Next week in the biotech space: Fate Therapeutics data readings, RenovoRx IPO in focus amid declining earnings
Biopharma stocks fell for the week ending August 13, defying optimism found in the broader market. Earnings continued to dominate the headlines, with small and mid-cap companies reporting during the week.
On the regulatory front, the Food and Drug Administration held its rendezvous with the PDUFA target date for Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ) against sleep disorders and issued a positive verdict. Merck & Co, Inc. (NYSE: MRK) and Eisai Co., Ltd. (OTC: ESALY) received approval for the combination Keytruda-Lenvima for the first-line treatment of advanced kidney cancer.
Moderna, Inc. (NASDAQ: MRNA) and Pfizer, Inc. (NYSE: PFE) –BioNTech SE (NASDAQ: BNTX) received a third approval for their respective COVID-19 vaccines for use in immunocompromised individuals. However, Moderna shares hit their all-time highs due to valuation concerns.
On the other hand, Sesen Bio, Inc. (NASDAQ: SESN) regulatory filing for Vicineum for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer has been fully answered.
Positive clinical results catalyzed a strong step in Fulcrum Therapeutics, Inc. (NASDAQ: FULC), and the results and a pipeline update sent stocks of Cortexyme, Inc. (NASDAQ: CRTX) skyrocketing. In the meantime, Axsome Therapeutics, Inc. (NASDAQ: AXSM) Stocks slumped due to a possible delay in approving its test subject for the treatment of major depressive disorders.
Eliem Therapeutics, Inc. (NASDAQ: ELYM) and Dermata Therapeutics, Inc. Common stock (NASDAQ: DRMA) were among the companies that debuted on Wall Street after going public.
Here are the main catalytic events for the week unfolding:
HC Wainwright Virtual Conference on Ophthalmology: August 17th
Third annual conference on brain metastases hosted by the Society for Neuro-Oncology, or SNO: 19.-20. August
Related Link: Moderna vs. BioNTech: How Do These Soaring COVID-19 Vaccine Stocks Compare?
- Fate Therapeutics, Inc. (NASDAQ: FATE) will present new Phase 1 data from the FT516 and FT596 programs in relapsed / refractory lymphoma at an investor event on Thursday, August 9th.
- Plus Therapeutics, Inc. (NASDAQ: PSTV) will present data from a planned clinical trial and a completed preclinical trial evaluating its lead investigational drug rhenium-186 nanoliposome for the treatment of leptomeningeal metastases at the SNO Brain Metastases Conference.
- Milestone Scientific Inc. (NYSE: MLSS) (Monday, before market opens)
- Biocept, Inc. (NASDAQ: BIOC) (Monday, after close of trading)
- Eton Pharmaceuticals, Inc. (NASDAQ: ETON) (Monday, after close of trading)
- STRATA Skin Sciences, Inc. (NASDAQ: SSKN) (Monday, after close of trading)
- Osmotica Pharmaceuticals plc (NASDAQ: OSMT) (Monday, after close of trading)
Based in Los Altos, California RenovaRx, Inc. (NASDAQ: RNXT) has filed for an offer of up to 1.85 million units of securities in an IPO. Each unit consists of one common share and a three-quarter warrant to purchase one common share at an exercise price of $ 14.40 per share assuming a market price of $ 12 per unit. RenovoRx expects the offering to cost between $ 11 and $ 13. The company’s shares have been admitted to listing on the Nasdaq under the ticker symbol “RNXT”.
RenovoRx is a clinical-stage biopharmaceutical company focused on the development of therapies for the local treatment of solid tumors and is currently conducting a Phase 3 registration trial for its lead product candidate RenovoGem.
- End of the resting phase of the IPO
- Absci Corporation (NASDAQ: ABSI)
- Caribou Biosciences, Inc. (NASDAQ: CRBU)
- Cytek Biosciences, Inc. (NASDAQ: CTKB)
- SOPHiA GENETICS SA (NASDAQ: SOPH)
- Candel Therapeutics, Inc. (NASDAQ: CADL)
Associated link: Attention biotech investors: Make a note of the PDUFA dates in August in your calendar