BioCentury | May 29, 2020
Management Tracks

Leaving Sanofi, Loew to guide Ipsen’s path forward for troubled musculoskeletal program

Incoming CEO David Loew will arrive as Ipsen tries to recover from setbacks that have hobbled development of palovarotene, one of its two candidates to treat rare disease FOP and the key to its billion-dollar...
BioCentury | May 1, 2020
Regulation

CHMP backs new therapy for 1L AML, triple combos for asthma

EMA’s CHMP this month recommended four new medicines for approval, including a new front-line therapy for AML and triple combination therapies for asthma. The agency recommended approval for Daurismo glasdegib from Pfizer Inc. (NYSE:PFE) to...
BioCentury | Apr 9, 2020
Finance

Keros rises 26% in trading debut during week of market gains

Keros priced an upsized IPO Wednesday and gained $4.08 (26%) to $20.08 despite continued pandemic-driven volatility in the markets. While the Arca NYSE Biotechnology (BTK) and NASDAQ Biotechnology (NBI) and the S&P Biotech ETF (XBI)...
BioCentury | Mar 17, 2020
Finance

With strengthened balance sheet, Keros is latest biotech looking to test IPO market

Keros’ $56 million series C round early this month appears to be the last stepping stone towards an IPO intended to fund its ongoing clinical work. Despite the volatile public markets, the hematological and musculoskeletal...
BioCentury | Jan 28, 2020
Clinical News

Acceleron readout supports sotatercept as disease-modifying option for PAH

Acceleron is readying to send its pulmonary arterial hypertension candidate to Phase III after announcing late Monday that the therapy combined with standard of care met primary and secondary endpoints in a proof-of-concept Phase II...
BioCentury | Jan 24, 2020
Clinical News

Ipsen’s $1B bet on Clementia fizzles with FOP trial stop

Ipsen has paused the clinical program for palovarotene in FOP, the asset behind its $1 billion acquisition of Clementia. The move puts the CVR that came with the deal at serious risk and could give...
BioCentury | Jan 1, 2020
Company News

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BioCentury | Dec 12, 2019
Company News

Dec. 11 Company Quick Takes: Kite, Alkermes, argenx, Reblozyl, Denovo-Sunesis

Kite submits BLA for CD19 CAR T in mantle cell Kite Pharma Inc. submitted Wednesday a BLA to FDA for KTE-X19 to treat mantle cell lymphoma after reporting Phase II data at the American Society...
BioCentury | Dec 6, 2019
Company News

FDA hold muddies Ipsen’s timeline for palovarotene in rare bone disease

A partial clinical hold on four studies of palovarotene that shaved $1.1 billion from Ipsen’s market cap on Friday could slow the biopharma’s timeline for a planned NDA to treat rare bone disease fibrodysplasia ossificans...
BioCentury | Dec 2, 2019
Company News

Dec. 2 Regulatory Roundup: Chipscreen’s approval; plus Priority Review for new Imfinzi, Keytruda indications; EMA reviewing Orchard, Amarin candidates; and more

A spate of regulatory news since the start of the Thanksgiving holiday included a drug approval for Chipscreen, a duo of Priority Reviews from FDA, a pair of EMA reviews, and the scheduling of two...
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