The Week Ahead In Biotech (April 11-17): Avenue Therapeutics FDA Decision and Conference Presentations In The Spotlight

Contrary to the strength in the broader market, biotech stocks ended the week ending April 9 lower. The weakness partly reflected a preference for risky bets at the expense of defensives such as healthcare stocks.

The biggest headline of the week was a disclosure by FibroGen, Inc. (NASDAQ:FGEN) that it had fudged data for its anemia drug, which sent its shares down about 48% during the week.

Two biopharma companies debuted on the Nasdaq following their initial public offerings, raising a combined $221.3 million.

Here are the key catalytic events for the unfolding week:

Conferences

American Association of Cancer Research, or AACR, Annual Meeting 2021 (virtual event): April 10-15

20th Annual Needham Virtual Healthcare Conference: April 12-15

The International Society of Nephrology, or ISN, World Congress of Nephrology, or WCN (virtual event): April 15-19

American Academy of Neurology, AAN, 2021 Meeting: April 17-22

PDUFA Dates

The FDA is scheduled to rule on the new drug application filed by Avenue Therapeutics, Inc. (NASDAQ:ATXI), a Fortress Biotech, Inc. (NASDAQ:FBIO), for its intravenous tramadol for the treatment of moderate to severe pain.

Related Link: After FDA Rejects Acadia Dementia Drug, Analysts Lament Lack Of Near-term Stock Drivers

Clinical Readouts/Presentations

AACR Meeting Presentations

Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI): new translational data from the Phase 1b trial of CMP-001 in subjects with advanced melanoma (Sunday)

Blueprint Medicines Corporation (NASDAQ:BPMC): interim analysis of Phase 2 data for avapritinib in patients with advanced systemic mastocytosis (Sunday)

Beigene: results from the Phase 3 study of tislelizumab versus docetaxel as second or third-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (Monday)

Affimed N.V. (NASDAQ:AFMD): positive initial clinical data from an investigator-sponsored Phase 1 study evaluating cord blood-derived natural killercells pre-complexed with Affimed's innate cell engager AFM13 (Tuesday)

WCN Meeting Presentations

Chinook Therapeutics, Inc. (NASDAQ:KDNY): Gd-IgA1 biomarker data in healthy volunteers from Parts 1 and Part 2 of the ongoing phase 1 study of BION-1301 in immunoglobin A nephropathy, as well as data from the phase 1 intravenous to subcutaneous bioavailability study in healthy volunteers (Thursday)

AAN Meeting Presentations

TG Therapeutics, Inc. (NASDAQ:TGTX): results of the ULTIMATE I & II Phase 3 trials evaluating ublituximab in relapsing forms of multiple sclerosis (Saturday)

Revance Therapeutics, Inc. (NASDAQ:RVNC): results from its ASPEN-1 Phase 3 clinical trial evaluating the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults (Saturday)

Standalone Releases

Auris Medical Holding Ltd. (NASDAQ:EARS) is scheduled to provide a business update on its pre-clinical asset AM-301 on Tuesday. AM-301 is being evaluated for protection against airborne viruses and allergens on Tuesday, April 13, 2021.

Earnings

Theratechnologies Inc. (NASDAQ:THTX) (Wednesday, before the market open)
Affimed N.V. (NASDAQ:AFMD) (Thursday, before the market open)
Centogene N.V. (NASDAQ:CNTG) (Thursday, before the market open)

IPOs

IPO Quiet Period Expiry

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

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