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biotechnology: Archive

Zacks Equity Research

Immix (IMMX) Up on Orphan Drug Tag for AL Amyloidosis Therapy

Immix (IMMX) gets ODD designation in the United States for lead candidate NXC-201 for the treatment of amyloid light chain (AL) Amyloidosis.

DVAXNegative Net Change ETONNegative Net Change IMMXNegative Net Change

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Moleculin (MBRX) Posts Update From Lung Cancer Study, Stock Up

Moleculin (MBRX) completes enrollment in the phase II portion of the development program for its lead candidate, Annamycin, to treat soft tissue sarcoma lung metastases. The stock rises 10%.

DVAXNegative Net Change CORTNegative Net Change MBRXPositive Net Change BTTXNo Net Change

Zacks Equity Research

Puma's (PBYI) Alisertib Gets FDA's Orphan Drug Tag for SCLC

Puma's (PBYI) alisertib receives the Orphan Drug designation from the FDA for treating patients with small cell lung cancer.

CORTNegative Net Change ANIKNegative Net Change PBYINegative Net Change ANVSNegative Net Change

Zacks Equity Research

Relmada (RLMD) Up on Positive Data for Anti-Depressant Candidate

Relmada's (RLMD) shares rise on long-term efficiency and safety data from the phase III study of its lead candidate REL-1017 to treat patients with major depressive disorder.

CORTNegative Net Change ANIKNegative Net Change RLMDNegative Net Change ANVSNegative Net Change

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Evaxion (EVAX) Up on Partnership With Afrigen for Gonorrhea Jab

Evaxion's (EVAX) shares gain as it collaborates with Afrigen Biologics to develop prophylactic mRNA vaccine targeting gonorrhea, based on Evaxion's EDEN technology.

CORTNegative Net Change ANIKNegative Net Change ANVSNegative Net Change EVAXNegative Net Change

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ARS Pharmaceuticals (SPRY) Down on CRL for Nasal Spray

ARS Pharmaceuticals, Inc. (SPRY) plunges on a surprise CRL by the FDA for its nasal spray curated for allergic reactions.

DVAXNegative Net Change ETONNegative Net Change SPRYPositive Net Change

Zacks Equity Research

Aquestive (AQST) Up on Reaffirming Anaphylm Development Pathway

Aquestive (AQST) stock rises 11.8% as the company intends to begin a pivotal pharmacokinetic study of Anaphylm as an oral epinephrine product candidate in the fourth quarter of 2023.

DVAXNegative Net Change CORTNegative Net Change AQSTNegative Net Change BTTXNo Net Change

Zacks Equity Research

Biotech Stock Roundup: GSK's Drug Approval, MRNA's Vaccine News, PTCT & SPRY Down

Regulatory updates from GSK and Moderna (MRNA) are in focus in the biotech sector.

GSKNegative Net Change MRNANegative Net Change PTCTNegative Net Change SPRYPositive Net Change

Zacks Equity Research

Atara (ATRA) Up 11% on Regulatory Update From Blood Cancer Study

Atara (ATRA) rises 11% on an update regarding the regulatory pathway for the company's lead product candidate, tab-cel, in the treatment of a rare, deadly and hematologic malignancy.

DVAXNegative Net Change CORTNegative Net Change ATRANegative Net Change BTTXNo Net Change

Zacks Equity Research

Marinus (MRNS) Up 20% on Financial and Pipeline Updates

Marinus' (MRNS) shares rise as it provides revenue and cash guidance for third-quarter 2023. The company also updates on the progress of its pipeline candidates targeting major central nervous system disorders.

CORTNegative Net Change ANIKNegative Net Change MRNSPositive Net Change ANVSNegative Net Change

Zacks Equity Research

Elutias (ELUT) Up on Sale of Orthobiologics Business for $35M

Elutias (ELUT) gains on divestiture of Orthobiologics business unit for $35 million to Berkeley Biologics LLC, a wholly-owned subsidiary of GNI Group Ltd.

ANIKNegative Net Change ANIPNegative Net Change ANVSNegative Net Change ELUTPositive Net Change

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Incyte (INCY) Down on FDA Nod for Another Myelofibrosis Drug

Incyte (INCY) declines on potential competition for lead drug Jakafi from Ojjaara for the treatment of intermediate or high-risk myelofibrosis.

GSKNegative Net Change DVAXNegative Net Change INCYNegative Net Change EXELNegative Net Change

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

PTC Therapeutics (PTCT) plunges on negative opinion from the Committee for Medicinal Products for Human Use for conditional marketing and full marketing authorization of Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy.

ANIKNegative Net Change PTCTNegative Net Change ANIPNegative Net Change ANVSNegative Net Change

Zacks Equity Research

Vertex (VRTX) Gets Positive CHMP Opinion for Kaftrio Expanded Use

Vertex's (VRTX) Kaftrio gets a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for extended use to treat younger age groups of two to five years old with cystic fibrosis.

VRTXNegative Net Change ANIKNegative Net Change CRSPNegative Net Change ANVSNegative Net Change

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Here's Why Rocket Pharmaceuticals (RCKT) Rises 53.8% in a Week

Rocket Pharmaceucticals (RCKT) soars 53.8% in a week on news of alignment with the FDA for the mid-stage study of RP-A501, an investigational gene therapy for treating Danon Disease.

DVAXNegative Net Change EXELNegative Net Change RCKTNegative Net Change

Zacks Equity Research

Biotech Stock Roundup: MRNAs Pipeline News, RCKT, BCYC Rally on Study Updates

Pipeline and regulatory updates from Moderna (MRNA) and Rocket Pharmaceuticals (RCKT) are in focus in the biotech sector.

BMYNegative Net Change GILDNegative Net Change MRNANegative Net Change RCKTNegative Net Change BCYCPositive Net Change

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Madrigal (MDGL) Gains on NDA for NASH Therapy Acceptance by FDA

Madrigal (MDGL) gains as new drug application for resmeritom to treat nonalcoholic steatohepatitis gets accepted by the FDA in the United States.

ANIKNegative Net Change VKTXNegative Net Change MDGLNegative Net Change AKRONegative Net Change

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Nektar (NKTR) Up on Positive New Data From Eczema Study

Nektar (NKTR) gains on positive new data for its pipeline candidate, rezpegaldesleukin, evaluated from an early-stage study for treating atopic dermatitis.

LLYNegative Net Change NKTRPositive Net Change ANIKNegative Net Change ANVSNegative Net Change

Andrew Rocco

"Blockbuster Status": 3 Bios to Buy and Hold

The biotech sector is notorious for its sky-high R&D costs, regulatory hurdles, and lengthy timelines to bring a drug to market. Stock Strategist Andrew Rocco unveils 3 biotech stocks that have broken through and are set up for long term growth.

NVONegative Net Change LLYNegative Net Change ABBVNegative Net Change

Zacks Equity Research

Lyra (LYRA) Posts Upbeat Data on Rhinosinusitis Study, Stock Up

Lyra (LYRA) gains on positive data from mid-stage study of LYR-220, treating patients with chronic rhinosinusitis who have had ethmoid sinus surgery.

CORTNegative Net Change ANIKNegative Net Change ANVSNegative Net Change LYRANegative Net Change

Zacks Equity Research

2seventy bio (TSVT) to Cut Jobs & Expand JW Therapeutics Deal

2seventy bio (TSVT) undertakes a restructuring program and announces plans to reduce 40% of its workforce. The company also plans to expand its collaboration with JW Therapeutics.

BMYNegative Net Change

Zacks Equity Research

Exelixis (EXEL) Gets Rights for Tumor Candidate From Insilico

Exelixis (EXEL) enters into a license agreement with Insilico Medicine for ISM3091, a potentially best-in-class USP1 inhibitor.

DVAXNegative Net Change EXELNegative Net Change ETONNegative Net Change

Zacks Equity Research

Arcutis (ARQT) Files sNDA for Zoryve in Atopic Dermatitis, Stock Up

Arcutis (ARQT) submits sNDA, seeking label expansion of Zoryve (roflumilast) cream 0.15% to treat patients with atopic dermatitis.

CORTNegative Net Change ANIKNegative Net Change ANVSNegative Net Change ARQTNegative Net Change