FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheime ...

Core Viewpoint - PolyPid Ltd. is set to submit a New Drug Application (NDA) for its lead product candidate D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgeries, with submissions beginning in early 2026 following positive feedback from the FDA [1][2][4]. Group 1: NDA Submission and FDA Interaction - The FDA has confirmed that PolyPid's existing clinical data, including results from the Phase 3 SHIELD II trial, is adequate for NDA submission and review [2][4]. - A rolling NDA review has been agreed upon, allowing PolyPid to submit completed sections starting in early 2026 [2][4]. - The in-person pre-NDA meeting originally scheduled for December 3, 2025, is no longer necessary as the objectives have been met [3]. Group 2: Product Details and Clinical Results - D-PLEX100 utilizes PLEX technology to provide prolonged and controlled antibacterial activity at the surgical site, releasing doxycycline over 30 days to prevent surgical site infections [5][6]. - The Phase 3 SHIELD II trial demonstrated a statistically significant 58% relative risk reduction in surgical site infection incidence following abdominal colorectal surgery with large incisions [5]. - D-PLEX100 has received Breakthrough Therapy designation from the FDA for its potential in preventing surgical site infections in elective colorectal surgery patients [5]. Group 3: Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered therapeutics [6]. - The company is also developing an innovative pipeline targeting oncology, obesity, and diabetes [6].

Group 1 - Moer Thread announced an issuance price of 114.28 CNY per share, with a total of 70 million shares to be publicly issued, aiming to raise 8 billion CNY, netting approximately 7.576 billion CNY after expenses [1] - EVE Energy signed a procurement framework agreement with Simo International for battery cells from 2026 to 2028, with the agreement effective until December 31, 2028, but does not specify a concrete amount [1] - Tuojing Technology's major shareholder, the National Integrated Circuit Industry Investment Fund, plans to reduce its stake by up to 3% through block trading from December 12, 2025, to March 11, 2026 [1] Group 2 - Shengyi Electronics announced that its shareholder, Dongguan Science and Technology Innovation Investment Group, plans to reduce its stake by up to 1% from December 12, 2025, to March 11, 2026, due to funding needs [2] - Deep Technology reported that it is a leading domestic high-end storage chip packaging and testing company, currently operating at full capacity in Shenzhen and Hefei, and is expanding based on customer demand [2] - Wengfeng Co. announced that its deputy general manager, Qin Guofen, is under investigation, but this matter is personal and will not significantly impact the company's operations [2] Group 3 - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology, has had its drug, Surulitinib, included in the breakthrough therapy designation for gastric cancer, with no other PD-1 monoclonal antibody approved for this indication globally [3] - Daye Co. is responding to the EU's anti-dumping investigation on Chinese lawnmowers, adjusting its overseas production structure and integrating resources to mitigate impacts [4]

Core Insights - Vertex Pharmaceuticals experienced steady double-digit revenue growth in Q3, driven by the expansion of its cystic fibrosis franchise and new product launches in acute pain and genetic therapies [1] - Despite revenue growth, the market reacted negatively due to margin compression and operational investments impacting overall sentiment [1] Financial Performance - Revenue reached $3.08 billion, exceeding analyst estimates of $3.06 billion, reflecting an 11% year-on-year growth [6] - Adjusted EPS was reported at $4.80, beating analyst expectations of $4.58 by 4.9% [6] - Adjusted EBITDA stood at $1.44 billion, surpassing estimates of $1.37 billion, with a margin of 46.8% [6] - The company slightly raised its full-year revenue guidance to $11.95 billion from $11.93 billion [6] - Operating margin decreased to 38.6% from 40.3% in the same quarter last year [6] - Market capitalization is currently at $103.9 billion [6] Analyst Insights - Analysts raised questions regarding the adoption of ALYFTREK, with management indicating that most newly eligible U.S. patients have begun using the therapy [6] - Inquiry into the long-term effects of proteinuria reductions with povetacicept was addressed, with expectations of correlation to stabilized eGFR [6] - Capital allocation priorities were discussed, with a focus on reinvestment in R&D and commercialization [6] - The importance of monthly auto-injector dosing for povetacicept was highlighted as a differentiator in the renal market [6] - The rationale behind the FDA's breakthrough therapy designation for povetacicept was explained, citing unmet needs and strong data [6]

Core Viewpoint - The FDA has accepted Sanofi's Tzield for expedited review to delay the progression of stage 3 type 1 diabetes, highlighting its potential to address a significant unmet medical need [1][2]. Regulatory Review - Tzield's supplemental biologics license application (sBLA) is part of the Commissioner's National Priority Voucher pilot program, which aims to reduce the review time from 10-12 months to 1-2 months while ensuring safety and efficacy standards [1]. - Tzield is also under review for accelerated approval, which allows the FDA to evaluate therapies for serious conditions based on surrogate endpoints [4][9]. Clinical Study Results - The sBLA is supported by the PROTECT phase 3 study, which demonstrated significant preservation of beta cell function by slowing the decrease in mean C-peptide levels compared to placebo [2][8]. - The PROTECT study involved 328 participants aged 8-17 years, with a randomization ratio of 2:1 for Tzield versus placebo [7]. Safety Profile - Adverse events in the PROTECT study were consistent with previous studies, with common events including headache, nausea, and gastrointestinal symptoms. 1.8% of participants developed cytokine release syndrome possibly related to Tzield [3]. Market Position - If approved, Tzield would be the first disease-modifying therapy for stage 3 type 1 diabetes in adults and pediatric patients aged eight years and older [9]. - Tzield is already approved in multiple countries, including the US, UK, China, and Canada, for delaying the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 [5][12]. Company Overview - Sanofi is an R&D-driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [13].

Core Insights - Cidara Therapeutics received Breakthrough Therapy designation from the FDA for its investigational flu drug CD388, leading to a significant increase in its stock price by over 12% despite a decline in the S&P 500 [1][2]. Group 1: Drug Development and Designation - The FDA's Breakthrough Therapy designation will expedite the approval process for CD388, a non-vaccine treatment aimed at preventing seasonal flu [2][4]. - CD388 is designed for individuals who are unable or unwilling to receive traditional vaccines [3][5]. - The drug is currently in phase 3 clinical testing, indicating advanced progress in its development pipeline [5]. Group 2: Market Reaction - Following the announcement of the FDA designation, Cidara's stock experienced a notable increase, closing more than 12% higher [1]. - This positive market reaction occurred during a broader market decline, highlighting investor confidence in the company's prospects [1].

Core Insights - U.S. stocks exhibited mixed performance, with the Dow Jones index declining by over 50 points on Thursday [1] - Taysha Gene Therapies Inc received Breakthrough Therapy designation from the FDA for TSHA-102, leading to a significant share price increase of 50.4% to $4.78 [1] Company Highlights - Taysha Gene Therapies Inc (NASDAQ:TSHA) saw its price target raised from $8 to $10 by Needham analyst Gil Blum, maintaining a Buy rating [1] - Bakkt Holdings Inc (NYSE:BKKT) experienced a 37.2% increase in share price to $46.81 following the completion of its Loyalty Business sale [4] - Canaan Inc – ADR (NASDAQ:CAN) shares surged by 29.8% to $1.35 after announcing a significant sales order for Bitcoin mining machines [4] - Ondas Holdings Inc (NYSE:ONDS) gained 25.5% to $9.18 after securing an initial order of 500 Wasp drones for U.S. defense market distribution [4] - Fair Isaac Corp (NYSE:FICO) shares rose 19.6% to $1,811.61 after launching the FICO Mortgage Direct License Program [4] - AST SpaceMobile Inc (NASDAQ:ASTS) jumped 12.3% to $63.98 after completing final assembly and testing of its BlueBird 6 satellite [4] - Joby Aviation Inc (NYSE:JOBY) rose 9.3% to $17.72, reflecting positive market sentiment [4] - Applied Digital Corp (NASDAQ:APLD) shares increased by 7.7% to $26.93, with crypto-linked stocks trading higher amid a rise in Bitcoin [4]

Core Insights - Seres Therapeutics is advancing its SER-155 Phase 2 study protocol for preventing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant, following positive feedback from the FDA [1][2][4] - The company is actively seeking capital to support the Phase 2 study and has implemented cost-reduction measures, including a 25% workforce reduction, to extend its cash runway into Q2 2026 [2][3][5] Company Developments - The SER-155 Phase 2 study is designed to be a placebo-controlled trial with approximately 248 participants, focusing on the prevention of bloodstream infections through 30 days post-transplant as the primary endpoint [4][7] - Interim clinical results are expected within 12 months of study initiation, which will facilitate timely engagement with the FDA regarding a potential Phase 3 study [4][7] - The company has received Breakthrough Therapy designation for SER-155, which has shown a 77% relative risk reduction in bloodstream infections in a prior Phase 1b study [7][8] Financial and Operational Strategy - The workforce reduction is expected to incur cash payments of approximately $1.0 to $1.4 million, primarily for severance costs, to be paid in Q4 2025 [5] - Cost-saving initiatives are anticipated to provide the company with additional opportunities to advance its strategic priorities and support its broader portfolio of product candidates [3][4]

Core Insights - Sanofi's new drug application (NDA) for tolebrutinib has had its target action date extended by three months to December 28, 2025, due to the submission of additional analyses deemed a major amendment by the FDA [1][5] - Tolebrutinib is an investigational oral Bruton's tyrosine kinase (BTK) inhibitor aimed at treating non-relapsing, secondary progressive multiple sclerosis (nrSPMS) [1][6] - The NDA is supported by data from three late-stage studies, showing that tolebrutinib delayed disability progression compared to placebo and Aubagio [2][5] Company Overview - Tolebrutinib is the first and only brain-penetrant BTK inhibitor targeting both nrSPMS and relapsing MS (RMS) [6][8] - Currently, there are no approved therapies for nrSPMS, highlighting a significant unmet medical need [6][7] - Sanofi acquired tolebrutinib through its purchase of Principia in 2020, and it holds Breakthrough Therapy designation from the FDA for the nrSPMS indication [8] Clinical Development - The FDA accepted the NDA for tolebrutinib under its priority review pathway in March 2025 [2][5] - A phase III study (PERSEUS) is ongoing to evaluate tolebrutinib in primary progressive MS, with data expected by the end of 2025 [8] - In 2022, the FDA placed a partial clinical hold on phase III studies due to drug-induced liver injury cases, leading to the discontinuation of studies in myasthenia gravis [9] Market Performance - Year-to-date, Sanofi's shares have decreased by 2.5%, while the industry has seen a growth of 0.9% [3]

Core Viewpoint - Revive Therapeutics Ltd. has successfully closed the first tranche of its private placement offering, raising a total of $60,900 through the issuance of 2,900,000 units at a price of $0.021 per unit, while also settling a note payable through the issuance of additional units [1][2][3]. Group 1: Offering Details - The first tranche of the offering consisted of 2,900,000 units, generating gross proceeds of $60,900 for the company [1]. - Each unit comprises one common share and one common share purchase warrant, with the warrant allowing the holder to acquire one common share at an exercise price of $0.05 for 36 months [2]. - The company issued an additional 3,209,523 units to settle a note payable of $67,400, maintaining the same issue price of $0.021 per unit [1][3]. Group 2: Use of Proceeds - The gross proceeds from the offering will be allocated for working capital and the payment of certain trade payables [2]. Group 3: Compensation Options - In connection with the offering, the company issued 100,000 compensation options to an investment dealer, allowing the dealer to purchase units at a price of $0.05 for 18 months [4]. - Each compensation unit consists of one common share and one-half of a common share purchase warrant, with the whole warrant allowing acquisition of one compensation share at an exercise price of $0.05 for 36 months [5]. Group 4: Company Overview - Revive Therapeutics is focused on developing innovative therapeutics for critical medical needs, leveraging FDA regulatory incentives for rapid advancement and market entry [6]. - The company is currently concentrating on the potential of Bucillamine for infectious diseases and medical countermeasures, as well as advancing its Psilocybin and molecular hydrogen therapeutic programs [6].