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Tuesday, June 25, 2019

FDA rejects Acer’s Edsivo application for rare connective tissue disorder

Thinly traded micro cap Acer Therapeutics (NASDAQ:ACER) is poised for a significant down move this morning on the news that it received a Complete Response Letter (CRL) from the FDA regarding its marketing application for EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS), an inherited collagen disorder characterized by thin, translucent easily bruised skin.
The CRL cites the need for a new clinical trial to assess celiprolol’s effect on reducing the risk of clinical events in vEDS patients.
Shares, currently halted, will resume trading at 9:00 am ET.
Update: Shares are down 76% premarket on increased volume.
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Humana collaborates with Aspen RxHealth to link patients, pharmacists

Humana (NYSE:HUM) has chosen Aspen RxHealth’s app-based platform to connect pharmacists with patients to deliver clinical services, including medication therapy management (MTM).
Aspen RxHealth will leverage their community of pharmacists to contact Humana Medicare Advantage members and review medications, provide education and answer questions about their therapy.
Humana launched this program in Tampa, Florida, with a potential expansion into other markets later this year.
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Tricida up 2% premarket on publication of veverimer data

Tricida (NASDAQ:TCDA) announces the publication of results from a Phase 3 clinical trial, TRCA-301E, evaluating lead candidate veverimer (TRC101) for the treatment of metabolic acidosis in patients with chronic kidney disease (CKD). The data are in the latest online edition of The Lancet.
The study met the primary efficacy endpoint of a statistically significant proportion of treated patients achieving at least a 4 mmol/L increase in serum bicarbonate compared to placebo. Specifically, 63% of patients receiving veverimer hit the threshold versus 38% for control (p=0.0015). Higher bicarbonate concentrations were observed at all timepoints.
The safety profile was favorable. Serious adverse events occurred in 2% of the treatment group compared to 5% in the control group. The rate of renal system adverse events also favored veverimer, 8% vs. 15%.
Veverimer is a non-absorbed polymer that binds to hydrochloric acid in the GI tract and is removed through feces excretion, thereby lowering the amount of acid in the body.
The company expects to file a U.S. marketing application in H2.
Shares are up 2% premarket on light volume.
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Bausch Health to reduce $100M debt

Bausch Health Companies (NYSE:BHC) will pay down an additional $100M of its senior secured term loans this week.
After this payment, BHC will have eliminated all mandatory amortization for Q1 2020.
Shares are up 1% premarket.
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Dermira up 9% premarket on Abbvie/Allergan deal

Dermira (NASDAQ:DERM) is up 9% premarket on light volume as buying ripples out from AbbVie’s bid for Allergan.
Its top drug is Obrexza (glycopyrronium) for primary axillary hyperhidrosis (excessive underarm sweating), approved in the U.S. a year ago.
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AbbVie in talks with Allergan for 6-7 weeks – CNBC

According to CNBC’s David Faber, AbbVie (ABBV -12.9%) was negotiating its deal with Allergan (AGN +28.2%) for six or seven weeks before today’s announcement. CEO Rick Gonzalez initiated talks.
Allergan will re-domicile as a U.S. company as a result.
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AbbVie/Allergan deal may stoke buying in drug makers

Premarket buying has perked up in certain pharma firms on the news of AbbVie’s $188/share bid for Allergan.
Selected tickers: Teva Pharmaceutical Industries (NYSE:TEVA)(+4%), Endo International (NASDAQ:ENDP)(+5%), Perrigo (NYSE:PRGO)(+1%)
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