Search This Blog

Thursday, December 19, 2019

Gilead files U.S. application for filgotinib for rheumatoid arthritis

Gilead Sciences (NASDAQ:GILD) has submitted a marketing application to the FDA seeking approval of filgotinib for patients with moderate-to-severe rheumatoid arthritis.
It filed the application with a Priority Review Voucher which, if the agency accepts it, shortens the review clock to six months.
The company is co-developing and co-commercializing the JAK1 inhibitor with Galapagos NV (NASDAQ:GLPG) under a 2015 agreement. The filing triggers a $20M milestone payment to GLPG.
Gilead Sciences (NASDAQ:GILD) has submitted a marketing application to the FDA seeking approval of filgotinib for patients with moderate-to-severe rheumatoid arthritis.
It filed the application with a Priority Review Voucher which, if the agency accepts it, shortens the review clock to six months.
The company is co-developing and co-commercializing the JAK1 inhibitor with Galapagos NV (NASDAQ:GLPG) under a 2015 agreement. The filing triggers a $20M milestone payment to GLPG.
Posted by at No comments:

NMC Health takes exception to ‘misleading’ Muddy Waters report

In a statement, NMC Health (OTC:NMMCF) regards the recent bearish report from Muddy Waters as “false and misleading” citing its track record of “significant, open and increasingly detailed disclosures” to the market.
The company then defends each point in MW’s short thesis.
The stock is down 13%, albeit on turnover of only 6,500 shares.
Posted by at No comments:

Medifast up 8% on rumored go-private bid

Medifast (MED +7.6%) is up, albeit on below-average volume, in apparent response to a report that shareholder Engaged Capital, owner of 9.99% stake, is mulling a bid to take the company private.
Update: Bloomberg reports that, according to informed sources, Engaged is considering a bid. It currently owns ~15% of the weight-loss meal provider.
Posted by at No comments:

Medicare expands coverage of Guardant360 liquid biopsy test

Medicare Administrative Contractor Palmetto GBA has expanded local coverage determination of Guardant Health’s (GH +0.5%) Guardant360 liquid biopsy assay to include its use across the majority of advanced solid tumors.
The updated policy covers the test for all fee-for-service Medicare beneficiaries with advanced cancers who meet the clinical criteria for complete genomic profiling with next-gen sequencing of tumor tissue to optimize treatment selection but lack available tissue for molecular profiling.
Posted by at No comments:

Monopar up big in U.S. debut

Monopar Therapeutics (MNPR N/A) has faced two volatility halts in its first day of trading. Shares are currently exchanging hands at $26.46, up 231% from its $8 IPO price.
Lead candidate is Fast Track-tagged Validive (clonidine mucobuccal tablet) for the treatment of oral mucositis in oropharyngeal cancer patients undergoing chemo.
Posted by at No comments:

Biogen to buy back $5B more of stock

The board of Biogen (NASDAQ:BIIB) has authorized the repurchase of up to an additional $5B of its outstanding common stock. All reacquired shares will be retired.
The share buy back program authorized in March is still in effect.
Shares up 1% after hours.
Posted by at No comments:

Genmab teams up with CureVac in mRNA-based antibodies

Copenhagen-based Genmab A/S (GMAB +0.1%) inks a five-year research collaboration and license agreement with German biotech CureVac AG aimed at developing mRNA-based antibody therapies for cancer.
The partnership will leverage CureVac’s mRNA technology and know-how with Genmab’s antibody technologies and expertise.
Under the terms of the agreement, Genmab will pay CureVac $10M upfront plus an equity investment of €20M.
CureVac will contribute a portion of the overall cost of developing the first candidate up to the IND stage after which Genmab will assume all development and commercialization activities and expenses. CureVac will be eligible for undisclosed milestones and tiered royalties on net sales.
Genmab will have three additional options to in-license candidates within the five-year period. CureVac will be eligible for $275M – 368M in milestones per licensed product in addition to tiered mid-single-to-low-double-digit royalties on net sales. CureVac will have the option to participate in the development and/or commercialization of one program subject to conditions.
Posted by at No comments:
Subscribe to: Posts (Atom)