Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Eli Lilly To Supply Additional 150K Doses Of COVID-19 Treatment To US Government
Eli Lilly And Co LLY has announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately $275 million.
The existing U.S. government supply of bebtelovimab, including the new purchase, is expected to meet present demand through late August 2022.
Bebtelovimab continues to maintain neutralization activity against the omicron variants.
An option for an additional 350,000 doses to be exercised no later than Sept. 14 will remain in the agreement.
89bio Posts Promising Pegozafermin Data For Severe Hypertriglyceridemia
89bio Inc ETNB announced topline results from the ENTRIGUE Phase 2 proof-of-concept study of pegozafermin for severe hypertriglyceridemia (SHTG).
Treatment with pegozafermin resulted in clinically meaningful and significant reductions in TG from baseline across all doses (with a 63% reduction in the highest dosing group).
Data also showed statistically significant improvements in key cardiovascular risk markers, reductions in liver fat, and improvements in glycemic control markers.
Can-Fite BioPharma Shares Jump After Piclidenoson Data In Psoriasis Trial
Can-Fite BioPharma Ltd CANF announced topline results from the COMFORT Phase 3 trial of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis.
The study data show that patients treated with oral Piclidenoson 2 mg or 3 mg twice daily had clinically equivalent efficacy responses.
Piclidenoson showed a favorable safety profile.
ObsEva's Linzagolix Approved in UK For Uterine Fibroids
The U.K. regulatory authority has approved ObsEva SA's OBSV Yselty (linzagolix), an oral GnRH antagonist, for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women.
Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.
The U.K. approval follows the granting of marketing authorization by the European Commission earlier in June 2022.
Oyster Point Outlines Restructuring Plan With Savings Of Up To $48M In 2023
Oyster Point Pharma Inc OYST will enact an operating expense streamlining plan to reduce employee and non-employee expenses (up to 50 roles) across the organization.
The plan is expected to reduce operating expenses by approximately $6-$8 million in the second half of 2022 and approximately $40-$48 million in 2023.
The company plans to continue to drive the launch of Tyrvaya with approximately 150-200 field-based sales resources.
Icosavax Shares Interim Data From RSV Vaccine Candidate
Icosavax Inc ICVX announced topline interim results from its Phase 1/1b trial of IVX-121, a VLP displaying a prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen, in young and older adults.
Interim data demonstrated a robust immunologic response in both groups, including at the lowest non-adjuvanted dose (25 µg).
IVX-121 was generally well-tolerated across all dosage groups.
Health Canada Approves Bristol Myers' Opdivo In Adjuvant Setting For Urothelial Carcinoma Patients
Health Canada approved Bristol Myers Squibb & Co's BMY Opdivo as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma at high risk of recurrence after undergoing radical resection.
The Health Canada approval based on CheckMate-274 Phase 3 trial demonstrates that Opdivo offers patients a chance to delay or potentially prevent disease recurrence. An improvement in overall survival has not yet been established.
ALX Oncology Receives FDA Orphan Drug Tag For Leukemia Candidate
The FDA has granted orphan drug designation to ALX Oncology Holdings Inc's ALXO evorpacept, a next-generation CD47 blocker for acute myeloid leukemia (AML).
"Receiving orphan drug designation in AML, and previously in gastric cancer, from the FDA is an important regulatory milestone and reflects the FDA's recognition of evorpacept's potential to improve clinical outcomes in patients with these advanced cancers," said Sophia Randolph, Chief Medical Officer.
89bio Inc ETNB has priced its underwritten public offering of 18.6 million shares and accompanying warrants to purchase up to 9.4 million shares at a combined price of $3.55 for gross proceeds of $94.5 million.
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