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The Week Ahead In Biotech: Novo Nordisk And Merck Await FDA Rulings, 2 IPOs On Deck

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The Week Ahead In Biotech: Novo Nordisk And Merck Await FDA Rulings, 2 IPOs On Deck

Biotech stocks rebounded in last week after declining modestly in the previous week.

Some of the drugs that cleared the FDA hurdle this week include Ardelyx Inc (NASDAQ: ARDX)'s constipation drug Ibsrela; South African drugmaker Apsen Pharmacare's hydroxyprogesterone caproate, indicated to prevent preterm birth in pregnant women; and GlaxoSmithKline plc (NYSE: GSK)'s Nucala for treating severe eosinophilic asthma in children, ages 8-11 years.

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The week turned out to be a disappointing one for a few nano- and micro-cap stocks, which reported negative clinical trial readouts. Tocagen Inc (NASDAQ: TOCA) tumbled about 78% after its brain cancer drug failed to ace a late-stage study and Ritter Pharmaceuticals Inc (NASDAQ: RTTR)'s pipeline asset to treat lactose intolerance also stumbled in a late-stage study, sending its shares to a record low.

Here are the key catalysts a biotech investor needs to focus on for the upcoming week.

Conferences

  • Retina Society Annual Meeting 2019 Annual Meeting – Sept. 11-15, in London
  • Global Summit On Cardiology & Heart Diseases – Sept. 16-17, in Dubai
  • European Association for the Study of Diabetes, or EASD, 55th annual meeting – Sept. 16-20, in Barcelona, Spain
  • 13th European Pediatric Neurology Society, or EPNS, Congress – Sept. 17 – 21, in Athens, Greece
  • 4th Antibodies, Antibiotics and Bio Therapeutics Congress: R&D, Market and B2B – Sept. 18-19, in Chicago
  • The 2019 annual global meeting of the International Gynaecologic Cancer Society, or IGCS – Sept. 19-21, in Rio de Janeiro, Brazil
  • 15th World Congress on Endocrinology & Diabetes - Sept. 20-21, in Prague, Czech Republic
  • World Kidney Meeting – Sept. 20-21, in Dallas

PDUFA Dates

The FDA is set to rule on Merck & Co., Inc. (NYSE: MRK)'s sNDAs for Pifeltro (doravirine, 100mg) as well as Delstrigo (doravirine100mg, lamivudine,3TC, 300 mg, and tenofovir disoproxil fumarate, 300 mg). Both decisions are due Friday.

Delstrigo, a combo treatment, is being evaluated in people living with HIV-1, and who are switching from a stable antiretroviral regimen and whose virus is suppressed.

Novo Nordisk A/S (NYSE: NVO)'s NDA for Semaglutide is pending before the FDA. The PDUFA action date for the drug, which is being evaluated as an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes, is fixed for Saturday.

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Clinical Trial Readouts

Kodiak Sciences Inc (NASDAQ: KOD) is due to present at the Retina Society 2019 annual meeting Phase 1b data for KSI-301 in wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion.

At the Retina Society 2019 annual meeting, MeiraGTx Holdings PLC (NASDAQ: MGTX) will present the results of a phase 1/2 trial of AAV-RPE65, an optimized gene therapy in adults and children with retinal dystrophy associated with bi-allelic variants in RPE65.

Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) is scheduled to present at the Global Summit On Cardiology & Heart Diseases initial Phase 1 data for AROAPOC31001 in familial chylomicronemia syndrome and hypertriglyceridemia.

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) is due to make multiple presentations, both oral and poster, on its Type 1 diabetes product candidate sotagliflozin at the EASD annual meeting.

bluebird bio Inc (NASDAQ: BLUE) will present Phase 2/3 data for Lenti-D hematopoietic stem cell gene therapy for cerebral adrenoleukodystrophy at the EPNS Congress.

vTv Therapeutics Inc (NASDAQ: VTVT) is scheduled to present at the EASD annual meeting, results from the Part 1 of the Simplici-T1 study of liver-selective glucokinase activator TTP399 as an adjunctive treatment for Type 1 diabetes.

Leap Therapeutics Inc (NASDAQ: LPTX) will present at the IGCL annual global meeting updated Phase 2 data for DKN-01 and paclitaxel in endometrial cancer.

IPOs

Exagen, a company that sells blood tests for diagnosing, prognosing or monitoring autoimmune diseases, proposes to offer 3.33 million shares in an IPO at an estimated price range of $14-$13. The company plans to list the shares on the Nasdaq under the ticker symbol "XGN."

IGM Biosciences is set to offer 7.81 million shares in an IPO, with the price estimated between $15 and $17 per share. The preclinical and clinical-stage immuno-oncology biotech looks to list its shares on the Nasdaq under the ticker symbol "IGMS."

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