Fagron Sterile Services US (FSS), a top-tier DEA and FDA-registered 503B Outsourcing Provider, produces reliable supply of high-quality sterile medications with cGMP compliant operations for patient-focused healthcare facilities across North America.
At this time, LET Gel from Fagron Sterile Services US, is the only Sterile Topical LET Gel on the market from a 503B Outsourcing Facility or compounding pharmacy.
FSS leveraged pharmaceutical expertise spanning three decades to quickly develop the first Sterile Topical LET Gel in the industry - listening to both customer needs and the FDA.
503B Outsourcing Facility innovates topical LET anesthetic gel to produce the first widely available sterile option.
Company supports patient safety; innovating topical anesthetic gel to produce the first widely available sterile option from a 503B Outsourcing Facility - hospital emergency rooms, urgent care centers, pediatric offices and healthcare providers will benefit - WICHITA, Kan., Oct. 20, 2020 /PRNewswire/ -- Fagron Sterile Services US (FSS), a leading 503B pharmaceutical outsourcing provider, today announced a new product innovation - the launch of the first sterile topical anesthetic LET Gel produced at scale through cGMP compliant operations.
Based on feedback from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP), Agios Pharmaceuticals (NASDAQ:AGIO) has decided to withdraw its European application seeking approval for Tibsovo (ivosidenib tablets) for the treatment of relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation.
CHMP said that data from the company’s single arm, uncontrolled Phase 1 study do not sufficiently support a positive benefit-risk balance for the proposed indication.
Tibsovo is currently approved in the U.S. for certain IDH1-positive leukemia patients.
16, 2020 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces the pricing of its initial public offering in the United States (the "Offering") of 8,563,300 American Depositary Shares ("ADS"), representing 68,506,400 ordinary shares, at an initial public offering price of US$13.50 per ADS, before underwriting discounts and commissions.
The Company has also granted the underwriters a 30-day option to purchase up to an additional 1,425,000 ADSs at the initial public offering price per ADS less underwriting discounts and commissions.
Forward-looking Statements Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, regarding the Company's business as well as the proposed Offering.
Any statement describing Company goals, expectations, intentions or beliefs, including as they relate to the proposed Offering and its expected closing, is a forward-looking statement and should be considered an at-risk statement.
Such statements are subject to certain risks and uncertainties, including market conditions, the satisfaction of customary closing conditions relating to the Offering and the impact of general economic, industry or political conditions in Australia, the United States or internationally.
ASLAN Pharmaceuticals (NASDAQ:ASLN) plans to develop ASLAN003, its next-generation inhibitor of dihydroorotate dehydrogenase (DHODH), in autoimmune conditions such as multiple sclerosis (MS).
Based on the specificity, potency and favourable safety profile identified in earlier clinical studies, the company believes ASLAN003 is a promising candidate for development in MS and other autoimmune diseases.
The company expects to share further details in early 2021.
ASLAN003 has been shown to be more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide.
The company offers pharmaceutical-grade medical cannabis, adult-use cannabis, and cannabis-derived extracts and derivative cannabis products under the Solei, RIFF, Good Supply, Aphria, P'tite Pof, and Broken Coast brands.
The company reported ($0.10) earnings per share (EPS) for the quarter, missing the Thomson Reuters’ consensus estimate of ($0.03) by ($0.07).
Separately, Cantor Fitzgerald upped their target price on Aphria from $12.50 to $15.50 and gave the company an overweight rating in a report on Monday, October 5th.
BidaskClub upgraded shares of Aphria (NASDAQ:APHA) from a hold rating to a buy rating in a report published on Tuesday morning, BidAskClub reports.
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The Swiss industrial company placed seventh for employee and workplace issues management within the rankings.
The biotechnology and pharmaceuticals company came in top of the “social capital” ranking, which relates to external social and product issues.
Issues such as access and affordability, which the ranking addresses under the “social capital” heading, are particularly important for companies like Philips, in the medical equipment and supplies industry.
They looked at sustainability metrics including environment, human capital (internal employee and workplace issues), social capital (external social and product issues), and business model and innovation.
The company, which makes materials used for home building, ranked fourth for employee and workplace issues management.
Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company, focuses on the discovery and development of various product candidates.
Matinas BioPharma is trading at a lower price-to-earnings ratio than its rivals, indicating that it is currently more affordable than other companies in its industry.
13.3% of Matinas BioPharma shares are held by company insiders.
Matinas BioPharma (NYSE: MTNB) is one of 714 publicly-traded companies in the “Pharmaceutical preparations” industry, but how does it contrast to its rivals?
Matinas BioPharma Holdings, Inc. has a research collaboration with the National Institute of Neurological Disorders and Stroke (NINDS) for the development of a novel therapy for the treatment of HIV, as well as with ViiV Healthcare to develop and evaluate formulations of antiviral drug candidates; and a feasibility collaboration with Genentech, Inc. for the development of oral formulations.
Finally, Meeder Asset Management Inc. raised its holdings in Amneal Pharmaceuticals by 30.5% in the 1st quarter.
Finally, Zacks Investment Research cut Amneal Pharmaceuticals from a “buy” rating to a “hold” rating in a report on Thursday, October 1st.
ValuEngine cut shares of Amneal Pharmaceuticals from a “sell” rating to a “strong sell” rating in a research report on Friday, July 10th.
Amneal Pharmaceuticals Inc (NYSE:AMRX) – Investment analysts at Piper Sandler boosted their Q3 2021 earnings per share (EPS) estimates for Amneal Pharmaceuticals in a research report issued to clients and investors on Thursday, October 8th.
Amneal Pharmaceuticals, Inc, together with its subsidiaries, develops, licenses, manufactures, markets, and distributes generic and specialty pharmaceutical products for various dosage forms and therapeutic areas.
The company offers its products primarily to home health care market for patients with bronchiectasis, cystic fibrosis, and neuromuscular disease.
Electromed, Inc. develops, manufactures, markets, and sells airway clearance therapy and related products that apply high frequency chest wall oscillation (HFCWO) therapy in pulmonary care for patients of all ages in the United States and internationally.
19.6% of Electromed shares are held by company insiders.
Electromed (NYSE: ELMD) is one of 59 publicly-traded companies in the “Electromedical equipment” industry, but how does it weigh in compared to its rivals?
Electromed, Inc. markets its products primarily to physicians and health care providers, as well as directly to patients.
Any statement describing Company goals, expectations, intentions or beliefs, including as they relate to the proposed Offering, is a forward-looking statement and should be considered an at-risk statement.
Forward-looking Statements Certain statements in this ASX announcement may contain forward-looking statements regarding the Company's business as well as the proposed Offering.
About Opthea Opthea (ASX:OPT) is a biopharmaceutical company developing a novel therapy to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
11, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces the launch of its initial public offering (the "Offering") of American Depositary Shares ("ADS"), each of which will represent eight of the Company's ordinary shares, in the United States.
Such statements are subject to certain risks and uncertainties, including market conditions and the trading price of the Company's ordinary shares on the ASX.
Get a free copy of the Zacks research report on Salarius Pharmaceuticals (SLRX) For more information about research offerings from Zacks Investment Research, visit Zacks.com Receive News & Ratings for Salarius Pharmaceuticals Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Salarius Pharmaceuticals and related companies with MarketBeat.com's FREE daily email newsletter.
Salarius Pharmaceuticals, Inc a clinical-stage biotechnology company, develops epigenetic-based cancer treatments.
Bank of New York Mellon Corp purchased a new position in Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX) in the first quarter, according to its most recent filing with the Securities & Exchange Commission.
According to Zacks, “Salarius Pharmaceuticals Inc. is a clinical-stage oncology company.
Zacks Investment Research upgraded shares of Salarius Pharmaceuticals (NASDAQ:SLRX) from a hold rating to a buy rating in a research note released on Wednesday morning, Zacks.com reports.
Allena Pharmaceuticals, Inc, a late-stage clinical biopharmaceutical company, engages in the development and commercialization of oral enzyme therapeutics to treat patients with rare and severe metabolic, and kidney disorders in the United States and internationally.
LADENBURG THALM/SH SH reiterated a buy rating and set a $8.00 price objective on shares of Allena Pharmaceuticals in a research report on Wednesday, July 15th.
Wedbush reiterated a buy rating and issued a $18.00 price objective on shares of Allena Pharmaceuticals in a report on Thursday, September 10th.
Zacks Investment Research cut shares of Allena Pharmaceuticals (NASDAQ:ALNA) from a buy rating to a hold rating in a research note released on Wednesday morning, Zacks.com reports.
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GSK provides the perfect defensive-growth combination of decent valuation, strong financial position, high dividend yield, and prospects of big upside through product development and M&A activities.
GSK’s share price has been moving in a tight range for years - as is typical with many pharmaceutical mammoths whose revenues and incomes remain stagnated by expiring patents and replacement products.
In addition to the joint venture she created between GSK’s consumer health business and that of US pharma group Pfizer, she also set a three-year timetable for separating the consumer health business from the pharma and vaccine businesses.
The structure of GSK was viewed as distracting to management, especially with the consumer healthcare business not necessarily blending well with the pharma and vaccine businesses.
In both vaccines and consumer healthcare, GSK enjoys leadership positions globally.
CDAK has developed significant collaboration partnerships with major pharma firms and the IPO appears priced within the typical range for biopharma companies.
The company’s lead drug candidate is exoSTING, an exosome therapeutic for the treatment of solid tumors that is “designed to target [antigen presenting cells] and acts by targeting the small molecule stimulator of interferon genes, or STING pathway, which has been preclinically validated as an attractive target for eliciting an anti-tumor immune response.”
Below is the current status of the company’s drug development pipeline: Investors in Codiak include Yukon Partners, Qatar Investment Authority, Alexandria Venture Investments, ARCH Venture Partners, EcoR1 Capital, Casdin Capital, Alaska Permanent Fund, Sirona Capital, Fidelity Management and Research, and Boxer Capital, among others.
The Asia-Pacific region will grow the fastest, as shown by the graphic below: Industry firms that provide or are developing related treatments include: Codiak’s recent financial results are typical of development stage biopharma firms in that they feature no revenue and significant R&D and G&A expenses associated with advancing its pipeline of treatment programs.
The market opportunity for treating solid tumors is the largest cancer market in the world, and is expected to reach over $400 billion in total size within the decade due to an aging world population and new treatment development.
DiaMedica Therapeutics Inc., a clinical-stage biopharmaceutical company, engages in the development of treatments for neurological and kidney diseases.
This table compares DiaMedica Therapeutics and HST Global’s top-line revenue, earnings per share and valuation.
Comparatively, 65.8% of HST Global shares are held by company insiders.
DiaMedica Therapeutics (NASDAQ:DMAC) and HST Global (OTCMKTS:HSTC) are both small-cap medical companies, but which is the superior business?
HST Global, Inc., an integrated health and wellness biotechnology company, develops and/or acquires a network of wellness centers for the homeopathic and alternative treatment of late stage cancer worldwide.
Summit Therapeutics plc, a biopharmaceutical company, focuses on the discovery, development, and commercialization of novel medicines to treat rare and infectious diseases in the United Kingdom and North America.
Separately, Zacks Investment Research downgraded SUMMIT THERAPEU/S from a “hold” rating to a “sell” rating in a research note on Friday.
Shares of SUMMIT THERAPEU/S stock opened at $3.40 on Tuesday.
SUMMIT THERAPEU/S (NASDAQ:SMMT) announced its quarterly earnings data on Sunday.
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The firm is advancing a pipeline of treatment candidates for ovarian and other cancers.
The company is a clinical stage firm developing treatments for ovarian and other cancers.
Given the IPOs’ reasonable valuation and the firm’s strong collaboration with Takeda, for life science investors with a long-term hold time frame, the IPO is worth a close look.
Below is a brief overview video of the warning signs of ovarian cancer: The firm's lead candidate, SL-172154, is currently in Phase 1 safety trials with ovarian cancer patients and management expects to enter the dose escalation phase of the trial in the second half of 2021.
Major competitive vendors that provide or are developing/funding treatments include: Shattuck’s recent financial results are atypical of an early stage biopharma in that they feature significant collaboration revenue from its partnership with Takeda Pharmaceuticals.