After three years of courtship (and turndowns), Merck pounced on the first glance of clinical data in $1.85B Pandion takeover

March 5, 2021 06:33 AM ESTUpdated 07:25 AM

After three years of courtship (and turndowns), Merck pounced on the first glance of clinical data in $1.85B Pandion takeover

Amber Tong

Senior Editor

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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Biotech Halftime Report: After a bumpy year, is biotech ready to rebound?

Brian Abrahams

Co-Head of Biotechnology Research

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

October 21, 2021 11:09 AM EDT

FDA+

How to collect and submit RWD to win approval for a new drug indication: FDA spells it out in a long-awaited guidance

Zachary Brennan

Senior Editor

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

October 20, 2021 03:56 AM EDT

People

Renowned Dana-Farber scientist, mentor and biopharma advisor David Livingston has died

John Carroll

Editor & Founder

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

ENDPOINTS CAREERS

Venture Senior Analyst/Associate

Austin, TX, USA

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David Lockhart, ReCode Therapeutics CEO

October 21, 2021 08:13 AM EDTUpdated 10:51 AM

Financing

Cell/Gene Tx

Pfizer throws its weight behind LNP player eyeing mRNA treatments for CF, PCD

Amber Tong

Senior Editor

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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October 21, 2021 07:07 AM EDT

Deals

Pharma

Bristol Myers pledges to sell its Acceleron shares as activist investors circle Merck's $11.5B buyout — report

Amber Tong

Senior Editor

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

October 21, 2021 04:05 PM EDTUpdated 05:18 PM

People

Exclusive: Athira CEO Leen Kawas resigns after investigation finds she manipulated data

Jason Mast

Editor

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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October 20, 2021 03:28 PM EDTUpdated 19 hours ago

Deals

Hedge fund jumps in with Avoro activists in an attempt to derail Merck's $11B Acceleron buyout

John Carroll

Editor & Founder

Avoro Capital, which made its bones blowing up the Seagen-Immunomedics deal and then selling the smaller biotech for $21 billion, is getting an assist in its quest to derail Merck’s $11 billion buyout of Acceleron $XLRN.

Wednesday morning one of Acceleron’s biggest investors joined the opposition. Darwin Global Management, a hedge fund which owns about 4% of Acceleron, blasted the Merck deal, saying the Big Pharma is getting the company for billions less than what it’s worth. Earlier, Holocene Advisers, reportedly a top-20 investor in Acceleron, said it would not tender its stock after criticizing the $180-per-share deal.

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ENDPOINTS CAREERS

Engineer II/III, Pilot Plant

Rubius Therapeutics

Cambridge, MA, USA

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

October 21, 2021 10:59 AM EDT

FDA+

Senators back FDA's plan to require mandatory prescriber education for opioids

Zachary Brennan

Senior Editor

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

October 21, 2021 07:12 AM EDT

Financing

Deals

AI

As AI continues to entice Big Pharma, a Carlyle-led drugmaker syndicate shells out $430M for cloud computing player

Max Gelman

Editor

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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