Nanoviricides up 54% [Jan 24, 20]

Vaccinex (Rochester, NY; $4.5M SBIR) up 36% [Jan 24, 20]

AMAG Pharma down 18% [Jan 24, 20]

Epizyme down 16% [Jan 24, 20] Epizyme won accelerated FDA approval for a drug developed to treat the rare cancer epithelioid sarcoma (ES). [Frank Vinluan, xconomy.com, Jan 23, 20]

Genetic testing company 23and Me is laying off about 14 percent of its staff amid slowing consumer demand for DNA tests. [xconomy.com, Jan 23, 20]

The first person diagnosed with the Wuhan coronavirus in the US is being treated by a few medical workers and a robot. The robot, equipped with a stethoscope, is helping doctors take the man's vitals and communicate with him through a large screen, said Dr. George Diaz, chief of the infectious disease division at the Providence Regional Medical Center in Everett, Washington. [Nicole Chavez and Nadia Kounang, CNN, Jan 24, 20]

MedImmune, AstraZeneca’s biologics division, is no more. The pharmaceutical giant announced last year that the name would be retired as part of a research and development restructuring. [xconomy.com, Jan 23. 20]

David Roux, Silicon Valley investor is giving $100 million to Northeastern University to establish a graduate school and research center in Portland (ME) [to] be known as the Roux Institute, will award certificates, master’s degrees and Ph.D.s in artificial intelligence and machine learning — geared in particular toward the life sciences. [Eduardo Porter, NYTimes, Jan 27, 20] Is money enough of launch pad for innovation?

Loudoun County (VA exurbs) offers up to $150,000 in grant competition for tech companies [Alex Koma, Washingon Business Journal, Jan 27, 20]

Last month, Robert D. Atkinson of the Information Technology & Innovation Foundation, together with our colleagues Mark Muro and Jacob Whiton, published a report calling for a renewed federal role in helping to balance the country’s growing geographic inequities. “The case for growth centers: How to spread tech innovation across America” carefully documents how and why the innovation economy—the driver of much of the nation’s growth—has become increasingly concentrated in a handful of coastal metropolitan areas, leaving much of the heartland struggling to keep pace. It also proposes a way for leaders in Washington, D.C. to boost lagging regions by selecting a small group of “growth center” metro areas (chosen via a competitive process) to receive a package of federal supports. [Jennifer Vey and Julie Wagner, Brookings, Jan 23, 20]  Calling for federal intervention in innovation markets appeals to politicians for the headlines of actually passing out money and hope.  Attention, folks, it's been tried over and over.  

The economy and easing of perceptions of financial strains boosted the president’s approval and narrowed margins in tests against possible Democratic rivals. [NYTimes, Jan 27, 20] The public sees only the increased economic activity from a national credit card and simply ignores the national debt basically since Reagan and supply-side political economy.

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Nanoviricides up 43% [Jan 23, 20]

Applied Genetic Tech down 15% [Jan 23, 20]

Surgical robotics giant Intuitive Surgical (Sunnyvale, CA; $4.5M SBIR, market cap $68B) reported decelerating sales and earnings growth, leading ISRG stock to slide in after-hours trading. [ALLISON GATLIN, Investor's Business Daily, Jan 23, 20]

Don't need no science. Hundreds of scientists across the federal government have been forced out, sidelined or muted since President Trump took office. The exodus has been fueled by policies that have diminished the role of science as well as specific steps such as moving agencies away from Washington. [Annie Gowen, Juliet Eilperin, Ben Guarino and Andrew Ba Tran , Washington Post, Jan 23, 20] Depletion of scientists and science no doubt foretells depletion of science investment that threatens corporate profits.

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Nanoviricides up 38% [Jan 22, 20]

Applied Genetic Tech down 25% [Jan 22, 20]

Karuna Thera down 19% [Jan 22, 20]

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Nanoviricides (Shelton, CT; no SBIR although President Anil Diwan won has won several NIH SBIR awards, founded 2005) up 153% [Jan 21, 20] in apparent reaction to the spread of an unknown respiratory virus in China that has claimed six livesannounced the pricing of an underwritten public offering with gross proceeds to the Company of $7.5 million [company press release, Jan 21, 20] develops therapeutics for patients suffering from life-threatening viral infections. Total funding $48M [crunchbase.com]

Novavax up 100% [Jan 21, 20]

CEL-SCI up 23% [Jan 21, 20]

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Novavax (Gaithersburg, MD; $200K SBIR)  up 20% [Jan 17, 20] a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced that [FDA] has granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older. [company press release, Jan 15, 20]

Viela Bio down 15% {Jan 17, 20]

Plug Power (Latham, NY; no SBIR) a leading provider of hydrogen engines and fueling solutions enabling e-mobility, received an order at the close of 2019 from a Fortune 100 customer for hydrogen fuel cell deployments across their distribution network over the next two years. This contract, valued at more than $172 million, is for Plug Power’s GenDrive fuel cell power, GenFuel hydrogen fuel, storage and dispensing infrastructure, and GenCare aftermarket service and support. [company press release, Jan 6, 20]

Geneoscopy (St Louis, MO; no SBIR, founded 2015) received the FDA’s Breakthrough Device Designation for its preventive screening test for colorectal cancer and precancerous adenomas. [Nathan Rubbelke, St. Louis Business Journal, Jan 16, 20] total funding $8M [crunchbase.com]

Xencor (Monrovia, CA; $900K SBIR, founded 1997) biopharma firm reached a licensing deal with pharma giant Gilead Sciences to develop and commercialize a group of Xencor’s antibody drugs to treat HIV. In exchange for licensing the drugs to Gilead, Xencor will receive an unspecified upfront payment and royalties from future commercialization of the drugs. (Howard Fine, LA Business Journal, Jan 8, 20] total funding $108M [crunchbase.com]

Neon Therapeutics (Cambridge, MA; no SBIR) closed 2019 by curtailing its cancer vaccine programs and laying off 24 percent of its workforce. The new path will now be as a division of cancer drug developer BioNTech (Germany) [which] announced that it has agreed to acquire Neon in a $67 million stock deal. [Frank Vinluan, xconomy.com. Jan 16, 20]

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RAPT Thera up 28% [Jan 16, 20]

Mersana Thera up 24% [Jan 16, 20]

Robots marching. many of the jobs that humans are doing today will be done by robots in the not too distant future. In fact, millions of human workers have already been displaced, and as you will see below experts are warning that the job losses are likely to greatly accelerate in the years to come. [Michael Snyder, Investment Watch, Jan 16, 20] The question is not what, but when; and the economics are about earning a living by the zillions not owning a robot enterprise. That question has partially led to a Trump demagogue without any credible solution. It's going to take a government driven by the bottom two-thirds of the populace.

“Faithful execution of the law does not permit the President to substitute his own policy priorities for those that Congress has enacted into law,” the GAO [Government Accountability] said it its legal decision. [Yuval Rosenberg, The Fiscal Times, Jan 16, 20] Congress's watchdog barks.

Who's winning? The six biggest U.S. banks have saved $32 billion in taxes, including $18 billion last year, as a result of the 2017 Trump tax cuts, Yalman Onaran reports at Bloomberg News. [Yuval Rosenberg, The Fiscal Times, Jan 16, 20]

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RAPT Thera up 17% [Jan 15, 20]

Emendo Biotherapeutics (New York, NY; no SBIR, founded 2015), aiming to apply CRISPR gene editing to a wider range of genetic diseases, has raised $61 million ... on its website, it contends that CRISPR is limited in its ability to treat dominant genetic diseases, which are diseases caused by a mutation to one copy of a gene. [Frank Vinluan, xconomy.com, Jan 15, 20]

II-VI a leader in engineered materials and compound semiconductors, announced the introduction of its water-cooled, aluminum variable radius mirror (VRM) for next-generation lasers with up to 20 kW output power. [company press release, Jan 16, 20] ..... announced the introduction of its electro-optic modulators, based on proprietary crystal technology, for ultrafast lasers in materials processing. [company press release, Jan 14, 20] announced that it signed a multiyear agreement of over $100M, the largest in the history of II-VI, to supply silicon carbide (SiC) substrates for gallium nitride (GaN) RF power amplifiers deployed in 5G wireless base stations. [company press release, Dec 5, 19]

The 27-0 vote against approval followed questioning of Nektar’s decision to run one pivotal trial and the extent to which it assessed the abuse risk. .... . The unanimous rejection followed the publication of a FDA briefing document that questioned the reliance on a single pivotal trial [Nick Paul Taylor, Fierce Biotech, Jan 15, 2020]

Eli Lilly has killed off its deal with immuno-oncology biotech NextCure after spending $25 million upfront on the pact just over a year ago. [Ben Adams, Fierce Biotech, Jan 13, 2020]

Virtual Incision (Lincoln, NE and Pleasanton, CA; no SBIR, founded 2006) a medical device company pioneering a first-of-its-kind miniaturized surgical robot, announced it has raised $20 million in a Series B+ financing ... the MIRA Surgical Robotic Platform in support of regulatory pathway to approval. The study will evaluate the safety and efficacy of the MIRA platform for colon resection surgeries in patients at a number of U.S. investigational sites. MIRA is an investigational robot that will enable surgeons to perform minimally invasive surgeries in any hospital or surgery center, without the need for a dedicated space or for the infrastructure typically required for other “mainframe” robotic systems ... an investigational device that is not available for sale in the United States [company press release, Jan 8, 20]

Inflammatix (Burlingame, CA; $1M SBIR), a pioneering molecular diagnostics company delivering precision medicine at the point of care, announced a $32 million Series C financing [to] advance HostDx™ tests for acute infections and sepsis to commercial launch in 2021. [company press release, January 10, 2020]

Tyra Biosciences (Carlsbad, CA; no SBIR) is taking aim at [tumor] rewiring, called acquired resistance, banking $50 million in its series A round [Amirah Al Idrus, Fierce Biotech, Jan 10, 20]

Novan’s antiviral SB206 has failed to beat placebo in two phase 3 trials in patients with molluscum contagiosum. The setback wiped 74% off Novan’s value and left its cash runway looking precariously short, but the biotech plans to start another trial in the belief it still has a path to approval. [Nick Paul Taylor, Fierce Biotech, Jan 3, 20]

PROMISS Diagnostics (Wauwatosa, WI; no SBIR), a startup that is developing a noninvasive, commercialized screening test for ovarian cancer that uses a machine learning algorithm to distinguish between a benign and malignant mass, has closed on $400,000 in capital to further develop its screening test. [WiscInno, Jan 12, 20]

Politicians are the biggest pushers of disinformation because it works, and they don’t pay for it. [Washington Post, Jan 13, 20] It only works with the gullible, against which the defense is education.

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BioCardia (San Carlos, CA; no SBIR) up 46% [Jan 13,20] announced the issuance of three new patents for the company's technology.

Liquidia Tech up 23% [Jan 13,20]

Eli Lilly announced a definitive agreement for Lilly to acquire Dermira (Menlo Park, CA;  no SBIR) for approximately $1.1 billion, in an all-cash transaction. Dermira is a biopharmaceutical company dedicated to developing new therapies for chronic skin conditions.  [joint companies press release, Jan 10, 20]

EQRx (Cambridge, MA; no SBIR) announced it is launching [with $200 million in Series A financing] to create novel, patent-protected medicines at prices that are more affordable for people and sustainable for healthcare systems. EQRx, a first of its kind biotechnology company, is focused on re-engineering the process from drug discovery to patient delivery with the goal of offering a market-based solution for the rising cost of medicines. [company press release, Jan 12, 20]  total funding $200M [crunchbase.com]

DTx Pharma (San Diego, CA; no SBIR)  announced the final closing of a Series A financing totaling $10.6 million dollars [to] speed development and deployment of their proprietary platform for delivery of RNA medicines. [company press release, Jan 6, 20]

Springworks Therapeutics (Stamford, CT; no SBIR) and Allogene Therapeutics (South San Francisco, CA; no SBIR) announced that they have entered into a clinical trial collaboration agreement. This agreement will evaluate ALLO-715, Allogene’s investigational anti-B-cell maturation antigen (BCMA) AlloCAR T therapy in combination with SpringWorks’ investigational gamma secretase inhibitor (GSI), nirogacestat, in patients with relapsed or refractory multiple myeloma.[joint companies press release, Jan 10, 20]

Neurocrine Biosciences (San Diego, CA; SBIR)is doubling down on epilepsy, striking its second agreement in as many months with a new deal that grants it the option to license an investigational treatment for a rare form of the disease. [xconomy.com, Jan 12, 20]

Amunix Pharmaceuticals (Mountain View, CA; $2M SBIR) biopharmaceutical company focused on developing pro-drugs to enable the promise of potent immune-activating biotherapeutics in solid tumors, today announced that it has provided a technology license to F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. to utilize Amunix’s technology platform, XTEN, to discover and develop non-oncology therapeutics against certain undisclosed targets. This agreement builds on Amunix’s previous technology assessment with Roche focused on using XTEN, a proprietary unstructured polypeptide, to extend drug half-life. [company press release, Jan 10, 20]

Solid Biosciences announced changes to its organizational structure to create a leaner company focused on advancing SGT-001, a gene transfer candidate for the treatment of Duchenne muscular dystrophy (Duchenne) ... will result in a reduction in corporate expenses and, based on the company’s current operating plans, are expected to extend the cash runway into 2021. [company press release, Jan 9, 20]

Trump Broke It. Now He Owns It. David Frum, The Atlantic: The president withdrew from a flawed deal with Iran, but had no realistic alternative. With that choice comes responsibility for what ensued. [DefenseOne, Jan 13, 20] An Army adage: if you don't know what you're doing, don't do it here.

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Nurix Therapeutics (San Francisco, CA; no SBIR, founded 2009) landed $55 million up front from Sanofi to kick off an alliance aiming to develop protein degradation drugs for multiple therapeutic areas. Nurix could earn up to $2.5 billion in milestone payments. [xconomy.com, Jan 10, 20] total funding $38M [crunchbase.com]

Blueprint Medicines (Cambridge, MA; no SBIR, founded 2011)  announced that [FDA] has approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT is the first precision therapy approved to treat a genomically defined population of patients with GIS  [company press release, Jan 9, 20]  total funding $240M [crunchbase.com]

Cerebral Therapeutics (Aurora, CA; no SBIR) a clinical-stage pharmaceutical company developing innovative treatments for uncontrolled neurological diseases, announced a $35 million Series B financing [company press release, Jan 7, 20] prior funding $11M [crunchbase.com]

DTx Pharma (San Diego, CA; no  SBIR, founed 2017) announced the final closing of a Series A financing totaling $10.6 million dollars [company press release, Jan 6, 20] prior funding $13M [crunchbase.com]

Aduro Biotech (Berkeley, CA; $600K SBIR, founded Y2K) is laying off nearly 60 percent of its workforce and closing its European office in a cash-saving move. The corporate shakeup comes one month after Novartis (NYSE: NVS) removed a clinical-stage Aduro cancer drug from its portfolio and nearly one year after a restructuring that cut the biotech’s workforce by 37 percent to focus on its cancer drug pipeline. [xconomy.com, Jan 10, 20] total funding $178M [crunchbase.com]

Nice political idea, but. State and local governments are estimated to spend more than $30 billion a year on business tax incentives, but new research finds that these deals do little to promote regional job growth. The research adds to growing skepticism over the practice of cities and states offering narrow, company-specific tax incentives as a means to attract jobs and economic development. [Andrea Nobel, Route50.com, Jan 9, 20] Politicians love to start good sounding handout programs, but don't have the long range patience that can wait for a credible test.

"Millions of Americans are still primed to swallow fake news." New York Times reports today in 2,500-word feature on election security ahead. [DefenseOne, Jan 10, 20] With the decline in news from soures with professional editors and fact checkers, truth beomes a slippery object. And with a president who typically offers multiple lies a day, where is a usable standard?

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Applied Genetic Tech (Alachua FL; $1M SBIR, funded 1999) up 123% [Jan 9, 20] reported positive interim six-month data from its ongoing Phase 1/2 clinical program in X-linked retinitis pigmentosa (XLRP). The results show that patients treated centrally with its product candidate demonstrated durable improvement in visual function six months after dosing. [company press release, Jan 9, 20] total funding $38M [crunchbase.com]

The Senate SB Committee showed concern about the leadership of SBA’s Office of Innovation and Investment, which overseas both the Small Business Investment Corporation (SBIC) program and SBIR/STTR policy office. In response, [nominated Administrator] Carranza agreed to address those concerns, ensure that the SBIR/STTR office’s staff backlog is addressed, and testify before the committee within 90 days about her solutions to these issues. [SSTI, Jan 8, 20] Fortunately the investment part of SBIR/STTR is run by the federal R&D agencies.  

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Hememics Biotechnologies (Rockville, MD; SBIR) startup logged a $2.5 million backing from a consortium of Vietnamese investors with an office in McLean. Hememics is developing pocket-sized point-of-care devices that it claims can detect pathogens under a minute, with an initial focus on sexually transmitted illnesses. [DCInno, Jan 7, 20]

True Bearing Diagnostics (Washington, DC; SBIR) biotech s seeking $20 million in new funding, according to the WBJ. The company is developing an RNA-based blood testing tool for the early detection of coronary disease [DCInno, Jan 7, 20]

Novome Biotechnologies  (South San Francisco, CA; $1M SBIR, founded 2016) engineering first-in-class, living medicines for chronic diseases, today announced that it has secured $33 million in a Series A financing [to] advance the Company’s lead hyperoxaluria program through Phase 1 clinical proof-of-concept work, as well as to expand its Genetically Engineered Microbial Medicines (GEMMs) platform to address additional indications. [company press release, Jan 7, 20] total funding $38M crunchbase.com]

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Five Prime Thera up 15% [Jan 6, 20]

Black Diamond Therapeutics (Cambridge, MA; no SBIR, founded 2016) filed for an IPO [with] a $100 million goal. ... is developing drugs to treat cancers with defined genetic mutations. The company has developed proprietary technology, dubbed Mutation Allostery Pharmacology (MAP), to analyze population-level genetic sequencing data in order to find mutations that drive cancer growth, according to the filing. [Frank Vinluan, xconomy.com, Jan 7, 19] total funding $197M [crunchbase.com]

Biointervene (San Diego, CA; no SBIR) announded Series A $30M financing [to] guide its lead compound, BIO-205, into human testing for neuropathic pain. [Sarah de Crescenzo, xconomy.com, Jan 7, 19]

Apellis Pharmaceuticals (Waltham, MA; no SBIR) announced positive results from the Phase 3 PEGASUS study evaluating pegcetacoplan (APL-2) in adults with paroxysmal nocturnal hemoglobinuria (PNH). also announced that it has commenced an underwritten public offering of 7,000,000 shares of its common stock. [company press releases, Jan 7, 20] works better than a blockbuster Alexion Pharmaceuticals medicine that is currently the standard of care. [Frank Vinluan, xconomy,com, Jan 7, 19]

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Acceleron Pharma is paying Fulcrum Therapeutics (no SBIR) $10 million up front to kick off a partnership aiming to identify small molecule drugs to treat pulmonary disease. [xconomy.com, Jan 3, 19]

Pfizer is taking the reins on experimental hemophilia A treatment SB-525 after partner Sangamo Therapeutics completed Phase 1/2 tests of the gene therapy. The pharmaceutical giant has already started enrolling patients in a Phase 3 study and will be responsible for further development. [xconomy.com, Jan 3, 19]

Intra-Cellular Therapeutics (no SBIR) won FDA approval for lumateperone (Caplyta), a treatment for schizophrenia in adults. But the drug’s label carries a boxed warning stating that elderly patients treated with antipsychotic drugs have an increased risk of death. [xconomy.com, Jan 3, 19]

Data from the Institute for Supply Management showed the U.S. manufacturing sinking deeper into contraction, with the headline index falling to a 10-year low of 47.2 in the final month of the year. ... “was the lowest reported since June 2009 and there was weakness evident in many of the survey’s underlying components,” wrote J.P. Morgan economist Daniel Silver in a research note. [Pedro Nicolaci da Costa, Forbes, Jan 4, 20]

The man who lied "wolf". Americans typically rally around wartime presidents. But Trump has a credibility problem. “Trump arrives at this perilous moment at a decided disadvantage: He can’t assume people will accept what he says as true, because millions have concluded it never is.” ​​​​​​[Peter Nicholas, White House correspondent, Jan 3, 19]

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IDEAYA Biosciences up 22% [Jan 2, 20]

Promega (Madison, WI; $3.7M SBIR) has signed a licensing agreement with MilliporeSigma, the U.S. life sciences business of German pharmaceutical and chemical company Merck KGaA. The agreement allows Promega to use MilliporeSigma’s genome-editing technology to create research products and services. [Katherine Davis, WiscInno, Jan 2, 20]

The threat to the West from China’s high-tech authoritarianism has become all too clear. Everything from its pioneering artificial-intelligence firms to its gulags in Xinjiang spread alarm across the world. Just as visible is America’s incoherent response, which veers between demanding that the Chinese government buy Iowan soyabeans and insisting it must abandon its state-led economic model. [The Economist, Jan 4, 20]

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RareCyte (Seattle, WA; $800K SBIR) creating liquid and tissue biopsy analysis platforms with emphasis on rare cell detection announced today the completion of a $22M financing [company press release, Dec 19, 19]

Annual GDP growth continued its long-term secular decline in the 2010s, meaning that the economy piddled along instead of really booming. Productivity growth—the crucial determinant of rising living standards in the long term—was abysmal. The country’s output grew mostly because its workers did more work, not because businesses became more effective and efficient and ingenious. ... The rich had it great, growing richer than they have ever been and accounting for a greater share of American wealth than at any other point since the Gilded Age. [Annie Lowrey, Atlantic Monthly, Dec 2019] Which will continue until the unwealthy classes face the reality that a tide of immigrant exclusion and low wealth taxes will not lift all boats.

The budget deficit has jumped over 50 percent since President Trump took office and is expected to top $1 trillion in 2020, partly as a result of the [Tax Cuts & Jobs] law. ... Starting in early 2018, senior officials in President Trump’s Treasury Department were swarmed by lobbyists seeking to insulate companies from the few parts of the tax law that would have required them to pay more. The crush of meetings was so intense that some top Treasury officials had little time to do their jobs, according to two people familiar with the process. [Jesse Drucker and Jim Tankersley, NYTimes, Dec 30, 19] Love your unlimited national credit card and tax breaks for lobbyist clients.

Net loss. Fed economists conclude, “We find the impact” from protection “is completely offset in the short-run by reduced competitiveness from retaliation and higher costs in downstream industries.” They add that they focused only on the impact of tariffs, not on the “increased uncertainty” from trade policy. A previous Fed study looked at uncertainty and found it has cut U.S. GDP growth by about a percentage point, which explains the deceleration to 2% from 3% in the last year. We realize this won’t persuade committed protectionists for whom tariffs are mainly about politics. [Editorial Board, Wall Street Journal, Dec 31, 19]

Trade Nothingburger. [Trade Rep] Lighthizer has said “a lot of hard things” have been left to future talks, which most analysts say will be arduous and unlikely to bear fruit before the November election. Bargaining over industrial subsidies is expected to be particularly tough. Though Trump launched the trade war to get China to change practices including its numerous subsidies, the commercial conflict has only convinced Xi to accelerate efforts to become self-sufficient — no matter the cost. [Bess Levin, Vanity Fair, Dec 31, 19] Stand by for hand-waving. 

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Don't want to know. In just three years, the Trump administration has diminished the role of science in federal policymaking while halting or disrupting research projects nationwide, marking a transformation of the federal government whose effects, experts say, could reverberate for years.  Mr. Trump has consistently said that government regulations have stifled businesses and thwarted some of the administration’s core goals, such as increasing fossil-fuel production.  [Brad Plumer and Coral Davenport, NYTimes, Dec 29, 19]

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Microbot Medical down 21% [Dec 27, 29] announced that it has entered into definitive agreements with certain institutional investors for the purchase in a registered direct offering [to raise $10M] [compant press release, Dec 27, 19]

Make America gag again. “Influencers” replaced experts, scientists and scholars; memes and misinformation started to displace facts. As the news cycle spun faster and faster, our brains struggled to cope with the flood of data and distraction that endlessly spilled from our phones. And in an era of data overload and short attention spans, it’s not the most reliable, trustworthy material that goes viral — it’s the loudest voices, the angriest, most outrageous posts that get clicked and shared. [Michiko Kakutani, New York Times, Dec 27, 19]

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Liquidia Tech up 43% [Dec 26, 19]

Technology giants are opening their checkbooks to keep pace in the hot field of artificial intelligence, where some of the best ideas and most sought-after talent reside in small startups and academia. [Asa Fitch, Wall Street Journal, Dec 27, 19]

IP review. The National Defense Authorization Act allows [DOD] to come up with a pilot program on IP evaluation [that] will review commercial valuation techniques for IP, examine contracting methods to expedite IP delivery and address the oversight’s feasibility to standardize IP practices. DoD should submit a report to Congress in November 2020. [Jane Edwards, govconwire, Dec 27, 19]

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Microbot Medical up 61% [Dec 24, 29]

Applied Genetic Tech up 24% [Dec 24, 29]

At a time when germs are growing more resistant to common antibiotics, many companies that are developing new versions of the drugs are hemorrhaging money and going out of business, gravely undermining efforts to contain the spread of deadly, drug-resistant bacteria.... One of the biggest developers of antibiotics, Melinta Therapeutics, recently warned regulators it was running out of cash. ... The problem is straightforward: The companies that have invested billions to develop the drugs have not found a way to make money selling them. [Andrew Jacobs, Wall Street Journal, Dec 25, 19]

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Intra-Cellular Therapies (New York, NY; $6M SBIR, founded 2002) up 193% [Dec 23, 19] focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA(R) (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. The Company expects to initiate the commercial launch of CAPLYTA in late Q1 2020. [company press release, Dec 23, 19] total funding $225M [crunchbase.com]

Microbot Medical (Hingham, MA; no SBIR) up 77% [Dec 23, 29] announced the revealing of LIBERTY(TM) , the world's first fully disposable robotic system for use in neurovascular, cardiovascular and peripheral vascular procedures. [company press release, Dec 23, 19]

Cabaletta Bio up 34% [Dec 23, 19]

Calithera Biosciences up 24% [Dec 23, 19]

Exagen up 24% [Dec 23, 19]

Cerecor up 23% [Dec 23, 19]

BioXcel Therapeutics up 17% [Dec 23, 19]

Monopar Thera down 19% [Dec 23, 29

Sarepta Therapeutics, the leader in precision genetic medicine for rare diseases, announced that Sarepta and Roche have entered into a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the United States. Sarepta will receive $1.15 billion in an upfront payment and an equity investment; up to $1.7 billion in regulatory and sales milestones; and royalties on net sales, anticipated to be in the mid-teens. In addition, Roche and Sarepta will equally share global development expenses. Sarepta retains all rights to SRP-9001 in the United States. [company press release, Dec 23, 29] The deal comes days after Roche advanced its push into gene therapies by closing the takeover of Spark Therapeutics. [Fierce Biotech, Dec 23, 19]

Johnson & Johnson announced the acquisition of TARIS Biomedical LLC (Lexingon, MA; no SBIR, founded 2008) specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including cancer. The company’s lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder. Financial terms not disclosed. [JNJ press release, Dec 20, 19]

Unrest in several parts of the world could also break badly next year," Northern Trust economist Carl Tannenbaum said. The drag from slower global growth is evident in trade data: Yes, the trade war with China hit exports to that country. But sales to the rest of the world are decelerating sharply. [Jeff Sparshott, Wall Street Journal, Dec 23, 19] Don't look for Trump to report that his beloved "eaasy to win" trade war are undercutting US outlook.

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Precision Biosciences up 18% [Dec 20, 19]

Robotic Research (Clarksburg, MD; $21M SBIR) a leading provider of autonomy and robotic technologies to government and commercial customers, announced receipt of a $16.5 million order for its warfighter localization sensor units, also known as WarLoc®, the U.S. Army Product Manager Sets, Kits Outfits and Tools (PM SKOT) to support forward-deployed U.S. military personnel. [company press release, Dec 19, 19]

Nuvera Fuel Cells (Billerica, MA; no SBIR), a provider of fuel cell power solutions for motive applications, announce construction of a fuel cell stack production line in the Hangzhou district government of Fuyang, China. [company press release, Dec 19, 19]

Eko Devices (Berkeley, CA; $300K SBIR) granted breakthrough device designation for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams. [Meg Bryant, BioWorld.com, Dec 18, 19]

Biogen is going all in on Alzheimer’s disease—the Big Biotech is picking up a tau-targeting treatment from Ionis Pharmaceuticals for $45 million upfront. Currently in phase 1, the antisense treatment, IONIS-MAPTRx, is designed to cut down on the production of tau proteins in the central nervous system. Formally known as MAPT (microtubule-associated protein tau)  [Amirah Al Idrus, Fierce Biotech, Dec 19, 19]

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Monopar Therapeutics (Wilmette IL; no SBIR) up 231% [Dec 19, 19] announced it priced an [IPO] to raise $9M ... a clinical stage biopharmaceutical company focused on developing proprietary therapeutics designed to improve clinical outcomes for cancer patients. The company's pipeline consists of Validive(R) for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for advanced soft tissue sarcoma; and a late-stage preclinical antibody MNPR-101. [company press release, Dec 19, 19]

Catalyst Biosciences (South San Francisco, CA; no SBIR) up 66% [Dec 19, 19] announced it has entered into a global license and collaboration agreement with Biogen Inc. (Nasdaq: BIIB) for the development and commercialization of pegylated CB 2782 (CB 2782-PEG) for the potential treatment of geographic atrophy (GA) associated dry age-related macular degeneration (dry AMD). ... Catalyst will receive a $15 million upfront payment and is eligible to receive up to $340 million in clinical, regulatory, and commercial milestone payments plus future tiered royalties based on net sales. [company press release, Dec 19, 19] total funding $205M [crunchbase.com]

PLx Pharma up 41% [Dec 19, 19]

PhaseBio Pharmaceuticals up 30% [Dec 19, 19]

Molecular Templates up 16% [Dec 19, 19]

Minerva Neurosciences down 18% [Dec 19, 19]

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Mirum Pharma up 44% [Dec 18, 19]

PhaseBio Phrma up 28% [Dec 18, 19]

PLx Pharma down 29% [Dec 18, 19]

Hermemics Biotechnologies (Rockville, MD; no SBIR) raised $2.5M to start clinical research of its pathogen-detecting technology. [Brent Wistrom, DCInno, Dec 18 19]

Triplet Therapeutics (Cambridge, MA; no SBIR), harnessing human genetics to develop treatments for repeat expansion disorders at their source, launched with $59 million in financing including a $49 million Series A financing [company press release, Dec 18, 19]

Organovo (San Diego, CA; $1.6M SBIR) and Tarveda Therapeutics, (formerly Blend Thera, Watertown, MA; no SBIR) clinical stage biopharmaceutical developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, announced that they have entered into a definitive merger agreement under which Tarveda would merge with a wholly-owned subsidiary of Organovo in an all-stock transaction. [joint company press relese, Dec 16, 19]

Industrial robotics startup Gecko Robotics (Pittsburgh, PA; no SBIR, funded 2016) raised $40 million in a series B round [Paul Sawers, venturebeat.com, Dec 16, 19]

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Viela Bio up 20% [Dec 17, 19]

Immunogen up 19% [Dec 17, 19]

Proteostasis down 64% [Dec 17, 19] announced positive topline results from the Company's global, multicenter, randomized, placebo-controlled, 28-day, Phase 2 study evaluating its proprietary cystic fibrosis transmembrane conductance regulator (CFTR) modulator combinations in F508del homozygous and heterozygous CF subjects 18 years of age and older. [company press release, Dec 17, 19]

SafeLi  (Shorewood, WI; one Phase II SBIR, founded 2016) as a university-incubated startup, with co-founders who are also co-inventors of the foundational patent “Synthesis and Applications of Graphene-based Nanomaterials”, SafeLi has secured an exclusive royalty-bearing, worldwide license to develop and commercialize product(s) covered by the licensed patent in all fields of use, with initial focus on Lithium Ion Batteries. These materials are based on abundant, non-toxic starting materials that offer low-cost, safer and higher capacity alternatives to graphite-only anode batteries. Batteries with the patented materials demonstrate higher capacity and faster charge rates than graphite. [WiscInno, Dec 17, 19]

Leidos agreed to acquire technology services contractor Dynetics (Huntsville AL; lots of SBIR) for $1.65B cash to further build up its position in the intelligence, civil and defense markets. [Jane Edwards, GovConWire.com, Dec 18, 19]

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announced the successful completion of its clinical pre-New Drug Application (NDA) meeting with [FDA] for maralixibat for the treatment of pruritus associated with Alagille syndrome. [company press release, Dec 16, 19]

Four years after BioMarin’s vosoritide posted proof-of-concept data, the drug hit the mark in phase 3, helping children with achondroplasia, the most common form of dwarfism, grow more quickly than those on placebo. [Amirah Al Idrus, Fierce Biotech, Dec 16, 19]

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Sarepta Thera up 31% [Dec 13, 19] announced that [FDA] has approved VYONDYS 53(TM) (golodirsen), an antisense oligonucleotide from Sarepta's phosphorodiamidate morpholino oligomer (PMO) platform, indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.... also announced today that it has entered into an agreement that provides up to $500 million of borrowing capacity [company press release, Dec 12, 19]

ChromaDex up 17% [Dec 12, 19]

Phoenix Analysis and Design Technologies (PADT) (Tempe, AZ; $4.5M prior SBIR) announced NASA has awarded a $755,000 Phase II STTR  to collaborate with Arizona State University (ASU) and Kennesaw State University (KSU, Georgia) to enable the development of stronger and lighter structures for space exploration. ... to develop a software tool for designing, virtually testing and optimizing strong, lightweight lattice structures for aerospace vehicles. The result will be a commercial software product that PADT plans to market. [company press release, Dec 10, 19] How nicely utilitarian and presumably low tech risk in the hands of experienced engineers. The Congresscritter will no doubt applaud as innovation is whatever the company and the federal agency say it is.

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Calyxt up 17% [Dec 12, 19]

Seattle Genetics has shared more of the tucatinib data it hopes will win it approval in HER2-positive breast cancer. The pivotal trial linked the tyrosine kinase inhibitor to reduced risk of progression and death in patients with and without brain metastases, leading Seattle Genetics CEO Clay Siegall to hail the data as “stunning.” [Nick Paul Taylor, Fierce Biotech, Dec 11, 19]

Zentalis (San Diego, CA; no SBIR) a clinical-stage biopharmaceutical focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental pathways in cancer, today announced the completion of an $85 million Series C financing. The Company has raised a total of $147 million in gross proceeds from private financings since its founding in December 2014. [company press release, Dec 9, 19]

Aspen Neuroscience (San Diego, CA; no SBIR) announced it raised a seed round of $6.5 million to support its work. Aspen’s lead drug candidate, which is in preclinical testing, is intended to replace neurons in the brains of people with the disease, which causes those cells to become damaged or die. [Sarah de Crescenzo, xconomy.com, Dec 12, 19]

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Dermira up 17% [Dec 11, 19] announced that [FDA] has granted Fast Track designation for lebrikizumab, its novel, investigational treatment being evaluated for patients with moderate-to-severe atopic dermatitis. [company press release, Dec 10, 19]

biotech startup True Bearing Diagnostics (Washington, DC;  no SBIR) is looking to raise $20M in a new funding round to further develop a RNA-based blood test tool for early detection of coronary artery disease, the WBJ reported  [Brent Wistrom, DCInno, Dec 11, 19]

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Eloxx Pharma up 27% [Dec 10, 19]

Microbot Medical up 17% [Dec 10, 19]

Congressman proposes neww DOD SBIR follow-on. The [proposed] legislation will allow SBIR awardees that have completed SBIR Phase II — that is, who have proved out the scientific, technical and commercial merit and potential of the idea — to apply for a special designation: Entrepreneurial Innovation, or Ei. Each year, at least ten Ei project candidates per service branch will be selected by a panel run by the Pentagon’s SBIR office and comprised of independent and un-conflicted technical and business advisers with an entrepreneurial perspective. Each of these will receive a DOD agency Ei Advocate. [Rep Ken Calvert, DefOne, Dec 9, 19] Nice idea, but DOD already does something like that by continuing to feed SBIR money to firms it likes. Just look up a list of firms with more than $50M SBIR.

Alienating a customer. China's government will replace all of its foreign computer equipment and software within three years, the Financial Times reported (paywall) Sunday. The order appears to be a tit-for-tat response to the Trump administration's (leaky) attempt to forbid U.S. companies from doing business with Huawei. But it is also part of a larger effort by China to stimulate its tech industry and reduce the country's reliance on foreign gear. [DefenseOne, Dec 10, 19] Fortress America will get lonelier and lonelier as trading diminishes.

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XBiotech (Austin, TX; no SBIR) up 75% [Dec 9, 19] announced today that it has entered into a definitive agreement with Janssen Biotech,[Johnson & Johnson sub], to sell XBiotech's novel antibody (bermekimab) that neutralizes interleukin-1 alpha (IL-1 ). IL-1 promotes disease-causing inflammation in a wide range of medical conditions. Janssen will acquire all rights to bermekimab, and XBiotech will be free to use its True Human Antibody discovery program to develop new antibody therapeutics that target IL-1 to treat non-dermatological diseases. XBiotech plans to re-enter clinical development expeditiously with a next generation anti-IL-1 therapeutic. ... Janssen will make a cash payment of $750 million [and] XBiotech may receive up to $600 million in potential milestone payments. [company press release, Dec 7, 19]

Dynavax (Berkeley, CA; $6.5M SBIR) up 15% [Dec 9, 19]

Dermira up 15% [Dec 9, 19]

Precision Biosciences (Durham, NC; $500K SBIR) down 52% [Dec 9, 19] announced updated interim clinical data from the ongoing Phase 1 trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191 [company press release, Dec 9, 19]

Tech jobs concentration. Just five metropolitan areas—Boston; San Diego; San Francisco; Seattle; and San Jose, Calif.—accounted for 90% of all U.S. high-tech job growth between 2005 to 2017, according to the research by think-tank scholars Mark Muro and Jacob Whiton of the Brookings Institution and Rob Atkinson of the Information Technology and Innovation Foundation. [Jon Hilsenrath, Wall Street Journal, Dec 9, 19]

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Cancer Genetics up 27% [Dec 6, 19]

Epizyme up 19% [Dec 6, 19]

Cerecor up 19% [Dec 6, 19]

It “will be a disaster for the world if America isolates herself,” [John Maynard Keynes, The Economic Consequences of the Peace, 1919] Few listened. The Americans’ brief flirtation with Wilsonian internationalism yielded to a resurgence of nationalism and nativism. [Jonathan Kirshner, New York Times, Dec 6, 19] Here we are again. Is democracy incapable of moderating its base urges?

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