Emma Walmsley joins #MeTooPay; Monopar postpones $40M IPO

October 4, 2019 11:25 AM EDT

Emma Walmsley joins #MeTooPay; Monopar postpones $40M IPO

Kathy Wong

Assistant Editor

→ GSK CEO Emma Walmsley has rallied together with some of the UK’s most successful businesswomen to highlight the pay discrimination they face in comparison to their male counterparts in the campaign #MeTooPay. The website lamented the frustrations of the women, stating, “we’re frustrated to still read stories about women not getting the pay they deserve. Women should not be paid less than men to do exactly the same job. It’s just wrong.”

Walmsley’s paycheck is one of the lowest in the industry — last year earning a $1.3 million raise with her total remuneration being $7.67 million — trailing behind her male peers.

→ Almost a month after Christopher Starr co-founder Monopar Therapeutics announced the terms for a $40 million IPO, the company is now postponing it, citing market conditions. The company had filed to offer 4.4 million shares at the price range of $8 to $10 and planned to list under the ticker $MNPR.

→ VIVUS has paid down $48.6 million of its Senior Secured Notes due in 2024. CEO of VIVUS, John Amos, said: “The $48.6 million repayment announced today is the first of these steps and will result in a net savings of interest of $10.5 million over the remaining term of the loan.” In addition, the company announced the departure of two of their execs — president Ken Suh and COO Scott Oehrlein.

→ Months after Verastem nabbed approval for its PI3K drug duvelisib (Copiktra), the company received more good news this morning with the securing of orphan designation for the drug for the treatment of T-Cell lymphoma. Currently, Copiktra is approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least 2 prior therapies and accelerated approval in follicular lymphoma (FL) after at least 2 prior systemic therapies in the US.

AUTHOR

Kathy Wong

Assistant Editor

kathy@endpointsnews.com

Kathy Wong on LinkedIn

Pioneering Click Chemistry in Humans

Shasqi

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

September 30, 2022 11:51 AM EDTUpdated 05:03 PM

FDA+

Advocates, experts cry foul over Amylyx's new ALS drug, citing issues with price, PhIII commitment

Max Gelman

Senior Editor

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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October 1, 2022 06:00 AM EDT

Weekly

Landmark Amylyx OK spurs debate; Some... positive? Alzheimer's data; Cancer trial bottleneck; Sanofi's CRISPR bet; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

September 29, 2022 04:43 PM EDTUpdated September 30, 08:21 AM

FDA+

Updated: After long and winding road, FDA approves Amylyx's ALS drug in victory for patients and advocacy groups

Max Gelman

Senior Editor

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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October 1, 2022 10:22 AM EDT

R&D

Pharma

Cell/Gene Tx

#AAO22: J&J’s first look at common eye disease portfolio pads the case for PhII of gene therapy

Kyle LaHucik

Associate Editor

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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September 30, 2022 03:21 PM EDTUpdated 04:32 PM

R&D

FDA+

Updated: Alnylam reinforces APOLLO-B patisiran data before heading to the FDA

Nicole DeFeudis

Editor

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

September 28, 2022 05:32 PM EDTUpdated September 29, 07:46 AM

Editor's note

I’m headed to London soon for #EUBIO22. Care to join me?

John Carroll

Editor & Founder

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

ENDPOINTS CAREERS

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Jerome Durso, Intercept Pharmaceuticals CEO

September 30, 2022 11:40 AM EDTUpdated 01:00 PM

R&D

Intercept's OCA fails a PhIII NASH trial, raising fresh doubts about its yearslong quest for an OK

Aayushi Pratap

News Reporter

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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Bo Cumbo, new Solid Bio CEO

September 30, 2022 07:45 AM EDTUpdated 04:51 PM

Deals

Cell/Gene Tx

Solid Bio gets a new CEO, $75M cash and drops lead drug as big investors jury-rig a merger deal

John Carroll

Editor & Founder

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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