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Deals:

Novartis will pay PTC Therapeutics up to $2.9 billion for its oral therapy to treat Huntington’s disease.

DualityBio entered into an exclusive $1 billion option agreement with GSK for DB-1324.

Thermo Fisher Scientific completed its $1 billion share repurchase plan.

Ipsen secured rights to a preclinical T-cell for tumors with French pharmaceutical company Biomunex in a $610 million deal. 

Novavax will sell its Czech manufacturing factory to Novo Nordisk for $200 million.

Takeda announced it will pay $200 million for rights to an anemia drug from Keros Therapeutics.

GSK agreed to a sizable partnership with Rgenta Therapeutics.

GSK also inked a deal potentially worth nearly $150 million with Danish biotech Muna Therapeutics.

Relay Therapeutics licensed lirafugratinib, an oral selective FGFR2 inhibitor, to Elevar Therapeutics for $75 million in upfront and regulatory milestones.

Gilead and Tubulis agreed to an exclusive option and license agreement to develop an ADC candidate for a select solid tumor target.

Langland US and BBK Worldwide will form a new patient activation division known as Heartbeat Clinical Research.

Supreme Group acquired Amendola Communications, a healthcare tech and life sciences PR and marketing agency. 

Olema Pharmaceuticals and Novartis will collaborate on a breast cancer clinical trial.

Lisata Therapeutics and Kuva Labs announced a global license agreement for solid tumor imaging.

Torrent Pharma is set to acquire three anti-diabetes brands from Boehringer Ingelheim.

Roche’s Genentech partnered with Chicago-area biotech COUR Pharmaceuticals to create nanoparticle treatments for an undisclosed autoimmune disease.

Function Health announced partnership with cancer diagnostics firm Grail to expand reach of cancer screening. 

Hepion Pharmaceuticals issued a letter to shareholders urging support for its proposed merger with Pharma Two B.

The Biden administration secured agreements with Vertex Pharmaceuticals and Bluebird Bio to test their sickle cell disease gene therapies on Medicaid patients.

FDA:

The agency approved Merus’ therapy to treat lung and pancreatic cancers.

The FDA approved AstraZeneca’s Imfinzi to treat LS-SCLC. 

The agency issued Applied Therapeutics a warning letter over “issues” regarding its conduct of a clinical trial for the drug candidate.

The FDA finalized recommendations aimed at simplifying the process for approving medical devices that use artificial intelligence.

The agency defended its use of non-binding guidance to Congress in a new report. 

The FDA granted clinical-stage biotech Restem’s Orphan Drug Designation for its umbilical cord outer lining stem cells program for the treatment of polymyositis and dermatomyositis.

Johnson & Johnson announced it is seeking approval for first the pediatric indications for Tremfya (guselkumab).

The agency accepted Cytokinetics’s New Drug Application for the heart disease drug Aficamten.

The FDA granted a Breakthrough Therapy designation to Merck’s sacituzumab tirumotecan (sac-TMT).

NovelMed received an Investigational New Drug application approval for NM8074 (ruxoprubart).

Sana Biotechnology said it received Fast Track Designation for SC291 in relapsed/refractory systemic lupus erythematosus.

Layoffs:

Swedish biotech Alligator Biosciences announced that it will lay off 70% of its employees.

Kronos Bio announced it is letting go nearly all its employees, including CEO Norbert Bischofberger.

Funding rounds: 

Atlas Venture completed its $450 million fundraise.

Nuvig Therapeutics announced $161 million in Series B financing. 

Bay Area biotech Maze Therapeutics completed a $115 million Series D round.

Antag Therapeutics raised an €80 million Series A funding round.

KisoJi Biotechnology raised $41 million.

Senti Biosciences unveiled an oversubscribed $37.6 million private placement. 

Jupiter Neurosciences, Inc. announced closing of $11 million Initial Public Offering.

NeuroSense Therapeutics announced a $5 million private placement offering.

Kane Biotech announced a $3 million private placement offering.

Purple Biotech announced a $2.8 million registered direct offering of American depositary shares. 

Industry news:

President-elect Donald Trump hosted the chief executives of Pfizer, Eli Lilly and PhRMA at Mar-a-Lago for a dinner with Robert F. Kennedy Jr., his nominee to lead the Department of Health and Human Services.

Trump‘s pick to run the Drug Enforcement Administration, Chad Chronister, said he’s withdrawing his name from consideration for the role.

Lilly released a study that found its weight loss drug Zepbound helped patients shed more weight than Novo’s Wegovy in the first randomized controlled clinical trial comparing the two drugs. 

Lilly also announced a $3 billion expansion of its recently acquired manufacturing facility in Wisconsin.

Sanofi will invest $1.05 billion to build a new insulin production base in Beijing.

The Supreme Court heard oral arguments in a case centered on the issue of vaping and e-cigarette regulation. 

The Supreme Court also heard arguments on Tennessee’s ban on transgender affirming care, which could have implications on other areas of healthcare. 

Some of the world’s largest hedge funds are hiring doctors, scientists and analysts to give them expert insight into the prospects for pharmaceutical stocks after big share swings in the sector, per reporting from Reuters.

Relmada said its depression drug is “unlikely” to meet the main goal of a late-stage trial.

Sweden-based drugmaker Orexo is giving up on Deprexis, its digital app meant to treat depression.

The U.S. Patent & Trademark Office withdrew a controversial proposal designed to prevent pharmaceutical companies from abusing the patent system.

Purple Biotech reported its lead oncology drug showed a 79% decrease in death risk in Phase 2 trial.

Arrakis Therapeutics, led by biotech veteran Michael Gilman, is transitioning from a focus on cancer to myotonic dystrophy.

Roivant Sciences said its subsidiary Kinevant Sciences’ phase 2 study of Namilumab failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis.

A U.S. District Court upheld the validity of Heron’s U.S. Patent Nos. 9,561,229 and 9,974,794, which cover the CINVANTI (aprepitant) injectable.

Coherus BioSciences announced plans to sell off the last biosimilar in its portfolio for $483 million.

Lawsuits involving J&J’s baby powder and its possible ties to ovarian cancer are set to remain paused until March, per orders from a judge overseeing the case.

The U.S. Court of Appeals for the Federal Circuit sided with a prior ruling against Novartis in a case related to a generic version of its Entresto drug.

Mangoceuticals initiated an investigation into a potential stock manipulation scheme following a recent reverse stock split.

Lilly and Pfizer responded to senators about their respective online platform’s financial and data sharing terms.

Unnatural Products said BridgeBio Pharma exercised its option to license macrocyclic peptide candidates discovered using its AI-enabled massively parallel chemistry platform.

Novocure said its electrical field medical device extended median survival by just over two months compared to a standard treatment in a Phase 3 study of patients with locally advanced pancreatic cancer.

Merus said its bispecific antibody drug showed ‘unexpected improvement’ in a second-line head and neck cancer study

CG Oncology said its immunotherapy candidate may deliver lasting responses in a certain form of bladder cancer based on Phase 3 trial data.

Enveric Biosciences announced two patents supporting EVM301 Series and EVM201 Series compounds.

See last week’s edition of Rx Rundown.