South San Francisco, CA, June 20, 2018 – Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, announced today that it has priced its initial public offering of 5,000,000 shares of its common stock at a public offering price of $15.00 per share. The gross proceeds to Kezar, before deducting underwriting discounts, commissions and offering expenses, is expected to be approximately $75 million. All of the common stock is being offered by Kezar. In addition, Kezar has granted the underwriters a 30-day option to purchase up to 750,000 additional shares of common stock to cover over-allotments, if any, at the initial public offering price, less the underwriting discounts and commissions. The common stock are expected to begin trading on The Nasdaq Global Select Market on June 21, 2018 under the trading symbol "KZR." The offering is expected to close on June 25, 2018, subject to customary closing conditions.
Kezar Life Sciences Announces Pricing of Initial Public Offering
FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D
San Francisco, CA, April 25, 2018 – OrphoMed, Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's lead candidate ORP-101 for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies aimed at treating serious conditions and addressing unmet medical needs. This designation allows early and frequent communications between the FDA and the company sponsor throughout the drug development and review process. Additionally, Fast Track designated drugs are eligible for priority review, which can expedite the FDA's review of a New Drug Application (NDA).
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Designation from the FDA for APX001
San Diego, CA, Mar. 19, 2018 – Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, including deadly fungal pathogens, today announced that the US Food and Drug Administration (FDA) has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company's lead antifungal product candidate. The QIDP designation, a provision under the U.S. Generating Antibiotic Incentives Now (GAIN) Act, was approved by Congress in 2012 to offer incentives to companies to bring to market new treatments for deadly infections. These incentives provide APX001 with eligibility for priority FDA review and fast-track status, and an additional five years of market exclusivity under the Hatch-Waxman Act. Amplyx had previously received QIDP designation as well as orphan drug designation from the FDA for APX001 for the treatment of invasive candidiasis, invasive aspergillosis, and coccidioidomycosis. This new QIDP status expands the eligible population to include the treatment of cryptococcosis.
IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss® Bone Stabilization System
East Providence, RI, January 09, 2018 – IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.
Liquidia Initiates Phase 3 Clinical Trial of LIQ861 in Patients with Pulmonary Arterial Hypertension
RESEARCH TRIANGLE PARK, NC – January 3, 2018 – Liquidia Technologies, Inc., a late-stage clinical biopharmaceutical company focused on improving the performance of medicine by precisely engineering drug particles, today announced the initiation of a Phase 3 clinical trial evaluating LIQ861 for the treatment of pulmonary arterial hypertension (PAH). LIQ861, developed using Liquidia’s proprietary PRINT® technology, is a powder formulation of treprostinil designed for deep-lung delivery using a disposable, dry powder inhaler (DPI). PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries, which often results in heart failure. Previously approved by the U.S. Food and Drug Administration (FDA) in oral, nebulized and parenteral formulations, treprostinil is a synthetic analog of prostacyclin, a vasoactive mediator deficient in patients with PAH yet essential to normal lung function to regulate vessel tone.
Pappas Capital Portfolio Company Rotation Medical Acquired by Smith & Nephew
Dec 6, 2017 –Pappas Capital, a life science venture capital firm, announced today that its portfolio company Rotation Medical Inc. has been acquired by Smith & Nephew plc, a UK-based global medical technology company. Smith & Nephew acquired the company for $125 million in initial cash consideration, plus an additional $85 million in potential milestone payments. Rotation is the second exit this year by a Pappas portfolio company. Earlier this year, portfolio company CoLucid Pharmaceuticals was acquired by Eli Lilly for nearly $1 billion. Since 2014, three portfolio companies founded or co-founded by Pappas have been sold to large pharmaceutical companies: CoLucid; Afferent Pharmaceuticals, bought by Merck in 2016 for $500 million upfront and $750 million in milestones; and Lumena Pharmaceuticals, bought by Shire in 2014 for more than $300 million.
Smith & Nephew Completes Acquisition of Rotation Medical Inc.
Dec 6, 2017 – Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, announces it has completed the acquisition of Rotation Medical Inc., the developer of a novel tissue regeneration technology for shoulder rotator cuff repair, supporting the Company’s strategy to invest in innovative technologies that meet unmet clinical needs. The acquisition cost is $125 million and up to a further $85 million over the next five years, contingent on financial performance.
Smith & Nephew Acquires Tissue Regeneration Technology for Shoulder Repair
Oct 23, 2017 – Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces that it has entered into a definitive agreement to acquire Rotation Medical Inc., a developer of a novel tissue regeneration technology for shoulder rotator cuff repair, for an initial cash consideration of $125 million and up to $85 million over the next five years, contingent on financial performance.
Amplyx Pharmaceuticals Raises $67 Million in Series C Financing
San Diego, CA, Aug 2, 2017 – Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, today announced that it has raised $67 million through a Series C financing led by Sofinnova Venture Partners and including other new investors Lundbeckfonden Ventures, Arix Bioscience and Pappas Capital. Existing investors New Enterprise Associates, RiverVest Venture Partners, 3×5 RiverVest II and BioMed Ventures also participated in the financing. In conjunction with the financing, Anand Mehra, M.D., managing partner at Sofinnova Ventures, and Johan Kördel, Ph.D., senior partner at Lundbeckfonden Ventures, will join the Amplyx board of directors.
Milestone Pharmaceuticals Closes $55 Million Series C Financing
Montreal, QC, CA, August 1, 2017 – Milestone Pharmaceuticals Montreal, Canada, Inc., a clinical stage cardiovascular company, today announced the completion of a US$55 million Series C financing. The round was led by Novo Holdings A/S, and included new investors Forbion Capital Partners and funds managed by Tekla Capital Management, with significant participation from Milestone’s existing investors Domain Associates, Fonds de solidarité FTQ, BDC Capital, Pappas Capital, and GO Capital.
