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Zacks News
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.
Denali Starts Dosing in Phase II Parkinson's Disease Study
by Zacks Equity Research
DNLI begins dosing in the phase IIa study on BIIB122 in approximately 50 participants with Parkinson's disease and LRRK2 pathogenic mutations confirmed by genetic testing.
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.
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.
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.
Exelixis Stock Surges 25% in a Month: Time to Buy or Sell?
by Zacks Equity Research
EXEL's shares move north 25% in a month on the back of strong third-quarter results and raised outlook. We are optimistic about the stock as we believe there is room for growth.
HALO Withdraws Acquisition Bid for EVO, Reaffirms '24 View, Stock Up
by Zacks Equity Research
Halozyme withdraws its proposal to acquire Evotec for 11 euro per share in cash. The company maintains its 2024 revenue guidance. Shares up.
Corcept Shares Rise More Than 60% in Three Months: Here's Why
by Zacks Equity Research
CORT's Cushing's syndrome drug, Korlym, is driving revenues. The NDA for relacorilant in Cushing's syndrome will be filed shortly.
JAZZ Secures FDA Approval for Ziihera in Biliary Tract Cancer
by Zacks Equity Research
Following the FDA's approval, Jazz's Ziihera becomes the first dual HER2-targeted bispecific antibody and chemotherapy-free treatment approved for biliary tract cancer.