The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Sarepta Flags Potential Delay In Gene Therapy Trial

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 9)

  • Akouos Inc AKUS
  • Castle Biosciences Inc CSTL
  • ESSA Pharma Inc EPIX
  • Kintara Therapeutics Inc (NASDAQ: KTRA
  • Kura Oncology Inc KURA
  • Merit Medical Systems, Inc. MMSI
  • Nurix Therapeutics Inc NRIX
  • Trillium Therapeutics Inc TRIL( reacted
  • to early-stage clinical readouts for blood cancer drugs and a $25-million investment by Pfizer Inc. PFE)
  • X T L Biopharmaceuticals Ltd XTLB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 9)

  • AnPac Bio-Medical Science Co Ltd – ADR ANPC
  • Genfit SA GNFT
  • Hoth Therapeutics Inc HOTH
  • Kymera Therapeutics Inc KYMR
  • Neurobo Pharmaceuticals Inc NRBO
  • Opiant Pharmaceuticals Inc OPNT
  • RA Medical Systems Inc RMED

Stocks In Focus

FDA Approves Label Expansion For GlaxoSmithKline's Triple Therapy to Treat Asthma

GlaxoSmithKline plc GSK and Innoviva Inc INVA said the FDA has approved a new indication for Trelegy Ellipta for the treatment of asthma in patients aged 18 years and older.

The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the U.S., the company said.

Innoviva manages the royalty for Trelegy, and is eligible to receive royalty revenues from it.

In after-hours trading, Innoviva rallied 10.92% to $13.

FDA Requests Additional Potency Assay For Releasing Commercial Material For Sarepta's Gene Therapy Study

Sarepta Therapeutics Inc SRPT said following a Type C ‘written responses only' meeting with FDA's Office of Tissues and Advanced Therapies regarding its investigational Duchenne muscular dystrophy gene therapy, the OTAT requested utilization of an additional potency assay for release of SRP-9001 commercial process material prior to dosing in a clinical study.

Sarepta said additional dialogue with the agency is required to determine the acceptability of the potency assay approach.

"SRPT has yet to comment on how the FDA's requests might impact timelines for Study 301, but we believe it is likely the Ph.3 trial will see a modest delay," SVB Leerink analyst Joseph Schwartz said in a note, commenting on the development.

The stock slid 4.58% to $124.51 in after-hours trading.

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

Roche Presents Promising New Data On Treatment For Rare Central Nervous System Disease

Roche Holdings AG Basel RHHBY announced new data on Enspryng to be presented at MSVirtual2020, the 8th joint ACTRIMS-ECTRIMS meeting, suggesting Enspryng significantly reduces relapse severity and frequency of neuromyelitis optica spectrum disorder, or NMOSD, a rare disease of the central nervous system. Additionally, the company announced longer-term efficacy data supporting the continued effect on reducing the risk of NMOSD relapse, as well as its favorable benefit-risk profile.

Sutro Announces Positive Results For Ovarian Cancer Drug Study

Sutro Biopharma Inc STRO announced updated interim Phase 1 safety and preliminary efficacy data for STRO-002 in ovarian cancer, showing an overall response rate of 24% in 33 evaluable patients with post-baseline scans, with durability of 44% of patients on treatment for 16 weeks or greater and 12% of patients on treatment for 1 year or greater.

"The observed rate of objective response, stable disease and overall disease control during this study suggest that STRO-002 is potentially superior to other targeted ADC therapies being studied currently in ovarian cancer," said Dr. Arturo Molina, Chief Medical Officer of Sutro.

The data is being presented at the 2020 xDigital Annual Global Meeting of the International Gynecologic Cancer Society.

In after-hours trading, the stock fell 8.75% to $12.

Quest Diagnostics Lifts FY20 Guidance

Quest Diagnostics Inc DGX raised its full-year guidance, citing faster than anticipated recovery in testing volume through the end of August.

Rockwell Medical Out-licenses Rights to Market Anemia Drug In South Korea

Rockwell Medical Inc RMTI said it has entered into an exclusive license agreement with Jeil Pharmaceutical for the rights to commercialize Triferic in South Korea.

The terms of the licensing agreement call for Rockwell out-licensing exclusive development and commercialization rights for Triferic in South Korea in return for an upfront fee and potential milestone payments and royalties on net sales.

Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment.

In after-hours trading, the stock jumped 25.20% to $1.54.

Sonoma Launches Two Products In Australia

Sonoma Pharmaceuticals Inc SNOA said it's launching two new products – Nasocyn and Oracyn - in Australia, based on its patented Microcyn and Microdacyn technology. The company said it is collaborating with its New Zealand and Australian partner Te Arai BioFarma for the launch. The products will be available without prescription through pharmacies, Sonoma said.

While Nasocyn works against running nose and reduces inflammation, Oracyn helps treat infections in the throat and mouth.

The stock rallied 18.85% to $8.07 in after-hours trading


Natera Inc NTRA, which is engaged in cell-free DNA testing, announced the launch of a proposed follow-on public offering of $250 million of shares of its common stock.

Spero Therapeutics Inc SPRO announced the commencement of an underwritten public offering of 8 million shares of common stock in the aggregate, comprising common stock and shares of non-voting series D convertible preferred stock with each share of series D convertible preferred stock being convertible into 1,000 shares of common stock. All the securities are being offered by the company.

The stock fell 2.46% to $12.48 in after-hours trading.

Trillium said it has commenced a public offering of up to 8.5 million common shares. The company said it intends to use the net proceeds for its ongoing and planned clinical trials for its CD47 program, including drug supply and for working capital and general corporate purposes.

The stock moved down 2.50% to $13.25 in after-hours trading.

Intra-Cellular Therapies Inc ITCI said it has commenced an underwritten public offering of $350 million of shares of its common stock. All of the shares in the offering are to be sold by the company.

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