The Daily Biotech Pulse: Positive Readout From Galapagos, Intersect ENT Strikes Distribution Deal, Sol Gel's Regulatory Filing Accepted For Review

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 10)

  • Agenus Inc AGEN
  • Akouos Inc AKUS
  • BioLife Solutions Inc BLFS
  • Checkpoint Therapeutics Inc CKPT
  • ESSA Pharma Inc EPIX
  • Fortress Biotech FBIO
  • Harmony Biosciences Holdings Inc HRMY
  • Inspire Medical Systems Inc INSP
  • Kintara Therapeutics Inc KTRA
  • Kura Oncology Inc KURA
  • Protagonist Therapeutics Inc PTGX
  • RedHill Biopharma Ltd RDHL
  • Silk Road Medical Inc SILK
  • Shockwave Medical Inc SWAV
  • Trillium Therapeutics Inc TRIL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 10)

  • ADiTx Therapeutics Inc ADTX
  • AnPac Bio-Medical Science Co Ltd – ADR ANPC(reacted to results for the half-year)
  • Burning Rock Biotech Ltd BNR
  • Evofem Biosciences Inc EVFM
  • Lexicon Pharmaceuticals, Inc. LXRX
  • Pandion Therapeutics Inc PAND
  • Satsuma Pharmaceuticals Inc STSA (reacted to a negative late-stage clinical readout for investigational migraine drug)

Stocks In Focus

Roche Presents Positive Long-Term Data For Multiple Sclerosis Drug

Roche Holdings AG Basel ADR Common Stock RHHBY announced at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS meeting new data that showed Ocrevus is a highly effective treatment option for people with relapsing-remitting multiple sclerosis who experienced a suboptimal response to their prior disease modifying therapy.

Further subgroup analysis from the two-year, open-label Phase 3b CASTING study also demonstrated that patients benefit across a wide range of disease related and demographic subgroups regardless of prior treatment background, Roche said.

Galapagos Reports Positive Midstage Results For Autoimmune Disease Drug

GALAPAGOS NV/S ADR GLPG announced positive topline results for the NOVESA Phase 2a clinical trial with investigational ziritaxestat in patients with diffuse cutaneous systemic sclerosis, or dcSSc.

"Ziritaxestat reached the primary endpoint of the study with a statistically significant change from baseline in the modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 vs -5.7 for placebo," Galapagos said.

The Phase 2a proof-of-concept trial evaluated the efficacy, safety and tolerability of ziritaxestat in 33 patients with dcSSc, a severe autoimmune disease, for which there is no approved drug.

In premarket trading, Galapagos shares were rising 8.9% to $136.99. 

See also: The Week Ahead In Biotech: Focus On Mallinckrodt FDA Decision, Conference Presentations

Lyra's LYR-210 Found Effective In Chronic Rhinosinusitis

Lyra Therapeutics Inc LYRA presented at the 66th Annual Meeting of the American Rhinologic Society data showing that its LYR-210 demonstrated a significant reduction of sinonasal type 2 inflammation in surgically naïve patients with chronic rhinosinusitis.

Intersect ENT Announces Agreement With Walgreens For Distributing Sinus Implant

Intersect ENT Inc XENT said it has signed a pharmacy services agreement with Walgreens Boots Alliance Inc's WBA AllianceRx Walgreens Prime for national specialty pharmacy distribution of the its Sinuva Sinus Implant.

"The agreement will facilitate broader physician and patient access to Sinuva by using the expertise and established specialty pharmacy infrastructure of AllianceRx Walgreens Prime to dispense SINUVA through either a patient's medical or pharmacy insurance benefit," Intersect ENT said.

Sol Gel Says FDA Accepts Regulatory Filing For Skin Inflammation Drug

Sol Gel Technologies Ltd SLGL, a clinical-stage dermatology company, said its NDA for Epsolay, an investigational proprietary topical cream for the treatment of inflammatory lesions of rosacea containing 5% encapsulated benzoyl peroxide, has been accepted for filing by the FDA.

The PDUFA date has been set for April 26, 2021.

The stock was trading 5.14% higher to $7.98 premarket Friday. 

On The Radar

Clinical Readouts

Atara Biotherapeutics Inc ATRA is scheduled to present at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS meeting with new 12-month data from all four cohorts in the Phase 1a study of ATA188 for the treatment of progressive forms of multiple sclerosis

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

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