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Regulatory

BLUE

Bluebird Bio Inc (NASDAQ:BLUE) stock is trading higher after presenting positive long-term data from its gene therapy program for beta-thalassemia at the ASH Annual Meeting. The data showed sustained treatment effects and improved quality of life for patients treated with ZYNTEGLO. This follows a recent drop in shares due to an FDA black box warning for another of its treatments, Lyfgenia.

Portfolio Pulse from Adam Eckert

December 11, 2023 | 1:47 pm

ASND

Ascendis Pharma A/S announced that the FDA has accepted for review the resubmitted NDA for TransCon PTH for treating adult hypoparathyroidism, with a PDUFA goal date of May 14, 2024.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:46 pm

AA

Alcoa Corporation (NYSE:AA) is engaging with the Spanish government to address financial losses at its San Ciprián complex, which includes an alumina refinery and an aluminum smelter. The refinery has been operating at half capacity since Q3 2022 to reduce losses. The smelter was curtailed in January 2022 but is set for a phased restart in January 2024. Alcoa faces challenges such as uncompetitive energy costs, delayed alternative energy supplies, a European market slowdown, and lower sales prices. Despite investing $65 million in 2023 to meet Viability Agreement terms, Alcoa seeks long-term solutions with government and worker representatives due to unsustainable business conditions.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:45 pm

CHRS

Coherus BioSciences' drug LOQTORZI has been recommended by the NCCN as the preferred Category 1 treatment for first-line treatment of nasopharyngeal carcinoma (NPC) in combination with chemotherapy, and as monotherapy in subsequent lines of therapy. This follows the FDA approval of LOQTORZI for the treatment of NPC. The recommendation is based on clinical studies showing significant improvements in progression-free survival and overall survival rates.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:36 pm

SCNI

Scinai Immunotherapeutics Ltd. (NASDAQ:SCNI) has announced the peer-reviewed publication of an article in Antiviral Research, showcasing the potential of their aerosolized NanoAbs for treating coronavirus infections. The NanoAbs, developed in collaboration with MPI-NAT and UMG, have shown promising results in neutralizing SARS-CoV-2 in cell culture and hamsters. The company is actively seeking partnerships for their COVID-19 project and is also progressing with an anti-IL-17 NanoAb for autoimmune diseases. Scinai's CDMO unit has garnered customer interest and received a grant from the Israeli Innovation Authority.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:30 pm

CYTO

Altamira Therapeutics Ltd. (NASDAQ:CYTO) provided an update on its business strategy, including the partial spin-off of its Bentrio business, transition to a pure-play RNA delivery company, and financial restructuring. The company completed the Bentrio transaction, retaining a significant stake and potential future income. Altamira is also partnering its legacy assets and advancing its RNA delivery platforms, OligoPhore and SemaPhore. Cost reductions and debt repayment have strengthened the balance sheet. A 20-for-1 reverse stock split is planned to comply with Nasdaq listing rules and attract institutional investors.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:18 pm

NMTC

NeuroOne Medical Technologies Corporation (NMTC) has received FDA 510(k) clearance to market its OneRF Ablation System, which is used to create radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:12 pm

NXTP

NextPlay Technologies Inc (NASDAQ:NXTP) stock surged 53% to $0.64 amid ongoing volatility following a notice from Nasdaq regarding the company's failure to file financial reports for several periods in 2023. Nasdaq warned of a potential suspension of trading starting December 7, unless NextPlay appeals. The company has paid for an appeal and believes it can regain compliance before the hearing. There is no certainty they will regain or maintain compliance, and no further updates have been provided.

Portfolio Pulse from Henry Khederian

December 11, 2023 | 1:06 pm

THAR

Tharimmune reported positive Phase 1 results for TH104, its treatment for pruritus in chronic liver disease patients, showing a 33.3% reduction in itching intensity. The drug was well tolerated, with no unexpected adverse events. The company is funded into early 2025 and anticipates US PK data and Phase 2a results in 2024.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:05 pm

ERAS

Erasca, Inc. has been granted FDA Fast Track Designation for its pan-RAF inhibitor, Naporafenib, for treating patients with advanced NRAS-mutated melanoma. This designation could expedite the development and review process for Naporafenib, potentially bringing it to market more quickly if it proves to be safe and effective.

Portfolio Pulse from Benzinga Newsdesk

December 11, 2023 | 1:02 pm