Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Biogen To Sell Stake In Biosimilar JV With Samsung Bioepis For Up to $2.3B
Biogen, Inc. BIIB said it has entered into an agreement whereby Samsung Biologics will acquire Biogen's equity stake in the Samsung Bioepis biosimilar joint venture for an aggregate consideration of up to $2.3 billion.
Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon achievement of certain commercial milestones.
The sale will give Biogen's management the capital to pursue strategic alternatives including business development while divesting its stake in a business where it did not have any long-term prospects for a reasonable return, Needham analyst Ami Fadia said of the announcement.
The stock was down 0.16% at $218.60 in premarket trading.
ALX Oncology's Evorpacept Gets Orphan Drug Designation For Gastric Cancer
ALX Oncology Holdings, Inc. ALXO announced that the U.S. Food and Drug Administration has granted orphan drug designation to evorpacept for the treatment of patients with gastric cancer and gastroesophageal junction cancer.
The stock was adding 11.42% to $16 in premarket trading.
Regeneron, Sanofi Voluntarily Withdraw Regulatory Application For Libtayo In Cervical Cancer
Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY announced the voluntary withdrawal of the supplemental biologic license application for Libtayo as a second-line treatment for patients with advanced cervical cancer.
The decision was made after the companies and the FDA were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the U.S. are ongoing, it added.
Regeneron shares were moving down 0.98% to $602.75, while Sanofi was seen retreating 0.83% to $52.42.
Provention Bio Plans to Resubmit Teplizumab Application Following Positive Type B Meeting With FDA
Provention Bio, Inc. PRVB announced its intent to resubmit the teplizumab BLA for the delay of clinical type 1 diabetes in at-risk individuals following its Type B pre-BLA resubmission meeting with the FDA.
The regulator has now deemed that Provention could proceed to resubmit the BLA.
The company received a complete response letter to the original application in early July.
The stock was jumping 10% to $3.74 in after-hours trading.
Related Link: The Week Ahead In Biotech (Jan. 23-29): Roche, Azurity FDA Decisions, J&J, Vertex Earnings, Samsara Vision IPO And More
Merck's Co-Developed Oral Antiviral Treatment Found To Be Active Against Omicron In Lab Studies
Merck & Co., Inc. MRK and Ridgeback Biotherapeutics announced data from six preclinical studies demonstrating that molnupiravir, an investigational oral antiviral COVID-19 medicine, was active against the SARS-CoV-2 variant Omicron.
BeiGene Application To Expand Label Of Brukinsa To Treat Blood Cancer Accepted For Review In China
BeiGene, Ltd. BGNE announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental new drug application for its Brukinsa as a treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and granted BRUKINSA breakthrough therapy designation.
Trinity Biotech Announces Successful Closing Of Debt Refinancing Agreement
Trinity Biotech plc TRIB announced the successful closing of its previously announced debt refinancing related to substantially all of the outstanding $99.9 million of exchangeable senior notes issued by its subsidiary.
The stock was gaining 5.17% to $1.22 in premarket trading.
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Earnings
Nurix Therapeutics, Inc. NRIX reported fourth-quarter collaboration revenues of $7.4 million, up from $6.7 million a year ago. The net loss per share widened from 51 cents to 85 cents, while the consensus called for a loss of 69 cents.
The stock was slipping 3.12% to $16.75 in premarket trading.
ResMed Inc.'s RMD fiscal-year second-quarter revenues climbed 12% to $894.9 million and non-GAAP EPS came in at $1.47. Analysts, on average, estimated EPS of $1.52 on revenues of $935.25 million.
The stock was slipping 2.39% to $219.51 in premarket trading.
Taro Pharmaceutical Industries Ltd. TARO reported third-quarter net sales of $138.98 million, down from $140.15 million a year ago. Net income per share slipped from 86 cent to 70 cents and also trailed the 91-cent-per-share consensus estimate.
In premarket trading, the stock was gaining 1.76% to $48.
Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates
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