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The Week Ahead In Biotech: PDUFA Dates, IPOs And More

Shanthi Rexaline

Some M&A activity, earnings news flow and clinical trial outcomes helped the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) preserve gains this week.

As the earnings season winds down, here're are some upcoming week's key biotech events/catalysts that investors should stay tuned for.

Medical/healthcare/Biotech Conferences

  • American Thoracic Society, or ATS, International Conference – May 18-23, in San Diego, California
  • 20th European Congress of Endocrinology, or ECE, – May 19-22, in Barcelona, Spain
  • World Federation of Hemophilia, or WFH, World Congress – May 20-24 in Glasgow, Scotland
  • UBS Global Healthcare Conference – May 21-23 in New York City
  • 55th ERA-EDTA Congress – May 24-27, in Copenhagen, Denmark

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

PDUFA Dates

Monday, May 21

The FDA is set to rule on Dova Pharmaceuticals Inc (NASDAQ: DOVA)'s NDA for avatrombopag for thrombocytopenia in chronic liver disease patients. Thrombocytopenia is a condition where the platelet count drops to low levels, causing internal bleeding.

Johnson & Johnson (NYSE: JNJ)'s Janssen unit and partner GENMAB A/S/S ADR (OTC: GMXAY) await FDA decision on the sBLA for darzalex in combination with bortezomib, melphalan and prednisone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Tuesday, May 22

The FDA will announce its decision on Insys Therapeutics Inc (NASDAQ: INSY)'s NDA for buprenorphine to treat moderate-to-severe post-operative pain after bunionectomy.

Friday, May 25

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)'s BLA for Pegvaliase to treat phenylketonuria is up before the FDA for review. Phenylketonuria is disorder involving deficiency of phenylalanine hydroxylase, an enzyme needed for metabolism of an essential amino acid present in most protein containing food. An accumulation of this amino acid in the blood is toxic to the brain.

Saturday, May 26

The FDA will announce its verdict on Recro Pharma Inc (NASDAQ: REPH)'s NDA for an intravenous formulation of meloxicam to treat acute pain following bunionectomy surgery.

Clinical Trial Outcomes

Ascendis Pharma A/S (NASDAQ: ASND) is scheduled to make a poster presentation of Phase I data for TransCon, its treatment candidate for hypoparathyroidism, at the ECE on Sunday, May 20.

Roche Holdings AG Basel ADR (OTC: RHHBY) will present new Phase 3 data from HAVEN 3 and 4 studies at the WFH 2018 World Congress on Monday, May 21.

Urogen Pharma Ltd (NASDAQ: URGN) is set to present interim Phase 3 data on Mitagel from the Olympus study on Monday.

VERONA PHARMA P/S ADR (NASDAQ: VRNA) is scheduled to announce Phase 2b data for RPL554 to treat chronic obstructive pulmonary disease at the ATS International Conference on Monday.

Biomarin will present updated Phase 2 data on BMN-270 for treating hemophilia A at the WFH 2018 World Congress between May 20-24.

Catalyst Biosciences Inc (NASDAQ: CBIO) is set to present Phase 1/2 data for its hemophilia B treatment combo CB2679d/ISU304 at the WFH 2018 World Congress on Tuesday.

Reata Pharmaceuticals Inc (NASDAQ: RETA) is scheduled to release interim Phase 2 data for Bardoxolone from the PHOENIX study that evaluated the treatment candidate for chronic kidney disease at the ERA-EDTA meeting on Friday.

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) will present interim biomarker data for ACH-4471 to treat C3 glomerulopathy at the ERA-EDTA meeting on Saturday.

Related Link: B Riley Likes Tocagen On Prospects For Company's Brain Cancer Drug

IPOs

Iterum Therapeutics is set to offer 5.33 million shares in an initial public offering. The company, which develops an antibiotic called sulopenem, seeks to list its shares on the Nasdaq under the ticker symbol ITRM.

Kiniksa Pharmaceuticals, a clinical-stage biotech company developing therapies for autoinflammatory and autoimmune conditions, is gearing up for a 7-million offering, with an estimated price range of $17-$19. The company is looking to list its shares on the Nasdaq under the ticker symbol KNSA.

Scholar Rock Holding is due to offer 5.36 million shares in an IPO. The shares are to be listed on the Nasdaq under the ticker symbol SRRK. The company is engaged in pre-clinical research, targeting growth factor inhibition for a variety of diseases.

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