BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

Among the 11 new medicines recommended for approval by EMA’s CHMP is the first antibody-drug conjugate, and most advanced BCMA-targeted agent, for multiple myeloma patients: GSK’s Blenrep belantamab mafodotin. FDA’s Oncologic Drugs Advisory Committee unanimously...
BioCentury | May 4, 2020
Deals

Stemline takeout gives Menarini U.S. oncology beachhead

Although Menarini will gain a modest-selling drug by acquiring Stemline for up to $677 million, the Italian biopharma will also establish a U.S. oncology presence as its cancer pipeline matures. The deal gives Menarini Group...
BC Extra | Aug 2, 2019
Company News

Aug. 2 Company Quick Takes: Daiichi's cancer drug gets U.S. approval, plus BioMarin, Acorda, Stemline and more

FDA approves Daiichi's pexidartinib  FDA approved Turalio pexidartinib from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to treat tenosynovial giant cell tumor. A Daiichi spokesperson told BioCentury the drug has been launched at a wholesale acquisition cost...
BC Extra | Jun 21, 2019
Preclinical News

June 21 Preclinical Quick Takes: AnaptysBio targets PD-1 for immune disease; plus Forty Seven, Homology and moreBy BioCentury Staff

AnaptysBio agonizes PD-1 for inflammatory disease  AnaptysBio Inc. (NASDAQ:ANAB) presented what CEO Hamza Suria called “the first data from anyone on a PD-1 agonist mAb” at the 2019 Federation of Clinical Immunology Societies (FOCiS) meeting...
BC Week In Review | Jan 18, 2019
Financial News

Acceleron, Stemline price upsized follow-ons

Acceleron Pharma Inc. (NASDAQ:XLRN) and Stemline Therapeutics Inc. (NASDAQ:STML) have each priced upsized follow-ons, as one company prepares for key regulatory submissions and the other conducts its first product launch. Acceleron said Jan. 16 that...
BC Extra | Jan 16, 2019
Financial News

Acceleron, Stemline price upsized follow-ons

Acceleron Pharma Inc. (NASDAQ:XLRN) and Stemline Therapeutics Inc. (NASDAQ:STML) have each priced upsized follow-ons, as one company prepares for key regulatory submissions and the other conducts its first product launch. Acceleron said Wednesday that it...
BC Week In Review | Jan 4, 2019
Clinical News

Stemline's Elzonris get FDA nod, first therapy for rare blood disorder

FDA approved Elzonris tagraxofusp-erzs (SL-401) from Stemline Therapeutics Inc. (NASDAQ:STML) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in patients ages two and older, making it the indication's first approved therapy. Stemline CEO Ivan Bergstein...
BC Extra | Dec 21, 2018
Company News

Stemline's Elzonris gets FDA nod, first therapy for rare blood disorder

FDA approved Elzonris tagraxofusp-erzs (SL-401) from Stemline Therapeutics Inc. (NASDAQ:STML) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in patients ages two and older, making it the indication's first approved therapy. Stemline CEO Ivan Bergstein...
BC Extra | Aug 13, 2018
Company News

Priority Review for Stemline's blood cancer therapy

Stemline Therapeutics Inc. (NASDAQ:STML) said FDA accepted and granted Priority Review to its BLA for Elzonris tagraxofusp (SL-401) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare form of acute myelogenous leukemia (AML). Its...
BioCentury | Apr 6, 2018
Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
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