The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Biotech stocks held steady in the recent week as earnings from the sector continue to trickle in. The week also saw presentations of clinical trial readouts at a couple of conferences.

The following are key catalysts that could move biotech stocks in the upcoming week.

Conferences

• International Conference on Biomarkers and Cancer Targets: Feb. 14-15 in Dubai, UAE
• 18th Global Ophthalmology, Optometry and Glaucoma Conference: Feb. 14-15, in Dubai
• ASCO Genitourinary Cancers Symposium: Feb. 14-16, in San Francisco, California

PDUFA Dates

MOTIF BIO PLC/S ADR MTFB's NDA for iclaprim to treat acute bacterial skin and skin structure infections awaits FDA clearance. The PDUFA date for the NDA is set for Wednesday, Feb. 13.

The FDA is set to rule on Bausch Health Companies Inc BHC's NDA for Duobrii, which is being evaluated for plaque psoriasis, on Friday, Feb. 15. The application was handed a CRL in June 2018 after which the company made a resubmission in August. 

Merck & Co., Inc. MRK awaits the FDA verdict on its sBLA for Keytruda as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The due date is Saturday, Feb. 16.

Adcom Meeting

A Feb. 12 joint meeting of FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is set to deliberate on Johnson & Johnson JNJ unit Janssen's NDA for an esketamine 28 mg single-use nasal spray device for treatment-resistant depression.

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

Clinical Trial Results

ASCO GU Cancers Symposium Presentations

Veru Inc VERU is scheduled to make a poster presentation of Phase 2 data on its hot flashes treatment candidate zuclomiphene citrate Feb. 14.

Pfizer Inc. PFE will present Feb. 14 a poster on Phase 3 data for Xtandi, its metastatic hormone-sensitive prostate cancer candidate.

Merck and Pfizer are due to present Feb.16 with Phase 3 data on Keytruda in combination with Inlyta for treating renal cell carcinoma.

AVEO Pharmaceuticals, Inc. AVEO is set to present Feb.16 an abstract of Phase 3 data for tivozanib, which is being evaluated as a third-line treatment for patients with renal cell carcinoma.

Calithera Biosciences Inc CALA is due to make a poster presentation Feb. 16 on the Phase 2 study of CB-839 and cabozantinib for renal cell carcinoma.

Earnings

Tuesday, Feb. 12

Wednesday, Feb. 13

• Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
• Natus Medical Inc BABY (before the market open)
• Vanda Pharmaceuticals Inc. VNDA (after the market close)

Thursday, Feb. 14

• Agios Pharmaceuticals Inc AGIO (before the market open)
• Incyte Corporation INCY (before the market open)
• Zoetis Inc ZTS (before the market open)
• Prothena Corporation PLC PRTA (after the market close)
• Acorda Therapeutics Inc ACOR (after the market close)

IPOs

Anchiano Therapeutics is set to offer 2.4 million shares in an IPO priced at $14.55 each. The biotech that develops therapies for early stage bladder cancer seeks to list its shares on the Nasdaq under the ticker symbol ANCN.

Stealth Biotherapeutics, which focuses on therapies for mitochondrial dysfunction, will offer 6.2 million shares priced between $12 and $14. The shares are to be listed on the Nasdaq under the ticker symbol MITO.

TCR2 Therapeutics will offer 5 million shares in an IPO with an estimated price range of $14-$16. This immuno-oncology biotech is looking to list its shares on the Nasdaq under the ticker symbol TCRR.