Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Merck Announces Publication Of Positive Late-Stage Data For Keytruda-Chemo Combo In Breast Cancer
Merck & Co, Inc. MRK announced the publication of results from the Phase 3 KEYNOTE-522 trial in the Feb. 10, edition of the New England Journal Of Medicine, showing neoadjuvant Keytruda, in combination with chemotherapy followed by adjuvant Keytruda as monotherapy significantly prolonged event-free survival compared with neoadjuvant chemotherapy followed by adjuvant placebo (in patients with high-risk, early stage triple-negative breast cancer.
The stock was up 0.46% at $76.88 in premarket trading.
Molecular Partners Says Partner Novartis Has Requested EUA For COVID-19 Antiviral Therapeutic Ensovibep
Molecular Partners AG MOLN said it was informed by its partner Novartis AG NVS that the company has requested emergency use authorization from the U.S. Food and Drug Administration for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.
Regeneron Seeks Label Expansion For Dupixent As Treatment Option For Atopic Dermatitis In Infants
Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY said the FDA accepted for priority review the supplemental biologics license application for Dupixent as an add-on maintenance treatment for children ages 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The target action date is June 9, 2022.
Related Link: The Week Ahead In Biotech (Feb. 6-12): Pfizer, AstraZeneca Earnings, Conference Presentations, IPOs And More
Innoviva To Invest $45M In Armata Subsidiary To Fund Its Bacteriophage Platform
Armata Pharmaceuticals, Inc. ARMP, a wholly owned subsidiary of Innoviva, Inc. INVA, said it has entered into a securities purchase agreement to sell its common stock and warrants to an Innoviva subsidiary. The gross proceeds to the company from the transaction are expected to be $45 million.
Armata said it intends to use the net proceeds from this transaction to advance its clinical pipeline and strengthen its bacteriophage platform.
Innoviva shares were adding 10.23% to $17.45 in premarket trading and Armata was gaining 1.38% to $5.15.
Mediwound Gets $9M Incremental Funding For Burn Treatment Regulatory Resubmission
MediWound Ltd MDWD said the BARDA has expanded its awarded contract with MediWound by providing supplemental funding of $9 million to support the NexoBrid BLA resubmission with the FDA and the ongoing expanded access treatment protocol.
"We look forward to continuing our long-lasting collaboration with BARDA and our U.S. commercial partner Vericel Corporation VCEL in order to make NexoBrid available to U.S. burn patients, as we continue to advance the preparation of the BLA resubmission anticipated in mid-2022," said Sharon Malka, CEO of Mediwound.
Click here to access Benzinga's FDA calendar.
Earnings
AstraZeneca PLC AZN reported that its fourth-quarter revenues increased 62% to $12.01 billion and core EPS came in at $1.67. The company guided to a high-teens percentage increase in revenues at constant exchange range in 2022 and a mid-to-high 20s percentage increase in core EPS. The company also announced an increase in its annual dividend.
The stock was rising 2.73% at $58.76 in premarket trading.
Seagen Inc. SGEN reported a decline in its fourth-quarter revenues from $601.29 million in 2020 to $429.85 million in 2021, with the drop reflecting a steep decline in collaboration and license agreement revenues. The company reversed from a profit of 90 cents per share to a loss of 95 cents per share. Analysts expected a narrower loss of 83 cents per share. For 2022, the company expects revenues of $1.665 billion to $1.745 billion, below the consensus estimate of $2.16 billion.
The stock was plunging 15.49% to $119.50 in premarket trading.
Viking Therapeutics, Inc. VKTX reported a narrower-than-expected loss for its fourth quarter.
The stock was seen advancing 4.56% to $3.90 in premarket trading.
Offerings
Aeglea BioTherapeutics, Inc. AGLE announced a proposed underwritten public offering of its common stock and investors pre-funded warrants to purchase shares.
The stock was retreating 15.54% to $3.26 in premarket trading.
Twist Bioscience Corporation TWST announced that it intends to offer and sell in an underwritten public offering up to $200 million of shares of its common stock.
In premarket trading, the stock was 4.04% to $62.
On The Radar
Adcom Meeting
FDA's Oncologic Drugs Advisory Committee is scheduled to meet on Thursday, Feb. 10 to discuss the BLA for sintilimab injection, submitted by Eli Lilly and Company's LLY partner Innovent.
The proposed indication for this product is in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
Clinical Readouts/Presentations
Denali Therapeutics Inc. DNLI is due to present at the WORLDSymposium, interim 49-week results of a phase 1/2 study of intravenous DNL310 (brain-penetrant enzyme replacement therapy) in MPS II.
Ocuphire Pharma, Inc. OCUP will present at the "Cataract Surgery: Telling Like It Is" conference results from the completed VEGA-1 Phase 2 trial of Nyxol alone and Nyxol together with low-dose pilocarpine in the treatment of presbyopia.
DiaMedica Therapeutics Inc. DMAC is scheduled to present at the American Heart Association 2022 International Stroke Conference Phase 2 data for Dm199 that is being evaluated for the treatment of acute ischemic stroke.
Earnings
Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
Laboratory Corporation of America Holdings LH (before the market open)
AlloVir, Inc. ALVR (before the market open)
23andMe Holding Co. ME (after the market close)
Bio-Rad Laboratories, Inc. BIO (after the market close)
DexCom, Inc. DXCM (after the market close)
Illumina, Inc. ILMN (after the market close)
Ultragenyx Pharmaceutical Inc. RARE (after the market close)
Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates
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