AS­CO loom­ing, Loxo, Bay­er line up a quick shot at FDA OK for their ground­break­ing ap­proach to can­cer ther­a­py

Just days away from learn­ing more about Loxo On­col­o­gy’s $LOXO close­ly-watched can­cer drug larotrec­tinib at AS­CO, the com­pa­ny is set­ting the stage with the news that the FDA has come through with a fast-paced pri­or­i­ty re­view plan to whisk the drug through an agency in­spec­tion process.

The short­ened pri­or­i­ty game plan gives Loxo and its part­ners at Bay­er a mar­ket­ing de­ci­sion date of No­vem­ber 26 with an­a­lysts giv­ing this one good odds of suc­cess based on the da­ta we’ve seen.

CEO Josh Bilenker’s state­ment to­day high­light­ed the drug’s fo­cus on tu­mor ge­net­ics rather than site of de­vel­op­ment, a twist that high­lights a new sec­tor in the field of can­cer drug de­vel­op­ment.

Last year at AS­CO Loxo cob­bled to­geth­er re­sponse da­ta from three ear­ly-stage tri­als, and scored big.

Specif­i­cal­ly there were 50 pa­tients — 43 adults and 12 chil­dren chil­dren and adults with TRK fu­sion can­cer — with 12% com­plete and 64% par­tial re­spon­ders. That’s a high rate of suc­cess and it fits with their ear­li­er state­ments on progress in the clin­ic. Small groups of pa­tients like this are al­so not un­usu­al for a can­cer type shared by on­ly a few thou­sand US pa­tients.

A few months lat­er Bay­er bought in, hand­ing over a $400 mil­lion up­front, $450 mil­lion in mile­stones for the de­vel­op­ment and first sale of larotrec­tinib, with an­oth­er $200 mil­lion on the ta­ble for LOXO-195. There’s al­so $500 mil­lion on the books for com­mer­cial goals.

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

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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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Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

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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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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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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.

Bil­lions of dol­lars worth of 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 setting several records 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.

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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