Tag: biopharmaceutical company

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are resolvable

JENA, Germany, July 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it has received a written notice (the “Notice”), dated July 11, 2025, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s common shares had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq under Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”).

Award Recognition underscores the importance of AI-driven drug discovery

– Absence of neurotoxicity of any grade in low-volume disease to-date –

MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the pricing of its previously announced underwritten public offering (the “Offering”) of (i) 31,500,000 of its common shares (the “Shares”), accompanying Series A common warrants (the “Series A Common Warrants”) to purchase an aggregate of 31,500,000 common shares and accompanying Series B common warrants (the “Series B Common Warrants”) to purchase an aggregate of 31,500,000 common shares , at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per pre-funded warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represents the combined public offering price for the Shares and accompanying common warrants less the $0.001 per share exercise price for each such pre-funded warrant. The proceeds to Milestone from the Offering, before deducting underwriting commissions and offering expenses payable by Milestone, are expected to be approximately $52.5 million. The Offering is expected to close on or about July 14, 2025, subject to satisfaction of customary closing conditions.

SOUTH SAN FRANCISCO, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”, “Company”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options to purchase an aggregate of 2,100 shares of the Company’s stock (the “Inducement Grant”) to newly hired employees on July 8, 2025 (the “Grant Date”), in connection with the commencement of employment.

MONTREAL, Quebec and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST) today announced that it has commenced an underwritten public offering (the “Offering”) of its common shares, accompanying Series A warrants to purchase common shares (the “Series A Warrants”) and accompanying Series B warrants to purchase common shares (the “Series B Warrants”), and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase common shares, accompanying Series A Warrants and accompanying Series B warrants. All securities to be sold in the Offering will be sold by Milestone. The Offering is subject to market and other conditions and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

NEWTON, Mass., July 10, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), will present new findings at the upcoming Alzheimer's Association International Conference (AAIC®) 2025 in Toronto. The presentations include a cost savings analysis of the use of pTau217 as a screening tool in Acumen’s Phase 2 ALTITUDE-AD trial of sabirnetug as well as a nonclinical study evaluating the relative selectivity of sabirnetug to targeting AβOs versus Aβ monomers. The conference will be held July 27-31, 2025, both in-person and online.

Company expects to submit deucrictibant IR capsule NDA to the U.S. FDA for the on-demand treatment of HAE attacks in 1H2026

MELBOURNE, Australia and INDIANAPOLIS, July 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that its next-generation PSMA¹ PET² imaging agent, Gozellix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).