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Zacks News
Fulcrum Before Q3 Earnings: How Should Investors Play the Stock?
by Ahan Chakraborty
FULC is expected to provide updates on its early-stage candidate for SCD, pociredir, in its third-quarter earnings release.
Fulcrum Stock Tanks 58% in a Month: Buying Opportunity or Risky Bet?
by Ahan Chakraborty
Despite the recent pipeline setback, investors are encouraged to buy the FULC stock based on the potential of its promising SCD candidate, pociredir.
Pacira's Exparel Receives Permanent New Product-Specific J-Code
by Zacks Equity Research
PCRX reports that the CMS has assigned a permanent product-specific J-code for Exparel, which is set to facilitate better insurance coverage for the drug.
RARE's Wilson Disease Candidate Betters Standard Therapy in Study
by Zacks Equity Research
Ultragenyx reports superior efficacy of UX701 for Wilson disease compared with standard therapy from the Stage 1 cohorts of its pivotal phase I/II/III study.
Zevra Stock Surges Close to 70% in 3 Months: Here's Why
by Zacks Equity Research
The FDA approval for ZVRA's Miplyffa (arimoclomol) capsules in September for treating Niemann-Pick disease type C drives the stock.
Down -57.53% in 4 Weeks, Here's Why Fulcrum Therapeutics (FULC) Looks Ripe for a Turnaround
by Zacks Equity Research
Fulcrum Therapeutics (FULC) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.
GILD Grants Right for HIV PrEP Candidate to Six Generic Companies
by Zacks Equity Research
Gilead signs non-exclusive, royalty-free voluntary licensing agreements with six generic companies to market its investigational medicine, lenacapavir, for HIV Prevention.
AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use
by Zacks Equity Research
The FDA grants priority review to AZN's sNDA for Calquence for untreated mantle cell lymphoma. A decision is expected in first-quarter 2025.
STTK Discontinues Cancer Program, Plans Workforce Cut, Stock Falls
by Zacks Equity Research
Shattuck stock plunges as it discontinues the clinical development of SL-172154 for two blood cancer indications and plans to reduce the workforce by 40%.
IONS' Rare Neurology Disorder Candidate Gets FDA's Fast Track Tag
by Zacks Equity Research
The FDA bestows a Fast Track designation to Ionis' investigational candidate, zilganersen, for treating a rare neurological disorder called Alexander disease.
PRME Stock Rises 11.8% on Collaboration With Bristol Myers
by Zacks Equity Research
Prime Medicine collaborates with Bristol Myers Squibb for the development of T-cell therapies. Shares gain.
AstraZeneca's Enhertu sBLA Gets FDA Priority Tag for Expanded Use
by Zacks Equity Research
The FDA grants priority review to AZN's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer. A decision is due in first-quarter 2025.
MRNA Begins Dosing in Pivotal Study on Norovirus Vaccine
by Zacks Equity Research
Moderna doses the first participant in a phase III study evaluating its mRNA norovirus vaccine candidate, mRNA-1403, in the United States.
AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V
by Zacks Equity Research
ABBV submits a BLA for Teliso-V to the FDA for treating previously treated non-small cell lung cancer patients with c-Met overexpression.
SAVA Stock Down on Settling Misleading Alzheimer's Study Data Claims
by Zacks Equity Research
Casava stock falls as the company agrees to pay a cumulative fine exceeding $40 million to settle misleading claims charges brought against it by the SEC.
SAGE, BIIB End Collaboration for Neurology Candidate SAGE-324
by Zacks Equity Research
Sage Therapeutics announces discontinuation of the collaboration agreement with Biogen related to SAGE-324 for essential tremor.
Bristol Myers Stock Up on FDA Nod for Schizophrenia Treatment
by Zacks Equity Research
The FDA approves BMY's differentiated schizophrenia treatment for adults and broadens its diverse portfolio. Shares gain.
BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies
by Zacks Equity Research
Biomea stock rises 9% after the FDA lifts clinical hold on two phase I/II studies evaluating the company's lead candidate, BMF-219, for diabetes.
MRK's Keytruda Combo Fails in Phase III Colorectal Cancer Study
by Zacks Equity Research
The phase III KEYFORM-007 study, evaluating Merck's Keytruda plus favezelimab for treating metastatic colorectal cancer, fails to meet the primary endpoint.
AZN's Tagrisso Gets FDA Nod for Expanded Use in NSCLC
by Zacks Equity Research
The FDA approves AstraZeneca's Tagrisso for treating unresectable, stage III EGFR-mutated non-small cell lung cancer.
CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study
by Zacks Equity Research
Celldex stock falls due to safety concerns related to the treatment of urticaria patients with barzolvolimab in a phase II study, despite robust efficacy data.
Roche's Lupus Study for Gazyva Meets Primary & Key Secondary Goals
by Zacks Equity Research
RHHBY announces meeting primary and key secondary goals in the late-stage study of its lymphoma drug, Gazyva/Gazyvaro, for treating active lupus nephritis.
WVE Stock Soars on Upbeat Efficacy Data From Muscle Disease Study
by Zacks Equity Research
Wave Life Sciences stock soars 53% on positive interim data from a mid-stage study showing superior efficacy of investigational DMD drug, WVE-N531.
BHVN Stock Up as Rare Neurological Disease Study Meets Primary Goal
by Zacks Equity Research
The pivotal BHV4157-206-RWE study evaluating Biohaven's pipeline candidate, troriluzole, for treating spinocerebellar ataxia meets its primary endpoint.
Here's Why Bausch Health Stock Gained 14.7% in a Week
by Zacks Equity Research
BHC stock rises 14.7% in a week after a report surfaced that the company is in talks with Jefferies Financial Group to push out maturities on some of its debt.