Sage CEO’s M&A chat­ter sparks a spike, and an awk­ward cor­rec­tion

Few biotech CEOs like to hype da­ta from tiny stud­ies quite as much as an en­thu­si­as­tic Jeff Jonas at Sage $SAGE. But on Thurs­day, he pumped it a lit­tle too hard.

Doni Bloom­field from Bloomberg taped him for a seg­ment on the Bay State Biotech Re­port in which he talked about SAGE-217’s shot at be­com­ing a “first-line” ther­a­py for de­pres­sion.

Not on­ly did the drug cut scores on de­pres­sion among se­vere­ly de­pressed peo­ple by 20%, he said, “there’s a good like­li­hood it will help peo­ple sleep.”

This for a drug that just cleared an open la­bel tri­al for de­pres­sion with just 13 pa­tients in a dis­ease that af­flicts mil­lions of peo­ple. In de­pres­sion, de­vel­op­ers typ­i­cal­ly run three big Phase III stud­ies to see if they can come up with two that are pos­i­tive, fig­ur­ing that the place­bo ef­fect by it­self will take down at least one of them. So this drug has quite a ways to go be­fore any­one can start tout­ing ben­e­fits and count­ing rev­enue.

Then, as of­ten hap­pens with Bloomberg re­porters, Bloom­field asked about the po­ten­tial for deal-mak­ing. And that’s when Jonas stepped over a very vis­i­ble line for a CEO of a pub­lic com­pa­ny.

The goal at Sage is to stay in­de­pen­dent, he said, but…“we’re on top of every­one’s M&A list.”

And, for good mea­sure, he added:

“We are hear­ing a great deal from a lot of com­pa­nies, es­pe­cial­ly since the de­pres­sion da­ta came out.”

Sound like buy­out talks? That’s what a lot of in­vestors heard, and they rushed to buy, pump­ing up the stock. But while an­a­lysts can say that a com­pa­ny is a prime takeover tar­get, pub­lic com­pa­ny CEOs have to be very care­ful what they com­mu­ni­cate to the mar­ket in an in­ter­view.

And, it turns out, the biotech had to wave off any talk of an ac­qui­si­tion. Here’s the com­pa­ny’s state­ment fol­low­ing up the in­ter­view:

Dur­ing the course of the in­ter­view, Dr. Jonas ac­knowl­edged the in­dus­try’s in­ter­est in the MDD (de­pres­sion) da­ta. Dr. Jonas’ state­ments did not im­ply that the Com­pa­ny was in dis­cus­sions with po­ten­tial buy­ers. Sage re­mains fo­cused on its core mis­sion of de­vel­op­ing nov­el med­i­cines in CNS dis­or­ders. Sage will have no fur­ther com­ment on these mat­ters and as a pol­i­cy does not com­ment on spec­u­la­tion re­gard­ing M&A ac­tiv­i­ties.

Sage is still ahead of the game, though. The com­pa­ny’s stock end­ed the day up 9% and is down 5% in pre-mar­ket trad­ing.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Credit: Galaxy Life Sciences

Galaxy Life Sci­ences lands $50 mil­lion deal to build in cen­tral Mass­a­chu­setts bio­man­u­fac­tur­ing park

Webster, MA-based real estate developer Galaxy Life Sciences struck a roughly $50 million deal to build in a biomanufacturing park in Worcester, an up-and-coming biotech hotspot about an hour west of Boston.

Galaxy paid $1.9 million for a 6-acre plot, on which it intends to construct a $50 million building grossing 95,000 to 180,000 square feet. The space will be designed to accommodate research and development, or manufacturing, and could employ 125 to 150 workers, according to the Worcester Telegram & Gazette. Construction is expected to begin this spring and wrap up in about a year.