Healthcare Roundup – FDA OKs Takeda’s brigatinib, Pfizer urges noteholders to reject offer by Huguenot Bond Liquidity

医疗保健精选——FDA批准武田药品的brigatinib,辉瑞敦促票据持有人拒绝Huguenot Bond Liquidity的报价
Published on: May 23, 2020
Author: Amy Liu

FDA OKs Takeda’s brigatinib for certain lung cancer patients in first-line setting

The FDA approves Takeda Pharmaceutical Company’s (NYSE:TAK) Alunbrig (brigatinib) for the first-line treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer.

The agency first approved the kinase inhibitor in April 2017 for ALK+ NSCLC patients who have progressed on or are intolerant of crizotinib (Pfizer’s Xalkori).

Shares up 4% after hours.

Pfizer urges noteholders to reject offer by Huguenot Bond Liquidity

Pfizer (NYSE:PFE) and its Wyeth unit recommend that holders of its Pfizer’s 7.200% notes due 2039 and Weyth’s 5.950% notes due 2037 reject the unsolicited tender offer made by Huguenot Bond Liquidity LLC on May 11.

Pfizer and Wyeth do not endorse Huguenot Bond Liquidity’s unsolicited tender offer, and neither Pfizer nor Wyeth is affiliated or associated with the offeror, the tender offer or the offer documentation.

PFE points out that Huguenot’s tender consideration, as calculated using a reference date of May 21, 2020, is ~7% lower than the last trade price of $166 per $100 principal amount of notes for the Pfizer notes and ~8% lower than the last trade price of $145 per $100 principal amount of notes for the Wyeth notes.

FDA OKs Evofem contraceptive Phexxi

The FDA has approved Evofem Biosciences’ (EVFM -2.5%) Phexxi (L-lactic acid, citric acid, potassium bitartrate) Vaginal Gel 1.8%/1%/0.4%, a contraceptive that works by maintaining an acidic environment in the vagina that is inhospitable to sperm.

The company refiled its U.S. application in December 2019 after receiving a CRL in 2016 in response to original submission.

Shares, while still in the red, are moving up from intraday lows.

T2 Biosystems sees demand for COVID-19 molecular test

T2 Biosystems (NASDAQ:TTOO) is up 27% premarket on robust volume on the heels of its disclosure that it “anticipates demand” for its SARS-CoV-2 test molecular test that is performed on its T2Dx instrument. It claims that the assay can generate a result in less than two hours with a sensitivity if less than 1K genomic equivalents per milliliter.

The company can currently manufacture up to 100,000 tests per month but believes it can ramp up to 1M per month with additional funding.

Generic Vascepa approved; Amarin slides

Hikma Pharmaceuticals (OTCPK:HKMPY) announces FDA approval for its Icosapent Ethyl Capsules, the generic equivalent to Vascepa.

AMRN -4.4% premarket

Biotechnology Coronavirus COVID-19 Genomics Healthcare Services Life Science Pharmaceutical