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

Ludwig Hantson, Alexion CEO

July 14, 2020 10:47 AM EDT

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

John Carroll

Editor & Founder

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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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

August 3, 2020 01:40 PM EDTUpdated August 4, 03:38 AM

R&D

Coronavirus

When will it end? Goldman economist gives late-stage vaccines a good shot at targeting 'large shares' of the US by mid-2021 — but the downside is daunting

John Carroll

Editor & Founder

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Sean Nolan and RA Session II

August 5, 2020 10:34 AM EDT

Venture

Startups

Less than 3 months after launch, the AveXis crew’s Taysha raises $95M Series B. Is an IPO next?

Jason Mast

Associate Editor

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

August 4, 2020 04:20 PM EDTUpdated 5 hours ago

Coronavirus

UPDATED: Novavax heralds the latest positive snapshot of early-stage Covid-19 vaccine — so why did its stock briefly crater?

John Carroll

Editor & Founder

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

view job offer post your job now

August 5, 2020 11:01 AM EDT

Venture

RA, Novartis back GentiBio's seed round, plans to launch development of EngTreg therapies

Nicole DeFeudis

Associate Editor

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

August 5, 2020 10:46 AM EDT

Deals

Stem cell player ViaCyte expands collaboration with Gore to develop subcutaneous diabetes treatment

Max Gelman

Associate Editor

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.

August 5, 2020 10:30 AM EDTUpdated 10:47 AM

Protocols

Myovant lands a fresh $200M loan as FDA marketing decision looms; Amarin goes it alone in Europe

John Carroll

Editor & Founder

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

August 5, 2020 08:56 AM EDTUpdated 09:39 AM

Coronavirus

Moderna CEO Stéphane Bancel outlines a prospective motherlode of Covid-19 vaccine revenue — will a backlash follow?

John Carroll

Editor & Founder

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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August 3, 2020 10:53 AM EDT

R&D

Regulatory

J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about?

John Carroll

Editor & Founder

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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August 5, 2020 07:36 AM EDTUpdated 09:09 AM

Coronavirus

Covid-19 roundup: J&J and BARDA agree to $1 billion for 100 million doses; Plasma reduces mortality by 50% — reports

Endpoints Staff

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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