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

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 14)

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

Stocks In Focus

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

Moderna Inc 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 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 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 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. SGEN.

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

ProQR Therapeutics NV 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 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 MOR proprietary HuCAL antibody technology.

Medtronic to Buy Spinal Implant Technology Company Medicrea

Medtronic PLC MDT announced a tender offer agreement for the acquisition of all outstanding shares of Medicrea International SA 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. 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 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 MNK new drug application for terlipressin, lyophilized powder for solution for injection, for the proposed indication of treatment of hepatorenal syndrome Type 1.