The Daily Biotech Pulse: Jazz Buys Tumor Drug Program, Sanofi's BLA For Multiple Myeloma Drug Accepted, Positive Results For ViiV

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 on July 9)

  • Apellis Pharmaceuticals Inc APLS
  • Athenex Inc ATNX
  • Eidos Therapeutics Inc EIDX
  • Enlivex Therapeutics Ltd ENLV
  • EXACT Sciences Corporation EXAS
  • Principia Biopharma Inc PRNB

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 9)

  • Aerpio Pharmaceuticals Inc ARPO
  • Five Prime Therapeutics Inc FPRX
  • Heat Biologics Inc HTBX
  • Ideaya Biosciences Inc IDYA
  • IMMUTEP LTD/S ADR IMMP (raised $7 million through an equity offering)
  • Immunomedics, Inc. IMMU
  • Invivo Therapeutics Holdings Corp NVIV
  • Jaguar Health Inc JAGX
  • OncoSec Medical Inc ONCS
  • Tcr2 Therapeutics Inc TCRR
  • Tonix Pharmaceuticals Holding Corp TNXP

See Also: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Stocks In Focus

ViiV Healthcare Reports Positive Phase 3 Results For 2-Drug Regimen Of HIV-1 Treatment

ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK with Pfizer Inc. PFE and SHIONOGI & CO L/ADR SGIOY as shareholders, announced positive Week 48 results from the Phase 3 TANGO study that evaluated its two-drug regimen in HIV-1 patients.

The study assessed whether adult HIV-1 patients who had maintained viral suppression for at least six months on a tenofovir alafenamide fumarate, or TAF,-containing three-drug regimen were able to maintain similar rates of viral suppression after switching to the two-drug regimen of dolutegravir plus lamivudine combination compared to continuing the TAF-containing regimen.

The company noted that the study met the primary endpoint of non-inferiority and the safety profile was consistent with the product labeling for the medicines.

Jazz To Buy Redx's Tumor Treatment Program For Up To $206.5M

Jazz Pharmaceuticals PLC JAZZ announced a definitive agreement for acquiring London-listed Redx Pharma's pan-RAF inhibitor program for the treatment of RAF and RAS mutant tumors.

Redx will perform certain pre-clinical activities for the program, while Jazz will be responsible for further development, regulatory activities and commercialization.

The agreement provides for Jazz paying an upfront payment of $3.5 million, and up to $203 million in additional development, regulatory and commercial milestone payments. Redx is also eligible to receive mid-single-digit percentage tiered royalties on future sales.

FDA Accepts For Review Sanofi's Biologic Drug For Multiple Myeloma

Sanofi SA SNY said the FDA has accepted for review its BLA for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma. Isatuximab is a monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell. The PDUFA date has been set for April 30, 2020.

Mirati Partners With Novartis For Solid Tumor Combo Drug

Mirati Therapeutics Inc MRTX announced a clinical collaboration agreement with Novartis AG NVS to evaluate the combination of MRTX849, its investigational KRAS G12C inhibitor and TNO155, Novartis' investigational SHP2 inhibitor, in patients with advanced solid tumors that harbor KRAS G12C mutations.

Mirati will sponsor the trial, while both companies will jointly oversee and the share the costs. Mirati noted that Novartis will provide its TNO155 free of cost.

On The Radar

AngioDynamics, Inc. ANGO

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