Core Viewpoint - Milestone Pharmaceuticals (MIST) received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray, intended for treating paroxysmal supraventricular tachycardia (PSVT) [1][2] Regulatory Issues - The CRL does not raise concerns about the clinical safety or efficacy of etripamil but highlights two Chemistry, Manufacturing, and Controls (CMC) issues that need to be resolved before approval [2][11] - The first issue involves nitrosamine impurities, with the FDA requesting additional data based on new draft guidance issued after MIST's NDA submission [3] - The second issue relates to a facility inspection involved in the drug's release testing, which underwent a change in ownership during the NDA review, necessitating a compliance evaluation [4] Market Reaction - Following the CRL issuance, MIST's shares fell by 66.2%, with a year-to-date loss of 67.8%, contrasting with the industry's growth of 2.2% [2][7] - Analysts remain cautiously optimistic about the drug's prospects, suggesting a potential commercial launch in 2026, delayed from the original expectation of mid-2025 [8][11] Company Response and Financial Position - MIST has expressed its intent to request a Type A meeting with the FDA to clarify the path forward and is committed to addressing the outstanding issues [9] - As of December 31, 2024, MIST reported $69.7 million in cash and short-term investments, providing a runway for ongoing development efforts, although additional capital may be needed if delays continue [10] Investor Perspective - The CRL is viewed as a temporary obstacle rather than a fundamental rejection of CARDAMYST's therapeutic potential, with the absence of clinical concerns being a positive indicator for eventual approval [11]

Core Insights - The global membrane chromatography market is projected to grow from an estimated USD 324.4 million in 2024 to USD 779.3 million by 2030, with a compound annual growth rate (CAGR) of 16.0% from 2025 to 2030 [3][7]. Market Overview - The growth of the membrane chromatography market is primarily driven by the increasing demand for biopharmaceuticals and a heightened regulatory focus on cleaning validation for downstream purification processes [3][4]. - Membrane chromatography offers significant advantages over traditional column chromatography, including higher binding capacities and reduced buffer consumption, which are critical for optimizing biopharmaceutical production [3][4]. Regulatory Environment - Regulatory approvals for biopharmaceutical manufacturing are fueling market growth, as evidenced by Boehringer Ingelheim Biopharmaceuticals China's successful pre-approval inspections by the European Medicines Agency and the U.S. Food and Drug Administration in April 2024 [5]. - The increasing endorsement of biopharmaceuticals by regulatory bodies is driving demand for membrane chromatography [5]. Research and Development - The biopharmaceutical industry's annual R&D spending exceeds USD 202 billion, significantly outpacing other sectors, which underscores the commitment to innovation and the growing number of product launches [6]. - Innovations such as Waters Corporation's introduction of the XBridge Premier GTx BEH SEC columns in August 2023 for gene therapy applications exemplify advancements in membrane chromatography technology [6]. Market Segmentation - The report segments the global membrane chromatography market based on product, technique, end use, and region, providing a comprehensive analysis of trends and forecasts from 2018 to 2030 [2][8]. - Key product segments include capsules, cassettes, cartridges, syringe filters, and membrane filters, among others [8][10]. Competitive Landscape - The competitive landscape includes major players such as 3M, Asahi Kasei, Danaher, Merck, and Thermo Fisher Scientific, highlighting the diverse market participants and their strategic positioning [10][12].

As filed with the Securities and Exchange Commission on February 10, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 7 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | - ...

As filed with the Securities and Exchange Commission on February 6, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 6 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | -- ...

As filed with the Securities and Exchange Commission on January 29, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | -- ...

As filed with the Securities and Exchange Commission on January 8, 2025. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 4 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | --- ...

As filed with the Securities and Exchange Commission on December 19, 2024. Registration No. 333-282324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | - ...

As filed with the Securities and Exchange Commission on November 7, 2024. Registration No. 333-282324 (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Number) | Identification Number) | Apimeds Pharmaceuticals US, Inc. 2 East Broad Street 2 nd Floor Hopewell, NJ 08425 ...

Table of Contents As filed with the Securities and Exchange Commission on August 15, 2024. Registration No. 333-280951 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) | Delaware | 2834 | 47-4671997 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or ...

As filed with the U.S. Securities and Exchange Commission on July 15, 2024. Registration No. 333-279771 Ontario, Canada 2834 Not Applicable (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO.1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specifie ...