As biotech IPOs siz­zle on vir­tu­al Wall Street, 3 new play­ers roll the dice on meg­a­money gam­bles top­ping $325M

Back in early January when I interviewed Generation Bio CEO Geoff McDonough on his $110 million mega-raise, he was thinking in terms of taking another 12 to 18 months to get into the clinic and then filing an IPO. They were, after all, still preclinical after 4 years in the lab.

But with investors still clearly focused on biotech during the pandemic, a lot of things are going faster now. Including IPOing, which is sizzling for the right companies.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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SPACs are rid­ing on the biotech IPO boom

Billionaire hedge fund manager Bill Ackman’s push to raise $4 billion for his blank check company, Pershing Square Tontine Holdings, is casting a spotlight on the SPACs. And amid a historic SPAC boom, biotechs are placing several milestones on what some observers say is shaping up to be a third major track — besides IPO and M&A — to go public.

“SPACs were approximately 3% of the IPO market back in 2014, now they are almost 35% of all new listings,” Jay Heller, the Nasdaq’s head of capital markets, told Endpoints News.

President Trump (left) and NIAID chief Anthony Fauci in the White House press room, April 22, 2020 (Michael Reynolds/Sipa via AP Images)

White House tries to dis­cred­it An­tho­ny Fau­ci — could he be on his way out?

For two months in late winter and early spring, Anthony Fauci and President Trump stood in uneasy co-existence at White House briefings — an unlikely truce between an infectious disease official who had helped combat AIDS and Ebola and a president who repeatedly denied the danger of a virus that would go on to kill 100,000 Americans, repeatedly rejected masks and certain social distancing efforts, and promoted a drug with little scientific basis.

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Sanofi keeps foot on the gas, agree­ing to five-year col­lab­o­ra­tion with MD An­der­son

Just four months after scoring its first cancer drug approval in a decade, Sanofi is staying on the oncology offensive.

The French pharma is planning to accelerate the development of potential treatments, partnering with the University of Texas MD Anderson Cancer Center in a five-year collaboration. By combining Sanofi’s pipeline with MD Anderson’s top-notch clinical trial program in oncology, the pair will launch biomarker-driven clinical studies to better understand which drug cocktails can effectively curb cancer progression.

Cy­to­ki­net­ics nabs Chi­nese part­ner, up to $450M as CV be­comes com­pa­ny fo­cus

Cytokinetics’ ALS programs may have seen better days, but its cardiovascular division has attracted well-backed partners, including Amgen and Royalty Pharma, who, in 2017 paid $90 million in exchange for a 4.5% royalty on their lead heart drug.

Now a Chinese drugmaker and a major investor are signing onto their second cardiovascular candidate, an experimental drug known as CK-274 and designed to treat hypertrophic cardiomyopathies — genetic conditions that cause heart muscles to become abnormally and potentially dangerously thick. Ji Xing Pharmaceuticals will pay Cytokinetics $25 million upfront for the rights to commercialize the drug in China and certain neighboring regions, along with $200 million in potential milestones.

Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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FDA re­jects Ver­ri­ca’s skin warts pitch, a month af­ter flag­ging ap­pli­ca­tion ‘de­fi­cien­cies’

Two years ago, Verrica Pharma landed a $75 million IPO on the promise they could develop the first ever-FDA approved drug for molluscum contagiosum, an infection that causes warts. Now that won’t happen, at least not this summer.

The FDA today rejected Verrica’s application to have their lead topical drug VP-102 approved for molluscum contagiosum. The news likely came as little surprise to Verrica or its investors; the biotech disclosed in late June that the FDA sent a letter saying “deficiencies” in their application precluded a discussion around labeling or post-marketing commitments.

Andrew Allen, Gritstone Oncology CEO

A neoanti­gen pi­o­neer says its tech is work­ing great. So what wrecked the share price?

Gritstone Oncology was one of the original neoantigen upstarts, raising cash and planning to disrupt the immuno-oncology field with a bold new approach to fighting cancer with a new brand of vaccines.

On Monday, the crew in charge ran out a full display of what they’ve been seeing in a Phase I study. And everything seems to be working perfectly with one big exception: It didn’t significantly shrink tumors, let alone eradicate them.

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