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biotechs: Archive

Zacks Equity Research

Roche's (RHHBY) Ocrevus Subcutaneous Gets European Commission Nod

Roche (RHHBY) obtains approval for the subcutaneous formulation of relapsing multiple sclerosis drug Ocrevus in Europe. In addition, a review of the company's MAA for gene therapy, Elevidys, is also underway.

RHHBYPositive Net Change SRPTPositive Net Change NERVPositive Net Change ALXOPositive Net Change

Zacks Equity Research

Novavax (NVAX) Seeks Nod for Updated COVID-19 Jab in Europe

Novavax (NVAX) seeks marketing authorization in the European Union for an updated version of its COVID-19 vaccine, which has been formulated to target the JN.1 variant.

SNYPositive Net Change PFEPositive Net Change MRNAPositive Net Change NVAXPositive Net Change

Zacks Equity Research

Alimera (ALIM) Rises on Merger Deal With ANI Pharmaceuticals

Alimera (ALIM) is set to be acquired by ANI Pharmaceuticals for approximately $381 million in upfront consideration. The transaction is expected to close in the third quarter of 2024.

ALIMPositive Net Change ANIPNegative Net Change RAPTPositive Net Change ALGSPositive Net Change

Zacks Equity Research

Novo Nordisk (NVO) to Invest $4.1B in Clayton Facility Expansion

Novo Nordisk (NVO) plans to invest $4.1 billion in order to expand its Clayton facility with a second manufacturing plant, boosting capacity for injectable treatments and creating 1,000 new jobs.

NVOPositive Net Change LLYPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Alnylam (ALNY) Soars as Heart Disease Drug Study Meets Goals

Alnylam (ALNY) soars as its phase III study, seeking to expand Anvuttra's label to include the treatment of ATTR amyloidosis with cardiomyopathy, achieves primary and all secondary endpoints.

ALNYNegative Net Change CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Sanghamitra Saha

Biotech ETF (BBH) Hits New 52-Week High

The biotech ETF BBH hit a 52-week high lately. Can it soar higher?

BBHPositive Net Change

Zacks Equity Research

Bristol Myers' (BMY) Krazati Gets FDA Nod for Colorectal Cancer

Bristol Myers (BMY) wins FDA approval for Krazati, in combination with Erbitux, as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.

BMYNegative Net Change LGNDPositive Net Change NERVPositive Net Change ALXOPositive Net Change

Zacks Equity Research

FDA Expands argenx's (ARGX) Vyvgart Label to Treat Rare Disorder

Per argenx (ARGX), the label expansion to Vyvgart Hytrulo makes it the first FDA-approved medication with a novel mechanism of action to treat chronic inflammatory demyelinating polyneuropathy.

HRTXPositive Net Change ARGXNegative Net Change TAKPositive Net Change ARQTPositive Net Change

Zacks Equity Research

Intra-Cellular's (ITCI) Caplyta Boosts Sales, Dependence a Woe

Intra-Cellular (ITCI) is witnessing strong Caplyta sales, driven by an increasing prescription rate. However, the company is heavily dependent on Caplyta sales for growth, which is a concern.

AXSMPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

GSK's Filing for Expanded Use of Jemperli Gets EMA Acceptance

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.

GSKPositive Net Change RAPTPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

Zacks Equity Research

Here's Why You Should Consider Buying Alvotech (ALVO) Stock

Here, we discuss some reasons why buying Alvotech (ALVO) stock now may turn out to be a prudent move.

JNJPositive Net Change TEVANegative Net Change ABBVPositive Net Change ALVONegative Net Change

Zacks Equity Research

FDA Expands Sarepta's (SRPT) DMD Gene Therapy Label

Following the label expansion, Sarepta's (SRPT) Elevidys is approved to treat all DMD patients aged four years and older, regardless of ambulation status.

RHHBYPositive Net Change PFEPositive Net Change SRPTPositive Net Change RGNXPositive Net Change SLDBPositive Net Change

Zacks Equity Research

Gilead (GILD) Up as Twice-Yearly HIV Shot Prevents Infection

Gilead's (GILD) twice-yearly, subcutaneous lenacapavir has demonstrated its potential as a new tool to help prevent HIV infections with zero infections and 100% efficacy. Shares gain.

GSKPositive Net Change GILDNegative Net Change LGNDPositive Net Change ALXOPositive Net Change

Zacks Equity Research

JAZZ Falls as Suvecaltamide Tremor Study Fails to Meet Goals

JAZZ shares are down 5% as it fails to achieve statistical significance on the primary and key secondary endpoint in a mid-stage tremor study on suvecaltamide.

JAZZPositive Net Change ANVSNegative Net Change ALXOPositive Net Change PRAXPositive Net Change

Nalak Das

Top 5 Small-Cap Biotechnology Stocks for a Stable Portfolio

We have narrowed our search to five small-cap biotech stocks with strong potential for the rest of 2024. These are: ARQT, BCYC, CSTL, PRME, LXRX.

LXRXPositive Net Change PRMEPositive Net Change BCYCPositive Net Change CSTLPositive Net Change ARQTPositive Net Change

Zacks Equity Research

Biotech Stock Roundup: ITCI Up on Study Data, ZNTL, OVID Down on Updates & More News

Intra-Cellular Therapies (ITCI) and Zentalis Pharmaceuticals, Inc. (ZNTL) are in the spotlight following pipeline and regulatory updates, respectively.

AMGNNegative Net Change MRNAPositive Net Change OVIDPositive Net Change ZNTLPositive Net Change

Debanjana Dey

Zacks Initiates Coverage of Enzo Biochem With Neutral Recommendation

Discover why Zacks rates Enzo Biochem as "Neutral", being the first on Wall Street to initiate coverage on the stock. Explore ENZ's notable revenue growth and financial health amid market challenges.

Zacks Equity Research

Should You Hold Kodiak Sciences (KOD) Stock in Your Portfolio?

Kodiak Sciences (KOD) is evaluating its lead candidate, tarcocimab, in a late-stage study for diabetic retinopathy, which is expected to support a regulatory filing for three eye disease indications.

CGENPositive Net Change KODPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Roche (RHHBY), Ascidian Team Up for RNA Exon Editing Therapeutics

Roche (RHHBY) gets exclusive, target-specific rights to Ascidian's RNA exon editing technology for undisclosed neurological targets for an initial payment of $42 million.

RHHBYPositive Net Change LGNDPositive Net Change NERVPositive Net Change ALXOPositive Net Change

Zacks Equity Research

Terns (TERN) Gains 13.6% YTD: Will the Momentum Continue?

Terns Pharmaceuticals, Inc. (TERN) outperforms the industry year to date on encouraging pipeline progress of its oncology candidate.

NVSPositive Net Change LGNDPositive Net Change ALXOPositive Net Change TERNPositive Net Change

Zacks Equity Research

Day One (DAWN) In-Licenses MabCare Cancer Candidate, Stock Up

Day One (DAWN) gains 11% on in-licensing exclusive worldwide rights to MabCare???s MTX-13, which is set to begin clinical studies for adult and pediatric solid tumor indications.

CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change DAWNPositive Net Change

Zacks Equity Research

Intra-Cellular (ITCI) Up as Second Depression Study Meets Goals

Intra-Cellular (ITCI) gains 10% after achieving key goals in the second late-stage study evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD.

CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Zentalis (ZNTL) Tanks After FDA Puts 3 Cancer Studies on Hold

Zentalis' (ZNTL) three studies evaluating azenosertib for three different cancer indications face the FDA's partial clinical hold following the death of two patients.

GSKPositive Net Change ZNTLPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

Zacks Equity Research

Regeneron (REGN) Outperforms Industry YTD: What Lies Ahead?

Regeneron (REGN) maintains momentum on the back of Dupixent profits and efforts to develop oncology portfolio despite near-term challenges.

REGNNegative Net Change SNYPositive Net Change RHHBYPositive Net Change BAYRYPositive Net Change

Zacks Equity Research

Mirum (MIRM) Soars on Interim Data From Liver Disease Studies

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.

MIRMPositive Net Change RAPTPositive Net Change ALGSPositive Net Change ACRVPositive Net Change