The Daily Biotech Pulse: Altimmune Reports Positive Preclinical Data For Intranasal COVID-19 Vaccine, AbbVie Licenses Morphic's Drug, Viveve Clinical Readout

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 24)

  • Abbott Laboratories ABT
  • Cancer Genetics Inc CGIX (announced a deal to buy organoid start up company StemoniX)
  • Cardiff Oncology Inc CRDF
  • Catabasis Pharmaceuticals Inc CATB
  • Cerus Corporation CERS (moved on FDA's emergency use authorization for plasma therapy as a potential COVID-19 treatment)
  • ESSA Pharma Inc EPIX
  • Fortress Biotech FBIO
  • Inozyme Pharma Inc INZY
  • Kamada Ltd. KMD (reacted to the news of EUA for plasma anti-COVID-19 therapy)
  • Keros Therapeutics Inc KROS
  • Lantern Pharma Inc. LTRN
  • Mirati Therapeutics Inc MRTX
  • Pacific Biosciences of California Inc PACB
  • Principia Biopharma Inc PRNB
  • Protagonist Therapeutics Inc PTGX
  • Qiagen NV QGEN
  • Revance Therapeutics Inc RVNC
  • Turning Point Therapeutics Inc TPTX (FDA granted a third fast-track designation to its lead drug candidate, repotrectinib)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 24)

  • Acorda Therapeutics Inc ACOR
  • Alector Inc ALEC
  • China SXT Pharmaceuticals Inc SXTC
  • Gritstone Oncology Inc GRTS
  • Happiness Biotech Group Ltd HAPP
  • Histogen Inc HSTO
  • Hoth Therapeutics Inc HOTH
  • Iterum Therapeutics PLC ITRM
  • Kymera Therapeutics Inc KYMR (IPOed Friday)
  • NanoVibronix Inc NAOV
  • Neurobo Pharmaceuticals Inc NRBO
  • Polypid Ltd PYPD
  • Poseida Therapeutics, Inc. PSTX
  • Recro Pharma Inc REPH
  • Teligent Inc (NEW JERSEY) TLGT
  • Tricida Inc TCDA (FDA rejected its drug to treat metabolic acidosis and requested additional data)
  • Unity Biotechnology Inc UBX
  • Viveve Medical Inc VIVE

Stocks In Focus

Qiagen Launches Rapid Antibody COVID-19 Test In US

Qiagen announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, a digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus.

The launch follows the company submitting emergency use authorization application to the U.S. The company expects to begin first shipments in late 2020.

The stock was trading down slightly at $51.57 premarket Tuesday.

Kamada Collaborates With Italy's Kedrion On Plasma-Based COVID-19 Treatment 

Close on heels of EUA for plasma therapy, Israeli biopharma Kamada said it is continuing to collaborate with Kedrion Biopharma of Italy for the development, manufacturing and clinical distribution of a plasma-derived anti-SARS-CoV-2 product.

The two companies said they are confident of eventually obtaining approval on both sides of the Atlantic for the clinical treatment of severely ill COVID-19 patients.

Under the terms of the agreement, Kamada is responsible for product development, manufacturing, clinical development with Kedrion's support and regulatory submissions.

Kedrion is responsible for collection and supply of plasma from convalescent COVID-19 patients and future distribution of the therapeutic product in the U.S., Europe, Australia and South Korea.

Kamada shares were up 1.79% at $11.94 premarket Tuesday.

Ovid, Takeda Report Positive Midstage Results For Seizure Drug

Ovid Therapeutics Inc OVID and Takeda Pharmaceutical Co Ltd TAK announced positive topline results from the randomized Phase 2 ELEKTRA study of soticlestat in children with Dravet syndrome or Lennox-Gastaut syndrome.

Ovid shares were rising 33.12% to $8.48 in premarket trading Tuesday, and Takeda was advancing 0.57% to $19.30.

See also: The Week Ahead In Biotech (Aug. 24-29): Lipocine Binary Event, Liver Congress In The Spotlight

Altimmune Reports Positive Preclinical Data For Nasal COVID-19 Vaccine Candidate

Altimmune Inc ALT reported additional results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID.

The results show potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice as early as 10 days following a single intranasal vaccination, with responses strongly biased toward CD8+ T cells.

The studies were conducted as part of Altimmune's ongoing collaboration with the University of Alabama at Birmingham.

In premarket trading Tuesday, Altimmune shares were rising 9.91% to $24.17.

Viveve Medical Reports Positive Preliminary Efficacy Data In Stress Urinary Incontinence Study

Viveve announced positive primary efficacy data from its three-arm, five-month stress urinary incontinence feasibility study, which is comparing the company's cryogen-cooled monopolar radiofrequency treatment and a cryogen-only sham treatment to an inert sham treatment for mild-to-moderate SUI in women.

Additionally, the company announced positive outcomes from an in-vivo preclinical study that was conducted to validate its new inert sham tip for use in the upcoming pivotal PURSUIT Trial in the U.S.

In premarket trading Tuesday, Viveve shares were jumping 41.51% to 75 cents.

AbbVie Exercises Option To License Morphic's Fibrotic Diseases Drug Candidate

Morphic Holding Inc MORF said AbbVie Inc ABBV has exercised a license option under their R&D collaboration agreement to develop Morphic's αvβ6 integrin inhibitors for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis and additional indications.

Morphic will receive a license fee of $20 million, with potential future development milestone payments and royalties from the sales of any commercialized candidates.

Organogenesis CFO Resign

Regenerative medicine company Organogenesis Holdings Inc ORGO announced the resignation of CFO Timothy Cunningham, effective Aug. 18, and the appointment of Henry Hagopian, the company's treasurer and vice president of finance, to the role on interim basis.

Cunningham's resignation is not due to any dispute or disagreement with the company or any matter relating to its accounting practices or financial statements, Organogenesis said. 

Offerings

Medical device company NanoVibronix said it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the latter has agreed to purchase on a firm commitment basis 4.33 million of its shares at 75 cents per share, less underwriting discounts and commission. The offering is expected to close Aug. 27.

The stock was sliding 22.93% to 67 cents in premarket trading Tuesday.

On The Radar

Earnings

Medtronic PLC MDT

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates

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