The Week Ahead In Biotech: Fate Therapeutics Data Readout, RenovoRx IPO In Focus Amid Tapering Earnings News Flow

Biopharma stocks retreated in the week ending Aug. 13, defying the optimism that was found in the broader market. Earnings continued to dominate the headlines, with small- and mid-cap companies among those reporting during the week.

On the regulatory front, the Food and Drug Administration kept its tryst with the PDUFA goal date for Jazz Pharmaceuticals, Inc. JAZZ's sleep disorder drug and issued a positive verdict. Merck & Co, Inc. MRK and Eisai Co. ,Ltd. ESALY received approval for Keytruda-Lenvima combo for the first-line treatment of advanced kidney cancer.

Moderna, Inc. MRNA and Pfizer, Inc. PFE-BioNTech SE BNTX received a third authorization for their respective COVID-19 vaccines to be used in immuno-compromised individuals. Moderna shares, however, came off its all-time high amid valuation concerns.

On the other hand, Sesen Bio, Inc. SESN's regulatory application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer was issued a complete response letter.

Positive clinical readout catalyzed a strong move in Fulcrum Therapeutics, Inc. FULC, and earnings and a pipeline update sent shares of Cortexyme, Inc. CRTX soaring. Meanwhile, Axsome Therapeutics, Inc. AXSM shares plummeted on a potential delay in the approval of its investigational asset to treat major depressive disorder.

Eliem Therapeutics, Inc. ELYM and Dermata Therapeutics, Inc. Common Stock DRMA were among the companies that made their Wall Street debuts following their initial public offerings.

Here are the key catalytic events for the unfolding week:

Conferences

H.C. Wainwright Ophthalmology Virtual Conference: Aug. 17
Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology, or SNO: Aug. 19-20

Related Link: Moderna Vs. BioNTech: How Do These High-Flying COVID-19 Vaccine Stocks Compare?

Clinical Readouts

• Fate Therapeutics, Inc. FATE will present at an investor event on Thursday, Aug. 9 new Phase 1 data from FT516 and FT596 programs in relapsed/refractory lymphoma.
• Plus Therapeutics, Inc. PSTV will present at the SNO Brain Metastases conference, data from one planned clinical trial and one completed preclinical study evaluating its lead investigational drug, Rhenium-186 Nanoliposome for the treatment of leptomeningeal metastases.

Earnings

• Milestone Scientific Inc. MLSS (Monday, before the market open)
• Biocept, Inc. BIOC (Monday, after the close)
• Eton Pharmaceuticals, Inc. ETON (Monday, after the close)
• STRATA Skin Sciences, Inc. SSKN (Monday, after the close)
• Osmotica Pharmaceuticals plc OSMT (Monday, after the close)

IPOs

IPO Pricing

Los Altos, California-based RenovoRx, Inc. RNXT has filed for offering up to 1.85 million units of securities in an initial public offering. Each unit comprises one share of common stock and a three-quarter warrant to purchase one share of common stock at an exercise price of $14.40 per share, assuming an initial public offering price of $12 per unit. RenovoRx expects to price the offering between $11 and $13. The company‘s shares have been approved for listing on the Nasdaq under the ticker symbol "RNXT."

RenovoRx is a clinical-stage biopharma focused on developing therapies for the local treatment of solid tumors and is currently conducting a Phase 3 registrational trial for its lead product candidate RenovoGem.

• IPO Quiet Period Expiry
• Absci Corporation ABSI
• Caribou Biosciences, Inc. CRBU
• Cytek Biosciences, Inc. CTKB
• SOPHiA GENETICS SA SOPH
• Candel Therapeutics, Inc. CADL

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