Turn­ing phar­ma castoffs in­to an in­stant for­tune, Vivek Ra­maswamy’s My­ovant bags a $218M IPO

In a flash­back to the bub­bly IPO boom of 2014, My­ovant Sci­ences has rung up $218 mil­lion in an overnight wind­fall af­ter pric­ing 14.5 mil­lion shares at $15 a pop — the high end of the range. Shares will start trad­ing to­day as the mar­ket weighs in on Vivek Ra­maswamy’s lat­est overnight Wall Street coup.

The for­mer hedge fund man­ag­er turned an Alzheimer’s re­ject at Glax­o­SmithK­line in­to a $315 mil­lion IPO for Ax­o­vant $AX­ON last year, steer­ing the failed ther­a­py straight in­to a Phase III paid for by his in­vestor fans.

This year’s IPO — a record set­ter for 2016 — is built on a deal with Take­da, which hand­ed over rights to a ther­a­py called re­l­u­golix in ex­change for a mi­nor­i­ty stake in the com­pa­ny. That drug is now head­ed in­to a trio of late-stage stud­ies for uter­ine fi­broids, en­dometrio­sis-as­so­ci­at­ed pain and prostate can­cer. Its sec­ond drug is RVT-602, an oligopep­tide kisspeptin ana­log for the treat­ment of fe­male in­fer­til­i­ty.

That’s the ba­sis of a new women’s health biotech with an in­spired cast of lead­ers. The biotech — cre­at­ed just last June — is be­ing helmed by Lynn Seely, the for­mer CMO at Medi­va­tion. And for­mer HHS Sec­re­tary Kath­leen Se­be­lius sits on the board.

Ra­maswamy went in­to the IPO with a Big Phar­ma al­ly in its cor­ner. A cou­ple of days ago Pfiz­er stepped up along with BB Biotech AG to flag their in­ter­est in in­vest­ing $30 mil­lion each in­to the IPO. Pfiz­er in ex­change gets a front row seat at the com­pa­ny, which cur­rent­ly is manned by a skele­ton crew of 9, and first rights to ne­go­ti­ate a deal to buy or li­cense My­ovant’s as­sets.

The mar­ket turned chilly to­ward the end of 2015, then took a bru­tal turn for biotech as a bear mar­ket sav­aged stocks and thinned the ranks of IPO seek­ers. Even the lat­est gene edit­ing of­fer­ing from CRISPR Ther­a­peu­tics failed to stay in range re­cent­ly. But the 30-year-old Ra­maswamy has breezed his way to an­oth­er big score with­out any of the heavy lift­ing in R&D and team build­ing that’s usu­al­ly re­quired to qual­i­fy for this kind of re­cep­tion.

Ra­maswamy is still able to mes­mer­ize the faith­ful with promis­es of big things to come from high-risk biotech as­sets. It’s an in­creas­ing­ly rare trait in the in­dus­try.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.