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Zacks News
Here's Why Leap Therapeutics (LPTX) is Poised for a Turnaround After Losing -28.92% in 4 Weeks
by Zacks Equity Research
Leap Therapeutics (LPTX) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.
Humanigen (HGEN) Plunges as COVID Study Fails to Meet Goal
by Zacks Equity Research
The NIAID's ACTIV-5/BET-B study evaluating Humanigen's (HGEN) lenzilumab plus remdesivir in hospitalized COVID-19 patients fails to meet the primary endpoint. Stock down.
Amryt (AMYT) Mycapssa Gets Orphan Drug Tag for Carcinoid Syndrome
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Amryt's (AMYT) Mycapssa for the treatment of carcinoid syndrome. Stock up in pre-market trading.
Perrigo (PRGO) Unit Files for OTC Birth Control Pill With FDA
by Zacks Equity Research
The FDA's potential approval of Perrigo (PRGO) unit, HRA Pharma's OTC birth control pills can make the drug the first of its kind to be made available without prescription in the United States.
Novo Nordisk's (NVO) Haemophilia A Study Meets Safety Endpoint
by Zacks Equity Research
Novo Nordisk's (NVO) phase I & II FRONTIER1 dose-escalation study investigating Mim8 for treating people with haemophilia A meets its primary safety endpoint.
Horizon (HZNP) Gets FDA Nod for Krystexxa's Label Expansion
by Zacks Equity Research
The FDA approves Horizon's (HZNP) sBLA for Krystexxa injection plus methotrexate to help people suffering from uncontrolled gout achieve a complete response to therapy.
Zacks.com featured highlights include Boot Barn, Canada Goose, Pediatrix Medical Group, Leap Therapeutics and Oncolytics Biotech
by Zacks Equity Research
Boot Barn, Canada Goose, Pediatrix Medical Group, Leap Therapeutics, and Oncolytics Biotech are part of Zacks Screen of the week article.
Editas (EDIT) Focuses on Developing Gene-Editing Eye Drug
by Zacks Equity Research
Editas' (EDIT) lead pipeline candidate, EDIT-101, which employs CRISPR gene editing to treat LCA10, holds potential. Dependence on partners for collaboration revenues a woe.
Acadia (ACAD) Down More Than 30% in Past 3 Months: Here's Why
by Zacks Equity Research
The recent setback faced by Acadia's (ACAD) resubmitted sNDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with ADP has hurt the stock.
Ride on Rising P/E Investing With These 5 Top-Ranked Stocks
by Sanghamitra Saha
Want to try an out-of-the-box approach? Tap Oncolytics Biotech (ONCY), Pediatrix Medical Group Inc (MD), Boot Barn (BOOT), Canada Goose (GOOS) and Leap Therapeutics (LPTX).
Adverum (ADVM) Completes IND Amendment for Gene Therapy Study
by Zacks Equity Research
Adverum (ADVM) completes IND amendment with the FDA for initiating the phase II LUNA study on its gene therapy candidate, ADVM-022, for treating wet-age-related macular degeneration. Stock up.
Vertex (VRTX) VX-880 Early Study Sees Lifting of Clinical Hold
by Zacks Equity Research
The FDA lifts clinical hold on Vertex's (VRTX) study on VX-880, its stem-cell-derived, fully differentiated islet replacement therapy that could offer a functional cure for type 1 diabetes patients.
Celldex (CLDX) Down on Interim Data From Phase Ib Study in CSU
by Zacks Equity Research
Celldex (CLDX) posts interim data from the phase Ib study evaluating barzolvolimab in patients with moderate to severe chronic spontaneous urticaria. Shares down.
Seagen (SGEN) Up More Than 20% in Past 3 Months: Here's Why
by Zacks Equity Research
Seagen (SGEN) is riding on the strong uptake of its marketed drugs that are approved for different cancer indications. Further label expansion of these drugs should boost the top line.
Graybug (GRAY) to Review Strategic Alternatives, Stock Up
by Zacks Equity Research
Graybug's (GRAY) board of directors is set to review strategic options focused on maximizing shareholder value, including a potential sale of the company. Shares rise.
Cybin (CYBN) Up on FDA Clearance of IND for CYB003 in MDD
by Zacks Equity Research
Cybin (CYBN) receives a "may proceed letter" and IND application clearance from the FDA for a phase I/IIa study evaluating CYB003 for potential treatment of major depressive disorder. Shares up.
uniQure (QURE) Up on Safety Data From Huntington's Disease Study
by Zacks Equity Research
uniQure (QURE) posts safety and biomarker data from the 10 patients enrolled in the lower-dose cohort of its ongoing phase I/II study evaluating AMT-130 for treating Huntington's disease.
Precision BioSciences' (DTIL) Stock Up This Week: Here's Why
by Zacks Equity Research
Shares of Precision BioSciences (DTIL) are up as the company inks a gene-editing deal with Novartis to develop a potentially curative treatment for disorders like sickle cell disease.
Apellis (APLS) Expands Deal for Targeted Complement Therapies
by Zacks Equity Research
Apellis (APLS) expands its current research and development deal with privately held company, Affilogic, to develop targeted complement therapies for delivery into the brain.
Exelixis (EXEL) Begins Study on XL092 Combo in Colorectal Cancer
by Zacks Equity Research
Exelixis (EXEL) starts the phase III STELLAR-303 study evaluating XL092 in combination with atezolizumab as compared to regorafenib for treating patients with metastatic colorectal cancer.
Bristol Myers' (BMY) Breyanzi sBLA Receives EMA Validation
by Zacks Equity Research
The EMA validates Bristol Myers' (BMY) type II variation application for the label expansion of Breyanzi for treating relapsed/refractory large B-cell lymphoma after first-line therapy.
Seagen (SGEN) Stock Up on Rumors of Acquisition by Merck
by Zacks Equity Research
Shares of Seagen (SGEN) rise after rumors of a buyout by Merck hit the market. However, a deal is not imminent at the moment.
FDA Panel Votes Against Acadia (ACAD) sNDA for Nuplazid
by Zacks Equity Research
An FDA advisory committee votes against Acadia's (ACAD) Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer's disease psychosis.
Addex (ADXN) Terminates Parkinson's-Related Dyskinesia Study
by Zacks Equity Research
Addex (ADXN) terminates the phase IIb/III study evaluating dipraglurant as a potential treatment for dyskinesia associated with Parkinson's disease. Shares fall.
Blueprint Medicines' (BPMC) Ayvakit Aids Growth Amid Rivalry
by Zacks Equity Research
Blueprint Medicines' (BPMC) lead drug, Ayvakit, approved to treat rare cancer and other rare diseases, has seen strong uptake since approval. However, stiff competition remains a concern.