The Week Ahead In Biotech (Aug. 29- Sept. 4): Merck's Keytruda Regulatory Decision, Stray Earnings On Tap In a Light Week

Biopharma stocks had a strong start to the week amid optimism generated by full approval accorded to the mRNA vaccine developed by Pfizer, Inc. PFE and BioNTech SE BNTX.

The stocks subsequently moved back and forth in a narrow range before ending higher for the week.

On the regulatory front, Ascendis Pharma A/S ASND received approval for Skytrofa for treating growth hormone deficiency in pediatric patients. The nod came ahead of the Sept. 25 PDUFA date.

Servier's Tibsovo received a label expansion, with the Food and Drug Administration approving it this time around for treating adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test.

Cassava Sciences, Inc. SAVA was in the news for all wrong reasons, as a public petition was filed, alleging data tampering with the clinical trials of its Alzheimer's disease candidate.

A slew of R&D collaborations and licensing deals were announced.

The week also witnessed the trading debut of oncology-focused biopharma RenovoRx, Inc. RNXT and the uplisting of Biotricity, Inc. BTCY.

PDUFA Dates

The FDA is scheduled to rule on Merck & Co., Inc.MRK- Eisai Co., Ltd. ESALY's regulatory application for Keytruda-Lenvima combination as a treatment option for patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The PDUFA goal date is fixed for Friday, Sept. 3.

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Clinical Readouts

INmune Bio, Inc. INMB is scheduled to deliver data from the Phase 2 trial of Quellor in hospitalized COVID-19 patients suffering from pulmonary complications to the Data Safety Monitoring Board in August

Regulatory Filings:

Pfizer and BioNTech are scheduled to complete filing of supplemental biological license application for their COVID-19 booster shot by the end of the week. The regulatory submission was initiated Wednesday.

Earnings

• Global Cord Blood Corporation CO (Monday, after the close)
• Burning Rock Biotech Limited BNR (Tuesday, before the market open)
• Connect Biopharma Holdings Limited CNTB (Tuesday, after the close)

IPOs

• IPO Quiet Period Expiry
• Adagio Therapeutics, Inc. ADGI
• Eliem Therapeutics, Inc. ELYM

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