Tokyo-based Astellas Pharma Inc.’s $3 billion buyout of Audentes Therapeutics Inc. pushed shares of the latter (NASDAQ:BOLD) midday to $58.76, up $30.14, or 105%, as Wall Street learned of the $60-cash-per-share amount agreed upon in the deal. Audentes, of San Francisco, and Astellas aim to pair their efforts in gene therapy, with the buyout expected to close in the first quarter of 2020. In the works by Audentes is lead candidate AT-132 for the treatment of X-linked myotubular myopathy. The BLA submission remains on track for the middle of next year and marketing authorization in the EU will be sought in the second half of 2020.

Biopharma companies continue their strong momentum in November

After being in the doldrums for majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing. Following a 10% increase in value in October, the BioWorld Biopharmaceutical index repeated the performance in November, with the sector’s elite companies posting significant gains in their share prices. Once again, the sector outperformed the general market, with the Dow Jones Industrial average gaining 4% in the period and the Nasdaq Composite index posting a 4.5% gain. Year-to-date, the index is tracking up a respectable 11%.

Hahn just a Senate vote away from becoming the FDA’s next commissioner

With today’s 18-5 vote in the Senate Health, Education, Labor and Pensions Committee (HELP) to send Stephen Hahn’s nomination to the full Senate, the oncologist who currently serves as chief medical officer at the MD Anderson Cancer Center is just a step away from becoming the next FDA commissioner. Before the vote, HELP Chair Lamar Alexander (R-Tenn.) cited Hahn’s extensive medical and research experience and called him a “proven leader” in large health systems. “All around, he’s exactly the type of nominee we should want to lead an agency as important as the FDA,” Alexander said.

Holding out for a hero: Protagonist takes a market hit

Protagonist Therapeutics Inc. stock (NASDAQ:PTGX) is nosediving at midday, down about 40%, after the company released preliminary results from its phase II open-label study of PTG-300, an injectable hepcidin mimetic to treat patients with transfusion-dependent beta-thalassemia. Dose-related drug exposure and reductions from baseline serum iron and transferrin saturation levels were noted in the data, with significant reductions at the 40-mg and 80-mg weekly doses (p < 0.02 for each assessment). Protagonist’s chief medical officer, Samuel Saks, said the early results “suggest the potential of finding an appropriate dose” for PTG-300 in its “continued development.” The past week has been a rough ride for hepcidin as La Jolla Pharmaceutical Co. discontinued its study LJ401-BT01 in treating iron overload in beta-thalassemia due to lack of efficacy while it reassesses further development of LJPC-401 (synthetic human hepcidin) based on recent mixed clinical results.

Ardelyx's tenapanor hits pivotal phase III endpoint in phosphate-lowering study

Ardelyx Inc. said top-line results of a phase III monotherapy study of its lead candidate, tenapanor, showed success in helping dialysis-dependent chronic kidney disease patients with hyperphosphatemia achieve a statistically significant reduction in serum phosphorus vs. placebo. The outcome put tenapanor on track for a mid-2020 NDA filing, the company said. Shares (NASDAQ:ARDX) rose 3.5% by midday, perhaps muted by a 16% discontinuation rate among patients on drug due to diarrhea, Piper Jaffray analyst Christopher Raymond noted. If approved, tenapanor could become the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.

Alteogen licenses ALT-B4 to a top 10 global pharma in potential $1B+ deal

HONG KONG – South Korean company Alteogen Inc. signed a nonexclusive global license agreement with a top 10 global pharmaceutical company for its recombinant human hyaluronidase enzyme, ALT-B4, in exchange for an up-front payment of $13 million. It is also eligible to receive additional payments of up to $1.37 billion tied to the achievement of development, regulatory approval and sales milestones. While specific details could not be disclosed, the deal provides validation to the company’s technology that could bode well for future licensing negotiations.

Indian pharma sector needs to learn from its competitors: report

NEW DELHI, India - While India is still an attractive prospect for investment in biotechnology, with plenty of potential waiting to be tapped by investors, the country needs to learn from the successful examples of other countries, including its Asian biotech competitors, according to a new report. Titled “Assessment of Indian Biotechnology Landscape 2019,” the report was prepared by the Institute for Competitiveness, India, the Indian arm of the global network of Institute of Strategy and Competitiveness of the Harvard Business School, and it attempts to provide a future roadmap to help the country achieve its ambition of a $100 billion biotech industry by 2025. It was released during a three-day Global Bio India meeting in New Delhi.

In India, government steps up efforts to develop more TB testing and treatment

HYDERABAD, India – India, home to a quarter of the global tuberculosis (TB) cases, plans to enhance its TB drug resistance and susceptibility testing capacity under a new initiative launched by the Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND). FIND announced the launch of its technical assistance project to boost TB drug susceptibility testing at the 50th Union World Conference on Lung Health in Hyderabad earlier this month. FIND said it would work with state-level officials in India’s high-burden TB states of Maharashtra in the west, Himachal Pradesh in the north and Tamil Nadu in the south.

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