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Home » Newsletters » BioWorld

BioWorld

Sep. 3, 2019

View Archived Issues

Regulatory actions for Aug. 30, 2019

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Financings

Sophiris Bio Inc., of San Diego, said it completed its registered direct offering of 5.33 million common shares (or pre-funded warrants to purchase common shares) at $0.75 each. In addition, in a concurrent private placement, the company issued the investor warrants to purchase up to 5.33 million common shares with an exercise price of $0.95 per share and a five-year exercise period. The gross proceeds are approximately $4 million. Read More

Holiday notice

BioWorld's offices were closed in observance of Labor Day in the U.S. No issue was published Monday, Sept. 2. Read More

Other news to note

Wntresearch AB, of Stockholm, and The Sage Group plc, of Newcastle Upon Tyne, England, will collaborate to identify and engage potential partners before the phase II readout of Foxy-5, a synthetic hexapeptide with a formylated N-terminus, as neo-adjuvant therapy in subjects with Wnt-5a low colon cancer. The clinical trial is set to end in March 2022. Sage specializes in strategy and negotiations for research companies. Read More

Bench Press: BioWorld looks at translational medicine

Researchers at the Christian Albrechts University of Kiel and the MRC London Institute of Medical Science have developed a way to screen four-way interactions between genetically simple hosts, their microbiome, nutrients and drugs.  Read More

S. Korea must ease regs, fast-track tech solutions to spur cell, gene therapy R&D

SEOUL – South Korea's investors have become very interested in the global cell and gene therapy market. Licensing and M&A deals in the field have been active – a good sign for Korean biopharma firms eager to tap in. Read More

Long-term growth hit by short-term troubles

SEOUL – After a decade of steady increases, venture capital (VC) investments in South Korea's biotech sector are more active. But for the country's strategic financial plan to be sustainable, it will have to further strengthen its science capabilities, according to experts at the Korea Bio Investment Conference (KBIC) last week in Seoul. Read More

SEC looks to ease administrative burdens of quarterly reporting

Quarterly financial reporting for public companies is costly and ties up senior management and board members for several days before each quarterly earnings report is released and the 10-Q is filed. Could this process be made more efficient and less frequent, such as a semi-annual filing like many reporting companies based in Europe have implemented? That was one of the questions considered by a roundtable hosted by the SEC's Division of Corporation Finance where key stakeholders delved into the impact of short-termism on U.S. capital markets and whether the SEC's current reporting system needs to be changed to ease administrative and other burdens on reporting companies. Read More

Turbulent markets catch up with cancer-focused companies in August

The turbulent financial markets that have seen the Dow Jones Industrial Average drop over 2% in August appear to have caught up with innovative mid-cap public companies engaged in exciting cancer research such as immuno-oncology. Up until now they have enjoyed strong investor support, but for the first time this year investors appear to be moving out of this sector and, as a result, share values have dipped dramatically. As a result, the BioWorld Cancer Index is trading down 11% in August.  Read More

Pharnext shares drop 40% as FDA requests second pivotal trial in CMT

DUBLIN – Shares in Pharnext SA plunged by more than 40% Friday on news that the FDA requires the company to undertake a second phase III trial of its Charcot-Marie-Tooth disease type 1A (CMT1A) therapy PXT-3003. Read More

Astrazeneca/Daiichi deal validates Merus bispecific

Merus N.V.'s second-quarter earnings report included an important update on phase I MCLA-117, which Jefferies analyst Maury Raycroft said could be a best-in-class "game-changer" for the treatment of acute myeloid leukemia (AML) – a candidate that "alone is a reason to own the stock," in his view. Read More

U.S. biosimilar market 'thriving' without government intervention

Drug pricing legislation will be high on the to-do list when the U.S. Congress returns from its August recess next week, as both the Senate and the House are expected to take action this month on competing packages of provisions aimed at controlling prescription drug prices. Read More

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