Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs July 15)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows July 15)
Related Link: Attention Biotech Investors: Mark Your Calendar For July PDUFA Dates
Stocks In Focus
Moderna Gains On S&P 500 Inclusion
Standard & Poor's announced Moderna, Inc. (NASDAQ:MRNA) will join the S&P 500 Index, effective before the market open Wednesday, July 21.
The stock was adding 7.67% to $279.60 in premarket trading.
FibroGen's Roxadustat Gets Unfavorable Adcom Verdict
FibroGen said the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee that met to discuss the new drug application for roxadustat voted against approval for the drug.
The committee voted 13-to-1 against approval of roxadustat for non-dialysis dependent patients and 12-to-2 against approval in dialysis dependent indications.
The stock was plunging 31.52% to $17.01 in after-hours trading.
Corvus Pharma Discontinues COVID-19 Study
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) announced it has discontinued its Phase 3 study of mupadolimab for COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations.
The company clarified that the discontinuation is not related to any safety or efficacy issues observed in study patients. Mupadolimab will now be advanced in oncology, where it is currently being studied in a Phase 1/1b clinical trial, it added.
In premarket trading, the stock was down 9.87% at $2.10.
Bristol-Myers Squibb's Opdivo-Yervoy Combo Flunks a Late-state Head & Neck Cancer Study
Bristol-Myers Squibb (NYSE:BMY) announced an update on the Phase 3 CheckMate -651 trial comparing Opdivo plus Yervoy to the EXTREME regimen (cetuximab, cisplatin/carboplatin and fluorouracil) as a first-line treatment in platinum-eligible patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Although Opdivo plus Yervoy showed a clear, positive trend towards overall survival In patients whose tumors express PD-L1 with a combined positive score equal to or more than 20, the study did not meet its primary endpoints. The safety profile of Opdivo and Yervoy in this trial was consistent with previously reported studies in solid tumors.
The stock was down 0.93% at $66.80 in premarket trading.
IPO
Regencell Bioscience Holdings, an early-stage bioscience company that focuses on traditional Chinese medicine for the treatment of neurocognitive disorders and degeneration, priced its IPO of 2.3 million ordinary shares at $9.50 per ordinary share. The shares are expected to commence trading on the Nasdaq under the ticker symbol "RGC." Regencell expects to receive aggregate gross proceeds of approximately $21.9 million from the offering.
Imago BioSciences, Inc., a clinical stage biopharma discovering medicines for the treatment of myeloproliferative neoplasms, priced its upsized IPO of 8.4 million shares of common stock at $16 per share. The aggregate gross proceeds from the offering are expected to be $134.4 million. All of the shares of common stock are being offered by Imago. The common stock is expected to begin trading on the Nasdaq under the symbol "IMGO."
TScan Therapeutics, Inc., a biopharma focused on the development of T-cell receptor engineered T cell therapies for the treatment of patients with cancer, priced its IPO of 6.67 million shares at 15 per share, for gross proceeds of $100 million. TScan's common stock is expected to begin trading on the Nasdaq under the symbol "TCRX."
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