNYPositive Net Change NERVNegative Net Change ALXOPositive Net Change

Zacks Equity Research

SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

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.

RAPTPositive Net Change ALGSNegative Net Change ACRVNegative Net Change

Sundeep Ganoria

Viking (VKTX) Skyrockets 197% YTD: Is the Stock Worth a Buy?

Despite having no marketed drugs, Viking's (VKTX) stock continues to experience robust price movement, driven by the company's encouraging progress with its pipeline.

NVOPositive Net Change LLYNegative Net Change VKTXPositive Net Change MDGLNegative Net Change

Zacks Equity Research

Longboard (LBPH) Up 14% as Epilepsy Drug Gets Breakthrough Tag

Longboard (LBPH) gains 14% as the FDA grants the Breakthrough Therapy designation to its investigational epilepsy treatment candidate, bexicaserin, for patients aged two years or older.

CGENPositive Net Change XENEPositive Net Change ALXOPositive Net Change

Zacks Equity Research

Mesoblast (MESO) Soars 208% YTD on Positive Regulatory Updates

Mesoblast (MESO) skyrockets 208.2% year to date on encouraging progress with its pipeline candidates.

NVSPositive Net Change INCYPositive Net Change MESOPositive Net Change ALXOPositive Net Change

Sweta Killa

4 Best-Performing Sector ETFs of June

We have highlighted four top-performing ETFs from different sectors that have led the way in June.

AMLPPositive Net Change BBPPositive Net Change MAGSPositive Net Change WGMIPositive Net Change

Zacks Equity Research

CHMP Endorses Moderna's (MRNA) mRNA-based RSV Vaccine

If approved, the RSV vaccine will be Moderna's (MRNA) second approved product in the European Union.

GSKPositive Net Change PFENegative Net Change MRNAPositive Net Change

Zacks Equity Research

FDA Rejects Rocket's (RCKT) Gene Therapy BLA for Rare Disease

Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte adhesion deficiency-I (LAD-I), a rare genetic disorder.

CGENPositive Net Change HRTXPositive Net Change RCKTNegative Net Change ARQTNegative Net Change

Zacks Equity Research

Regeneron (REGN) Gets Positive CHMP Opinion for Lymphoma Drug

Regeneron (REGN) gets positive CHMP recommendation for odronextamab for the treatment of adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma.

REGNPositive Net Change SNYPositive Net Change BAYRYNegative Net Change

Zacks Equity Research

Apellis (APLS) Falls on Second Negative CHMP Opinion for GA Drug

Apellis (APLS) declines as CHMP issues a second negative opinion for the approval of intravitreal pegcetacoplan to treat GA in the EU. The company plans to seek re-examination of the same.

CGENPositive Net Change APLSPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

PTC Therapeutics (PTCT) Down on Negative CHMP Opinion on DMD Drug

PTC Therapeutics (PTCT) falls as the EC's advisory committee adopts a negative opinion regarding the renewal of the conditional marketing approval of Translarna to treat nmDMD in the EU.

CGENPositive Net Change PTCTPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

CDC Narrows Age Recommendation for Use of RSV Vaccine

The U.S. CDC recommends that adults aged 75 years and above get an RSV shot. Those aged 60 to 74 years should only get the shot if they are at high risk for severe RSV due to chronic conditions.

GSKPositive Net Change PFENegative Net Change MRNAPositive Net Change

Zacks Equity Research

Pfizer (PFE), BioNTech's Updated COVID-19 Jab Gets CHMP Nod

Pfizer (PFE) and BioNTech's Omicron JN.1-adapted COVID-19 vaccine gets the Committee for Medicinal Products for Human Use's positive opinion recommending marketing authorization.

PFENegative Net Change MRNAPositive Net Change NVAXPositive Net Change BNTXPositive Net Change

Zacks Equity Research

Cogent (COGT) Up on SUMMIT Study Update Post Positive FDA Meeting

Cogent (COGT) announces a positive FDA meeting and alignment on MS2D2, a novel patient-reported outcome measure for the SUMMIT study. The company's shares rise on the news.

CGENPositive Net Change COGTPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Denali (DNLI) Outperforms Industry in 3 Months: Here's Why

Denali (DNLI) gains 11.9% in three months on positive updates on its candidates.

SNYPositive Net Change BIIBPositive Net Change DNLIPositive Net Change ALXOPositive Net Change

Zacks Equity Research

Merck's (MRK) New Pneumococcal Jab Capvaxive Gets CDC Panel Vote

Merck's (MRK) vaccine, Capvaxive, gets unanimous recommendation by a CDC committee for adults aged 65 years and older for pneumococcal vaccination and those with certain other underlying conditions.

MRKNegative Net Change CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Biotech Stock Roundup: ALNY Up on Study Success, ALIM on Merger News & Other Updates

Alnylam Pharmaceuticals (ALNY) and Alimera Sciences, Inc. (ALIM) are in the spotlight following study and merger updates, respectively.

ALNYPositive Net Change ALIMPositive Net Change JAZZPositive Net Change SRPTPositive Net Change ANIPNegative Net Change