Busted in the wake of a CRL, Athenex brings out budget axe after ‘going concern’ alert

Johnson Lau, Athenex CEO (Derek Gee/Buffalo News via AP Images, Pool)

March 17, 2022 01:31 PM EDT

Busted in the wake of a CRL, Athenex brings out budget axe after 'going concern' alert

John Carroll

Editor & Founder

Athenex’s stock price dropped off a cliff a year ago when the FDA managed to surprise its backers with a CRL and a demand for a new trial for its lead therapy for metastatic breast cancer. A brief bounce soon after with a $70 million biotech buyout failed to halt the slide, leaving its shares in the penny stock arena.

And now the other shoe is dropping as the company’s auditors wave a red warning flag about Athenex’s ability to keep chugging along at this rate.

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August 7, 2022 08:02 AM EDTUpdated 6 hours ago

R&D

Pharma

UPDATED: In a fresh disappointment, Amgen spotlights a major safety issue with KRAS combo

John Carroll

Editor & Founder

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Addressing the ‘Capacity Crunch’ with a Scalable Platform Process Approach

Brianna Barrett

Ph.D., Associate Director, Technical Sales, Forge Biologics

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

August 6, 2022 06:00 AM EDT

Weekly

A $5B Pfizer buyout? Amgen, Gilead headline M&A Thursday; Alnylam's ATTR sweep; Andrew Lo's rare disease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Chief Scientific Officer

Experimental Drug Development Centre

Singapore

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

August 5, 2022 12:02 PM EDTUpdated 12:55 PM

Deals

Breaking: Pfizer in hot pursuit of a $5B buyout of Global Blood Therapeutics — report

John Carroll

Editor & Founder

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

August 4, 2022 08:00 AM EDTUpdated 01:59 PM

R&D

UPDATED: Amgen chief Bradway nabs a rare disease player in $4B buyout as the M&A tempo accelerates

John Carroll

Editor & Founder

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

August 3, 2022 12:13 PM EDT

Bioregnum

Pharma

George Yancopoulos says he's on the trail of the holy grail: ‘This could represent the next breakthrough for immunotherapy’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

August 5, 2022 01:51 PM EDT

R&D

Pharma

Manufacturing

US declares monkeypox a national health emergency, as new drugmakers consider entering vaccine race

Tyler Patchen

News Reporter

Kyle LaHucik

Associate Editor

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

ENDPOINTS CAREERS

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CAI

Boston, MA, USA

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Vlad Coric, Biohaven CEO

August 5, 2022 01:30 PM EDT

Pharma

Biohaven touts surge in Nurtec sales ahead of Pfizer takeover

Nicole DeFeudis

Editor

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

August 5, 2022 01:13 PM EDT

Pharma

Marketing

Pharma brands chill in the pharmacy retail aisle with new style ads on refrigeration screens

Beth Snyder Bulik

Senior Editor

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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