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The Daily Biotech Pulse: Gilead, Lilly COVID-19 Treatment Supply Agreements, CareDx's Positive Preannouncement, Aziyo Biologics Debuts On Wall Street

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The Daily Biotech Pulse: Gilead, Lilly COVID-19 Treatment Supply Agreements, CareDx's Positive Preannouncement, Aziyo Biologics Debuts On Wall Street

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. 7)

  • 10X Genomics Inc (NASDAQ: TXG)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Adaptive Biotechnologies Corp (NASDAQ: ADPT)
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
  • argenx SE – ADR (NASDAQ: ARGX)
  • Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Cassava Sciences Inc (NASDAQ: SAVA)
  • Castle Biosciences Inc (NASDAQ: CSTL)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • CymaBay Therapeutics Inc (NASDAQ: CBAY)
  • Eidos Therapeutics Inc (NASDAQ: EIDX)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • InVitae Corp (NYSE: NVTA)
  • Insulet Corporation (NASDAQ: PODD)
  • Intellia Therapeutics Inc (NASDAQ: NTLA)
  • Kura Oncology Inc (NASDAQ: KURA)
  • Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)
  • Mirati Therapeutics Inc (NASDAQ: MRTX)
  • Natera Inc (NASDAQ: NTRA)
  • Novocure Ltd (NASDAQ: NVCR)
  • Ocular Therapeutix Inc (NASDAQ: OCUL) (preannounced positive Q3 revenues)
  • Oncorus Inc (NASDAQ: ONCR) (debuted on Friday)
  • Prelude Therapeutics Inc (NASDAQ: PRLD)
  • Pulmonx Corp (NASDAQ: LUNG)
  • Qiagen NV (NYSE: QGEN)
  • Repligen Corporation (NASDAQ: RGEN)
  • Stoke Therapeutics Inc (NASDAQ: STOK) (announced decision to dose STK-001 in children and adolescents in its Phase 1/2a study for Dravet syndrome)
  • Surface Oncology Inc (NASDAQ: SURF)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM)
  • TG Therapeutics Inc common stock (NASDAQ: TGTX)
  • Turning Point Therapeutics Inc (NASDAQ: TPTX)
  • Twist Bioscience Corp (NASDAQ: TWST)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)
  • Veracyte Inc (NASDAQ: VCYT)
  • Vericel Corp (NASDAQ: VCEL)
  • Zai Lab Ltd – ADR (NASDAQ: ZLAB)

Down In The Dumps

(Biotech Stocks Hitting 52-Week Lows Oct. 7)

  • Akouos Inc (NASDAQ: AKUS)
  • C4 Therapeutics Inc (NASDAQ: CCCC) (went public Friday)
  • Harmony Biosciences Holdings Inc (NASDAQ: HRMY)
  • Inhibrx Inc (NASDAQ: INBX)
  • Outset Medical Inc (NASDAQ: OM)
  • Polypid Ltd (NASDAQ: PYPD)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN)
  • Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)

Stocks In Focus

CareDx Expects Q3 Revenue Ahead Of Consensus

CareDx Inc (NASDAQ: CDNA) preannounced preliminary revenue of about $53 million for the three months ended Sept. 30, 2020, up 57% year-over-year. This came in ahead of the $44.68-million consensus estimate. Testing revenues increased from $28.2 million to $45.2 million.

The stock was up 14.04% at $50.02 premarket Thursday. 

Gilead Signs Veklury Supply Agreement With European Commission

Gilead Sciences, Inc. (NASDAQ: GILD) announced a joint procurement agreement with the European Commission to enable rapid and equitable access to Veklury, or remdesivir, the first antiviral drug proven to be effective for the treatment of COVID-19 in the European Union.

The agreement enables participating countries in the EU and the European Economic Area and the U.K. to purchase Veklury for both real-time demand and stockpiling needs, coordinated by the European Commission, Gilead said

The agreement covers purchases of Veklury over the next six months and has the option to be extended. In the EU, EEA and U.K., Veklury is indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen.

The stock was adding 0.76% to $62.32 premarket Thursday.

Pfizer's Hormone Therapy Aces Late-Stage Study In Child Growth Hormone Deficiency

Pfizer Inc. (NYSE: PFE) said its Phase 3 study evaluating somatrogon dosed once-weekly in children from 3 years old to less than 18 years of age with growth hormone deficiency met its primary endpoint of improved treatment burden compared to Genotropin for injection administered once-daily.

See also: The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO

Lilly, Gates Foundation To Supply Potential COVID-19 Antibody Treatment To Low-, Middle-Income Countries

Eli Lilly And Co (NYSE: LLY), which offered an update on its anti-COVID-19 antibody program Wednesday, said it has agreed with the Bill & Melinda Gates Foundation to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19 to benefit low- and middle-income countries.

The stock was rising 1.71% to $151.50 in premarket trading Thursday.

Merck Reports Positive Results For Midstage Study Of HIV-1 Combo Therapy

Merck & Co., Inc. (NYSE: MRK) announced positive week 96 data from the Phase 2b trial evaluating the efficacy and safety of islatravir, its investigational oral nucleoside reverse transcriptase translocation inhibitor, in combination with doravirine in treatment-naïve adults with HIV-1 infection.

Protagonist Up On Momentum Buy

Protagonist Therapeutics Inc (NASDAQ: PTGX) shares were up 15.2% to $24.72 premarket. The gains came amid a lack of any company-specific catalyst.

On The Radar

IPOs

Silver Spring, Maryland-based Aziyo Biologics priced its initial public offering of 2.94 million shares at $17 per share, at the midpoint of the previously estimated price range of $16-$18. The regenerative medicine company's shares will be listed on the Nasdaq under the ticker symbol "AZYO." Gross proceeds from the offering are expected to be $50 million.

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

 

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