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Zacks News
AbbVie's Recently Acquired Parkinson's Drug Meets Third Study Goal
by Zacks Equity Research
Data from a late-stage study shows that treatment with flexible doses of ABBV's tavapadon reduced the burden of Parkinson's disease.
MRK's Keytruda & Lynparza Combo Meets Goal in Ovarian Cancer Study
by Zacks Equity Research
The KEYLYNK-001 study evaluating Merck's Keytruda plus chemotherapy followed by maintenance with Lynparza meets the primary goal in epithelial ovarian cancer.
Incyte's Late-stage NSCLC Study Meets Primary and Secondary Goals
by Zacks Equity Research
INCY's phase III study, evaluating retifanlimab in combination with platinum-based chemotherapy for the treatment of metastatic non-small cell lung cancer, meets primary and secondary endpoints.
Beam Therapeutics Appoints Sravan Emany as New CFO, Shares Up
by Zacks Equity Research
BEAM appoints Sravan K. Emany as its new chief financial officer, effective Dec. 19. Shares rise on this leadership transition.
AFMD Stock Down Despite FDA's RMAT Status for Lymphoma Therapy
by Zacks Equity Research
The FDA bestows a Regenerative Medicine Advanced Therapy tag to Affimed's acimtamig in combination with AlloNK for treating Hodgkin lymphoma. Shares fall.
GSK Expands Vaccine Collaboration With Zhifei in China
by Zacks Equity Research
GSK expands the licensing deal with Zhifei to market its shingles vaccine in China for an additional eight years till 2034.
STOK Shares Up on FDA's Breakthrough Tag for Dravet Syndrome Drug
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy designation to Stoke Therapeutics' zorevunersen for the treatment of Dravet syndrome. Stock rises.
AstraZeneca's Imfinzi Gets FDA Nod for Expanded Use in SCLC
by Zacks Equity Research
The FDA approves AZN's Imfinzi for treating patients with limited-stage small-cell lung cancer based on phase III ADRIATIC study data.
Cytokinetics Initiates Confirmatory Study on Heart Failure Drug
by Zacks Equity Research
CYTK opens enrollment in the phase III COMET-HF study on omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction.
JANX Stock Hits Record High on Prostate Cancer Study Data
by Zacks Equity Research
An early-stage study data shows that treatment with Janux's JANX007 generates deep and durable efficacy responses in heavily pretreated patients with mCRPC.
RZLT Stock Rises on FDA's Orphan Designation for Rare Disease Drug
by Zacks Equity Research
The FDA bestows an Orphan Drug status to Rezolute's ersodetug for treating hypoglycemia due to tumor hyperinsulinism. Shares rise.
FDA Accepts Cytokinetics' Application for Cardiovascular Drug
by Zacks Equity Research
CYTK's NDA is seeking approval for the lead pipeline candidate, aficamten, which the FDA accepted and assigned a target action date of Sept. 26, 2025.
PTCT Stock Soars on Licensing Deal With NVS for Huntington's Therapy
by Zacks Equity Research
Per the terms, PTC will receive $1 billion in upfront payment from Novartis upon the deal's closure. It is also eligible for milestone payments of up to $1.9 billion.
SNTI Stock Skyrockets on Initial Data From Phase I Cancer Study
by Zacks Equity Research
Senti Bio posts upbeat initial data from a phase I study on SENTI-202 for the treatment of relapsed/refractory hematologic malignancies. Stock soars.
ESPR Files New Drug Submissions for Nexletol & Nexlizet in Canada
by Zacks Equity Research
Esperion files new drug submissions in Canada for Nexletol and Nexlizet as a treatment for reducing bad cholesterol and cardiovascular risk. Shares rise.
Allogene Therapeutics Loses 23% Year to Date: How to Play the Stock?
by Sundeep Ganoria
The dip in ALLO's share price can be attributed to strategic changes in its pipeline, which delayed bringing its lead drug to market by at least two years.
Altimmune Stock Up More Than 25% in a Month: Here's Why
by Zacks Equity Research
ALT's recent progress related to the development of the lead product candidate, pemvidutide, for treating obesity and MASH is aiding the stock.
Mirum Shares Surge More Than 90% in 6 Months: Here's Why
by Zacks Equity Research
MIRM's lead drug, Livmarli, is driving revenues and the momentum is likely to continue. The company's efforts to build its pipeline beyond Livmarli also hold promise.
GSK Gets EC Nod for Liquid Version of Meningococcal Vaccine Menveo
by Zacks Equity Research
The European Commission approves fully liquid presentation of GSK's meningococcal vaccine, Menveo, to protect against invasive meningococcal disease.
Grifols Stock Declines After Brookfield Drops Buyout Offer
by Zacks Equity Research
Brookfield decides to drop its buyout offer for GRFS following discrepancies over the company's valuation.
Small Caps Are Winners of 2024: 5 Picks With Solid Short-Term Upside
by Nalak Das
These five small cap stocks have strong growth potential for 2025. These are: TALK, RYAM, CSTL, PBAM, RSSS.
ODAC to Discuss Exelixis' Application for Cabometyx Label Expansion
by Zacks Equity Research
The FDA notified EXEL that its sNDA seeking label expansion of cabozantinib will be discussed at an ODAC meeting in March 2025.
AstraZeneca's Combination Therapy Meets Goal in Prostate Cancer Study
by Zacks Equity Research
Data from a late-stage study shows that treatment with a three-drug combo involving AZN's Truqap benefits patients with an aggressive form of prostate cancer.
NTLA Up as FDA Grants RMAT Status to Genome-Editing Therapy
by Zacks Equity Research
The FDA bestows a Regenerative Medicine Advanced Therapy tag to Intellia's nex-z for treating hereditary transthyretin (ATTR) amyloidosis with polyneuropathy.
FDA Accepts GSK's BLA for Blenrep Combos in Multiple Myeloma
by Zacks Equity Research
The FDA accepts GSK's BLA seeking approval of Blenrep combinations for treating relapsed/refractory multiple myeloma. A decision is due on July 23, 2025.