Core Viewpoint - Travere Therapeutics experienced a significant decline in stock value due to a regulatory setback regarding its leading drug candidate, Filspari, which is under FDA review for a kidney disorder [1][6]. Group 1: Regulatory Developments - The FDA has extended the review timeline for Travere's New Drug Application for Filspari, with a new target action date set for April 13, three months later than the original deadline of January 13 [2][3]. - This extension follows the company's submission of additional information requested by the FDA to better characterize the clinical benefits of Filspari [3]. Group 2: Market Reaction - Following the news of the FDA's extension, Travere's shares fell nearly 15% in a single day as investors reacted negatively to the delay [1]. - The market's reaction may be seen as an overreaction, as delays due to "major amendments" are not uncommon in the regulatory process [4]. Group 3: Drug Significance - Filspari, if approved for focal segmental glomerulosclerosis (FSGS), would be the first drug approved for this disorder, adding significant value to Travere's portfolio [3]. - The drug is already FDA-approved for treating IgA nephropathy, indicating its potential in the renal therapeutic area [3].

Core Insights - MoonLake Immunotherapeutics received FDA feedback on the clinical evidence strategy for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS) following a Type B meeting request [1] - SLK showed significant improvements in key outcomes across over 1,000 patients in the MIRA, VELA-1, and VELA-2 trials [1] Data Summary - MIRA trial results indicated a 43% response rate with 120mg SLK, showing a 29 percentage point (ppt) improvement over placebo (p < 0.001) at week 12 [2] - VELA-1 trial met all primary and key secondary endpoints with statistical significance across all pre-specified analysis strategies [2] - In VELA-2, SLK achieved a 36% response rate with 120mg SLK at week 16, with a 10ppt delta to placebo (p = 0.033) [3] - A higher-than-expected placebo response affected the primary composite analysis in VELA-2, resulting in a 9% delta to placebo (p=0.053) [3] Regulatory Outlook - MoonLake requested a Type B meeting with the FDA to gain regulatory clarity and continue preparing for the Biologics License Application (BLA) [4] - The FDA indicated that substantial evidence of effectiveness for SLK may be established without additional clinical trials in HS [4] - The FDA advised that VELA-2 trial results should be included in the marketing application to inform SLK's safety, regardless of effectiveness decisions [4] Future Plans - MoonLake is on track to submit the BLA in the second half of 2026 [5] - In June 2025, Merck & Co. Inc. reportedly approached MoonLake with a bid exceeding $3 billion [5] - Following the latest developments, MLTX stock increased by 27.55% to $14.40 [5]

Core Viewpoint - A lawsuit has been filed against MoonLake Immunotherapeutics and its senior executives for potential violations of federal securities laws, following disappointing results from its Phase 3 VELA trials for sonelokimab [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, under the case caption Peters v. MoonLake Immunotherapeutics, et al., No. 1:25-cv-08612 [2]. - Investors have until December 15, 2025, to request to be appointed to lead the case [2]. Group 2: Company Background - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on developing therapies for inflammatory diseases [3]. - The company conducted Phase 3 VELA trials for sonelokimab, aimed at treating moderate to severe hidradenitis suppurativa [3]. Group 3: Clinical Data and Allegations - MoonLake claimed that its "strong clinical data" from the Phase 2 MIRA trial indicated higher clinical responses and differentiation of sonelokimab from competitors [4]. - Allegations suggest that the clinical data and Nanobody structure did not provide a superior clinical benefit, raising doubts about the drug's regulatory approval and commercial viability [5]. Group 4: Stock Performance - Following the announcement of disappointing results from the VELA Phase 3 trials on September 28, 2025, MoonLake's stock price plummeted by $55.75 per share, nearly 90%, from $61.99 on September 26, 2025, to $6.24 on September 29, 2025 [6].

Core Viewpoint - Biogen's supplemental new drug application (sNDA) for a higher dose of Spinraza received a complete response letter (CRL) from the FDA, requesting updates to the Chemistry, Manufacturing, and Controls section without citing clinical data deficiencies [1][8]. Regulatory Developments - The company plans to resubmit the regulatory application quickly based on readily available information [2]. - A similar application for the higher dose of Spinraza is under review in the EU, while the high-dose regimen has already been approved in Japan [6][5]. Dosing Regimen - The new higher dosing regimen includes two initial 50 mg doses at a 14-day interval, followed by a 28 mg maintenance dose every four months, compared to the current regimen of four loading doses of 12 mg [3][4]. - This new regimen is expected to reduce dosing frequency and provide significant clinical benefits for SMA patients [4]. Clinical Data and Benefits - The regulatory filings are supported by data from the phase II/III DEVOTE study, which showed statistically significant improvement in motor function in infants treated with the higher dose [4]. - Management believes that the higher dose could slow neurodegeneration more effectively, with greater reductions in neurofilament observed as early as day 64 [5]. Competitive Landscape - Spinraza faces competition from Novartis' Zolgensma and Roche/PTC Therapeutics' Evrysdi, both approved for SMA, which has negatively impacted Spinraza's sales [10][11]. - Sales of Spinraza declined by 8.5% in Q2 2025 due to increased competitive pressure, and global revenues are expected to remain flat in 2025 [11]. Stock Performance - Biogen's shares have decreased by 8.9% this year, contrasting with a 4.3% increase in the industry [7].

As filed with the Securities and Exchange Commission on December 1, 2023 Registration No. 333-275056 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 CONDUIT PHARMACEUTICALS INC. (Exact name of Registrant as specified in its charter) | | | (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 4995 ...