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.
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:
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
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.
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)
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.
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)
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