The Daily Biotech Pulse: Merck's Wonder Cancer Drug Snags Another Approval, Decision Day For Zogenix, UniQure Out-Licenses Gene Therapy

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 24)

• ACADIA Pharmaceuticals Inc. ACAD
• BioXcel Therapeutics Inc BTAI
• Brainstorm Cell Therapeutics Inc BCLI (announced new clinical program focused on the development of NurOwn as a treatment for Alzheimer's disease)
• Burning Rock Biotech Ltd BNR (went public June 12)
• Cardiff Oncology Inc CRDF
• ESSA Pharma Inc EPIX
• Five Prime Therapeutics Inc FPRX
• Horizon Therapeutics PLC HZNP
• IGM Biosciences Inc IGMS
• Inovio Pharmaceuticals Inc INO
• Kamada Ltd. KMDA
• Novavax, Inc. NVAX
• Passage Bio Inc PASG
• Pliant Therapeutics Inc PLRX
• Translate Bio Inc TBIO
• Twist Bioscience Corp TWST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 24)

• Genetron Holdings Ltd – ADR GTH (went public Friday)
• Vaccinex Inc VCNX

Stocks In Focus

Merck's Keytruda Approved For Skin Cancer

Merck & Co., Inc. MRK said the FDA as approved Keytruda, its anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

In pre-market trading, Merck shares were down 0.65% to $75.38.

UniQure Out-Licenses Investigational Late-Stage Hemophilia B Gene Therapy For Up To $2.05B

Gene therapy company Uniqure NV QURE said it has entered into a licensing agreement with CSL Behring, providing the latter with exclusive global rights to etranacogene dezaparvovec, uniQure's investigational gene therapy for patients with hemophilia B.

The agreement provides for uniQure receiving a $450 million upfront cash payment and potentially up to $1.6 billion in payments based on regulatory and commercial milestones. The company is also eligible to receive tiered double-digit royalties in a range of up to a low-20s percentage of net product sales arising from the collaboration.

UniQure said the proposed transaction will provide significant financial resources to advance and expand its pipeline of gene therapy candidates, anchored by AMT-130 in Huntington's disease, and to invest further in its leading gene therapy manufacturing and technology platform to support pipeline growth.

The stock was down 16.39% at $52.60 premarket Thursday.

La Jolla Agrees To Buy Tetraphase

After protracted three-way wrangling, Tetraphase Pharmaceuticals Inc TTPH clinched a definitive merger agreement to be bought by La Jolla Pharmaceutical Company LJPC for $43 million in upfront cash, plus potential future cash payments of up to $16 million pursuant to contingent value rights.

Melinta, which had earlier agreed to buy Tetraphase, terminated the agreement, and was paid $1.15 million as a break-up fee.

In after-hours trading, Tetraphase shares declined 1.85% to $2.65, while La Jolla gained 2.08% to $4.90.

See also: The Week Ahead In Biotech: Karyopharm, Zogenix, Heron, Chiasma On The Radar Ahead Of FDA Decisions

Theravance Doses First Patient In Phase 2 COVID-19 Study

Theravance Biopharma Inc TBPH said the first COVID-19 patient has been dosed in a Phase 2 study of TD-0903, its lung-selective, nebulized Janus kinase inhibitor in development for the potential treatment of hospitalized patients with acute lung Injury caused by COVID-19.

Offerings

HUTCHISON CHINA/S ADR HCM announced that it has entered into a definitive agreement for the sale of $100 million of shares at $25 per ADS through a private placement to private equity firm General Atlantic.

This fundraise could increase to $200 million through a warrant granted with a term of 18 months for a further $100 million in Chi-Med shares exercisable at a price per share equivalent to $30 per ADS, the company said. 

Erytech Pharma SA ERYP announced the signing of an agreement with the Luxembourg-based European High Growth Opportunities Securitization Fund for issuing convertible notes valued up to a maximum of 60 million euros ($67.2 million) in the event of conversion of all the notes, subject to the regulatory limit of 20% dilution.

Erytech said the financing line aims at improving its financial strength and extending its cash horizon for the next key development milestones.

Xeris Pharmaceuticals Inc XERS said it has commenced concurrent underwritten public offerings of $20 million in shares of its common stock and $60 million in aggregate principal amount of convertible senior notes due 2025. The company expects the net proceeds to finance the commercialization of Gvoke and repay a $20 million loan, among other things.

The stock was down 19.96% at $4.25 premarket. 

Evelo Biosciences Inc EVLO priced its underwritten public offering of 12 million shares of its common stock at $3.75 per share for gross proceeds of $45 million. All of the shares in the offering are to be sold by the company. The offering is expected to close on or about June 29.

The stock was down 8.98% at $3.65 premarket. 

Nantkwest Inc NK priced its underwritten public offering of 7.41 million shares, with 3.7 million shares to be priced at $9.50 per share and the remaining 3.7 million shares at $12.12 per share to its CEO and principal stockholder Dr. Patrick Soon-Shiong. The aggregate gross proceeds from the offering are expected to be approximately $80.1 million.

In after-hours trading, the stock shed 9.39% to $11.

Translate Bio said it has commenced an underwritten public offering of $125 million of its common stock. In addition, Shire, a subsidiary of Takeda Pharmaceutical Co Ltd TAK, is offering 6.825 million of its common stock in the offering. The company clarified that it will not receive any proceeds from the shares sold by Shire.

Translate Bio shares were down 6.64% at $24.89 premarket Thursday.

Magenta Therapeutics Inc MGTA priced its underwritten public offering of 7.5 million shares of its common stock at $8 per share for gross proceeds of $60 million. All the shares earmarked for the offering are sold by the company.

On The Radar

PDUFA Dates

The FDA is set to rule on Zogenix, Inc.'s ZGNX NDA for Fintepla as a potential treatment candidate for seizures associated with Dravet syndrome.

Earnings

• Aethlon Medical, Inc. AEMD (after the close)

Related Link: Evoke Gets FDA Nod For Gimoti, A Nasally-Administered Gastroparesis Drug