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

Shanthi Rexaline

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

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 21)

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

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

Novartis AG (NYSE: 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 (NYSE: 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 (NASDAQ: 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 (NASDAQ: BNTX) and Pfizer Inc. (NYSE: 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.

View more earnings on GILD

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 (NYSE: 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. (NASDAQ: 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 (NASDAQ: 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 (NYSE: 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 (NASDAQ: BIIB) (before the market opens)
  • Quest Diagnostics (before the market opens)

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