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Home » Newsletters » BioWorld

BioWorld

Aug. 12, 2016

View Archived Issues

Gutsy Protagonist: IBD plot thickens in $90M go-public bid to capture orals laurels

Protagonist Therapeutics Inc.‘s $90 million IPO sold 7.5 million shares at $12 each, after the Milpitas, Calif.-based firm had first planned for $70 million by offering 5.84 million shares with insiders buying as much as $40 million. The upsized win bodes well not only for the company’s efforts in oral vs. injectable therapies but also for others hoping to find their places on the public market, though shares (NASDAQ:PTGX) didn’t see much action Thursday, closing at $11.70, down 30 cents. Read More

Ascendis advances hGH program with phase III kick-off

A pivotal phase III study launched by Ascendis Pharma A/S to test its long-acting Transcon growth hormone (GH) in children with GH deficiency moves the Danish company one step closer to entering the $3 billion daily human GH market. The trial will measure annualized height velocity at 52 weeks for the company’s weekly prodrug treatment and compare it to Pfizer Inc.’s daily human GH treatment, Genotropin (somatropin). Read More

Safety data in hand, Athera looks to buddy-up on cardiovascular antibody

A decade after its launch by researchers affiliated with Sweden’s Karolinska Institute, privately held Athera Biotechnologies AB concluded the phase I program of its fully human monoclonal antibody, dubbed PC-mAb, and validated its safety and tolerability in patients with peripheral artery disease (PAD). The long road for the company included out-licensing of a second promising candidate to conserve capital and an option deal with Boehringer Ingelheim GmbH (BI) that was terminated several years later when the German pharma reprioritized its R&D strategy. Read More

Regulatory front

The Drug Enforcement Agency (DEA) denied two petitions to reschedule marijuana, which will remain a Schedule I substance under the Controlled Substances Act. According to a post in the Federal Register, the DEA cited scientific and medical recommendations from the Department of Health and Human Services, the FDA and the National Institute on Drug Abuse that marijuana does not meet the criteria for currently accepted medical use in treatment, there is a lack of accepted safety for its use under medical supervision and it has a high potential for abuse. Read More

Financings

Tapimmune Inc., of Jacksonville, Fl., raised gross proceeds of about $8.5 million from two transactions: a $2.5 million private placement with new investors who agreed to buy about 6.3 million shares of the company’s common stock (OTCQB:TPIV) and five-year warrants to purchase an equal number of the company’s shares at an exercise price of 50 cents per share; and the exercise of outstanding warrants from existing investors that will generate gross proceeds of $6 million. Read More

Earnings

Collegium Pharmaceutical Inc., of Canton, Mass., reported cash and cash equivalents of $110.7 million, compared to $95.7 million at the end of last year. Net loss for the quarter was $24.5 million, or $1.05 per share (basic and diluted), as compared to net loss of $4.7 million, or 45 cents per share (basic and diluted), for the same period last year. Read More

Other news to note

Mallinckrodt plc, of Chesterfield, U.K., said it entered a merger agreement with Stratatech Corp., of Madison, Wis., a privately held regenerative medicine company focused on the development of skin substitute products. Its developmental products include Stratagraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. If approved, Stratagraft could be the first biological off-the-shelf skin substitute product for treatment of severe burns. Read More

In the clinic

Proteostasis Therapeutics Inc., of Cambridge, Mass., disclosed in a midyear update data from phase I testing in healthy volunteers suggesting a dose-linear pharmacokinetic drug profile that supports once-daily dosing of PTI-428, a modulator of cystic fibrosis transmembrane conductance regulator (CFTR). Data from 24 subjects confirmed the expected and dose-dependent relationship between PTI-428 exposure and the magnitude of CFTR mRNA increase. Read More

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