iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB), ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) – The Week Ahead In Biotech (April 11-17): Avenue Therapeutics FDA Decision and Conference Presentations In The Spotlight – About Your Online Magazine


Contrary to the strength of the broader market, biotechnology stocks ended the week ending April 9 on a low. The weakness partly reflected a preference for risky bets over defensive ones, such as health stocks.

The FDA news flow of the week was mostly borderline negative. ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) was delivered to complete letter of reply for its regulatory application seeking to expand its Nuplazid label to include dementia-related psychosis.

The biggest headline of the week was a disclosure of FibroGen, Inc. (NASDAQ: FGEN) that had counterfeit data from his anemia drug, which dropped his stock by about 48% during the week.

Provention Bio, Inc. (NASDAQ: PRVB) the shares were under pressure after the communication of a probable delay in the approval of its candidate for the treatment of Type 1 diabetes, teplizumab. The company also said that the FDA is not convinced with the pharmacokinetic data from the teplizumab binding study that was done to establish its comparability with an existing product from Teplizumab. Eli Lilly and Company (NYSE: LLY) Lilly’s product data was submitted as part of the teplizumab biological license application.

Two biopharmaceutical companies debuted on Nasdaq after their initial public offerings, raising a combined total of $ 221.3 million.

Here are the main catalytic events for the week:

Conferences

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

20th Annual Needham Virtual Health 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 decide on the new drug application submitted by Avenue Therapeutics, Inc. (NASDAQ: ATXI), one Fortress Biotech, Inc. (NASDAQ: FBIO), for its intravenous tramadol for the treatment of moderate to severe pain.

Related link: After the FDA rejects the dementia drug Acadia, analysts regret the lack of short-term stock drivers

Clinical readings / presentations

AACR meeting presentations

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

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

Mirati Therapeutics, Inc. (NASDAQ: MRTX) and BeiGene, Ltd. (NASDAQ: BGNE): Phase 1b safety / tolerability data and preliminary antitumor activity for Mirati sitravatinib plus BeiGene tislelizumab in patients with advanced platinum-resistant ovarian cancer, as well as patients with unresectable refractory / resistant PD- (L) 1 or melanoma metastatic (Sunday)

Beigene: Results of 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)

N.V. (NASDAQ: AFMD): Initial positive clinical data from a Phase 1 study sponsored by the investigator that evaluated natural killer cell cells derived from umbilical cord blood pre-complexed with Affimed AFM13 innate cell engagement (Tuesday)

WCN meeting presentations

Chinook Therapeutics, Inc. (NASDAQ: KDNY): Data from the Gd-IgA1 biomarker 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 bioavailability study for subcutaneous in healthy volunteers (Thursday)

AAN meeting presentations

TG Therapeutics, Inc. (NASDAQ: TGTX): Results of Phase 3 ULTIMATE I and II assays evaluating ublituximab in recurrent forms of multiple sclerosis (Saturday)

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

Standalone versions

Auris Medical Holding Ltd. (NASDAQ: EARS) is scheduled to provide a business update on its AM-301 preclinical asset 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 opens)
N.V. (NASDAQ: AFMD) (Thursday, before the market opens)
Centogene N.V. (NASDAQ: CNTG) (Thursday, before the market opens)

IPOs

Expiry of the IPO silence period

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

Related link: Attention, biotechnology investors: mark your PDUFA April dates on your calendar

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Paula Fonseca