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biotechs: Archive

Zacks Equity Research

Milestone Pharma (MIST) Down on Regulatory Update for Etripamil

Milestone Pharma (MIST) plunges 31% following an RTF letter from the FDA due to insufficient data to begin a substantive review of the regulatory filing for etripamil nasal spray to treat PSVT.

AGENPositive Net Change PBYIPositive Net Change ADMANegative Net Change MISTNegative Net Change

Zacks Equity Research

FDA Rejects Amgen's (AMGN) NDA Seeking Full Nod for Lumakras

Per the FDA, Amgen (AMGN) will need to complete an additional confirmatory study on Lumakras in certain lung cancer patients before February 2028 to secure full approval.

BMYPositive Net Change AMGNNegative Net Change MRTXPositive Net Change GLPGPositive Net Change

Sundeep Ganoria

3 Under-$10 Drug Stocks Wall Street Analysts Recommend Buying

We present three small biotech stocks, which most analysts on Wall Street are optimistic about. These companies have upside potential for 2024 following signals of a stabilizing market.

ALLONo Net Change ARQTPositive Net Change CCCCPositive Net Change

Zacks Equity Research

Bristol Myers (BMY) to Buy Cancer Drug-Maker RayzeBio for $4.1B

Bristol Myers (BMY) is set to acquire RayzeBio for $4.1 billion to strengthen and diversify its already established oncology portfolio. The transaction is expected to close in the first half of 2024.

BMYPositive Net Change MRTXPositive Net Change

Sweta Killa

5 Leveraged ETFs That Are Up More Than 50% in December

The demand for leveraged ETFs have increased as investors seek to register big gains in a short span.

LABUPositive Net Change DPSTNegative Net Change NAILPositive Net Change CONLNegative Net Change CARUNo Net Change

Zacks Equity Research

Sarepta (SRPT) Seeks Label Expansion for DMD Gene Therapy

Sarepta (SRPT) files a supplement with the FDA seeking to expand its recently-approved gene therapy Elevidys' label to treat all DMD patients, regardless of age and ambulatory status.

RHHBYPositive Net Change NVOPositive Net Change SRPTPositive Net Change GLPGPositive Net Change

Zacks Equity Research

Senti Bio (SNTI) Rises as FDA Clears IND for Cancer Candidate

The FDA clears Senti Bio's (SNTI) investigational new drug application for SENTI-202 for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia. Stock rises.

TAROPositive Net Change PBYIPositive Net Change TRDANegative Net Change SNTIPositive Net Change

Zacks Equity Research

Karuna (KRTX) Up 48% on $14B Buyout Offer From Bristol Myers

Bristol Myers (BMY) is set to acquire Karuna (KRTX) for $330 per share. This transaction is expected to close in the first half of 2024.

BMYPositive Net Change ABBVNegative Net Change CEREPositive Net Change

Zacks Equity Research

Cidara (CDTX) Up on EC Nod for Rezzayo in Invasive Candidiasis

Cidara's (CDTX) Rezzayo (rezafungin acetate) gets approval from the European Commission for the treatment of invasive candidiasis in adults. The stock rises 11.1%.

TAROPositive Net Change PBYIPositive Net Change CDTXNegative Net Change TRDANegative Net Change

Zacks Equity Research

Merck (MRK) & Daiichi Sankyo's Lung Cancer ADC Gets Priority Tag

Merck (MRK) and Daiichi Sankyo's regulatory filing for HER3-DXd gets the FDA's priority review grant for the treatment of adult patients with lung cancer. A final decision is expected on Jun 26, 2024.

MRKNegative Net Change AGENPositive Net Change PBYIPositive Net Change ADMANegative Net Change

Ahan Chakraborty

What Awaits These 4 Drug Stocks That More Than Doubled in 2023?

Here are four drug, biotech stocks, AMPH, DERM, CNTA & AQST, which have more than doubled in 2023 with room for further growth in 2024.

AMPHNegative Net Change DERMNegative Net Change AQSTPositive Net Change CNTANegative Net Change

Zacks Equity Research

Fluor Corporation and Align Technology have been highlighted as Zacks Bull and Bear of the Day

Fluor Corporation and Align Technology are part of the Zacks Bull and Bear of the Day article.

FLRPositive Net Change ALGNNegative Net Change SRPTPositive Net Change VRNAPositive Net Change DNLINegative Net Change

Zacks Equity Research

Bristol Myers (BMY) to Buy Karuna Therapeutics for $14B

Bristol Myers (BMY) announces a second acquisition in two months. It is set to buy Karuna Therapeutics, Inc. (KRTX) for $14 billion to strengthen its neuroscience portfolio.

BMYPositive Net Change ABBVNegative Net Change MRTXPositive Net Change

Sundeep Ganoria

3 Beaten-Down Biotech Stocks to Buy for a Turnaround in 2024

Here we present three biotech stocks, SRPT, DNLI and VRNA, which took a beating in 2023 but have upside potential for 2024.

SRPTPositive Net Change VRNAPositive Net Change DNLINegative Net Change

Kinjel Shah

Pharma Stock Roundup: FDA Nod to AZN's Eplontersen, CRL to MRK's Cough Candidate

FDA approves AstraZeneca (AZN) and Ionis' (IONS) Wainua (eplontersen) for ATTRv-PN and gives CRL to Merck's chronic cough candidate, gefapixant.

SNYPositive Net Change AZNPositive Net Change PFENegative Net Change MRKNegative Net Change IONSPositive Net Change

Zacks Equity Research

Biotech Stock Roundup: CGEN Up on GILD Deal, MRNA Gains on Study Data & More

Compugen (CGEN) and Moderna (MRNA) are in the news on collaboration and study updates, respectively.

GILDPositive Net Change MRNANegative Net Change CGENNegative Net Change ARGXPositive Net Change

Zacks Equity Research

Merck's (MRK) Chronic Cough Drug Gets Another CRL From FDA

Per the FDA, the data submitted by Merck (MRK) for its chronic cough drug did not provide sufficient evidence to prove its clinical benefit in patients.

GSKPositive Net Change NVOPositive Net Change MRKNegative Net Change GLPGPositive Net Change

Zacks Equity Research

GSK, Hansoh Ink Deal to Develop Lung Cancer ADC Candidate

GSK enters into an exclusive licensing agreement with China-based Hansoh to develop and commercialize the latter's lung cancer candidate, HS-20093.

GSKPositive Net Change AGENPositive Net Change PBYIPositive Net Change ADMANegative Net Change

Zacks Equity Research

Immunovant (IMVT) Up on Upbeat Initial Batoclimab GD Study Data

Immunovant (IMVT) announces positive initial data from the mid-stage study of batoclimab in patients with Graves' disease. The stock gains 12% in the after-market hours, following the news.

AGENPositive Net Change PBYIPositive Net Change ADMANegative Net Change IMVTPositive Net Change

Zacks Equity Research

argenx (ARGX) Tanks on Top-Line Data From Pemphigus Study

argenx's (ARGX) phase III ADDRESS study, evaluating efgartigimod subcutaneous for treating pemphigus, fails to meet primary and secondary endpoints. Stock falls.

PBYIPositive Net Change DERMNegative Net Change ARGXPositive Net Change TRDANegative Net Change

Ekta Bagri

3 Cancer-Focused Biotechs That Appear Promising Bets for 2024

With the spotlight on oncology-focused companies in the biotech sector in 2023, we discuss three stocks that have a promising oncology portfolio/pipeline for 2024.

BMYPositive Net Change LLYPositive Net Change BGNEPositive Net Change ALLONo Net Change TNGXPositive Net Change

Zacks Equity Research

bluebird (BLUE) Stock Down on Raising Additional Capital

bluebird (BLUE) issues shares to raise capital to support the commercialization and manufacturing of its three approved gene therapies. Its shares are down on the dilution of equity.

VRTXNegative Net Change CRSPPositive Net Change TRDANegative Net Change

Zacks Equity Research

FDA Accepts Merck's (MRK) BLA for 21-Valent Pneumococcal Jab

The FDA grants priority review to Merck's (MRK) filing seeking approval for its 21-valent pneumococcal conjugate vaccine in adults. A final decision is expected in June 2024.

PFENegative Net Change NVOPositive Net Change MRKNegative Net Change GLPGPositive Net Change

Zacks Equity Research

Anavex (AVXL) Rises as CHMP Deems Blarcamesine Eligible for MAA

The CHMP agrees that Anavex's (AVXL) blarcamesine for Alzheimer's disease is eligible for submission for a Union Marketing Authorisation in the EU. Shares rise.

PBYIPositive Net Change DERMNegative Net Change AVXLPositive Net Change TRDANegative Net Change

Zacks Equity Research

Gilead (GILD), Compugen Collaborate for Immunotherapy Program

Gilead (GILD) enters into a license agreement with Compugen for its pre-clinical immunotherapy program.

GILDPositive Net Change CGENNegative Net Change RCUSPositive Net Change ACLXPositive Net Change