Jam

Merck’s Phase 3 CORALreef Lipids trial revealed that enlicitide, an investigational oral PCSK9 inhibitor, significantly reduced LDL-C levels by 55.8% in adults with or at risk for ASCVD. The study demonstrated sustained reductions at one year and improvements in other lipid parameters. Enlicitide’s safety profile was comparable to placebo, with high treatment adherence. The oral formulation may address unmet needs in ASCVD management due to the availability of current injectable PCSK9 inhibitors. Merck plans to seek regulatory approval based on these findings and other CORALreef trials.

Vor Bio (VOR) announced positive Phase 3 results for telitacicept in IgA nephropathy (IgAN) patients in China. The study met its primary endpoint, demonstrating a statistically significant 58.9% reduction in proteinuria versus 8.8% for placebo at Week 39 (p<.0001). Telitacicept also showed stabilization of kidney function and a reduced risk of eGFR decline. Serious adverse events were less frequent with telitacicept. RemeGen has submitted a BLA to China’s CDE for telitacicept in IgAN.

Regeneron (REGN) announced positive Phase 2 data for REGN7508Cat and REGN9933A2, two factor XI antibodies, in preventing postoperative venous thromboembolism (VTE) after total knee replacement. REGN7508Cat showed a 7.1% VTE rate, outperforming enoxaparin. REGN9933A2 had a 17.2% VTE rate. Importantly, no major bleeding events occurred. Phase 3 trials are underway. An investor roundtable is scheduled for November 10, 2025.

Organon presented data at ACAAI 2025 showing VTAMA cream’s efficacy in children (2-17) with atopic dermatitis (AD). A sub-analysis of Phase 3 trials (ADORING 1 & 2) revealed early and clinically meaningful improvements in skin clearance (vIGA-AD, EASI-75), patient-reported outcomes (POEM), and itch (PP-NRS) at week 8, regardless of comorbidities like asthma or allergies. This largest pediatric VTAMA data set supports its use as a treatment option, demonstrating a favorable safety and efficacy profile.

Metsera Inc. has announced an amended merger agreement with Pfizer, valued at up to $86.25 per share, comprising $65.60 upfront and a contingent value right (CVR) of up to $20.65 based on milestones. The Metsera Board unanimously recommends shareholder approval, citing optimal value and deal certainty. This decision follows concerns raised by the U.S. Federal Trade Commission regarding a previous deal with Novo Nordisk. The board prioritizes the Pfizer merger due to its expectation of swift closure and immediate value delivery to shareholders.

Surface Metals (CSE: SUR / OTCQB: SURMF) granted 250,000 stock options to a consultant at $0.255 and reported that executives voluntarily surrendered 499,999 options (strike price $3.84) issued April 14, 2022. The company also retained IDR Marketing Inc. for six months starting October 29, 2025, to enhance public relations, brand awareness, and digital marketing. IDR’s principal is Linda Josey, an arm’s-length party. This targets improved visibility in the lithium and gold exploration market.

Vera Therapeutics (VERA) submitted a BLA to the FDA for accelerated approval of atacicept for IgAN, supported by Phase 3 ORIGIN 3 interim data. The analysis showed a 46% reduction from baseline and a 42% reduction versus placebo in 24-hour UPCR at week 36. The safety profile was reportedly comparable to placebo. The ORIGIN 3 trial, involving 431 adults, continues to assess eGFR, with study completion expected in 2027. Atacicept, if approved, would be the first dual BAFF/APRIL modulator for IgAN.

On November 7, 2025, Nextech3D.ai (NEXCF) announced the termination of its letter of intent to sell up to 80% of Toggle3D.ai (TGGL) to TQG Technologies. The decision stemmed from the parties’ inability to finalize the transaction structure within agreed timelines. No deposit was received, and no Toggle shares were sold. Toggle3D.ai remains pre-revenue and under “care and maintenance” while Nextech explores strategic alternatives, prioritizing cash preservation. Further updates will be provided.

BIO-key International (BKYI) will release its Q3 2025 results before market open on November 14, 2025, followed by an investor call at 10:00 a.m. ET. CEO Mike DePasquale and CFO Cecilia Welch will lead the call, discussing company performance and strategic initiatives. A live webcast and replay will be available to investors. The call will include a Q&A session, and the webcast replay will be accessible for three months. Dial-in details are provided for both U.S. and international participants.

Cruisers Yachts, a MarineMax subsidiary, announced record performance at the Fort Lauderdale International Boat Show with the unveiling of four new models. These include the 50 FLY, emphasizing open-air entertainment, and the 38 VTR/EC models, marking the brand’s entry into the day yacht segment. The 50 GLS Coupe now offers a midship enclosure for extended usability. President Mark Pedersen highlights the company’s focus on customer needs, shaping the future of luxury on-water leisure through innovative design and versatility.