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

Presentations at the European Society of Medical Oncology meeting created some volatility in stocks, while the week also saw earnings releases from big-cap pharma companies.

The following catalytic events are likely to determine the course of biotech stocks in the upcoming week.

Conferences

• The American Academy of Ophthalmology, or AAO, 2018 Annual Meeting – Oct. 27-30, in Chicago
• 4th World Congress on Digestive & Metabolic Diseases – Oct. 29-30, in San Francisco
• 12th International Conference on Hematology & Hematological Oncology – Oct. 29-30, in San Francisco
• 6th International Conference on HIV/AIDS, STDs and STIs – Oct. 29-30
• International Conference on Gastrointestinal Cancer and Therapeutics – Oct. 29-30, in San Francisco
• 12th International Conference on Alzheimer's Disease & Dementia – Oct. 29-31, in Valencia, Spain
• 23rd American World Dentistry Congress – Nov. 2-3, in San Francisco
• World Congress on Mental Health, Psychiatry and Psychology – Nov. 2-3, in Columbus
• International Conference on Ophthalmology & Ophthalmic Surgery – Nov. 2-3, in Columbus
• International Conference on Eye and Vision – Nov. 2-3, in Columbus

PDUFA Dates

The FDA is set to announce Oct. 28 its verdict on TherapeuticsMD Inc TXMD's TX-001HR to treat moderate-to-severe vasomotor symptoms due to menopause.

Merck & Co., Inc. MRK awaits FDA approval for Keytruda along with carboplatin-paclitaxel or nab-paclitaxel for first-line treatment of metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression. The PDUFA date is set for Oct. 30.

Trevena Inc TRVN's NDA for Oliceridine to treat moderate to severe acute pain is pending before the FDA. The PDUFA date is set for Nov. 2. FDA's Anesthetic and Analgesic Drug Products Advisory Committee, which met Oct. 11 to review the NDA, voted eight against and seven in favor of approving Oliceridine.

Theratechnologies Inc THERF's sBLA for single vial formulation of EGRIFTA that is being evaluated for reducing abdominal fat in HIV- patients is pending before the FDA, with the agency set to rule on the application Nov.3.

The PDUFA date for AcelRx Pharmaceuticals Inc ACRX's NDA for sufentanil sublingual tablets for treating moderate-to-severe acute pain is set for Nov. 3. A FDA Committee, which met Oct. 12 to discuss the pipeline candidate endorsed it by a 10-3 vote.

The FDA is also set to rule Nov. 3 on Coherus Biosciences Inc CHRS's BLA for Pegfilgrastim biosimilar CHS-1701.

Adcom Meeting

A joint committee of Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee on Nov. 1 will discuss efficacy, safety and risk-benefit profile of Alkermes Plc ALKS's NDA for buprenorphine and samidorphan sublingual tablets, being evaluated as an adjunctive treatment of major depressive disorder.

The same joint committee will discuss the efficacy, safety, and benefit-risk profile of SAGE Therapeutics Inc SAGE's brexanolone 5 mg/mL intravenous injection, tested for postpartum depression.

See Also: Novartis To Buy Endocyte In $2.1B Deal

Clinical Trial Results

BioTime, Inc. BTX is due to present interim readout of the Phase 1/2 study of its dry age-related macular degeneration treatment candidate OpRegen at the AAO 2018 annual meeting to be held between Oct. 27 and Oct. 30.

Pending October Releases

Entera Bio Ltd ENTX is due to release Phase 2 pharmacokinetic and pharmacodynamic data for EB612, its pipeline candidate for hypoparathyroidism.

Esperion Therapeutics Inc ESPR is scheduled to release Phase 3 data for its hypercholesterolemia candidate bempedoic acid. Acorda Therapeutics Inc ACOR will release Phase 2 data for its primary sclerosing cholangitis treatment candidate BTT1023.

Earnings

Monday

• Brainstorm Cell Therapeutics Inc BCLI (before the market open)
• Veracyte Inc VCYT (after the market close)

Tuesday

• Allergan plc AGN (before the market open)
• BIO-TECHNE Corp TECH (before the market open)
• Blueprint Medicines Corp BPMC (before the market open)
• Array Biopharma Inc ARRY (before the market open)
• Incyte Corporation INCY (before the market open)
• Pfizer Inc. PFE (before the market open)
• Amgen, Inc. AMGN (after the market close)
• Acceleron Pharma Inc XLRN (after the market close)
• EXACT Sciences Corporation EXAS (after the market close)
• Clovis Oncology Inc CLVS (after the market close)
• NeoGenomics, Inc. NEO

Wednesday

• Acorda Therapeutics (before the market open)
• ArQule, Inc. ARQL (before the market open)
• Integra Lifesciences Holdings Corp IART (before the market open)
• Ophthotech Corp OPHT (before the market open)
• Orthopediatrics Corp KIDS (after the market close)

Thursday

• ABIOMED, Inc. ABMD (before the market open)
• Emergent Biosolutions Inc EBS (after the market close)
• Puma Biotechnology Inc PBYI (after the market close)
• NewLink Genetics Corp NLNK (after the market close)
• Exelixis, Inc. EXEL (after the market close)
• Revance Therapeutics Inc RVNC (after the market close)
• Retrophin Inc RTRX (after the market close)
• TESARO Inc TSRO (after the market close)

Friday

• AbbVie Inc ABBV (before the market open)
• ImmunoGen, Inc. IMGN (before the market open)
• Obalon Therapeutics Inc OBLN (before the market open)

IPO

Medical device maker Axonics Modulation Technologies will offer 6.667 million shares in an IPO, priced in a range of $14-$16. Post the offering, the shares are to be listed on the Nasdaq under the ticker symbol AXNX.

Eton Pharmaceuticals, which develops liquid formulation of drugs, is all set to offer 3 million shares, priced at $6. The shares will be listed on the Nasdaq under the ticker symbol ETON.

Orchard Therapeutics is planning a 13.33 million IPO at an estimated price range of $14-$16. The shares of the developer of stem cell gene therapies to treat rare diseases, will be listed on the Nasdaq under the ticker symbol ORTX.

Tiziana Life Sciences, a developer of antibody therapies to treat non-alcoholic steatohepatitis, multiple sclerosis, Crohn's disease and cancer, will offer 1.01 million shares priced at $9.90. The company seeks to list the shares on the Nasdaq under the ticker symbol TLSA.

Twist Bioscience, a manufacturer of synthetic genes and other DNA-based products, is planning a 5-million share IPO, priced at $14-$16. The shares will be listed on the Nasdaq under the ticker symbol TWST.

IPO Quiet Period Expiry

Guardant Health Inc GH