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

After ending almost flat in the week ended Sept. 14, biotech stocks have seen some bounce in the running week, with the iShares NASDAQ Biotechnology Index IBB up about 1.3 percent through Thursday.

Altimmune Inc ALT more than doubled in the week, while the worst decliner of the week was nano-cap Egalet Corporation EGLT, which announced termination of an offer to repurchase its debt due 2020, suggesting it would default on the loan.

The following are catalysts in the upcoming week that could sway biotech stocks:

Conferences

• 21st European Society for Clinical Virology, or ESCV, Meeting: Sept. 23-26 in Athens, Greece
• The International Association of Study of Lung Cancer, or IASLC, 19th World Conference on Lung Cancer: Sept. 23-26 in Toronto
• 9th International conference on Clinical Research and Diagnosis: Sept.. 24-25 in Chicago
• 3rd International Conference on Diagnostic Microbiology and Infectious Diseases: Sept. 24-25 in Montreal
• 3rd World Conference on Breast and Cervical Cancer: Sept. 24-25 in Abu Dhabi
• 27th International Conference on Pediatrics, Neonatology and Pediatric Nursing: Sept. 24-25 in Tokyo
• 18th International Conference on Glaucoma & Retinal Diseases: Sept. 24-25 in Dallas
• 5th World Heart and Brain Conference: Sept. 24-26 in Abu Dhabi
• International Conference on Neuroimmunology, Neurological disorders and Neurogenetics: Sept. 26-27 in Montreal
• 20th World Congress on Radiology and Oncology: Sept. 26-27 in Chicago
• 18th World Congress on Optometry and Vision Science: Sept. 26-27 in Montreal
• 29th International Congress on Prevention of Diabetes and Complications: Sept. 27-28 in Berlin
• 10th Euro-Global Conference on Infectious Diseases: Sept. 27-29 in Rome
• 15th International Conference on Clinical and Experimental Dermatology: Sept. 28-29 in San Antonio, Texas
• 7th Annual Summit on Microbiology: Education, R&D and Market: Sept. 28-29 in San Antonio

PDUFA Dates

• The FDA is set to rule Thursday, Sept. 27 on Adamis Pharmaceuticals Corp ADMP's sNDA for low-dose Symjepi, chemically epinephrine, injection in the treatment of anaphylaxis.
• The low-dose version is 0.15 mg in strength and is intended to potentially treat patients weighing 33-65 pounds.
• The agency will also announce its verdict on Insmed Incorporated INSM's Amikacin Liposome Inhalation Suspension for treating nontuberculous mycobacterial lung disease caused by mycobacterium avium complex.. The PDUFA date is set for Friday, Sep. 28.
• Antares Pharma Inc ATRS's testosterone deficiency treatment candidate XYOSTED is up before the FDA for review. A decision on the application is due Saturday, Sept. 29.

Clinical Trials

• Chimerix Inc CMRX is due to release Phase 1 data for its CMX51 in norovirus at the 21st ESCV meeting Sunday, Sept. 23.
• Checkpoint Therapeutics Inc CKPT and Fortress Biotech FBIO will present preliminary Phase 1/2 data for its non-small cell lung cancer treatment candidate CK-101 at the IASLC Monday, Sept. 24.
• Syndax Pharmaceuticals Inc SNDX is set to present updated Phase 2 data for its recurrent NSCLC and colorectal cancer combo treatment option Entinostat plus Keytruda, which is being evaluated in a study dubbed ENCORE, at the IASLC Monday, Sept. 24.
• Spectrum Pharmaceuticals, Inc. SPPI will present Phase 2 data for its poziotinib — which is being evaluated on NSCLC patients with exon 20 insertion mutation in EGFR or HER2 — at the IASLC Monday, Sept. 24.
• Loxo Oncology Inc LOXO is due to present updated Phase 1 data for its LOXO-292 for treating RET-fusion NSCLC, medullary thyroid cancer and other tumors at the IASLC between 3:15 and 4:45 p.m. ET Tuesday, Sept. 25.
• Novocure Ltd NVCR will present final Phase 2 data for its tumor treating fields for mesothelioma Tuesday, Sept. 25.

See also: Viking Shares Jump After Fatty Liver Drug Meets Midstage Trial Endpoints

Q3/September Schedule

• Novo Nordisk A/S (ADR) NVO will release Phase 2 data for its concizumab, which is under evaluation as a treatment option for hemophilia A. The company is also set to release Phase 3 extension data for its adult growth hormone deficiency treatment candidate somapacitan.
• GALAPAGOS NV/S ADR GLPG is due to release Phase 2 data for its combo treatment GLPG 2451+2222+2737 for cystic fibrosis in homozygous F508del patients.
• Omeros Corporation OMER is scheduled to release Phase 2 data for its OMS721 in IgA nephropathy.
• Inovio Pharmaceuticals Inc INO will release Phase 1 data for its prostate cancer treatment candidate INO-5150.
• Ra Pharmaceuticals Inc RARX is scheduled to release Phase 1b pharmacokinetics data for RA101495 SC, its pipeline candidate for atypical hemolytic uremic syndrome.
• Lexicon Pharmaceuticals, Inc. LXRX is due to release Phase 1b data for its Type 2 diabetes treatment candidate LX2761.
• Syndax Pharma is set to release Phase 3 progression-free survival data for E2112, its treatment candidate for HR-positive and HER2-negative breast cancer.
• Cytokinetics, Inc. CYTK will release interim analysis of Phase 1b data for its CK-2127107 for limited mobility. The company will also release results of a Phase 2 study of the same candidate in COPD.
• AnaptysBio Inc ANAB is due to release Phase 2a data for its ANB020 that is being evaluated in severe adult eosinophilic asthma.
• Celsion Corporation CLSN is likely to release Phase 1b data for its ovarian cancer treatment candidate GEN-1.
• CTI BioPharma Corp CTIC is due to release interim Phase 2 data for pacritinib, its pipeline candidate for myelofibrosis.
• Amarin Corporation plc (ADR) AMRN is due to release Phase 3 data for its Vascepa to treat high triglycerides with mixed dyslipidemia.
• Geron Corporation GERN and Johnson & Johnson JNJ are scheduled to release a primary analysis of data from the Phase 2 IMbark study for their Imetelstat in myelofibrosis.
• Proteostasis Therapeutics Inc PTI is set to release final Phase 1 data for its cystic fibrosis treatment PTI-801.
• TapImmune Inc. TPIV will release Phase 2 interim response data for TPIV200, which is being evaluated as second-line treatment for triple-negative breast cancer.
• Radius Health Inc RDUS is expected to release Phase 1 data for AB122 in the treatment of solid tumors.
• Spero Therapeutics Inc SPRO is due to release final Phase 1 data for its SPR994 in healthy volunteers to assess its safety.
• Arena Pharmaceuticals, Inc. ARNA will release Phase 2 data for its olorinab to treat pain associated with Crohn's disease.
• Alnylam Pharmaceuticals, Inc. ALNY is set to release interim analysis of Phase 3 data for its acute hepatic porphyrias treatment Givosiran.

Earnings

Thursday

• AngioDynamics, Inc. ANGO (ahead of the market open)

IPOs

• Entasis Therapeutics Holdings, a clinical-stage biotech developing therapies for multi-drug resistant bacteria, is set to offer 4.41 million shares in an IPO, with the price estimated between $16 and $18. The shares are to be listed on the Nasdaq under the ticker symbol ETTX.
• Arvinas Holding, a biotech company developing protein degradation therapies for advanced cancer, is seeking to list its shares on the Nasdaq under the ticker symbol ARVN by offering 6.67 million shares in an IPO, priced in the $14-$16 range.
• Urovant Sciences is due to offer 10 million shares in an IPO, with the shares expected to be priced between $14 and $16. The shares would be listed on the Nasdaq under the ticker symbol UROV. The company develops an acquired oral therapy for overreactive bladder.
• Sutro Biopharma, a biotech company developing immuno-oncology therapies, is offering 5 million shares priced between $14 and $16. The shares are to be listed on the Nasdaq under the ticker symbol STRO.
• Gritstone Oncology, a biotech company developing a therapy to enhance checkpoint immuno-oncology drugs, will offer 6.07 million shares in a price range of $13-$15. The shares would be listed on the Nasdaq under the ticker symbol GRTS.
• Ra Medical Systems seeks to list its shares on the Nasdaq under the ticker symbol RMED. The company that commercializes excimer lasers used to treat dermatologic and vascular diseases will offer 3.33 million shares in an IPO, with an estimated price range of $14-$16.

Related Link: Development Deal With Takeda Pharma Sends Molecular Templates Shares Rocketing Higher