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Zacks News
TG Therapeutics' Shares Soar on Positive Early-Stage Data
by Zacks Equity Research
TG Therapeutics (TGTX) announces positive first clinical data from its once daily, oral, BTK inhibitor, TG-1701, as a single agent and as a triple therapy in combination.
Regeneron Reports Initial Data for Multiple Myeloma Drug
by Zacks Equity Research
Regeneron (REGN) reports initial data for REGN5458, a BCMAxCD3 bispecific antibody, in patients with relapsed or refractory (R/R) multiple myeloma.
bluebird Reports Positive Top-Line Data on Myeloma Drug
by Zacks Equity Research
bluebird (BLUE) and partner Bristol-Myers report positive top-line results from a phase II study on idecabtagene vicleucel in patients with relapsed and refractory multiple myeloma.
Alexion (ALXN) Looks Good: Stock Adds 6% in Session
by Zacks Equity Research
Alexion (ALXN) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.
Sage Therapeutics' Depression Drug Fails in Study, Stock Down
by Zacks Equity Research
Sage Therapeutics' (SAGE) phase III study on pipeline candidate SAGE-217 for the treatment of major depressive disorder fails to meet the primary endpoint.
Spero Posts Preliminary Data on SPR720 for Pulmonary Disease
by Zacks Equity Research
Spero (SPRO) reports preliminary findings from a phase I first-in-human study on SPR720, presently being evaluated for the treatment of nontuberculous mycobacterial pulmonary disease.
Ra Pharmaceuticals Begins Phase II Study on Autoimmune Drug
by Zacks Equity Research
Ra Pharmaceuticals (RARX) begins dosing of the first patient in its phase II study of zilucoplan for the treatment of immune-mediated necrotizing myopathy.
Zealand Initiates Second Late-Stage CHI Study on Dasiglucagon
by Zacks Equity Research
Zealand (ZEAL) announces initiation of the second phase III study to evaluate dasiglucagon in pediatric patients with congenital hyperinsulinism.
Biogen's Lupus Candidate Meets Endpoint in Phase II Study
by Zacks Equity Research
Biogen (BIIB) posts favorable top-line results from a phase II study evaluating BIIB059 for treating cutaneous and systemic lupus erythematosus. The study tastes success by achieving its main goal.
Seattle Genetics, Astellas Tie Up With Merck for Cancer Study
by Zacks Equity Research
Seattle Genetics (SGEN) and Astellas team up with Merck for a late-stage study to evaluate the enfortumab vedotin and Keytruda combo in patients with previously untreated metastatic urothelial cancer.
Amarin's Vascepa MAA for Heart Risk Indication Accepted in EU
by Zacks Equity Research
The EMA validates Amarin's (AMRN) regulatory application seeking approval for Vascepa as a treatment to reduce risk of cardiovascular events.
Puma Biotech Expands Pierre Fabre License to Add Countries
by Zacks Equity Research
Puma Biotech (PBYI) stretches its license deal with Pierre Fabre, granting the latter commercial rights to Nerlynx in new countries across Europe and parts of Africa. Stock rallies.
Acorda (ACOR) Down More Than 80% Year to Date: Here's Why
by Zacks Equity Research
Acorda's (ACOR) lead MS drug Ampyra is hit by generic competition in the United States, which is hurting the company's top line of late. Parkinson's disease drug Inbrija seems an ideal replacement.
Incyte's NDA for Pemigatinib Gets FDA's Priority Review Tag
by Zacks Equity Research
The FDA accepts and grants priority review to Incyte's (INCY) new drug application for pemigatinib as a second-line treatment for patients with FGFR2 translocated cholangiocarcinoma.
Clovis (CLVS) Looks Good: Stock Adds 6.3% in Session
by Zacks Equity Research
Clovis (CLVS) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.
Sorrento Turns Down Two All-Cash Takeover Bids, Stock Jumps
by Zacks Equity Research
Sorrento (SRNE) rejects an all-cash unsolicited acquisition proposal from two unknown biopharmaceutical companies. The stock shoots up.
Global Blood's (GBT) Oxbryta Secures FDA Approval for SCD
by Zacks Equity Research
Global Blood's (GBT) Oxbryta wins the FDA nod to address sickle cell disease in patients aged 12 years and above. The approval comes three months ahead of schedule.
Alexion Gets Approval for Label Expansion of Soliris in Japan
by Zacks Equity Research
Alexion (ALXN) gets Japan Ministry of Health, Labour and Welfare's approval for the label expansion of Soliris.
Biogen Ends Enrollment in Eye Disorder Study on Gene Therapy
by Zacks Equity Research
Biogen (BIIB) completes enrollment in the global phase III STAR clinical study evaluating the gene therapy timrepigene emparvovec for the treatment of a rare, inherited retinal disorder.
Vertex (VRTX) Gets French Reimbursement for CF Drug Orkambi
by Zacks Equity Research
The French reimbursement for Vertex's (VRTX) cystic fibrosis medicine Orkambi removes a key overhang for the stock.
Alnylam's Givosiran Gets FDA Nod for Acute Hepatic Porphyria
by Zacks Equity Research
Alnylam (ALNY) gets FDA approval for givosiran injection, to be marketed by the trade name of Givlaari, for the treatment of adults with AHP.
Achillion's (ACHN) Danicopan Gets EMA's PRIME Tag for PNH
by Zacks Equity Research
Achillion's (ACHN) lead pipeline candidate danicopan receives PRIME status from the EMA as a treatment option for PNH in patients, who are not adequately responding to a C5 inhibitor.
Axovant's GM1 Gangliosidosis Candidate Gets Orphan Drug Tag
by Zacks Equity Research
The FDA grants Orphan Drug status to Axovant's (AXGT) gene therapy candidate, AXO-AAV-GM1, being developed for the treatment of GM1 gangliosidosis. Shares decline despite the positive news.
Alkermes to Acquire Rodin Therapeutics, Boost CNS Pipeline
by Zacks Equity Research
Alkermes (ALKS) will acquire Rodin Therapeutics for an upfront cash payment of $100 million and up to $850 million in milestone payments.
Celgene's Revlimid-Rituximab Combo Gets Positive CHMP Opinion
by Zacks Equity Research
Celgene (CELG) gets a positive CHMP opinion, recommending the approval of Revlimid in combination with Rituxan for the treatment of adult patients with previously treated FL.