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06/15/2019 | Press release | Distributed by Public on 06/15/2019 11:23

The Week Ahead In Biotech: Conferences, PDUFA Dates Clinical Trial Readouts And IPOs

Cboe - Market News Story

The Week Ahead In Biotech: Conferences, PDUFA Dates Clinical Trial Readouts And IPOs

Shanthi Rexaline 6/15/2019 11:38:29 AM

For biotech stocks, the week was back loaded with multiple conferences scheduled for the later half of the week. Nevertheless, there were volatile moves in some low-float, thinly traded stocks.

Looking ahead, keep an eye on the following key catalysts.

Conferences

  • The Annual European Congress of Rheumatology of the European League Against Rheumatism - June 12-16, in Switzerland
  • 24th European Hematology Association Congress - June 13-16, in Amsterdam, Netherlands
  • European Society of Human Genetics Conference - June 15-18, in Gothenburg, Sweden
  • The International Association of Parkinson's Disease and Related Disorders (IAPR) World Congress on Parkinson's Disease and Related Disorders - June 16-19, Montreal, Canada
  • 5th International Conference on Influenza and Zoonotic Diseases - June 17-18, in Berlin, Germany
  • 9th World Congress on Rare Diseases and Orphan Drugs - June 17-18, in Berlin
  • International Conference On Malignant Lymphoma - June 18-20, in Switzerland
  • Oxalosis Hyperoxaluria Foundation, or OHF, International Hyperoxaluria Workshop - June 21-22, in Boston, Massachusetts

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

PDUFA Dates

The FDA is set to rule on Merck & Co., Inc. (NYSE: MRK)'s sBLA in Keytruda for treating patients with advanced small cell lung cancer, whose disease has progressed after two or more lines of prior therapy. The PDUFA date is scheduled for Monday, June 17.

Clinical Trial Readouts

ArQule, Inc. (NASDAQ: ARQL) is scheduled to present Phase 1/2 data for ARQ 092 to treat overgrowth diseases at the European Society of Human Genetics Conference June 17.

Affimed NV (NASDAQ: AFMD) will present updated Phase 1b/2a data for AFM13 in CD30-postive lymphoma at the International Conference On Malignant Lymphoma June 17. The company will also present updated Phase 1b data for AFM13 with Merck's Keytruda in Hodgkin's Lymphoma at the same conference Saturday, June 22.

Beigene Ltd . (NASDAQ: BGNE) will present updated Phase 2 data for its Zanubrutinib in relapsed or refractory mantle cell lymphoma at the International Conference On Malignant Lymphoma Wednesday, June 19. The company will also present Phase 1b data for Zanubrutinib and Obinutuzumab in relapsed/refractory follicular lymphoma at the International Conference On Malignant Lymphoma Thursday, June 20.

Epizyme Inc . (NASDAQ: EPZM) is due to present updated Phase 2 data for its Tazemetostat in follicular lymphoma at the International Conference On Malignant Lymphoma Friday, June 21.

Morphosys Ag (NASDAQ: MOR) will present already-released Phase 2 data for Lenalidomide + MOR208 in relapsed or refractory diffuse large B cell lymphoma at the International Conference On Malignant Lymphoma, Saturday, June 22.

Theravance Biopharma Inc (NASDAQ: TBPH) is set to release Phase 2, 5-month data for its Ampreloxetine in nOH at the IAPRD 2019 World Congress on Parkinson's Disease and Related Disorders to be held between June 16-19.

Allena Pharmaceuticals Inc (NASDAQ: ALNA) will present detailed Phase 2 data for Reloxaliase ALLN-177 in primary hyperoxaluria at the OHF International Hyperoxaluria Workshop to be held between June 21-22.

IPOs

Akero Therapeutics, which develops therapies for NASH and other metabolic disorders, is scheduled to offer 5 million shares in an IPO, to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol AKRO.

Atreca proposes to offer 7.35 million shares in an IPO, with the price estimated in the range of $16-$18. The shares of the company developing therapies for solid tumors are likely to be listed on the Nasdaq under the ticker symbol BCEL.

Dermatological-disease focused Dermavant Sciences will offer 7.7 million shares in an IPO to be priced in the range of $12-$14. The company seeks a Nasdaq listing under the ticker symbol DRMT.

Genomic sequencing company Personalis is targeting a Nasdaq listing under the ticker symbol PSNL, by offering 6.67 million shares in the price range of $14-$16.

Prevail Therapeutics is scheduled to offer 7.352 million shares in an IPO, with the price estimated to be $16-$18. The shares would be listed on the Nasdaq under the ticker symbol PRVL.

Stoke Therapeutics, which develops RNA-targeted therapies for rare genetic disorders has planned a 6.7-million share IPO, to be priced between $14 and $16. The company proposes to list the shares on the Nasdaq under the ticker symbol STOK.