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The Week Ahead In Biotech: ESMO Conference, PDUFA Dates, Clinical Trial Results, Large-Cap Pharma Earnings And IPOs

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The Week Ahead In Biotech: ESMO Conference, PDUFA Dates, Clinical Trial Results, Large-Cap Pharma Earnings And IPOs
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Biotech stocks are staging a rebound following the losses incurred in the week ended Oct. 12 amid catalysts that include the third-quarter earnings season and presentations at the European Society of Medical Oncology, or ESMO, 2018 Congress in Munich, Germany.

After having lost about 4.5 percent in the week ended Oct. 12, the iShares NASDAQ Biotechnology Index (NASDAQ: IBB) is on the path to redemption.

Here's what could sway sentiment for biotech stocks in the coming week:

Conferences

  • ESMO 2018 Congress: Oct. 19-23, in Munich
  • Global Cardiology Summit: Oct. 22-23 in Osaka, Japan
  • Third International conference on Digestive and Metabolic Diseases: Oct. 22-23 in Berlin
  • 26th European Pediatrics Congress: Oct. 22-23 in Amsterdam, Netherlands
  • 27th European Cardiology Conference: Oct 22- 24 in Rome, Italy
  • 18th Annual Meeting on Oral Care & Oral Cancer: Oct. 24-25 in Boston
  • 9th International Conference on Gynaecology, Obstetrics and Women Health: Oct. 24-25 in Osaka
  • 11th Clinical Trials On Alzheimer's Disease, CTAD: Oct. 24-27 in Barcelona, Spain
  • BTIG Biotech Conference: Oct. 25 at the Langham Hotel in New York
  • 18th Global Dermatology Congress: Oct. 25-26 in Budapest, Hungary
  • American Society of Nephrology, or ASN, 2018 Annual Meeting: Oct. 25-28 in San Diego, California
  • 4th World Congress on Polycystic Ovarian Syndrome: Oct. 26-27 in Boston
  • 15th World Pediatrics Conference: Oct. 26-27 in Toronto, Canada
  • American Academy of Ophthalmology 2018 Meeting: Oct. 27-30 in Chicago

PDUFA Dates

The FDA is set to rule on Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)'s sNDA for Xyrem oral solution, which is being evaluated to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients. The PDUFA date is scheduled for Saturday, Oct. 27.

Clinical Trial Results

Selecta Biosciences Inc (NASDAQ: SELB) is due to present Phase 2 data for its tophaceous gout candidate SEL-212 at the ACR meeting Tuesday, Oct. 23.

Biogen Inc (NASDAQ: BIIB) will likely present updated Phase 2 data for BAN2401, its treatment candidate for Alzheimer's disease at the CTAD meeting on Thursday, Oct. 25.

Tricida Inc (NASDAQ: TCDA) will present efficacy data from the Phase 3 study of its chronic kidney disease candidate TRCA-301 at the ASN meeting on Thursday, Oct. 25. Phase 3 efficacy data released in June 2018 showed that the trial met the specified endpoints.

Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) will present Phase 1 data for DCR-PHXC, its pipeline candidate for primary hyperoxaluria at the ASN on Thursday, Oct. 25.

Regenxbio Inc (NASDAQ: RGNX) is due to present updated Phase 1 data for its wet age-related macular degeneration treatment candidate RGX-314 at the AAO meeting Friday, Oct. 26.

BioTime, Inc. (NYSE: BTX) will present interim readout of Phase 1/2 data for Cohort 4 at the AAO meeting.

ESMO Presentations Continue

Sunday, Oct. 21

Loxo Oncology Inc (NASDAQ: LOXO): Duration of response data for larotrectinib, or LOXO-101, in solid tumors that harbor a TRK fusion.

Mirati Therapeutics Inc (NASDAQ: MRTX): Updated Phase 1b data for sitravatinib in non-small cell lung cancer.

Incyte Corporation (NASDAQ: INCY): Interim Phase 2 data for INCB54828 in cholangiocarcinoma.

Aeglea Bio Therapeutics Inc (NASDAQ: AGLE): Phase 1 data for pegzilarginase in solid tumors.

NuCana PLC (NASDAQ: NCNA): Additional Phase 1b data for NUC-1031 front-line treatment for advanced biliary tract cancer.

Merck & Co., Inc. (NYSE: MRK) and AstraZeneca plc (NYSE: AZN): Presentation of Phase 3 data for Lynparza in first-line ovarian cancer.

Clovis Oncology Inc (NASDAQ: CLVS): Initial Phase 2 readout for rucaparib in castrate-resistant prostate cancer and Phase 2 data for Lucitanib in HR-positive, Her2-negative metastatic breast cancer.

Leap Therapeutics Inc (NASDAQ: LPTX): Phase 1/2 data for DKN-01 and Merck's Keytruda in esophagogastric adenocarcinoma.

See Also: Drug Companies To Disclose Pricing Information In Ads

Monday, Oct. 22

CytomX Therapeutics Inc (NASDAQ: CTMX): Updated Phase 1/2 data for CX 072 in solid tumors.

Neon Therapeutics Inc (NASDAQ: NTGN): Phase 1b data for NEO-PV-01 and Bristol-Myers Squibb Co (NYSE: BMY)'s nivolumab NT-001 in melanoma, lung cancer or bladder cancer.

Merck: Phase 3 data for Keytruda KN-048 in head and neck cancer.

NuCana: Additional Phase 1 data for NUC-3373 in solid tumors.

Protagonist Therapeutics Inc (NASDAQ: PTGX): Phase 2b data for PTG-100 in ulcerative colitis.

Sellas Life Sciences Group Inc (NASDAQ: SLS): final Phase 2b data for NeuVax in combination with Herceptin in breast cancer.

Epizyme Inc (NASDAQ: EPZM): Phase 2 data for tazemetostat in epithelioid sarcoma.

Kura Oncology Inc (NASDAQ: KURA): Updated Phase 2 data for tipifarnib in head and neck squamous cell carcinomas.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO): Phase 2 data for tivozanib and Opdivo in renal cell cancer.

Mirati Therapeutics: Updated Phase 2 data for sitravatinib plus nivolumab in non-small cell lung cancer. 

Earnings

Tuesday, Oct. 23

  • Alkermes Plc (NASDAQ: ALKS) (before the market open)
  • Biogen (before the market open)

Wednesday, Oct. 24

  • Anika Therapeutics Inc (NASDAQ: ANIK) (after the market close)
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (before the market open)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the market close)

Thursday, Oct. 25

  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the market close)
  • Bristol-Myers Squibb (before the market open)
  • Merck (before the market open)
  • Celgene Corporation (NASDAQ: CELG) (before the market open)
  • Gilead Sciences, Inc. (NASDAQ: GILD) (after the market close)
  • ResMed Inc. (NYSE: RMD) (after the market close)
  • Novocure Ltd (NASDAQ: NVCR) (before the market open)
  • Seattle Genetics, Inc. (NASDAQ: SGEN) (after the market close)

Friday, Oct. 26

  • Zimmer Biomet Holdings Inc (NYSE: ZBH (before the market open)

IPOs

Alzheon, which develops small-molecule therapies for Alzheimer's disease, is set to offer 2.5 million shares in an IPO with an estimated price range of $13-$15. The company seeks to list its shares on the Nasdaq under the ticker symbol ALZH.

Israeli biotech company Gamida Cel is set to offer 3.571 million shares in an IPO, with the shares expected to be priced between $13 and $15.The shares are to be listed on the Nasdaq under the ticker symbol GMDA.

IPO Quiet Period Expirations

  • Entasis Therapeutics Holdings Inc (NASDAQ: ETTX)
  • Urovant Sciences Ltd (NASDAQ: UROV)
  • Sutro Biopharma Inc (NASDAQ: STRO)
  • RA Medical Systems Inc (NYSE: RMED)
  • Gritstone Oncology Inc (NASDAQ: GRTS)

Posted-In: Biotech Earnings News Health Care Previews FDA IPOs Top Stories Best of Benzinga

 

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