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Zacks News
ACELYRIN (SLRN) Fails to Meet Goal in HS Study, Stock Down 54%
by Zacks Equity Research
ACELYRIN (SLRN) fails to achieve statistically significant primary endpoint result in the hidradenitis suppurativa study of its lead candidate, izokibep. The stock of the company falls 54%.
Aquestive's (AQST) Libervant Accepted for FDA Review, Stock Up
by Zacks Equity Research
Aquestive (AQST) announces FDA acceptance of a regulatory application seeking approval for Libervant to treat pediatric patients with frequent seizure activity. The stock rises 4.7% in response.
Bicycle (BCYC) to Begin Pivotal Bladder Cancer Study, Stock Up
by Zacks Equity Research
Bicycle (BCYC) aligns with the FDA on the design of a mid-late-stage registrational study for its bladder cancer drug, BT8009, with the potential to support its accelerated approval. The stock rises 9%.
J&J (JNJ) Seeks Approval for Bladder Cancer Drug in Europe
by Zacks Equity Research
J&J's (JNJ) erdafitinib is already marketed as Balversa in the United States for FGFR-altered metastatic UC. Balversa is approved by the FDA under the accelerated pathway.
Bristol Myers' (BMY) Pulmonary Fibrosis Drug Positive in Phase II
by Zacks Equity Research
Bristol Myers (BMY) posts encouraging data from a phase II study in progressive pulmonary fibrosis.
Gilead's (GILD) Trodelvy Combo Shows Promise in NSCLC Study
by Zacks Equity Research
Gilead's (GILD) breast cancer drug Trodelvy, in combination with Keytruda, shows positive data in a phase II lung cancer study.
Codexis (CDXS) Transfers Leasing Rights to Vaxcyte, Stock Up
by Zacks Equity Research
Codexis (CDXS) transfers the leasing rights of its San Carlos, CA location to Vaxcyte to focus on technology development, inducing cost savings, to extend its cash runway to mid-2026. The stock rises 7%.
Merck's (MRK) Ebola Vaccine Gets Approval for Kids in Europe
by Kinjel Shah
The European Commission approves Merck's (MRK) Ebola vaccine for use in children as young as one year.
CymaBay (CBAY) Stock Up on Positive Results From PBC Study
by Zacks Equity Research
CymaBay (CBAY) reports encouraging data from the phase III study of seladelpar in PBC patients. Stock up.
Alnylam's (ALNY) Zilebesiran Meets Goals in Mid-Stage Study
by Zacks Equity Research
Alnylam's (ALNY) mid-stage study of zilebesiran in the treatment of hypertension in patients at high cardiovascular risk meets primary and key secondary endpoints.
Journey Medical (DERM) & Maruho Ink Deal for Qbrexza Asia Rights
by Zacks Equity Research
Journey Medical (DERM) enters into a second licensing agreement with Maruho to develop and commercialize Qbrexza to treat hyperhidrosis in certain Asian countries. The stock surges 18.4%.
NeuBase (NBSE) Surges 107% on New Shareholder Acquiring Stake
by Zacks Equity Research
With NeuBase (NBSE) exploring strategic alternatives to the company, Symetryx joins the company's shareholder base and urges the board to issue a unique $1 per share dividend.
J&J (JNJ) to End Pulmonary Hypertension Study on Opsumit
by Zacks Equity Research
The decision to end the CTEPH study on J&J's (JNJ) Opsumit (macitentan) was made at the recommendation of the study's independent DMC, following a pre-planned interim analysis.
Mirum Pharma (MIRM) Stock Rises 42% Year to Date: Here's Why
by Zacks Equity Research
Mirum Pharma (MIRM) surges 42% year to date due to encouraging progress in label-expansion efforts of Livmarli, along with strategic initiatives, to expand its commercial portfolio.
BioCardia (BCDA) Dips 26% on Flunking Heart Failure Study
by Zacks Equity Research
Based on one-year follow-up data from a pivotal phase III study, BioCardia (BCDA) reveals that its CardiAMP cell therapy is unlikely to achieve the primary endpoint for the treatment of heart failure.
AstraZeneca (AZN) Gets FDA CRL for Ultomiris in New Indication
by Zacks Equity Research
AstraZeneca (AZN) said the CRL for Ultomiris for NMOSD indication does not raise any concerns about the efficacy and safety data from the study.
Roche's (RHHBY) Application for PNH Drug Accepted by FDA
by Zacks Equity Research
Roche (RHHBY) biologics license application seeking approval for crovalimab for paroxysmal nocturnal hemoglobinuria gets FDA acceptance.
Novo Nordisk (NVO) Launches Wegovy in UK Amid Supply Issues
by Zacks Equity Research
Novo Nordisk (NVO) announces the controlled and limited launch of Wegovy in the U.K. amid rising demand for weight loss treatment and supply constraints.
Viatris (VTRS) Gets Tentative Approval for HIV Regimen for Kids
by Zacks Equity Research
Viatris (VTRS) obtains tentative approval from the FDA for a pediatric formulation of abacavir/dolutegravir/lamivudine, a once-daily treatment for children living with HIV.
Biogen's (BIIB) Stock Outperforms Industry YTD: Here's Why
by Zacks Equity Research
While most of Biogen's (BIIB) key drugs are facing declining sales, new products, like Leqembi in Alzheimer's disease, Qalsody in amyotrophic lateral sclerosis and zuranolone in depression, can help revive growth.
Seagen's (SGEN) Late-Stage Cervical Cancer Study Meets Goals
by Zacks Equity Research
Seagen (SGEN) and Genmab announce that the late-stage study of Tivdak in the second-line treatment of adult patients with recurrent or metastatic cervical cancer meets the primary and secondary goals.
FTC Allows Amgen (AMGN) to Proceed With $28B Horizon Buyout
by Zacks Equity Research
Per the settlement terms, Amgen (AMGN) is prohibited from bundling its products with Horizon's Tepezza or Krystexxa. Amgen expects to complete the Horizon acquisition before 2023-end.
Centessa (CNTA) Surges 72% in the Past 3 Months: Here's Why
by Zacks Equity Research
Centessa (CNTA) shares rise significantly in the past three months due to the encouraging progress in the development of its lead pipeline candidate, SerpinPC, which is currently in mid-late-stage studies.
5 Biotech Stocks to Buy as New Drug Approvals Drive Industry Prospects
by Ekta Bagri
New drug approvals and pipeline progress are likely to help maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and a solid pipeline progress position EXEL, DVAX, ACLX, ANIP and VNDA well amid volatility.
Roche's (RHHBY) Late-Stage Lung Cancer Study Meets Primary Goal
by Zacks Equity Research
Roche's (RHHBY) late-stage ALK-positive non-small cell lung cancer study evaluating Alecensa meets the primary endpoint of disease-free survival.