The Week Ahead In Biotech: PDUFA Dates, IPOs And More

The iShares NASDAQ Biotechnology Index (ETF) IBB is almost flat for the week after adding about 5 percent in the week ended April 13.

Will the following catalytic events lead to a resumption of the rally?

Medical/Healthcare/Biotech Conferences

• The European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) – April 21-24 in Madrid, Spain.
• American Academy of Neurology (AAN) 2018 Annual Meeting – April 21-27 in Los Angeles.

PDUFA Dates

Saturday, April 28

The FDA is scheduled to announce its verdict on Mallinckrodt PLC MNK's Sucampo unit's sNDA for Lubiprostone, for treating pediatric functional constipation. Following a three-month extension sought by the FDA in January, the new PDUFA date of April 28 was set. Lubiprostone is currently approved to treat opioid-induced constipation.

Adcom Meeting Schedule

FDA's Arthritis Advisory Committee is set to meet on April 23 to discuss the NDA for Eli Lilly And Co LLY- Incyte Corporation INCY combine's baricitinib tablets for treating adult patients with moderately to severely active rheumatoid arthritis, who have had an inadequate response or intolerance to methotrexate.

The committee is set to deliberate on efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk-benefit considerations.

Related Link: Medtech Supplier IntriCon Rallies After Bullish Stifel Initiation

Clinical Trial Outcomes

Tetraphase Pharmaceuticals Inc TTPH is scheduled to present Phase 3 data for its Eravacycline, which is being tested in a study dubbed IGNITE4 for complicated intraabdominal infections.

Top-line data from the Phase 3 trial released in July 2017 demonstrated non-inferiority of eravacycline to meropenem for the primary efficacy endpoint of clinical response at the test-of-cure visit.

The data presentation is due at the ECCMID on April 22.

Tocagen Inc TOCA will release updated Phase 1 data for Toca 511 & Toca FC at the AAN on April 24. Toca 511 & Toca FC is a combo drug of a gene therapy agent and a prodrug being tested in patients with recurrent high-grade glioma, a type of brain tumor.

Argenx NV – ADR ARGX will present full Phase 2 data for ARGX-113, which is tested for myasthenia gravis, at the AAN on April 24. Top-line data from the Phase 2 proof-of-concept trial released in December showed a clinically meaningful and statistically significant benefit of ARGX-113 over placebo

MediciNova, Inc. MNOV is due to release abstract of the Phase 1b/2a data for MN-166, a treatment candidate for amyotrophic sclerosis, at the AAN on April 27.

Related Link: Hologic's SculpSure Body Contouring Treatment Scores Distribution Win

Earnings

Tuesday, April 24

• Eli Lilly
• Biogen Inc BIIB
• Edwards Lifesciences Corp EW

Wednesday, April 25

• Integra Lifesciences Holdings Corp IART
• The Medicines Company MDCO
• BioMarin Pharmaceutical Inc. BMRN

Thursday, April 26

• AbbVie Inc ABBV
• Amgen, Inc. AMGN
• Alexion Pharmaceuticals, Inc. ALXN
• Bristol-Myers Squibb Co BMY
• Zimmer Biomet Holdings Inc ZBH
• Vertex Pharmaceuticals Incorporated VRTX

Friday, April 27

• Sanofi SA (ADR) SNY

IPOs

Taipei-based Taiwan Liposome Company, a developer of lipid-based pharma products, is set to offer 4.7 million shares in an U.S. IPO offering. The company seeks to list its shares on the NASDAQ under the ticker symbol TLC.

Quiet Period Expiry

• Genprex Inc GNPX – Priced on March 29 (trading at a discount to $5 offer price).
• Unum Therapeutics Inc UMRX – Priced on March 29 (trading at a discount to $12 offer price).
• Homology Medicines Inc FIXX – Priced on March 28 (trading at a premium to $16 offer price).