The Week Ahead In Biotech (Dec. 12-18): Hematology Conference Presentations, FDA Decisions For Calliditas, Argenx, Intra-Cellular & Eagle Pharma And More

Biotech stocks closed out the week ending Dec. 10 with modest losses as investors moved money out of defensives and into risky bets amid the broader market rebound.

Multiple conference presentations took center stage during the week, moving stocks in either direction. On the regulatory front, the Food and Drug Administration authorized AstraZeneca plc's AZN pre-exposure prophylactic COVID-19 treatment. AbbVie, Inc. ABBV unit Allergan received clearance for its Vuity, the first eye drop approved in the U.S. to treat presbyopia.

Reata Pharmaceuticals, Inc. RETA came under significant selling pressure during the week after an Adcom committee did not recommend approval of its bardoxolone methyl capsules for slowing the progression of chronic kidney disease in those with the rare Alport syndrome. The stock fell 63% for the week.

Cingulate Inc. CING and NeuroSense Therapeutics Ltd.NRSN were among the companies that debuted this week following their initial public offerings.

Here are the key catalytic events for the unfolding week:


63rd American Society of Hematology, or ASH, Annual Meeting & Exposition: Dec.11-14, in Atlanta, Georgia


The FDA is set to rule on Calliditas Therapeutics AB (publ)'s CALT new drug application for Nefecon as a treatment option for IgA nephropathy. The PDUFA date has been set for Wednesday, Dec. 15.

Eagle Pharmaceuticals, Inc. EGRX has a Generic Drug User Fee Act date on Wednesday for its generic version of Endo International Plc ENDP Par unit's Vasostrict.

The FDA is expected to rule on Intra-Cellular Therapies, Inc.'s ITCI Caplyta for the expanded indication of bipolar disorder, The PDUFA date is on Friday, Dec. 17.

Also by the same day, the regulator is due to announce its verdict on argenx SE's ARGX biologic license application for efgartigimod for the treatment of generalized myasthenia gravis.

Related Link: Novavax Shares Jump After Head Of EU Drug Regulator Hints At Imminent Authorization For COVID-19 Vaccine

Clinical Readouts/Presentations

ASH Conference Presentations

A slew of companies are scheduled to present at the conference. Among those presenting are:

Allogene Therapeutics, Inc. ALLO & Cellectis S.A. CLLS: updated Phase 1 data from the ALPHA2 study of ALLO-501A in large B-cell lymphoma and from the Phase 1 UNIVERSAL single dose cohorts of ALLO-715 in relapsed/refractory multiple myeloma (Monday)

bluebird bio, Inc. BLUE: updated results from the Phase 1/2 HGB-206 study of LentiGlobin for sickle cell disease gene therapy

Roche Holding AG RHHBY: initial results from Phase 1/2 study of sub-cutaneous administration of Mosunetuzumab in patients with relapsed/refractory B-cell non-Hodgkin lymphomas (Monday)

Bristol-Myers Squibb Company BMY: initial Phase 1 data for CC-99282 in patients with relapsed or refractory non-Hodgkin lymphoma ( Monday)

AbbVie: Phase 1/2 safety and preliminary efficacy data for Venetoclax Plus Daratumumab and dexamethasone in multiple myeloma


Westport, Connecticut-based Intensity Therapeutics, Inc. INTS has filed a preliminary prospectus with the SEC for offering 2.143 million shares in an initial public offering. The clinical-stage biopharma, focused on localized cancer reduction treatments, expects the offering to be priced between $6 and $8. It has applied for listing the shares on the Nasdaq under the ticker symbol INTS.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

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