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

The upcoming week could see some action due to the presence of a host of catalytic events that include PDUFA dates and earnings releases. Here are are the ones a biotech investor should keep a tab on.

Conferences

• Alzheimer's Association International Conference, or AAIC – July 22-26, in Chicago
• 20th World Dermatology and Aesthetic Congress - July 23-24 in Kuala Lumpur , Malaysia
• 13th Global Dermatologists Congress - July 23-24 in Moscow, Russia
• Global Meeting on Diabetes and Endocrinology - July 23-24 in Kuala Lumpur, Malaysia
• Annual Biotechnology Congress - July 23-24 in Vancouver, Canada
• 24th International Conference on Neuroscience and Neurochemistry - July 23-24, in Birmingham, UK
• 6th International Congress on Gynecology & Gynecologic Oncology - July 23-24 in Rome, Italy
• 11th International Conference on Vascular Dementia - July 23-25 in Moscow, Russia
• 29th Euro-Global Summit on Cancer Therapy & Radiation Oncology - July 23-25 in Rome, Italy
• 27th Euro-Global Neurologists Meeting - July 23 – 25 in Moscow, Russia
• 5th World Congress on Mental Health and Well-being - July 25-26 in Pacific Gateway Hotel at Vancouver Airport, British Columbia, Vancouver, Canada
• 20th Annual congress on Eating Disorders, Obesity and Nutrition - July 26-27 in Amsterdam, Netherlands
• 11th International Virology and Microbiology - July 27-28 in Vancouver, Canada
• 2nd International Conference on Women`s Health, Obstetrics and Female Reproductive System - July 27-28 in Vancouver, Canada

PDUFA Dates

The FDA is set to rule on Insys Therapeutics Inc INSY's NDA for its Buprenorphine sublingual spray on July 28. The candidate is being evaluated for moderate-to-severe postoperative pain after bunionectomy.

DURECT Corporation DRRX's schizophrenia treatment candidate RBP-7000, which has been licensed to U.K.-based biotech INDIVIOR PLC/S ADR INVVY has a PDUFA action date of July 28.

Neurocrine Biosciences, Inc. NBIX and AbbVie Inc ABBV await FDA verdict on their Elagolix for acute endometriosis-associated pain. Although the exact PDUFA date wasn't announced, based on the three-month extension in the review period announced by the FDA on April 10, the decision could come through in July or early August.

Adcom Meeting

FDA's Pulmonary-Allergy Drugs Advisory Committee is set to discuss GlaxoSmithKline plc (ADR) GSK's sBLA for mepolizumab injection, which is evaluated as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease. The Adcom meeting is scheduled for July 25.

Clinical Trial Results

Biogen Inc BIIB is scheduled to present Phase 2 data for its BAN2401 to treat Alzheimer's disease at the AAIC on July 25. The data released July 5 showed the treatment candidate slowed disease progression.

Probable Releases (Mid-2018/Early Q3 Schedule)

BIOLINERX Ltd/S ADR BLRX is due to release Phase 3 data for its BL-8040, evaluated in a study called GENESIS to treat stem-cell mobilization for autologous transplantation.

GlaxoSmithKline plc (ADR) GSK could release Phase 2b data for its amyloidosis treatment anti-SAP mAb.

Altimmune Inc ALT is scheduled to release Phase 1data for its anthrax vaccine candidate Nasoshield.

Galectin Therapeutics Inc. GALT is set to release Phase 1 data for its melanoma treatment combo GR-MD-02 and Keytruda. The data is key as it will determine whether the company will proceed with Phase 2 trials.

See Also: A Look At Biotech In 2018 And The Biggest Catalysts Coming Up In The Second Half Of The Year

Earnings

Monday

Veracyte Inc VCYT

Tuesday

Eli Lilly And Co LLY
Biogen Inc BIIB

Wednesday

Laboratory Corp. of America LH
Anika Therapeutics Inc ANIK
Gilead Sciences, Inc. GILD
Varian Medical Systems, Inc. VAR
Vertex Pharmaceuticals Incorporated VRTX

Thursday

Allergan plc AGN
ABIOMED, Inc. ABMD
Alexion Pharmaceuticals, Inc. ALXN
Amgen, Inc. AMGN
Baxter International Inc BAX
Cytokinetics, Inc. CYTK
Edwards Lifesciences Corp EW
Celgene Corporation CELG
Seattle Genetics, Inc. SGEN
Retrophin Inc RTRX

Friday

AbbVie Inc ABBV
Zimmer Biomet Holdings Inc ZBH

IPO

Aquestive Therapeutics, a company focused on differentiated therapy products to address unmet medical needs, is set to offer 4 million shares in an IPO, with an estimated price range of $14-$16. The company seeks to list its shares on the Nasdaq under the ticker symbol AQST.

Liquidia Technologies will offer 4.55 million shares in an IPO, priced between $10 and $12. The shares are to be listed on the Nasdaq under the ticker symbol LQDA.

IPO Quiet Period Expiry

Neon Therapeutics Inc NTGN
Forty Seven Inc FTSV
Entera Bio Ltd ENTX
Tricida Inc TCDA
Neuronetics Inc STIM
Translate Bio Inc TBIO