Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Syros' Blood Cancer Drugs Land Orphan Designation From FDA
Syros Pharmaceuticals, Inc. SYRS said the U.S. Food and Drug Administration has granted orphan drug designation to tamibarotene for the treatment of myelodysplastic syndrome. Tamibarotene is being evaluated in combination with Bristol-Myers Squibb Company's BMY Vidaza in the SELECT-MDS-1 Phase 3 trial for RARA-positive patients with newly diagnosed, higher-risk MDS.
The stock was advancing 8.29% to $2.09 in premarket trading.
Mersana Strikes Antibody-Drug Conjugate R&D Collaboration Deal With J&J Unit For Over $1B
Mersana Therapeutics, Inc. MRSN announced a research collaboration and license agreement with Johnson & Johnson's JNJ Janssen unit discover novel antibody-drug conjugates for three targets. Under the terms of the agreement, Janssen will provide proprietary antibodies for three targets. Mersana will apply its expertise and its proprietary Dolasynthen platform to discover novel ADC product candidates.
Mersana will receive an upfront payment of $40 million. Mersana is eligible to receive reimbursement of certain costs as well as more than $1 billion in potential milestone payments, plus mid-single-digit to low double-digit percentage royalties on worldwide net sales of ADCs against the selected targets.
FDA Clears Pardes Pardes To Commence Phase 1 Study Of Oral Antiviral Treatment
Pardes Biosciences, Inc. PRDS said its investigational new drug application for PBI-0451, a direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases, has been cleared by the FDA.
This allows the company to proceed with the initiation of additional Phase 1 clinical trials in the U.S. Pending additional engagement with FDA and other regulators, the company expects to commence global Phase 2/3 studies of PBI-0451 in SARS-CoV-2 infected patients in mid-2022.
The stock was adding 3.56% to $10.79 in premarket trading.
Galera Gains On Disclosure Of Novo Nordisk's Stake
Galera Therapeutics, Inc. GRTX disclosed in a filing with the SEC that Novo Holdings A/S, the holding company of Danish biopharma Novo Nordisk A/S NVO, has a 9.3% stake in the biotech.
In premarket trading, the stock was up 8.33% at $2.60.
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Earnings
Valneva SE VALN reported a 216% increase in total revenues. The company guided to 2022 revenues of 430 million euros to 590 million euros ($485 million to $666 million), which includes 350-500 million euros in COVID-19 vaccine sales.
The U.S.-listed shares of the French vaccine maker were up 2.44% at $35.31 in premarket trading.
Arrowhead Pharmaceuticals, Inc.'s ARWR fourth-quarter revenues climbed from $21.3 million in 2020 to $27.4 million in 2021. The loss per share widened from 20 cents to 60 cents. Analysts had estimated a smaller loss of 45 cents per share.
The stock was down 4.52% to $50.25 in premarket trading.
Roche Holding AG RHHBY warned of slowing revenue growth in 2022 as sales from COVID-19 testing kits slow and amid biosimilar competition to a few of its top-selling drugs.
Quest Diagnostics, Inc. DGX reported below-consensus fourth-quarter revenues, while its adjusted EPS exceeded estimates. The company's full-year EPS guidance was in line to above consensus estimates. Separately, the company announced the stepping down of its long-term CEO Steve Rusckowski, effective Nov. 1, and the appointment of James Davis, executive vice president, general diagnostics, to the role, as part of its leadership succession planning.
In premarket trading, the stock was down 4.35% to $130.
Merck & Co., Inc. MRK reported above-consensus revenues and adjusted EPS for the fourth quarter. The full-year revenues guidance exceeded the consensus, while adjusted EPS guidance trailed expectations.
Among the other companies that reported before the market open were Abiomed, Inc. ABMD, Biogen Inc. BIIB, Eli Lilly and Company LLY and Cardiovascular Systems, Inc. CSII.
Offerings
NRx Pharmaceuticals, Inc. NRXP said it has closed its previously announced private placement priced at a premium to market 7.82 million shares of its common stock and unregistered preferred investment options to purchase up to an aggregate of 7.82 million shares of common stock. The purchase price for one share of common stock and one investment option to purchase one share of common stock was $3.195. The investment options have an exercise price of $3.07 per share, are exercisable six months following issuance, and have a term equal to five years following the date of initial exercise.
The stock was up 10.20% to $3.24 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates
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