The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight

Biotech stocks could not sustain the uptrend in the holiday-shortened week, even as traders digested COVID-19-related news flow, clinical readouts, ASCO presentations and a few FDA approvals.

Arca Biopharma Inc ABIO was the best performing biotech stock of the week, as it rallied in reaction to an announcement from the company regarding testing of its pipeline asset for COVID-19-associated coagulopathy.

The week also saw Merck & Co., Inc. MRK taking a giant leap of faith into the COVID fray after remaining non-committal thus long.

Here are the key catalysts for the unfolding week.

Conferences

Jefferies Virtual Healthcare Conference: June 2-4
European Academy of Allergy and Clinical Immunology, or EAACI, Digital Conference 2020: June 6-8

PDUFA Dates

The FDA is set to rule on Menlo Therapeutics Inc's MNLO FMX103 - 1.5% minocycline foam -, which came into its stable via its Foamix acquisition, as a treatment option for moderate-to-severe papulopustular rosacea. (Tuesday)

Neurocrine Biosciences, Inc. NBIX and AbbVie Inc ABBV await FDA verdict on the latter's NDA for elagolix, which is being evaluated for treating uterine fibroids. (likely on Thursday)

Merck's sNDA for its triple combo antibiotic Recarbrio has a PDUFA date of June 6.

See Also: PhaseBio Analyst Says Coronavirus Study Creates Near-Term Catalyst

Clinical Readouts

ASCO 2020 Annual Meeting (presentations during the plenary session scheduled for Sunday)

AstraZeneca plc AZN is scheduled to present detailed results from the Phase 3 ADAURA trial of its Tagrisso in early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.

Merck will present results of a Phase 3 study evaluating Keytruda as a first-line treatment of patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.

EAACI Digital Conference Presentations

Celldex Therapeutics, Inc. CLDX will make a late-breaking poster presentation of data from the Phase 1 healthy volunteer study of its KIT inhibitor, CDX-0159.

Standalone Releases

Replimune Group Inc REPL is scheduled to provide updated Phase 1/2 data from patients with melanoma and non-melanoma skin cancers treated with RP1 combined with Bristol-Myers Squibb Co's BMY Opdivo. (Wednesday)

Earnings

Protalix Biotherapeutics Inc PLX (Monday, before the market open)

IPO

Legend Biotech, a clinical-stage biotech engaged in the discovery and development of novel cell therapies for oncology and other indications, has filed to offer 18.425 million ADSs in an IPO, with each ADS representing two ordinary shares. The company expects the IPO to be priced between $18 and $20. It has applied to list its ADSs on the Nasdaq under the ticker symbol "LEGN."

California-based Pliant Therapeutics, Inc. is planning a 6-million share offering to be priced between $14 and $16. The clinical-stage biopharma focused on discovering and developing novel therapies for the treatment of fibrosis has applied to list its shares on the Nasdaq under the ticker symbol "PLRX."

IPO Quiet Period Expiry

Ayala Pharmaceuticals Inc AYLA