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The Daily Biotech Pulse: Moderna To Kickstart Phase 3 Study On July 27, Immutep Awarded Antibody Patent

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The Daily Biotech Pulse: Moderna To Kickstart Phase 3 Study On July 27, Immutep Awarded Antibody Patent

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 July 14)

  • Altimmune Inc (NASDAQ: ALT) (priced its $115 million worth of common stock and pre-funded warrant offering)
  • Beigene Ltd (NASDAQ: BGNE)
  • Bicycle Therapeutics PLC (NASDAQ: BCYC)
  • Bio-Rad Laboratories, Inc. (NYSE: BIO)
  • Imv Inc (NASDAQ: IMV) (provided an update on its coronavirus vaccine program)
  • INmune Bio Inc (NASDAQ: INMB)( announced positive interim Phase 1b data for its Alzheimer's drug)
  • OncoSec Medical Inc (NASDAQ: ONCS)
  • Qiagen NV (NYSE: QGEN)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (announced initiation of clinical study of its fostamatinib for treating COVID-19 pneumonia)
  • TIZIANA LF SCIE/S ADR (NASDAQ: TLSA)
  • Vaxart Inc (NASDAQ: VXRT)
  • VBI Vaccines Inc (NASDAQ: VBIV)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 14)

  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ: ANPC)
  • BELLUS Health Inc (NASDAQ: BLU)
  • Brickell Biotech Inc (NASDAQ: BBI)
  • Forma Therapeutics Holdings Inc (NASDAQ: FMTX)(IPO quiet period expired)
  • Genfit SA (NASDAQ: GNFT)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
  • INVENTIVA SA/ADR (NASDAQ: IVA) (IPOed Friday)
  • Iterum Therapeutics PLC (NASDAQ: ITRM)
  • NanoVibronix Inc (NASDAQ: NAOV)
  • Nkarta Inc (NASDAQ: NKTX) (IPOed Friday)
  • Oncternal Therapeutics Inc (NASDAQ: ONCT)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)
  • ORIC Pharmaceuticals Inc (NASDAQ: ORIC)
  • Poseida Therapeutics, Inc. (NASDAQ: PSTX) (IPOed Friday)
  • Recro Pharma Inc (NASDAQ: REPH)
  • Repare Therapeutics Inc (NASDAQ: RPTX)(sell-side coverage began following expiry of IPO quiet period; Morgan Stanley initiated coverage of shares with a Buy rating)
  • Royalty Pharma plc (NASDAQ: RPRX)
  • Sonnet Biotherapeutics Holdings Inc (NASDAQ: SONN)

Stocks In Focus

Moderna Publishes Positive Efficacy, Safety Data For Coronavirus Study, to Start Phase 3 Trial July 27

Moderna Inc (NASDAQ: MRNA) announced the publication in the New England Journal of Medicine detailed interim Phase 1 data for its mRNA-1273 vaccine candidate against the novel coronavirus, showing the vaccine candidate induced rapid and strong immune responses.

The vaccine candidate induced binding antibodies to the full-length SARS-CoV-2 Spike protein in all participants after the first vaccination, with all participants seroconverting by Day 15, the company said.

"These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study," said Tal Zaks, Chief Medical Officer of Moderna.

Moderna expects to commence the Phase 3 study on July 27.

The stock climbed 16.07% to $87.10 in after-hours trading.

Immutep Awarded Patent For Out-licensed Antibody

IMMUTEP LTD/S ADR (NASDAQ: IMMP) said the U.S. Patent and Trade Mark Office has granted a patent entitled "Antibody molecules to LAG-3 and uses thereof," which is related to embodiments of LAG525, a humanized form of its IMP701 antibody which is out-licensed to Novartis AG (NYSE: NVS).

The patent is co-owned by Novartis and Immutep and will expire on March 26, 2035.

The stock skyrocketed 95.45% to $2.15 in after-hours trading.

GlaxoSmithKline's Multiple Myeloma Treatment Candidate Unanimously Endorsed By FDA Panel

GlaxoSmithKline plc (NYSE: GSK) said FDA's Oncologic Drugs Advisory Committee voted 12-0 in favor of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The drug linker technology used has been licensed from Seattle Genetics, Inc. (NASDAQ: SGEN).

ProQR Gets $30M Debt Funding That Extends Cash Runway Into 2023

ProQR Therapeutics NV (NASDAQ: PRQR) said it has clinched a $30 million convertible debt financing agreement with Pontifax Medison Debt Financing, the healthcare-dedicated venture and debt fund of the Pontifax life science funds.

"If fully drawn down, this capital would extend ProQR's cash runway into 2023, which is beyond a number of anticipated catalysts and value inflection points for our clinical stage programs," the company said in a statement.

The company also said it expects the funding to accelerate advancement of its translational platform and discovery programs."

The stock gained 10.77% to $5.45 in after-hours trading.

Acorda Gets $12.7M Income Tax Refund From IRS

Acorda said in an 8-K filing it received a $12.7 million income tax refund from the IRS including interest, pursuant to the Coronavirus Aid, Relief, and Economic Security Act. The provisions of the Act allowed the company to carry back 2019 net operating losses to tax years 2017 and 2018, resulting in the refund, it said.

The stock jumped 31.43% to 96 cents in after-hours trading.

J&J Gets Label Expansion For Psoriasis Drug

Johnson & Johnson's (NYSE: JNJ) Janssen unit announced FDA approval of Tremfya as a treatment for adult patients living with active psoriatic arthritis.

Tremfiya is a fully human monoclonal antibody generated utilizing Morphosys Ag's (NASDAQ: MOR) proprietary HuCAL antibody technology.

Medtronic to Buy Spinal Implant Technology Company Medicrea

Medtronic PLC (NYSE: MDT) announced a tender offer agreement for the acquisition of all outstanding shares of Medicrea International SA (OTC: MRNTF), which facilitates spinal surgery through artificial intelligence, predictive modeling and patient specific implants. The agreement values each of Medicrea shares at 7 euro.

Offerings

Zynex Inc. (NASDAQ: ZYXI) said it priced its previously announced underwritten public offering of an aggregate of 2.5 million shares at $22.00 per share. The company said it is selling 1.25 million shares, with the remaining 1.25 million shares being sold by certain stockholders. The company expects gross proceeds of $27.5 million from the shares sold by it.

The stock slipped 7.67% to $24.21 in after-hours trading.

Adaptive Biotechnologies Corp (NASDAQ: ADPT) announced the commencement of a proposed underwritten public offering of 8 million shares of its common, with 6 million shares being offered by the company and 2 million by a selling shareholder.

In after-hours trading, the stock fell 2.64% to $42.11.

On The Radar

Adcom Meeting

The Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss Mallinckrodt PLC's (NYSE: MNK) new drug application for terlipressin, lyophilized powder for solution for injection, for the proposed indication of treatment of hepatorenal syndrome Type 1.

 

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