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biotechs: Archive

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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 INCYNegative 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 PFEPositive 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 ARQTPositive 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.

REGNNegative Net Change SNYPositive Net Change BAYRYPositive 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 PFEPositive 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.

PFEPositive 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.

MRKPositive 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.

ALNYNegative Net Change ALIMPositive Net Change JAZZPositive Net Change SRPTPositive Net Change ANIPNegative Net Change

Zacks Equity Research

Moderna (MRNA) Shares Decline on RSV Vaccine Efficacy Data

Moderna (MRNA) stock sinks after new data shows the efficacy of its mRNA-based RSV vaccine fell sharply in the second year and was lower than that of rival vaccines marketed by GSK and Pfizer.

GSKPositive Net Change PFEPositive Net Change MRNAPositive Net Change

Zacks Equity Research

FDA Expands AbbVie's (ABBV) Epkinly Label in Follicular Lymphoma

Following the label expansion, AbbVie's (ABBV) Epkinly is the first bispecific antibody approved to treat relapsed/refractory (R/R) follicular lymphoma and R/R diffuse large B-cell lymphoma.

ABBVPositive Net Change HRTXPositive Net Change GMABPositive Net Change ARQTPositive Net Change

Zacks Equity Research

Intellia (NTLA) Shares Fall as CFO Glenn Goddard Steps Down

Intellia (NTLA) appoints Edward Dulac as its new chief financial officer after Glenn Goddard steps down from his role with effect from Jun 30.

REGNNegative Net Change NTLAPositive Net Change RAPTPositive Net Change ALGSPositive Net Change

Zacks Equity Research

Beam Therapeutics (BEAM) Begins Dosing in Phase I/II AATD Study

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.

BEAMPositive Net Change RAPTPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

Zacks Equity Research

Dr. Reddy's (RDY) to Acquire Haleon's Nicotine Addiction Drug

Dr. Reddy's (RDY) is set to acquire Haleon's leading global NRT brand, Nicotinell, and its related portfolio across all formats of the drug for GBP 500 million to boost its OTC presence worldwide.

RDYPositive Net Change ANVSNegative Net Change ALXOPositive Net Change HLNPositive Net Change

Zacks Equity Research

Novo Nordisk's (NVO) Hypertension Drug Study Fails to Meet Goal

Novo Nordisk (NVO) declines as a late-stage study of its uncontrolled hypertension and advanced chronic kidney disease candidate, ocedurenone, fails to achieve the primary goal.

NVOPositive Net Change CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

CASI Pharmaceuticals (CASI) Up on Buyout Offer for China Business

CASI Pharmaceuticals (CASI) gets a proposal letter from its chairman for acquiring its business operations in China. Its shares rise on the news.

CGENPositive Net Change CASINegative Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Bayer's (BAYRY) AskBio Advances Parkinson Disease Study

Bayer's (BAYRY) wholly owned and independently operating subsidiary AskBio started recruitment in the phase II study for Parkinson's disease.

BAYRYPositive Net Change CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

AstraZeneca's (AZN) Imfinzi Meets Study Goal in Bladder Cancer

Data from a late-stage study shows that treatment with AstraZeneca's (AZN) Imfinzi plus chemotherapy before and after bladder removal surgery improves survival in patients.

AZNPositive Net Change TBPHPositive Net Change HRTXPositive Net Change ARQTPositive Net Change

Zacks Equity Research

Do Options Traders Know Something About Amicus (FOLD) Stock We Don't?

Investors need to pay close attention to Amicus (FOLD) stock based on the movements in the options market lately.

FOLDPositive Net Change

Zacks Equity Research

ImmunityBio (IBRX) Gains 17% in the Past Week: Here's Why

ImmunityBio (IBRX) rises 17% in the past week as it announces insurance coverage as well as the treatment of the first patients with its newly approved bladder cancer immunotherapy, Anktiva.

CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change IBRXPositive Net Change