Adam Morgan of Velan Capital Investment Management (L) and Radius Health CEO Kelly Martin

Ac­tivist in­vestors at­tempt to change the course at Ra­dius Health, six months af­ter two dis­ap­point­ing read­outs

Fol­low­ing a dis­ap­point­ing da­ta re­veal and sub­se­quent stock drop late last year, Ra­dius Health is now fac­ing an ac­tivist at­tack from two mi­nor­i­ty in­vestors aim­ing to right the ship.

Ve­lan Cap­i­tal In­vest­ment Man­age­ment and Reper­toire Part­ners filed their proxy state­ments Tues­day morn­ing in a bid to nom­i­nate a slate of three new board mem­bers at Ra­dius’ an­nu­al share­hold­er meet­ing next month. The Ve­lan-Reper­toire group, which col­lec­tive­ly owns a 7.7% stake, al­leges Ra­dius’ cur­rent di­rec­tors have un­der­tak­en a bad com­mer­cial strat­e­gy for its one ap­proved prod­uct and are un­fit to serve be­cause they own al­most no shares in the com­pa­ny.

“This rais­es an ob­vi­ous ques­tion: why should you con­tin­ue to trust a Board that has over­seen a pre­cip­i­tous de­cline in share price while re­main­ing large­ly in­su­lat­ed from the pain we as stock­hold­ers have felt?” the group posit­ed to share­hold­ers rhetor­i­cal­ly.

The proxy launch is not the first time Ra­dius has un­der­gone at­tempt­ed ac­tivist re­forms. Much of the biotech’s cur­rent C-suite and board were ap­point­ed fol­low­ing a sig­nif­i­cant shift in April 2020, which saw a new CEO, chair­man and five di­rec­tors jump aboard.

But Ve­lan and Reper­toire ar­gue this group was un­qual­i­fied to take the reins from the start, point­ing to the com­pa­ny’s poor stock per­for­mance rel­a­tive to the Nas­daq biotech in­dex — a neg­a­tive 48% rel­a­tive re­turn as of March 7 — and oth­er com­pos­ite fig­ures.

The ac­tivists al­so point­ed to con­text-free quotes from earn­ings calls and in­vestor events ap­pear­ing to show CEO Kel­ly Mar­tin ad­mit­ting his lack of knowl­edge in Ra­dius’ dis­ease re­search ar­eas, such as os­teo­poro­sis.

Should Ra­dius share­hold­ers vote for the three Ve­lan-Reper­toire nom­i­nees, the ac­tivists say they will cen­tral­ize the fo­cus on com­mer­cial­iz­ing its ap­proved os­teo­poro­sis drug Tym­los, en­sur­ing its ex­per­i­men­tal breast can­cer drug elaces­trant has enough fund­ing to push for­ward and dis­con­tin­u­ing de­vel­op­ment for oth­er “non-core” projects.

The group specif­i­cal­ly calls out RAD011 as a pro­gram it would drop. This can­di­date is cur­rent­ly un­der de­vel­op­ment for seizures as­so­ci­at­ed with An­gel­man syn­drome and hy­per­pha­gia as­so­ci­at­ed with Prad­er-Willi syn­drome.

For its part, Ra­dius ac­knowl­edged the at­tack in its own proxy state­ment and let­ter to share­hold­ers is­sued Mon­day. The com­pa­ny tout­ed its Tym­los com­mer­cial­iza­tion strat­e­gy and says it’s prepar­ing to file for a la­bel ex­pan­sion to in­clude male os­teo­poro­sis pa­tients and a new patent ap­proval ex­tend­ing its ex­clu­siv­i­ty to 2040.

Ex­ecs brushed back the at­tack in the let­ter, writ­ing to share­hold­ers:

To date Ve­lan and Reper­toire have not of­fered unique rec­om­men­da­tions, in­sights or analy­sis that this board and man­age­ment team have al­ready an­a­lyzed and de­ter­mined not to be in the best in­ter­ests of Ra­dius and our stock­hold­ers. They have on­ly stat­ed that they do not like or ap­pre­ci­ate the Com­pa­ny’s bal­anced ap­proach and port­fo­lio and in­stead would have the Com­pa­ny fo­cus all ef­forts on a sin­gle com­mer­cial prod­uct.

Tues­day’s news comes about six months af­ter Ra­dius re­vealed a Phase III study for an in­jectable ver­sion of Tym­los did not achieve non-in­fe­ri­or­i­ty com­pared to the orig­i­nal in post­menopausal women with os­teo­poro­sis. The com­pa­ny al­so re­port­ed at the time that a tri­al for elaces­trant mus­tered sta­tis­ti­cal sig­nif­i­cance, but in­vestors were dis­ap­point­ed by the re­sults, caus­ing the biotech’s shares $RDUS to fall more than 40%.

Ge­of­frey Porges, for­mer­ly of SVB Se­cu­ri­ties, wrote to in­vestors at the time that the Phase III Tym­los miss was “not such a ship­wreck” and could still hit the mar­ket by 2025. That would rep­re­sent a rough­ly two-year de­lay, how­ev­er, and Ra­dius would like­ly need to en­gage in “non-tra­di­tion­al” fi­nanc­ing to fund ad­di­tion­al stud­ies.

Tym­los was Ra­dius’ first-ever drug ap­proval, get­ting an FDA nod back in 2017 and go­ing up against heavy­weights in J&J and Am­gen. Elaces­trant’s glob­al com­mer­cial rights were ac­quired by the Menar­i­ni Group in 2020 for $30 mil­lion, and Menar­i­ni is on the hook for $320 mil­lion in mile­stones and roy­al­ties in the low to mid-teens.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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