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Biotech Business Roundup – October

As October comes to an end, we’re back with our third installment of Excedr’s monthly news roundup. We use this roundup to focus on fundraising, M&A, IPOs, FDA approvals, and more. We also cover a range of cutting-edge research and study in our Biotech Research roundup, so you can access the news that matters most to you.

Interested in other posts? Give our blog a visit, you’ll find it filled with informative pieces on different science and finance-related topics, including lab equipment, the affordability of leasing, and how to start a lab in 2020.

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Business News

October has shown us that the interest in biotech IPOs has not slowed, making this year one of the strongest years in the past five for biotech and biopharma companies. We also saw a couple of headline-worthy M&As, as well as an important lift on a clinical hold. It seems that Q4 will keep up the trends we’ve seen so far this year, as the biotech sector continues to perform above and beyond.

FDA lifts clinical hold on Solid Biosciences DMD gene therapy trial

After Solid Biosciences announced that the FDA lifted the clinical hold on its IGNITE DMD phase I/II clinical trial, shares of the company soared more than 70% in premarket trading. The hold had been in place since November of 2019 due to safety concerns, as a patient had experienced a serious adverse event related to a type of novel gene-transfer. This is the second time Solid Bio’s study has been put on hold. However, with the announcement of the hold being lifted, the company expects to resume dosing of patients in the phase I/II study by the first quarter of 2021. Their experimental gene therapy, SGT-001, is being used to treat patients with Duchenne muscular dystrophy, an inherited disorder that inhibits the body’s ability to produce a key muscle protein, dystrophin.

Covis Group to acquire AMAG Pharmaceuticals in a $647M deal

Covis, a pharmaceutical company, based in Luxembourg with operations in Zug, Switzerland, agreed earlier this month to acquiring Massachusetts-based AMAG Pharmaceuticals. The deal, at $13.75 per share, adds up to about $498 million on a fully diluted basis, and about $647 million on an enterprise basis. It also includes debt obligations that are expected to be assumed or repaid net of cash. According to Michael Porter, Covis’ CEO, “AMAG’s category-leading treatments are strong strategic complements to our existing therapeutic portfolio.” AMAG currently has two commercial products, one under the name Makena which is used to decrease the risk of preterm birth in women with a singleton birth who has a history of this type of preterm birth. Their second product, Feraheme, is used to treat iron deficiency anemia, or IDA, in adults intolerant or unresponsive to oral iron, or in some cases those who have chronic kidney disease. AMAG believes the partnership with Covis is the right move for the company, representing both a compelling opportunity for shareholders and a chance for their portfolio to continue to thrive under new leadership.

Bristol Myers Squibb announces deal to purchase MyoKardia for a staggering $13B in cash

The deal, announced earlier this month, prices Myokardia shares at $225 per share, and represents a 61% premium to the closing price of MyoKardia shares at the beginning of October. Bristol Myers Squibb’s chief commercial officer, Chris Boerner, said in a statement that the addition of MyoKardia’s lead drug, mavacamten, “really enhances our position and gives us an opportunity to continue to be seen as a leader in the cardiovascular space, and certainly to maximize the value of this asset.” MyoKardia released results back in May regarding mavacamten’s use in a disorder called hypertrophic cardiomyopathy. Those results showed that the drug could increase a patient’s oxygen capacity when the wall of the left ventricle thickens and weakens the heart’s ability to pump blood effectively. Although Bristol is mostly viewed as a major player in oncology by investors, their presence in cardiovascular disease continues to grow. Bristol’s CEO, Giovanni Caforio, believes the acquisition will “further strengthen our outstanding cardiovascular franchise through the addition of mavacamten.”

Codiak pull off $83M Wall Street debut after withdrawing first IPO attempt in 2019

Codiak Biosciences was able to raise $83 million in its successful IPO closing this September but fell short of the $100 million they originally sought. The company had initially filed for an IPO in April 2019 but subsequently withdrew that filing. When they first emerged in 2015, they received  $31 million in VC funding, and followed that up with two successful fundraising rounds, taking place in 2015 and 2017, respectively. Codiak believes that the money they have in the bank, plus what was raised through their initial public offering, can fund their work into the middle of 2022, yet this projection may have to be adjusted as it was based on receiving $100 million in their IPO deal. The Cambridge, Massachusetts-based biotech is known for exoSTING, its lead program, which delivers a drug that activates the STING (stimulator of interferon genes) pathway in tumors. Most of the money raised will be used to advance this program.

Through a successful Series A funding round, Ori Biotech has a chance to change how cell and gene therapies are manufactured

Ori Biotech, the New Jersey-based company, has been developing a manufacturing platform that will help patients get better access to lifesaving treatments. The platform is designed to close, automate, and standardize cell and gene therapy manufacturing for developers. The end-goal is for the platform to allow developers to move their treatments from the pre-clinical process to scaling commercially much more quickly, as the “drug discovery pipeline can take, on average, a decade to get from the lab to the patient.” Ori will be using the $30 million they recently secured in Series A funding to push the development of their platform. To date, they’ve been able to raise $40 million in total. The company is young, currently employing eight people in total, but serious growth is expected over the next few years. Ori Biotech hopes to change the way our healthcare system works by speeding up the pace of drug development.

Eli Lilly bets $135M on biotech startup Disarm Therapeutics and their treatments for neurological diseases

In mid-October, Eli Lilly reached a deal with Cambridge, Massachusetts-based Disarm Therapeutics for $135 million upfront. Eli Lilly is taking a gamble on the success of Disarm’s portfolio of experimental medicines meant to “prevent the degeneration of axons, the thin tails of nerve cells that send out electrical impulses.” The move is considered a risk, as many neurodegenerative diseases remain a mystery to drug developers. Eli Lilly has firsthand experience with the pitfalls of developing treatments for these diseases, having watched an Alzheimer’s drug, solanezumab, stumble and falter after a series of lengthy studies. Regardless of setbacks, the need for new brain drugs “remains significant”, pushing pharmaceutical companies to continue monitoring therapies that have a chance to make an impact. Disarm is providing one such opportunity, and for this reason, Eli Lilly has gone to the effort to reach a deal. They even included the possibility of paying out another $1.2 billion in milestone payments.

Amid concerns over a lack of transparency regarding COVID-19, academics and health policy experts push for trial protocols

More than two dozen academics and health policy experts are urging several vaccine makers, as well as federal officials, to fully disclose all information concerning trial protocols and agreements. Although sharing clinical trial details is unusual, many experts believe increased transparency would help ensure accountability and build trust among the public during a period of time in which a highly unprecedented race for a safe and effective vaccine is extremely politicized by the Trump administration. Last month, a group of drugmakers, including Pfizer and AstraZeneca, released their trial protocols in a particularly out of the ordinary move to provide transparency.

Sarepta launches startup focused on developing gene therapy for rare disease, equipping the company with $107M

from Florida, AavantiBio, in a push to increase its investment in gene therapy. Although Sarepta is best known for its RNA technology platform, it wants to become more involved in gene therapies, having already developed a list comprising two dozen experimental treatments. Six of these have reached human testing. A former Sarepta executive Alexander “Bo” Cumbo will be acting as CEO, while AavantiBio’s co-founders, Barry Byrne and Manuela Corti, will serve on the board of directors, alongside Cumbo. AavantiBio, equipped with $107 million from a successful Series A round, will join Pfizer and Novartis in the hunt for a gene therapy to treat Friedreich’s ataxia. 

RA Capital Management secures $461M, closing its second venture capital fund

RA Capital, a Boston-based, multi-stage investment manager, has raised an additional $461 million to invest in private biotech companies. Due to the success of RA’s first fund, the company has been able to raise a larger successor, bringing its total private deal capacity up to $1.3 billion. It goes to show that the public’s interest in backing biotech IPOs has not slowed down, and exemplifies an incredibly fruitful time for biotechnology and biomedical innovation. Several of the companies RA invested in this year, using its Nexus fund, have gone public, as the investment manager continues to make new investments. Although the biotech sector has had its issues with volatility, this year continues to outperform.

Flagship Pioneering’s’ Foghorn Therapeutics nets $120M in Nasdaq debut

The Cambridge, Mass.-based Foghorn Therapeutics has raised $120 million in their IPO debut, surpassing their initial filing to raise $100 million. The company joins a long list of successful biotech IPOs. This year, 72 biotech and biopharma companies have gone public, raising a total of $13.2 billion, according to Jordan Saxe, Nasdaq head of healthcare listings. Foghorn was founded in 2016, and is known for its gene traffic control platform, which will be developed further using the $120 million Foghorn has secured.