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Zacks News
Can-Fite (CANF) Files Patent Applications for Namodenoson
by Zacks Equity Research
Can-Fite (CANF) files patent applications in several countries for treating all advanced solid tumors. The filing comes after Can-Fite's drug cleared all tumor lesions in advanced liver cancer.
Pluristem (PSTI) Misses Study Goal to Treat COVID-Related ARDS
by Zacks Equity Research
Pluristem's (PSTI) phase II studies evaluating PLX-PAD cells for treating acute respiratory distress syndrome associated with COVID-19 fail to achieve the primary endpoint.
ACADIA (ACAD) Up on Resubmission Plan for Nuplazid sNDA to FDA
by Zacks Equity Research
ACADIA (ACAD) to resubmit sNDA for Nuplazid (pimavanserin) to the FDA for treating hallucinations and delusions associated with dementia focused on Alzheimer's disease psychosis. Shares rise.
Bellus (BLU) Stock Surges on Data From Chronic Cough Study
by Zacks Equity Research
Bellus Health (BLU) achieves the primary endpoint in a phase IIb study evaluating BLU-5937 for the treatment of refractory chronic cough.
Intellia (NTLA) Begins Dosing in Hereditary Angioedema Study
by Zacks Equity Research
Intellia (NTLA) doses the first patient in a phase I/II study to evaluate NTLA-2002 as a single-dose therapy for preventing attacks in patients having hereditary angioedema.
SpringWorks (SWTX) & AbbVie Unite for Multiple Myeloma Drug
by Zacks Equity Research
SpringWorks Therapeutics (SWTX) collaborates with AbbVie (ABBV) to evaluate the combination of nirogacestat with AbbVie's ABBV-383 for relapsed or refractory multiple myeloma.
Angion (ANGN) Kidney Drug Misses Third Study Goal in 2021
by Zacks Equity Research
Angion's (ANGN) phase II study evaluating ANG-3777 in cardiac surgery-associated acute kidney injury fails to achieve the primary endpoint.
Heron's (HRTX) Zynrelef Gets FDA Nod for Label Expansion
by Zacks Equity Research
The FDA grants label expansion to Heron???s (HRTX) Zynrelef for pain relief after small to medium abdominal surgeries, lower extremity total joint replacements, and foot and ankle surgeries in adults.
Affimed (AFMD) Starts AFM24-102 Study With Roche's Tecentriq
by Zacks Equity Research
Affimed (AFMD) starts recruiting patients in a phase I/IIa study to evaluate the combination of AFM24 and Roche's atezolizumab in solid tumors.
Bayer's (BAYRY) Phase III Study on Nubeqa Combo Meets Goal
by Zacks Equity Research
Bayer's (BAYRY) phase III study evaluating Nubeqa in combination with docetaxel and androgen deprivation therapy for treating metastatic hormone-sensitive prostate cancer meets the primary endpoint.
Amicus (FOLD) Filings for AT-GAA in Pompe Disease Accepted by EMA
by Zacks Equity Research
The European Medicines Agency accepts Amicus Therapeutics' (FOLD) MAA for AT-GAA, a potential treatment for Pompe disease.
Merck's (MRK) Keytruda Gets FDA Nod for Expanded Melanoma Use
by Zacks Equity Research
Post FDA approval, Merck's (MRK) anti-PD-1 therapy Keytruda is now approved as an adjuvant treatment for adult & pediatric patients with stage IIB, IIC or III melanoma following complete resection.
Adagene (ADAG) Gets FDA Nod to Begin Solid Tumor Antibody Study
by Zacks Equity Research
The FDA grants Adagene (ADAG) a clearance to initiate clinical studies of its investigational candidate ADG116 in combination with pembrolizumab to treat advanced/metastatic solid tumors.
Novavax (NVAX) Stock Up YTD on COVID-19 Vaccine Potential
by Zacks Equity Research
Novavax (NVAX) is likely to generate huge revenues as the company has started filing approvals for emergency use of its COVID-19 vaccine in multiple nations.
Gilead (GILD) Gets EU Nod for Breast Cancer Drug, Trodelvy
by Zacks Equity Research
The European Commission grants marketing authorization to Gilead's (GILD) Trodelvy as a monotherapy for the second-line treatment of adults with metastatic triple-negative breast cancer.
CRISPR's (CRSP) CAR-T Cell Therapy Gets FDA's RMAT Designation
by Zacks Equity Research
The FDA grants a Regenerative Medicine Advanced Therapy designation to CRISPR Therapeutics' (CRSP) CTX110 targeting CD19+ B-cell malignancies.
Gilead (GILD) Files BLA for Bulevirtide for Hepatitis Delta Virus
by Zacks Equity Research
Gilead (GILD) submits a biologics license application to the FDA for bulevirtide for the treatment of chronic hepatitis delta virus infection in adults with compensated liver disease.
AbbVie's (ABBV) Skyrizi Gets Nod for Psoriatic Arthritis in EU
by Zacks Equity Research
AbbVie (ABBV) secures approval in the EU for Skyrizi to treat adult patients with active psoriatic arthritis.
Novavax (NVAX) COVID Jab Gets Philippines Nod, Under Review in EU
by Zacks Equity Research
Novavax's (NVAX) secures approval for its COVID vaccine in the Philippines. The EMA begins reviewing the company's regulatory submission for its COVID vaccine. Evidently, the stock gains.
CRISPR (CRSP) to Begin Clinical Study on Diabetes Therapy Drug
by Zacks Equity Research
CRISPR Therapeutics (CRSP) receives clearance from Health Canada to initiate clinical studies for VCTX210, its investigational therapy for the treatment of type 1 diabetes.
Wall Street Analysts See a 98% Upside in Precision BioSciences (DTIL): Can the Stock Really Move This High?
by Zacks Equity Research
The average of price targets set by Wall Street analysts indicates a potential upside of 98% in Precision BioSciences (DTIL). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
Precision BioSciences (DTIL) Reports Q3 Loss, Tops Revenue Estimates
by Zacks Equity Research
Precision BioSciences (DTIL) delivered earnings and revenue surprises of 68.33% and 181.35%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?
Analysts Estimate Precision BioSciences (DTIL) to Report a Decline in Earnings: What to Look Out for
by Zacks Equity Research
Precision BioSciences (DTIL) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Precision (DTIL) Inks Deal With Tiziana for Cancer Candidate
by Zacks Equity Research
Precision (DTIL) signs an exclusive license agreement with Tiziana to explore the latter's fully human anti-CD3 mAb, foralumab, for treating various cancer indications. Stock up.
Precision BioSciences (DTIL) Surpasses Q2 Earnings and Revenue Estimates
by Zacks Equity Research
Precision BioSciences (DTIL) delivered earnings and revenue surprises of 194.74% and 202.63%, respectively, for the quarter ended June 2021. Do the numbers hold clues to what lies ahead for the stock?