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.

FDA news flow of the week was mostly bordering on the negative. ACADIA Pharmaceuticals Inc. ACAD was handed down a complete response letter for its regulatory application seeking expansion of the label of its Nuplazid to include dementia-related psychosis.

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

Provention Bio, Inc. PRVB shares came under pressure after it communicated a likely delay in the approval of its Type 1 diabetes treatment candidate teplizumab. The company also said the FDA is not convinced with the pharmacokinetic data from the bridging study of teplizumab that was done to establish its comparability with an existing product from Eli Lilly and Company LLY. Data from Lilly's product was submitted as part of the teplizumab biologic license application.

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. ATXI, a Fortress Biotech, Inc. 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. CMPI: new translational data from the Phase 1b trial of CMP-001 in subjects with advanced melanoma (Sunday)

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

Mirati Therapeutics, Inc. MRTX and BeiGene, Ltd. BGNE: Phase 1b safety/tolerability and preliminary antitumor activity data for Mirati's sitravatinib plus BeiGene's tislelizumab in patients with advanced platinum-resistant ovarian cancer as well as patients with PD-(L)1 refractory/resistant unresectable or metastatic melanoma (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. 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. 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. TGTX: results of the ULTIMATE I & II Phase 3 trials evaluating ublituximab in relapsing forms of multiple sclerosis (Saturday)

Revance Therapeutics, Inc. 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. 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. THTX (Wednesday, before the market open)
Affimed N.V. AFMD (Thursday, before the market open)
Centogene N.V. CNTG (Thursday, before the market open)

IPOs

IPO Quiet Period Expiry

Gain Therapeutics, Inc. GANX
Instil Bio, Inc. TIL
Finch Therapeutics Group, Inc. FNCH
Connect Biopharma Holdings Limited CNTB
Universe Pharmaceuticals INC UPC
Movano Inc. MOVE

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