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

Shanthi Rexaline

Biotech stocks staged a recovery this week, thanks to a deal in the space and news concerning positive pipeline developments. The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) gained 4.26 percent this week compared to S&P 500's 1.45 percent.

Can this uptrend be sustained? Stay tuned to the following catalytic events that can determine the direction of biotech in the upcoming week.

PDUFA Dates

Monday, April 16

Bristol-Myers Squibb Co (NYSE: BMY) awaits FDA verdict on its advanced renal cell carcinoma treatment combo option CM-214, which is Opdivo and Yervoy combined. The sBLA was accepted for review by the FDA in December.

Tuesday, April 17

The FDA is set to announce its decision concerning Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)'s BLA for Burosumab, which is being tried for pediatric and adult patients with X-linked hypophosphatemia. Ultragenyx is co-developing the pipeline candidate with Japan's Kyowa Hakko Kirin.

The verdict on Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)'s persistent immune thrombocytopenia, or ITP, treatment candidate tavalisse is scheduled for April 17.

Adcom Meeting Schedule

The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA is set to meet on April 19 to discuss GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)'s Epidiolex – a cannabidiol oral solution - for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older.

Conferences

  • The American Association for Cancer Research Annual Meeting 2018 - April 14-18 in Chicago, Illinois
  • European Society of Gastrointestinal Endoscopy Days 2018 – April 19-21 in Budapest, Hungary
  • North American Society For Psychosocial Obstetrics and Gynecology Annual Meeting 2018 – April 19-22 in Philadelphia
  • Fourth International Conference On Antimicrobials, Multiple Drug Resistance & Antibiotics Resistance – April 20-21 in Las Vegas, Nevada

Clinical Trial Outcomes

Blueprint Medicines Corp (NASDAQ: BPMC) is scheduled to release the initial Phase 1 data on BLU-667, evaluated for RET-altered solid tumors, at the American Association for Cancer Research Meeting on April 15.

OncoSec Medical Inc (NASDAQ: ONCS) is due to present Phase 1 data for its triple-negative breast cancer pipeline candidate ImmunoPulse IL12 at the AACR on April 15.

Aeglea Bio Therapeutics Inc (NASDAQ: AGLE) will release the Phase 1 escalation data for AEB 1102, being tested for solid tumors at the AACR on April 15.

Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) is due to present Phase 1 data for CYC065 to treat advanced cancers at the AACR on April 15.

ArQule, Inc. (NASDAQ: ARQL) is set to present Phase 1b data pertaining to its solid tumor treatment candidate Miransertib at the AACR on April 15.

Merck & Co., Inc. (NYSE: MRK) will present the Phase 3 data from a study dubbed EORTC1325/KEYNOTE-054, which tested its Keytruda as a monotherapy for surgically resected high-risk melanoma, at the AACR on April 15. In January, the company released the results of the trial, which showed that the study met the primary endpoint.

Merck is also due to present the Phase 3 data from the MK-3475/KEYNOTE-189 study, which evaluated Keytruda plus chemotherapy compared to chemotherapy alone in patients with non-small cell lung cancer with lower level of PD-L1 expression, at the AACR on April 16. The results presented earlier showed that the study met the primary endpoints of overall survival and progression-free survival.

See Also: Stifel Sees Challenging Road Ahead For vTv Therapeutics After Failed Alzheimer's Trial

Bristol-Myers Squibb will make a Phase 2 data presentation of CM-568, a opdivo-yervoy combo therapy for first-line non-small cell lung cancer, at the AACR on April 16. The company will also present at the Congress Phase 3 data for CM-227 (Opdivo-Yervoy combo) in patients with first-line non-small cell lung cancer. Interim data released on Feb. 5 showed that the study met one of the co-primary endpoints of progression-free survival.

Tocagen Inc (NASDAQ: TOCA) will release Phase 1b data for its solid tumor treatment candidate toca 511 at the AACR on April 16.

TESARO Inc (NASDAQ: TSRO) is scheduled to release preliminary Phase 1 data for TSR-042 being evaluated to treat solid tumor, at the AACR on April 16.

Dynavax Technologies Corporation (NASDAQ: DVAX) will present Phase 1b/2 data for SD-101 in combination with Keytruda in patients with melanoma. The data is due to be presented at the AACR on April 17.

IPOs

U.K.-based specialty biopharma company Mereo BioPharma Group, which focuses on rare and specialty diseases, is set to offer 3.97 million shares in an IPO. The shares are to be listed on the Nasdaq under the ticker symbol MREO.

Germany's MorphoSys, which licenses antibodies to pharma companies and is a developer of lymphoma therapies, will offer 8.3 million shares in an IPO. The shares are to be listed on the Nasdaq under the ticker MOR.

Surface Oncology is set to list its shares on the Nasdaq under the ticker symbol SURF following an IPO of 6 million shares, priced between $13-$15. The clinical-stage biotech company focuses on antibody cancer therapies.

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