Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Britain Approves Global Blood Therapeutics' Sickle Cell Treatment
U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Global Blood Therapeutics Inc's GBT Oxbryta (voxelotor) for hemolytic anemia due to sickle cell disease (SCD) in patients 12 and above.
The approval comes for Oxbryta as monotherapy or in combination with hydroxycarbamide (hydroxyurea).
Voxelotor is the first medicine authorized in Great Britain to directly inhibit sickle hemoglobin polymerization, the molecular basis of sickling, and the destruction of red blood cells in SCD.
European Approval For AbbVie's Upadacitinib For Ulcerative Colitis
The European Commission has approved AbbVie Inc's ABBV Rinvoq (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for active ulcerative colitis in patients who did respond to previous treatments.
The approval is based on the results of three Phase 3 studies: two for induction and one for maintenance, wherein Rinvoq achieved the primary endpoint of clinical remission and all secondary endpoints, including clinical response and mucosal healing.
Owlet Announces Workforce Reduction
Owlet Inc OWLT implemented a restructuring program to reduce operating expenses and conserve cash resources.
The company will cut its workforce by approximately 74 employees, expected to complete in Q3 of 2022.
Owlet expects to incur an estimated total amount of approximately $1.1 million in Q3.
Pear Therapeutics Lays Off 9% Of Its Staff
Pear Therapeutics Inc PEAR announced restructuring focused on cost reductions on pipeline candidates, discovery programs, and business development.
The company will cut its headcount by approximately 25 employees, representing approximately 9%, reducing operating expenses by approximately $28.0 million over the next 18 months.
Pear expects to incur a one-time charge of approximately $0.9 million in Q3 of 2022.
Angion Biomedica Evaluates Strategic Options
Angion Biomedica Corp ANGN has commenced exploring and evaluating strategic options to enhance and preserve shareholder value. Angion has engaged Oppenheimer & Co Inc as the company's exclusive financial advisor to assist in this process.
"To preserve as much of the over $60 million in cash and cash equivalents in place at the end of the second quarter, we are discontinuing development of ANG-3070 for all indications and discontinuing most other development activities pending the conclusion of this process," stated Jay Venkatesan, Angion's President & CEO.
Seagen Shares Jump On Positive Data From Urothelial Cancer Trial
Seagen Inc SGEN and Astellas Pharma Inc ALPMF announced topline results from the phase 1b/2 EV-103 trial (KEYNOTE-869) cohort K of Padcev (enfortumab vedotin-ejfv) in bladder cancer.
The cohort evaluates Padcev with Merck & Co Inc's MRK Keytruda as first-line treatment for unresectable locally advanced or metastatic urothelial cancer patients who are ineligible to receive cisplatin-based chemotherapy.
In patients treated with enfortumab vedotin and pembrolizumab, results demonstrated a 64.5% confirmed objective response rate, the primary endpoint of Cohort K.
SGEN shares are up 3.27% at $178.50 during the premarket session.
Immuron's IND Application For Bacterial Infection Candidate Placed On Clinical Hold
The U.S. Naval Medical Research Center (NMRC) has received FDA feedback related to Immuron Limited's IMRN Investigational New Drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC.
The agency has specified that the IND does not contain sufficient information to assess the risk to subjects in the proposed clinical studies.
The IND has been placed on clinical hold until the FDA has received and reviewed a response from the NMRC justifying dosing, safety monitoring, and a risk mitigation plan.
FDA Accepts Biogen's Application For Amyotrophic Lateral Sclerosis Treatment
The FDA has accepted Biogen Inc BIIB and Ionis Pharmaceuticals Inc's IONS marketing application seeking approval for tofersen for superoxide dismutase 1 amyotrophic lateral sclerosis.
The application has been granted priority review with a Prescription Drug User Fee Act action date of January 25, 2023.
The FDA has noted that it plans to hold an Advisory Committee meeting, date yet-to-be-determined.
Offerings
Legend Biotech Corporation LEGN intends to offer and sell $250 million of American Depositary Shares, each representing two ordinary shares, in an underwritten public offering.
IVERIC bio Inc ISEE has entered into a debt financing facility with Hercules Capital Inc HTGC and Silicon Valley Bank, providing the company with a total borrowing capacity of up to $250 million in non-dilutive debt financing.
Shares are up 5.29% at $11.34 during the premarket session.
On The Radar
Earnings
Neogen Corporation NEOG: Before the market open.
IVERIC bio ISEE: Before the market open.
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