The Daily Biotech Pulse: Immunic To Develop COVID Treatment, Gilead Strikes IO Partnership

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 April 21)

• Alnylam Pharmaceuticals, Inc. ALNY
• Arcturus Therapeutics Ltd ARCT
• Arvinas Inc ARVN
• Exelixis, Inc. EXEL
• GenMark Diagnostics, Inc GNMK
• Keros Therapeutics Inc KROS
• Kiniksa Pharmaceuticals Ltd KNSA
• Moderna Inc MRNA
• OraSure Technologies, Inc. OSUR
• Repro-Med Systems, Inc. KRMD
• Vertex Pharmaceuticals Incorporated VRTX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 21)

• Cyclacel Pharmaceuticals Inc CYCC(announced pricing of $20 million common stock offering)
• Nabriva Therapeutics PLC – ADR NBRV
• Viveve Medical Inc VIVE

Stocks In Focus

Novartis' Cell Therapy Gets Regenerative Medicine Advanced Therapy Designation For Follicular Lymphoma

Novartis AG NVS said the FDA granted Regenerative Medicine Advanced Therapy designation to Kymriah for an investigational new indication to treat patients with relapsed or refractory follicular lymphoma. Kymriah is a CAR-T cell therapy and has already been approved for pediatric and young adult acute lymphoblastic leukemia, and adult diffuse large B-cell lymphoma.

Actinium Prices Common Stock Offering at Discount

Actinium Pharmaceuticals Inc ATNM said it has priced its previously-announced underwritten public offering of 183.33 million shares at 15 cents per share. The company expects to raise gross proceeds of $27.5 million from the offering.

The company said it intends to use the net proceeds to complete its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate, Iomab-B, and support its BLA filing, among other things.

The stock was slumping 27.94% to 17 cents in pre-market trading Wednesday.

Immunic's Antiviral Investigational Assets Found Effective Against Coronavirus In Animal Studies

Immunic Inc IMUX reported that IMU-838, its lead asset has successfully demonstrated preclinical activity against SARS-CoV-2. More specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19, the company said.

The company said these positive results have encouraged it to prepare a clinical development program for IMU-838 as a potential treatment option for patients with COVID-19 and potential other, future viral pandemics.

In premarket trading Wednesday, the stock was jumping 88.08% to $16.10. 

BioNTech, Pfizer Get German Regulatory Nod For Human Testing Of COVID-19 Vaccine Candidate

BioNTech SE – ADR BNTX and Pfizer Inc. PFE said the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech's BNT162 vaccine program to prevent COVID-19 infection. The companies are awaiting FDA nod to begin human testing in the U.S.

In pre-market trading, BioNTech shares were soaring 52.15% to $64.30 and Pfizer was seen adding 5.56% to $37.60.

Quest Begins Offering Antibody Testing For Coronavirus

Quest Diagnostics Inc DGX said it has begun to perform antibody testing for coronavirus using blood samples. The company already gives healthcare providers access to its molecular diagnostic laboratory testing.

Gilead Strikes Immuno-oncology And Cell Therapy Collaboration With oNKo-innate

Gilead Sciences, Inc. GILD, its Kite unit and oNKo-innate announced a 3-year cancer immunotherapy research collaboration to support the discovery and development of next-gen drug and engineered cell therapies focus on natural killer, or NK, cells.

oNKo-innate will run screens to identify and validate targets to seed internal Gilead immuno-oncology discovery programs, while for Kite, oNKo will create and evaluate NK constructs for Kite's development of next-generation cell therapies.

The stock was gaining 2.15% to $80.22 in pre-market trading.

VBI Vaccines Announces Secondary Offering Of Common Stock

VBI Vaccines Inc VBIV announced that it has commenced an underwritten public offering of its common shares. The company said it intends to use the net proceeds to support the regulatory filings, pre- commercialization, and launch planning activities for Sci-B-Vac in the U.S., Europe, and Canada, for the continued advancement of its pipeline programs, and for general corporate purposes.

In pre-market trading, the stock was slumping 30.13% to $1.09.

met its co-primary efficacy endpoints and six key secondary endpoints. In addition, relugolix combination therapy was generally well-tolerated including minimal bone mineral density loss over 24 weeks.

Myovant Reports Positive Results For Latestage Study of Drug to Treat Endometriosis-Related Pain

Myovant Sciences Ltd MYOV announced results from the Phase 3 SPIRIT 2 study of once-daily relugolix combination therapy in women with pain associated with endometriosis, which showed the study met its co-primary efficacy endpoints and six key secondary endpoints.

In pre-market trading, shares were adding 7.08% to $12.40.

On The Radar

Earnings

• Biogen Inc BIIB (before the market opens)
• Quest Diagnostics (before the market opens)