The Week Ahead In Biotech: 2 IPOs Plus FDA Decisions On Moderna's COVID Vaccine And Drugs From Amgen, MacroGenics

Biotech stocks advanced for a third straight week, defying the broader market weakness. The space got solid support from positive stock reactions to presentations made at hematology and breast cancer conferences.

Positive vaccine news continued to flow. Pfizer Inc. PFE and BioNTech SE – ADR BNTX received the first regulatory nod for their mRNA vaccine, BNT162b2, in the U.K. On Friday, the U.S. followed suit and granted emergency use authorization for the investigational vaccine.

Four IPOs from biopharma and medical device makers garnered combined gross proceeds of $1 billion.

Here are the events to watch for in the coming week:

Conferences:

13th International Conference on Cachexia, Sarcopenia and Wasting Disease, or ICCSWD (virtual event): Dec. 11-13
Revolutionizing Atopic Dermatitis, or RAD, Virtual Conference: Dec. 13-14
19th International Symposium on Pediatric Neuro-Oncology, or ISPNO: Dec. 13-16

PDUFA Dates

The U.S. Food and Drug Administration is scheduled to rule on MacroGenics Inc's MGNX biologics license application for margetuximab, which is being evaluated in combination with chemotherapy for treating patients with metastatic HER2-positive breast cancer. The PDUFA goal date is Dec. 18.

MacroGenics has partnered with Zai Lab Ltd – ADR ZLAB in China, Hong Kong, Macau and Taiwan for the investigational treatment of breast cancer.

The regulator will also decide on Amgen, Inc.'s AMGN BLA for ABP 798, a candidate to compete against Roche Holdings AG's Basel ADR Common Stock RHHBY Rituxan. The decision date is Dec. 19.

Adcom Review

The FDA's Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss Novartis AG's NVS supplemental new drug application for Entresto (sacubitril and valsartan) tablets, for the proposed indication of heart failure with preserved ejection fraction.

Moderna MRNA will face the FDA's Center for Biologics Evaluation and Research's Vaccines and Related Biological Products Advisory Committee on Dec. 17 regarding the EUA application it has filed for its coronavirus vaccine candidate mRNA-1273. This is the same committee that gave the go-ahead for the vaccine from Pfizer and BioNTech last week.

Related Link: Moderna Says U.S. Has Committed To Another 100M Doses of COVID-19 Vaccine

Clinical Readouts/Presentations:

Stealth BioTherapeutics Corp MITO will present at the ICCSWD, results of the MMPOWER-3 Phase 3 study of elamipretide in individuals with mtDNA replisome disorders. (Sunday, 10:30 a.m. -11:40 a.m.)

Cellectar Biosciences Inc CLRB is scheduled to present at the ISPNO, Phase 1 data on CLR 131 in solid tumors.

Arvinas Inc ARVN on Monday will provide clinical program updates for its Protac protein degraders ARV-471 and ARV-110. The presentation will include updates from the Phase 1 dose escalation studies of ARV-471 in patients with locally advanced or metastatic ER positive/HER2 negative breast cancer and ARV-110 in men with metastatic castrate-resistant prostate cancer.

Arena Pharmaceuticals, Inc. ARNA is scheduled to present at the RAD 2020 virtual conference data from the Phase 2b ADVISE trial of etrasimod in participants with moderate-to-severe atopic dermatitis. The presentation is fixed for Monday between 8:50 a.m. and 8:57 a.m.

Tcr2 Therapeutics Inc TCRR will release on Monday, ahead of the market open, interim data from the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors.

Gossamer Bio Inc GOSS will release initial results from the ongoing two-week Phase 1b clinical trial of GB002, its inhaled PDGFR inhibitor, for the treatment of pulmonary arterial hypertension. The release is scheduled for Tuesday, 11 a.m.

Earnings

Champions Oncology Inc CSBR (Monday, after the close)
Centogene NV CNTG (Wednesday, before the market open)
Applied DNA Sciences Inc APDN (Thursday, after the close)

IPOs

San Diego, California-based BioAtla, Inc., a clinical-stage biopharma developing highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancer, is planning to offer 9.4 million shares in an initial public offering at an estimated price range of $15-$17. The company has applied for listing its shares on the Nasdaq under the ticker symbol BCAB.

Qilian International Holding Group Limited, a pharmaceutical and chemical company based in China, has filed to offer 5 million ordinary shares in an IPO, which is expected to be priced between $4 and $7 per share. The company has received approval from the Nasdaq for listing its shares on the exchange under the ticker symbol QLI.

IPO Quiet Period Expiry

Olema Pharmaceuticals Inc OLMA
Maravai Lifesciences Holdings Inc MRVI
Sotera Health Co SHC

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