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Zacks News
Pacira (PCRX) Preliminary '23 Revenues Solid, Exparel Strong
by Zacks Equity Research
Pacira (PCRX) posts preliminary revenues for the fourth quarter and full year 2023.
Collegium (COLL) Shares Rise on Financial Outlook for 2024
by Zacks Equity Research
Collegium (COLL) reports financial guidance for full-year 2024 and business updates. Shares of the company rise on the same.
Assertio (ASRT) Shares Fall as Dan Peisert Steps Down as CEO
by Zacks Equity Research
Assertio (ASRT) appoints Heather Mason as its interim CEO as its current CEO, Dan Peisert, steps down from his role. Shares of the company fall on the same.
Bristol Myers (BMY) NSCLC Drug Application Gets EMA Validation
by Zacks Equity Research
Bristol Myers' (BMY) repotrectinib is under review in the European Union for the treatment of locally advanced or metastatic ROS1-Positive NSCLC and NTRK-positive solid tumors.
Voyager (VYGR) Gains on Gene Therapy Deal With Novartis
by Zacks Equity Research
Voyager (VYGR) enters into a capsid license agreement with Novartis for Huntington's disease and spinal muscular atrophy. The infusion of cash will extend the company's cash runway.
BEAM Stock Rallies More Than 25% in 3 Months: What Next?
by Zacks Equity Research
BEAM is making good progress with its lead pipeline candidate, BEAM-101, which is being developed for treating sickle cell disease. Also, the recent restructuring efforts are expected to reduce costs.
Roche (RHHBY) to Acquire LumiraDx's Point of Care Technology
by Zacks Equity Research
Roche (RHHBY) is set to acquire LumiraDx's Point of Care technology for $295 million and an additional payment of up to $55 million.
Bayer (BAYRY) Loses 28% in 2023: What to Expect in 2024?
by Zacks Equity Research
Bayer (BAYRY) faced challenges in 2023 as sales declined in the Crop Science division. Pipeline setbacks also weighed on the stock.
Amicus (FOLD) Banks on Galafold, Overdependence a Concern
by Zacks Equity Research
Amicus' (FOLD) lead drug, Galafold, is witnessing solid uptake since its launch. The drug holds blockbuster potential. However, overdependence on Galafold for revenues remains a concern.
Iovance (IOVA) Falls After Clinical Update on Lung Cancer Drug
by Zacks Equity Research
Iovance (IOVA) is likely to pause enrollment in the phase II IOV-LUN-202 study evaluating its tumor infiltrating lymphocyte therapy, LN-145, for treating non-small cell lung cancer. Stock declines.
Coherus (CHRS) Stock Rallies on FDA Nod for Udenyca Onbody
by Zacks Equity Research
The FDA approves Coherus' (CHRS) Udenyca Onbody, an on-body injector presentation of Udenyca (pegfilgrastim-cbqv). Shares of the company rise on the news.
Senti Bio (SNTI) Rises as FDA Clears IND for Cancer Candidate
by Zacks Equity Research
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.
Cidara (CDTX) Up on EC Nod for Rezzayo in Invasive Candidiasis
by Zacks Equity Research
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%.
Bausch Health (BHC) Ulcerative Colitis Drug Meets Primary Goal
by Zacks Equity Research
Bausch's (BHC) amiselimod achieves the primary and key secondary endpoints, including clinical and endoscopic measures, in the double-blind period of a phase II study.
Sanofi (SNY) Discontinues Tusamitamab Ravtansine Cancer Program
by Zacks Equity Research
Sanofi (SNY) stops the development of tusamitamab ravtansine after a phase III study on the candidate for second-line metastatic non-small cell lung cancer fails to meet the primary endpoint.
argenx (ARGX) Tanks on Top-Line Data From Pemphigus Study
by Zacks Equity Research
argenx's (ARGX) phase III ADDRESS study, evaluating efgartigimod subcutaneous for treating pemphigus, fails to meet primary and secondary endpoints. Stock falls.
bluebird (BLUE) Stock Down on Raising Additional Capital
by Zacks Equity Research
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.
Roche's (RHHBY) sBLA for Xolair Gets FDA Priority Review Tag
by Zacks Equity Research
The FDA accepts and grants priority review to Roche's (RHHBY) supplemental biologics license application for Xolair for the reduction of food allergic reactions. A decision is due in the first quarter of 2024.
Anavex (AVXL) Rises as CHMP Deems Blarcamesine Eligible for MAA
by Zacks Equity Research
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.
Invivyd (IVVD) Surges on Positive Data From COVID-19 Study
by Zacks Equity Research
Invivyd (IVVD) reports positive initial data from the phase III CANOPY study on VYD222 for the prevention of symptomatic COVID-19. Stock shoots up on the news.
Arcutis (ARQT) Up on FDA Nod for Zoryve in Seborrheic Dermatitis
by Zacks Equity Research
The FDA approves Arcutis' (ARQT) NDA for Zoryve topical foam 0.3% for treating seborrheic dermatitis in individuals nine years of age and above.
Mirum (MIRM) Down on Failure of Mid-Stage Study on Livmarli
by Zacks Equity Research
Mirum (MIRM) faces a setback in its efforts to expand its lead drug Livmarli's label for the indication of biliary atresia in patients who have undergone a Kasai surgery.
Bristol Myers (BMY) Stops Late-Stage Colorectal Cancer Study
by Zacks Equity Research
Bristol Myers (BMY) decides to discontinue the phase III colorectal cancer study as it was unlikely to meet its primary endpoints upon completion.
Gilead (GILD) Outperforms Industry in 6 Months: What Lies Ahead?
by Zacks Equity Research
Gilead (GILD) gains 3.7% in six months as its oncology portfolio gains traction and its HIV business maintains momentum.
NextCure (NXTC) Down on Shelving Plans to Develop Candidate
by Zacks Equity Research
NextCure (NXTC) plans to focus on developing LNCB74 and stop the development of NC762 to conserve cash. The company's shares decline on the same.