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The Daily Biotech Pulse: Catabasis Halts Duchenne Muscular Dystrophy Study, Lilly's COVID-19 Trial Disappointment, Merck, Pfizer Earnings

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The Daily Biotech Pulse: Catabasis Halts Duchenne Muscular Dystrophy Study, Lilly's COVID-19 Trial Disappointment, Merck, Pfizer Earnings

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. 26)

  • Amicus Therapeutics, Inc. (NASDAQ: FOLD)
  • Beam Therapeutics Inc (NASDAQ: BEAM)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • EXACT Sciences Corporation (NASDAQ: EXAS)
  • Kodiak Sciences Inc (NASDAQ: KOD)
  • Mirati Therapeutics Inc (NASDAQ: MRTX) (reacted to a positive clinical data readout)
  • Repligen Corporation (NASDAQ: RGEN)
  • Spruce Biosciences Inc (NASDAQ: SPRB)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 26)

  • Avenue Therapeutics Inc (NASDAQ: ATXI)
  • Baudax Bio Inc (NASDAQ: BXRX)
  • Biogen Inc (NASDAQ: BIIB)
  • DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ: DBVT)
  • Entasis Therapeutics Holdings Inc (NASDAQ: ETTX)
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)
  • Gilead Sciences, Inc. (NASDAQ: GILD)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Kiromic Biopharma Inc (NASDAQ: KRBP)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)
  • Oncternal Therapeutics Inc (NASDAQ: ONCT)
  • Opiant Pharmaceuticals Inc (NASDAQ: OPNT)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Recro Pharma Inc (NASDAQ: REPH)
  • Rockwell Medical Inc (NASDAQ: RMTI)
  • Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)
  • Tricida Inc (NASDAQ: TCDA)

Stocks In Focus

Catabasis Ends Duchenne Muscular Dystrophy Trials After Failed Late-Stage Study

Catabasis Pharmaceuticals Inc (NASDAQ: CATB) said the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy did not meet the primary endpoint, which was a change from baseline in the North Star Ambulatory Assessment over one year.

The secondary endpoint of timed function tests such as time to stand; 10-meter walk/run; and four-stair climb also did not show statistically significant improvements, the company said.

Consequently, the company said it is stopping activities related to the development of edasalonexent, including the ongoing GalaxyDMD open-label extension trial. Catabasis also said it plans to work with external advisors to explore and evaluate strategic options going forward.

The stock was down 64.18% at $1.92 premarket Tuesday.

Dexcom Pre-Announces Q3 Revenue, Announces Retirement Of Chief Commercial Officer

DexCom, Inc. (NASDAQ: DXCM) preannounced third-quarter revenues of $500.9 million, representing 26% year-over-year growth. Analysts, on average, estimate revenues of $476.75 million.

The company also announced that longtime executive Rick Doubleday, who is serving as chief commercial officer, will retire at the end of 2020.

The stock was down 5.26% at $396 premarket. 

Lilly's Antibody Monotherapy Candidate Found Ineffective In Advanced COVID-19

Eli Lilly And Co's (NYSE: LLY) updated data from the NIAID-sponsored ACTIV-3 clinical trial evaluating the efficacy of its bamlanivimab in hospitalized COVID-19 patients suggests the antibody treatment candidate is unlikely to help them recover from this advanced stage of their disease, the company said in a statement. 

No additional COVID-19 patients in this hospitalized setting will receive bamlanivimab, Lilly said. 

All other studies are ongoing, including the NIH-sponsored ACTIV-2 trial testing bamlanivimab in recently diagnosed mild to moderate COVID-19 patients; the BLAZE-1 Phase 2 trial that is evaluating bamlanivimab monotherapy and in combination with etesevimab in recently-diagnosed COVID-19 patients in a non-hospitalized setting; and the BLAZE-2 Phase 3 trial that is evaluating bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities. 

Lilly shares were down 4.57% premarket at $135.23. 

Related Link: The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs

Novartis Q3 Beats Estimate, Company Raises FY20 Core Operating Income Guidance

Novartis AG's (NYSE: NVS) third-quarter net sales from continuing operations rose 1% to $12.26 billion, and its core operating income climbed 9% due to lower spending and improved gross margin. Core EPS came in at $1.52, ahead of the $1.45 consensus estimate.

The company raised its 2020 core operating income guidance from low double-digit growth to low double-digits-to-mid-teens percentage growth. The company expects net sales to grow by mid-single digits.

Exelixis Says Japanese Partner Files For Label Expansion For Combo Drug To Treat Renal Cancer

Exelixis, Inc. (NASDAQ: EXEL) said its Japanese partner Takeda Pharmaceutical Co Ltd (NYSE: TAK) and Ono Pharma have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare for manufacturing and marketing approval of Cabometyx in combination with Bristol-Myers Squibb Co's (NYSE: BMY) Opdivo for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma.

NantKwest Appoints Veteran Health Care Exec Richard Adcock As CEO

Nantkwest Inc (NASDAQ: NK) announced the appointment of Richard Adcock as its CEO effective immediately. Adcock will replace Patrick Soon-Shiong, who will become executive chairman of the board.

The stock was up 0.89% at $9.11 premarket Tuesday.

Aerpio Begins Midstage Study Of Razuprotafib In Moderate-To-Severe COVID-19 Patients

Aerpio Pharmaceuticals Inc (NASDAQ: ARPO) said it has begun dosing of the first patient with razuprotafib in the military-sponsored Phase 2 trial targeting the prevention and treatment of acute respiratory distress syndrome in patients with moderate-to severe COVID-19.

The stock was down 0.78% premarket at $1.27. 

FDA OKs Vanda To Initiate Midstage Allergic Conjunctivitis Study

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) said the FDA has approved an investigational new drug application to evaluate the cystic fibrosis transmembrane conductance regulator activator VSJ-110 for the treatment of allergic conjunctivitis.

Vanda said it plans to initiate enrollment in the Phase 2 study by the end of 2020 and anticipates results of this study in 2021.

The stock rose 2.59% to $10.70 in after-hours trading.

Offerings

Mirati, which announced positive early-stage results for its KRAS G12C inhibitor MRTX849 in non-small cell lung cancer, said it intends to offer $700 million in shares of common stock in an underwritten public offering, and a selling stockholder intends to offer 375,000 shares in the offering.

The stock slid 2.89% to $191 in after-hours trading.

On The Radar

Clinical Readouts

Galera Therapeutics Inc (NASDAQ: GRTX) is due to present at the ASTRO annual meeting data from its Phase 1b/2a clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy for locally advanced pancreatic cancer. The presentation is scheduled between 3 p.m. and 4:15 p.m.

Earnings

  • Laboratory Corp. of America Holdings (NYSE: LH) (before the market open)
  • Merck & Co., Inc. (NYSE: MRK) (before the market open)
  • Pfizer Inc. (NYSE: PFE) (before the market open)
  • NeoGenomics, Inc. (NASDAQ: NEO) (before the market open)
  • Masimo Corporation (NASDAQ: MASI) (after the close)
  • DexCom (after the close)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) (after the close)
  • Omnicell, Inc. (NASDAQ: OMCL) (after the close)
  • Zynex Inc. (NASDAQ: ZYXI) (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

 

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