iShares NASDAQ Biotechnology Index Fund (NASDAQ: IBB), (ABBV) – The Week Ahead in Biotechnology (December 12-18): Hematology Conference Presentations, FDA Decisions for Calliditas, Argenx, Intra-Cellular & Eagle Pharma, etc.

Biotech stocks closed the week ending Dec. 10 with modest losses as investors shifted money from defenses to risky bets amid the broader market rebound.

Multiple conference presentations took center stage over the week, shifting actions back and forth. On the regulatory front, the Food and Drug Administration has authorized AstraZeneca plc (NASDAQ: AZN) Pre-exposure prophylactic treatment for COVID-19. AbbVie, Inc. (NYSE: ABBV) The Allergan Unit has received approval for its Vuity, the first eye drops approved in the United States to treat presbyopia.

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

Cingulate inc. (NASDAQ: CING) and NeuroSense Therapeutics Ltd.(NASDAQ: NRSN) were among the companies that debuted this week after their IPO.

Here are the main catalytic events for the week ahead:


63rd American Society of Hematology, or ASH, annual meeting and exhibition: December 11-14 in Atlanta, GA

PDUFA dates

The FDA is expected to rule on Calliditas Therapeutics AB (publ) ‘s (NASDAQ: CALT) New drug application for Nefecon as a treatment option for IgA nephropathy. The date of the PDUFA has been set for Wednesday, December 15.

Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) has a generic drug user fee bill date Wednesday for its generic version of Endo International Plc (NASDAQ: ENDP) Vasostrict of the unit Par.

The FDA is expected to rule on Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) Caplyta for the Expanded Indication of Bipolar Disorder, PDUFA date is Friday, December 17.

Also on the same day, the regulator must announce its verdict on argenx SE (NASDAQ: ARGX) biologic license application for efgartigimod for the treatment of generalized myasthenia gravis.

Related Link: Novavax Shares Jump After Head of EU Medicines Regulatory Authority Hints Looming Clearance for COVID-19 Vaccine

Clinical readings / presentations

Presentations at the ASH conference

A large number of companies are scheduled to present at the conference. Among those who present:

Allogene Therapeutics, Inc. (NASDAQ: ALLO) & Cellectis SA (NASDAQ: CLLS): Update of Phase 1 Data from ALPHA2 Study of ALLO-501A in Large B Cell Lymphoma and Phase 1 UNIVERSAL Single Dose Cohorts of ALLO-715 in Multiple Myeloma in relapse / refractory (Monday)

bluebird bio, Inc. (NASDAQ: BLUE): Updated results from LentiGlobin Phase 1/2 HGB-206 for gene therapy in sickle cell disease

Roche Holding SA (NASDAQ: RHHBY): First Results of Phase 1/2 Study of Subcutaneous Administration of Mosunetuzumab in Patients with Relapsed / Refractory Non-Hodgkin B-Cell Lymphoma (Monday)

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

AbbVie: Preliminary Phase 1/2 Safety and Efficacy Data for Venetoclax Plus Daratumumab and Dexamethasone in Multiple Myeloma


Based in Westport, Connecticut Intensity Therapeutics, Inc. (NASDAQ: INTS) has filed a preliminary prospectus with the SEC to offer 2.143 million shares in an initial public offering. The clinical-stage biopharmacy, focused on localized cancer reduction treatments, expects the offer price to be between $ 6 and $ 8. It has applied to list the shares on Nasdaq under the symbol INTS.

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

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