Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
AstraZeneca/Merck's Lynparza Scores European Approval In Early Breast Cancer
The European Union has approved AstraZeneca Plc AZN and Merck & Co Inc's MRK Lynparza (olaparib) for human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
The approval for Lynparza comes as monotherapy or in combination with endocrine therapy for the adjuvant treatment in the breast cancer setting with germline BRCA1/2 mutations.
Syros Bone Marrow Cancer Candidate Poised To Get European Orphan Drug Tag
The European Medicines Agency issued a positive opinion on Syros Pharmaceuticals Inc SYRS's application for orphan drug designation for tamibarotene for myelodysplastic syndrome (MDS).
The FDA granted orphan drug designation to tamibarotene in MDS in February 2022.
The ongoing SELECT-MDS-1 Phase 3 trial is evaluating the safety and efficacy of tamibarotene in combination with azacitidine for RARA-positive patients with newly diagnosed HR-MDS.
Data from the pivotal trial are expected in Q4 of 2023 or Q1 of 2024, with a potential new drug application filing in 2024.
FDA Says Travere's Sparsentan Data Not Sufficient For Accelerated Approval In One Indication
FDA indicated that the interim analysis from the ongoing Phase 3 DUPLEX study and the recent limited additional estimated glomerular filtration (eGFR) data-cut do not meet the threshold to support an application for accelerated approval of Travere Therapeutics Inc TVTX's sparsentan in focal segmental glomerulosclerosis.
The FDA recommends the company pursue traditional approval based on a two-year eGFR slope.
Related content: Biotech Investors: August's Key PDUFA Catalysts You Must Know
BioCryst Resumes Enrollment In BCX9930 In Rare Diseases
The FDA lifted a partial clinical hold on BioCryst Pharmaceuticals Inc's BCRX BCX9930 program.
The company will resume enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930.
Clinical evidence and recent laboratory studies have informed the company's hypothesis that crystals form in the kidneys of some patients. The company believes that lowering the dose to 400 mg and ensuring adequate hydration will dilute the drug concentration in the urine below the threshold where crystals can form.
Shares are up 16.1% at $12.95 during the premarket session.
Data Committee Recommends PDS Biotechnology's Combo Head, Neck Cancer Trial To Continue Unchanged
PDS Biotechnology Corporation PDSB said the independent Data Monitoring Committee recommended continuing the Phase 2 VERSATILE-002 trial with no modifications.
The trial is evaluating PDS0101 plus Merck & Co Inc's MRK Keytruda (pembrolizumab) for recurrent or metastatic HPV16-positive head and neck cancer.
PDS0101 combo study continues to appear safe and well tolerated. There were no drug discontinuations related to toxicity.
Amgen Scoops Up ChemoCentryx For Almost $4B
Amgen Inc AMGN has agreed to acquire ChemoCentryx Inc CCXI for $52 per share in cash, representing an enterprise value of approximately $3.7 billion.
"The acquisition of ChemoCentryx represents a compelling opportunity for Amgen to add to our decades-long leadership in inflammation and nephrology with TAVNEOS, a transformative, first-in-class treatment for ANCA-associated vasculitis," said Robert Bradway, chairman & CEO of Amgen.
CCXI shares are up 113.% at $51.36 during the premarket session.
Gilead Sciences Acquires MiroBio
Gilead Sciences Inc GILD has agreed to acquire a privately held U.K.-based biotechnology company, MiroBio, for approximately $405 million in cash.
The acquisition will provide Gilead with MiroBio's proprietary discovery platform and the entire portfolio of immune inhibitory receptor agonists.
Poseida Therapeutics Inc PSTX has priced its underwritten public offering of 20 million at $3.50 per share for gross proceeds of $70 million.
Shares are slipping 18.2% at $3.69 during the premarket session.
Avinger Inc AVGR announced a registered direct offering of 1.48 million shares and a private placement of 1.37 million.
The purchase price for one share and the associated preferred investment options is $1.752.
Shares are down 7.88% at $1.52 during the premarket session.
On The Radar
Acadia Pharmaceuticals Inc ACAD: Resubmitted supplemental marketing application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis.
Travere Therapeutics Inc TVTX: Before the market open.
Selecta Biosciences Inc SELB: Before the market open.
Aurinia Pharmaceuticals Inc AUPH: Before the market open.
Intellia Therapeutics Inc NTLA: Before the market open.
Adaptimmune Therapeutics PLC ADAP: Before the market open.
Arbutus Biopharma Corp ABUS: Before the market open.
Agios Pharmaceuticals Inc AGIO: Before the market open.
Eli Lilly And Co LLY: Before the market open.
Amgen Inc AMGN: After market close.
Vir Biotechnology Inc VIR: After market close.
Eiger Biopharmaceuticals Inc EIGR: After market close.
PTC Therapeutics Inc PTCT: After market close.
Vertex Pharmaceuticals Incorporated VRTX: After market close.
Voyager Therapeutics Inc VYGR: After market close.
Puma Biotechnology Inc PBYI: After market close.
Neurocrine Biosciences Inc NBIX: After market close.
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