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 Aug. 11)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Aug. 11)
Stocks In Focus
Xeris Allows Xeris To Proceed With Phase 1 Study of Hyperthyroidism Treatment
Xeris Pharmaceuticals, Inc. (NASDAQ:XERS) said the Food and Drug Administration has allowed the investigational new drug application for its XeriSol levothyroxine for hypothyroidism to proceed.
The active IND enables Xeris to initiate a Phase 1 clinical study for XP-8121 using its novel formulation of levothyroxine in a subcutaneous injection for the treatment of hypothyroidism. The Phase 1 study will characterize Pharmacokinetics and evaluate the safety and tolerability of XP-8121 in healthy participants, the company said.
The stock was up 14.04% at $2.68 in premarket trading.
Merck-Eisai's Drug Combo Gets FDA Approval as First-line Treatment For Kidney Cancer
The approval is based on results from the pivotal Phase 3 KEYNOTE-581 trial, in which the combo treatment demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival, overall survival and confirmed objective response rate.
Merck shares were up 0.36% at $75.48 in premarket trading.
Related Link: The Week Ahead In Biotech (Aug. 8-14): Jazz Pharma FDA Decision, Earnings Deluge and IPOs In The Spotlight
C4 Therapeutics' Multiple Myeloma Drug Gets Orphan Drug Designation
C4 Therapeutics, Inc. (NASDAQ:CCCC) said the FDA granted orphan drug designation to CFT7455 for the treatment of multiple myeloma. The designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.
In premarket trading, the stock was up 1.64% at $36.50.
Earnings
Revolution Medicines, Inc. (NASDAQ:RVMD) reported a decline in its second-quarter revenue from $10 million in 2020 to $8.7 million in 2021. The loss per share widened from 46 cents to 60 cents. The company guided to full-year GAAP loss of $170 million to $190 million.
The stock was slipping 2.53% to $26.22 in premarket trading.
TELA Bio, Inc. (NASDAQ:TELA) reported second-quarter revenue of $7.6 million, up 116% year-over-year. The revenue exceeded the consensus estimate. The loss per share widened from 53 cents to 57 cents.
The stock was jumping 18.77% to $15.44 in premarket trading.
TRACON Pharmaceuticals, Inc. (NASDAQ:TCON)'s second-quarter net loss narrowed from 70 cents per share to 58 cents per share, while analysts expected a narrower loss of 31 cents per share.
In premarket trading, the stock was down 8.47% to $3.35.
On The Radar
PDUFA Dates
The FDA is scheduled to rule on Jazz Pharmaceuticals plc (NASDAQ:JAZZ)'s supplemental new drug application for Xywav (JZP-258) as a treatment option for idiopathic hypersomnia in adults. The PDUFA goal by date is Thursday, Aug. 12.
Click here to access Benzinga's FDA Calendar.
Earnings
Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
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