The Daily Biotech Pulse: Gilead Gets Full Approval For Remdesivir, Akebia's Positive Readout, Foghorn IPO

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Oct. 22)

Amicus Therapeutics, Inc. FOLD
Beam Therapeutics Inc BEAM
Bio-Rad Laboratories, Inc. BIO
CymaBay Therapeutics Inc CBAY
Halozyme Therapeutics, Inc. HALO
Immunomedics, Inc. IMMU
Kodiak Sciences Inc KOD
Nevro Corp NVRO
Praxis Precision Medicines Inc PRAX
Repligen Corporation RGEN
Replimune Group Inc REPL (priced its common stock offering of 4.69 million shares at $40 apiece.

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 22)

  • Artelo Biosciences Inc ARTL
  • Avenue Therapeutics Inc ATXI
  • Aziyo Biologics Inc AZYO
  • DBV Technologies ADR Representing 0.5 Ord Shs DBVT
  • FSD Pharma Inc HUGE
  • Gilead Sciences, Inc. GILD
  • Invivo Therapeutics Holdings Corp NVIV (priced its $15 million worth of common stock offering)
  • Jaguar Health Inc JAGX
  • Lexicon Pharmaceuticals, Inc. LXRX
  • Metacrine Inc MTCR
  • Rockwell Medical Inc RMTI
  • Satsuma Pharmaceuticals Inc STSA
  • Silence Therapeutics ADR Representing 3 Ord Shs SLN

Stocks In Focus

Akebia Presents Positive Phase 3 Data For Anemia Drug In Chronic Kidney Disease Patients

Akebia Therapeutics Inc AKBA presented at the American Society of Nephrology Kidney Week 2020 Reimagined, clinical data from its global INNO2VATE Phase 3 program, which demonstrated the efficacy and cardiovascular safety of vadadustat for the treatment of anemia due to chronic kidney disease, or CKD, in adult patients on dialysis.

Vadadustat is Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor in development for the treatment of anemia due to CKD.

The stock rose 7.32% to $3.52 in after-hours trading.

Gilead's Veklury Receives Full Approval For Treating Hospitalized COVID-19 Patients

Gilead said the FDA approved its antiviral drug Veklury (remdesivir) for the treatment of adults and pediatric patients, 12 years of age and older and weighing at least 40 kg, with COVID-19 and requiring hospitalization. Veklury had previously received emergency use authorization from the FDA for treating COVID-19 patients.

The drug, which is the only FDA-approved treatment for COVID-19, is now widely available in hospitals across the country, Gilead said.

In after-hours trading, the stock rallied 7.1% to $64.98.

Retrophin to Acquire Rare Metabolic Disorder Drug Company Orphan Technologies For Up to $517 million

Retrophin Inc RTRX announced a definitive agreement to acquire Orphan Technologies Limited, a privately held, clinical-stage biopharma focused on the development of product candidate OT-58 for the treatment of classical homocystinuria, for $90 million in cash.

Orphan Technologies shareholders will also be eligible to receive up to $427 million in additional cash payments contingent upon the achievement of key milestones in the development and commercialization of OT-58.

Retrophin said it will also pay a tiered mid-single digit royalty on future net sales of OT-58 in the US and Europe, and potentially make a milestone payment in the event a pediatric rare disease voucher is granted.

OT-58 is a novel investigational enzyme replacement therapy being evaluated in Phase 1/2 development for the treatment of classical HCU, a rare metabolic disorder characterized by elevated levels of plasma homocysteine that can lead to life-threatening thrombotic events such as stroke and heart attacks, ophthalmologic and skeletal complications, as well as developmental delay.

The deal is anticipated to close in the fourth quarter of 2020.

Kezar Life Sciences Gets Orphan Drug Designations For Drug to Treat Autoimmune Inflammatory Myopathies

Kezar Life Sciences Inc KZR said the FDA has granted orphan drug designations for KZR-616 for the treatment of polymyositis and dermatomyositis. Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality.

Offerings

Milestone Pharmaceuticals Inc MIST said it priced its previously announced underwritten public offering of 3.81 million of its shares at $5.25 per share. The prefunded warrants issued to certain investors in lieu thereof, to purchase common shares were priced at $5.24 per underlying share.

The company expects the offering to close Oct. 27.

The stock slipped 16.14% to $5.87 in after-hours trading.

On The Radar

Clinical Readouts

Mustang Bio Inc MBIO, founded by Fortress Biotech FBIO, is scheduled to present at the Prostate Cancer Foundation's annual scientific retreat initial Phase 1 data on CAR-T cell therapy MB-105 in patients with PSCA-positive metastatic castration-resistant prostate cancer. The presentation is fixed for Oct. 23, at 2:50 pm.

IPOs

Foghorn Therapeutics, which is engaged in the development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, priced its initial public offering of 7.50 million shares of its common stock at $16.00 apiece. Foghorn's common stock will begin trading on the Nasdaq under the ticker symbol FHTX.

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